Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 961
Healthy volunteers: no

Brief summary:
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

Detailed description:

Arms:
arm 1: All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each. arm 2: All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.

Interventions: intervention 1: Semaglutide intervention 2: Placebo (semaglutide)
Intervention descriptions: intervention 1: Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study. intervention 2: Semaglutide placebo injected once-weekly from week 13 to week 40.

Protocol document:
SAP_002.pdf: 
Cover Page for 6WDWLVWLFDO$QDO\VLV3ODQ 
Sponsor name: 
Novo Nordisk A/S 
NCT number 
NCT03989232 
Sponsor trial ID: 
NN9535-4506 
Official title of study: 
Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly 
Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects 
With Type 2 Diabetes 
Document date*: 
15'HFHPEHU 2020 
*Document date refers to the date on which the document was most recently updated.
Note: The date in the header from Page 2 is the date of compilation of the documents and not of an update to content.


Link
Link
Link
List of contents
Statistical analysis plan......................................................................................................................
MedDRA searches for safety focus areas.........................................................................................
MedDRA searches – list of preferred terms.....................................................................................
CONFIDENTIAL
Date:
Novo Nordisk
Version:
Status:
Once-weekly Semaglutide
Trial ID: NN9535-4506
Clinical Trial Report
Appendix 16.1.9
15 December 2020
1.0
Final
16.1.9 Documentation of statistical methods
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Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
1 of 28
NN9535-4506
Statistical analysis plan
Biostatistics Aalborg 1
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
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Table of contents 
Page
Table of contents...............................................................................................................................................2 
Table of tables...................................................................................................................................................3 
Version history..................................................................................................................................................4 
1 Introduction.................................................................................................................................................5 
1.1 
Objectives and endpoints ....................................................................................................................5 
1.1.1 
Primary objective.................................................................................................................5 
1.1.2 
Secondary objective.............................................................................................................5 
1.1.3 
Primary endpoint .................................................................................................................5 
1.1.4 
Secondary endpoints............................................................................................................5 
1.1.4.1 
Confirmatory secondary endpoint....................................................................5 
1.1.4.2 
Supportive secondary endpoints ......................................................................5 
1.2 
Trial design .......................................................................................................................................13 
2 Statistical hypotheses ................................................................................................................................13 
3 Sample size determination........................................................................................................................13 
4 Analysis sets...............................................................................................................................................15 
5 Statistical analyses.....................................................................................................................................16 
5.1 
General considerations......................................................................................................................16 
5.2 
Subject disposition............................................................................................................................17 
5.3 
Primary endpoint analysis.................................................................................................................17 
5.3.1 
Main analytical approach...................................................................................................17 
5.3.1.1 
Primary hypothetical estimand.......................................................................17 
5.3.1.2 
Primary treatment policy estimand ................................................................18 
5.3.2 
Sensitivity analyses ...........................................................................................................18 
5.3.2.1 
Primary hypothetical estimand.......................................................................18 
5.3.2.2 
Primary treatment policy estimand ................................................................18 
5.3.3 
Overview of statistical analyses and intercurrent events...................................................19 
5.4 
Secondary endpoint analysis.............................................................................................................20 
5.4.1 
Confirmatory secondary endpoints....................................................................................20 
5.4.1.1 
Main analytical approach...............................................................................20 
5.4.1.2 
Sensitivity analyses........................................................................................21 
5.4.2 
Supportive secondary endpoints........................................................................................21 
5.5 
Exploratory endpoint analysis...........................................................................................................22 
5.6 
Other safety analyses ........................................................................................................................22 
5.7 
Other analyses...................................................................................................................................23 
5.7.1 
Subgroup analyses.............................................................................................................23 
5.7.1.1 
Hypothetical strategy .....................................................................................23 
5.7.1.2 
Treatment policy strategy...............................................................................23 
5.7.2 
Subpopulation analysis......................................................................................................24 
5.7.2.1 
Hypothetical strategy .....................................................................................24 
5.7.2.2 
Treatment policy strategy...............................................................................24 
5.8 
Interim analyses ................................................................................................................................25 
6 Supporting documentation.......................................................................................................................26 
6.1 
Appendix 1: List of abbreviations.....................................................................................................26 
6.2 
Appendix 2: Changes to protocol-planned analyses.........................................................................27 
6.3 
Appendix 3: Definition and calculation of endpoints, assessments and derivations ........................27 
7 References..................................................................................................................................................28 
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
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Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
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EudraCT No: 2018-004529-96
Page:
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Table of tables
Page
Table 1 
Overview of estimands ................................................................................................................7 
Table 2 
Power for different scenarios.....................................................................................................14 
Table 3 
Statistical analyses of the confirmatory endpoints.....................................................................19 
Table 4 
Statistical handling of intercurrent events for the primary analyses of the confirmatory 
endpoints....................................................................................................................................20 
Table 5 
Statistical analyses of the supportive secondary endpoints .......................................................21 
Table 6 
Endpoints...................................................................................................................................27 
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CONFIDENTIAL


Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
4 of 28
Version history
This Statistical Analysis Plan (SAP) for trial NN9535-4506 is based on the protocol version 4.0 
dated 15JUN2020.
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Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
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1
Introduction
This SAP covers specification of statistical considerations and analyses for efficacy data and safety 
data available at time of partial data base lock performed after the date of last subject last treatment,
where Novo Nordisk will become unblinded and complete efficacy data will be available and 
analysed, but where safety data will only be partial complete.
Only additional statistical analyses have been included, hence there are no changes to protocol 
specified statistical analyses.
1.1
Objectives and endpoints
1.1.1
Primary objective
To establish the superior effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c. 
1.0 mg once-weekly on glycaemic control in subjects with T2D, on a background of metformin 
with or without SU treatment.
1.1.2
Secondary objective
To compare the effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c. 1.0 mg once-
weekly in subjects with T2D, on a background of metformin with or without SU treatment, on:
x
Body weight
x
Vital signs
x
Hypoglycaemia
x
General safety and tolerability
1.1.3
Primary endpoint
x
Change from baseline (week 0) to week 40 in HbA1c (%-point)
1.1.4
Secondary endpoints
1.1.4.1
Confirmatory secondary endpoint
x
Change from baseline (week 0) to week 40 in body weight (kg)
1.1.4.2
Supportive secondary endpoints
Supportive secondary effect endpoints
Change from baseline (week 0) to week 40 in:
x
Fasting plasma glucose (FPG) (mmol/l)
x
Body mass index (BMI) (kg/m2)
x
Waist circumference (cm)
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
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Status:
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
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Page:
x
HbA1c < 7% at week 40 (yes/no)
x
HbA1c ≤ 6.5% at week 40 (yes/no)
x
Weight loss ≥ 5% at week 40 (yes/no)
x
Weight loss ≥ 10% at week 40 (yes/no)
Supportive secondary safety endpoints
x
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic
episodes from first dose to week 40
x
Change from baseline (week 0) to week 40 in pulse rate (bpm)
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
11 September 2020
Status:
Final
Novo Nordisk
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
1.0
Page:
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Table 1
Overview of estimands
Objective
Estimand strategy
Estimand category
Estimand
Primary Objective:
To establish the superior effect 
of semaglutide s.c. 2.0 mg once-
weekly versus semaglutide s.c. 
1.0 mg once-weekly on 
glycaemic control in subjects 
with T2D, on a background of 
metformin with or without SU 
treatment
Hypothetical
Primary (except US)
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in HbA1c
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Mean difference
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in FPG
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Mean difference
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
11 September 2020
Status:
Final
Novo Nordisk
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
1.0
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Objective
Estimand strategy
Estimand category
Estimand
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: HbA1c < 7% at week 40
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Odds ratio
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: HbA1c ≤ 6.5% at week 40
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Odds ratio
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
11 September 2020
Status:
Final
Novo Nordisk
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
1.0
Page:
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Objective
Estimand strategy
Estimand category
Estimand
Treatment policy
Primary (US)
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in HbA1c
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “regardless of initiation of rescue 
medication” (treatment policy). Discontinuation of trial product due to adverse event: “regardless of 
trial product discontinuation due to adverse event” (treatment policy). Change in dose during and after 
dose escalation: “regardless of change in dose” (treatment policy).
Population level summary measure: Mean difference
Secondary Objective:
To compare the effect of 
semaglutide s.c. 2.0 mg once-
weekly versus semaglutide s.c. 
1.0 mg once-weekly in subjects 
with T2D, on a background of 
metformin with or without SU 
treatment, on body weight, vital 
signs, hypoglycaemia, general 
safety and tolerability
Hypothetical
Secondary (except 
US)
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in body weight
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Mean difference
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
11 September 2020
Status:
Final
Novo Nordisk
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
1.0
Page:
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Objective
Estimand strategy
Estimand category
Estimand
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in BMI
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Mean difference
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in waist circumference
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Mean difference
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
11 September 2020
Status:
Final
Novo Nordisk
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
1.0
Page:
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Objective
Estimand strategy
Estimand category
Estimand
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Body weight loss ≥ 5% at week 40
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Odds ratio
Secondary*
Treatment condition:  2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Body weight loss ≥ 10% at week 40
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “had rescue medication not been 
available” (hypothetical). Discontinuation of trial product before week 40: “had patients adhered to 
treatment” (hypothetical). Change in dose during and after dose escalation: “regardless of change in 
dose” (treatment policy).
Population level summary measure: Odds ratio
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Statistical analysis plan
UTN: U1111-1224-5162
Date:
11 September 2020
Status:
Final
Novo Nordisk
Trial ID: NN9535-4506
EudraCT No: 2018-004529-96
Version:
1.0
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Objective
Estimand strategy
Estimand category
Estimand
Treatment policy
Secondary (US)
Treatment condition: 2.0 mg semaglutide s.c. once-weekly or 1.0 mg semaglutide s.c. once-weekly
Variable/Endpoint: Change from baseline to week 40 in body weight
Population of interest: All randomised
Intercurrent event strategy: Initiation of rescue medication: “regardless of initiation of rescue 
medication” (treatment policy). Discontinuation of trial product due to adverse event: “regardless of 
trial product discontinuation due to adverse event” (treatment policy). Change in dose during and after 
dose escalation: “regardless of change in dose” (treatment policy).
Population level summary measure: Mean difference
The hypothetical estimand will be considered the primary estimand except in the US, where FDA specifically has requested the treatment policy estimand to be the primary.
*Not related to any confirmatory hypothesis
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Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
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EudraCT No: 2018-004529-96
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1.2
Trial design
See protocol section 5.
2
Statistical hypotheses
The statistical testing strategy will be performed for the primary analysis of each of the two 
estimand strategies separately. I.e. statistical testing will be performed separately for the 
hypothetical strategy and the treatment policy strategy. In order to preserve the overall type-I error 
in the strong sense at a 5% significance level (two-sided) within each estimand strategy, the 
conclusion of superiority of semaglutide 2.0 mg versus semaglutide 1.0 mg will be evaluated 
hierarchically according to the sequence below. The treatment difference is defined as μ = 
(semaglutide 2.0 mg minus semaglutide 1.0 mg).
1. Superiority of semaglutide 2.0 mg versus semaglutide 1.0 mg on change from baseline to
week 40 in HbA1c
x
H0: μ ≥ 0.0 %-point against Ha: μ < 0.0 %-point
2. Superiority of semaglutide 2.0 mg vs. semaglutide 1.0 mg on change from baseline to week
40 in body weight
x
H0: μ ≥ 0.0 kg against Ha: μ < 0.0 kg
3
Sample size determination
The primary endpoint is change from baseline (week 0) to week 40 in HbA1c (%-point) and the 
confirmatory secondary endpoint is change from baseline (week 0) to week 40 in body weight (kg). 
Both endpoints will be tested for superiority. The type-I error rate will be controlled in the strong 
sense across the primary and the confirmatory secondary hypotheses, separately for each estimand, 
at an overall alpha level (two-sided) of 0.05. Multiplicity control and criteria for confirming the 
hypotheses is described in section 2.
The sample size calculation is performed to ensure sufficient power for confirming superiority of 
semaglutide 2.0 mg vs. semaglutide 1.0 mg on change from baseline to week 40 in HbA1c (%-point) 
based on each estimand separately.
Primary endpoint
An on-treatment HbA1c treatment effect of −0.26%-point was predicted based on exposure-response 
modelling.
To accommodate the treatment policy estimand, the on-treatment effect is adjusted by 15% based 
on results from the SUSTAIN phase 3a programme, where a lower effect was observed for the
treatment policy estimand as compared to the on-treatment effect. With the adjusted HbA1c
treatment effect of −0.22%-point and a standard deviation of 1.1%-point, 964 subjects will be 
randomised in order to obtain 87% power for confirming superiority for the primary endpoint based 
on the treatment policy estimand and at least 87% power for confirming superiority for the primary 
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Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
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EudraCT No: 2018-004529-96
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endpoint based on the hypothetical estimand. This is based on a 1:1 randomisation, a two-sided
significance level of 0.05, and a t-test. The assumed standard deviation is based on the SUSTAIN 
programme.
Confirmatory secondary endpoint
With 964 subjects randomised to ensure sufficient power (87%) for confirming superiority for the 
primary endpoint based on the treatment policy estimand, a marginal power of 90% for confirming 
that semaglutide 2.0 mg is superior to semaglutide 1.0 mg on change from baseline to week 40 in 
body weight (based on each estimand) is obtained if the true treatment difference is as low as 
- 0.84 kg. This is based on a 1:1 randomisation, a two-sided significance level of 0.05, a t-test, and a
standard deviation of 4.0 kg. The assumed standard deviation is based on the SUSTAIN
programme.
Sensitivity analyses for the sample size calculation
The sensitivity of power for confirming superiority for the primary endpoint based on the treatment 
policy estimand for a fixed sample size of 964 subjects is presented in Table 2.
Table 2
Power for different scenarios
Scenario
On-treatment 
effect 
Adjusted for the 
treatment policy 
estimand 
Adjusted 
treatment effect
Randomised 
subjects
Power
Scenario 1
-0.25 %-point
15 %
-0.21
964
84 %
Scenario 2
-0.25 %-point
20 %
-0.20
964
81 %
Scenario 3
-0.27 %-point
15 %
-0.23
964
90 %
Scenario 4
-0.27 %-point
20 %
-0.22
964
87%
Scenario 5
-0.29 %-point
15 %
-0.25
964
94 %
Scenario 6
-0.29 %-point
20 %
-0.23
964
90 %
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Statistical analysis plan
CONFIDENTIAL
Date:
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Trial ID: NN9535-4506
Version:
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UTN: U1111-1224-5162
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4
Analysis sets
Data selection for statistical analyses will be a two-step process, first selecting subjects based on the 
analysis population and subsequently events/data for those subjects based on the observation period. 
Full analysis set (FAS): All randomised subjects. Subjects will be analysed according to the 
treatment to which they were assigned at randomisation.
Safety analysis set (SAS): All subjects exposed to at least one dose of trial product. Subjects will be 
analysed according to the trial product received for the majority of the period they were 
on treatment.
‘In-trial’ observation period: This observation period is defined as the period from the date of 
randomisation to the first of the following dates, both inclusive:
x
The follow-up visit (P11)
x
Date of death
x
Date when subject withdrew informed consent
x
Date of last contact for subjects lost to follow-up
‘On-treatment’ observation period: This observation period is a sub-set of the ‘in-trial’ observation 
period and represents the time period where subjects are considered exposed to trial product. The 
observation period starts at the date of first dose of trial product and ends at an endpoint-specific 
end-date. For adverse events including hypoglycaemic events, the observation period ends at the 
first date of any of the following:
x
The follow-up visit (P11)
x
The treatment discontinuation follow-up visit (P11A)
x
The date of last dose of trial product +49 days
x
The end-date for the ‘in-trial’ observation period
The follow-up visit is scheduled to take place 7 weeks after the last date on trial product, i.e., 49 
days.
For efficacy and other safety assessments (laboratory assessments, body measurements, and vital 
signs) the ‘on-treatment’ observation period ends at the last date on trial product with a visit 
window of +14 days. Hence, for these assessments, the ‘on-treatment’ observation period reflects 
the period in which subjects are treated.
‘On-treatment without rescue medication’ observation period: This observation period is a sub-set 
of the ‘on-treatment’ observation period and represents the time period where subjects are 
considered treated with trial product but have not initiated any rescue medications. The observation 
period starts at the date of first dose of trial product and ends at the first date of any of the
following:
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Statistical analysis plan
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Date:
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Version:
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x
Initiation of rescue medication
x
The date of last dose of trial product +14 days
Data points collected outside an observation period will be treated as missing in the analysis. 
Baseline data will always be included in an observation period.
Rescue medication is defined as any new anti-diabetic medication and/or intensification of anti-
diabetic medication initiated at or after date of randomisation and before last date on trial product. 
The following rules will be applied based on the concomitant medication data reported by the 
investigator, to determine whether or not the recorded anti-diabetic medication is 1. New anti-
diabetic medication or 2. Intensification of anti-diabetic medication
New anti-diabetic medication: Anti-diabetic medication (4th-level ATC code) that is initiated after 
randomisation and is new compared to the anti-diabetic background medication at randomisation 
and with a dosing duration of more than 21 days. 
Intensification of anti-diabetic medication: A more than 20% increase in the dose of anti-diabetic 
medication after randomisation as compared to the anti-diabetic medication dose at randomisation 
(5th-level ATC code not changed) and with a dosing duration of more than 21 days.
Before data are locked for statistical analysis, a review of all data will take place. In general 
subjects should not be excluded from an analysis set and observations should not be excluded from 
an observation period, if they fulfil the criteria. If subjects or observations are excluded, the reasons 
for their exclusion must be documented before database lock and described in the clinical trial 
report. Any decision to exclude either a subject or single observation from the statistical analysis is 
the joint responsibility of the members of the Novo Nordisk study group.
5
Statistical analyses
5.1
General considerations
The comparison presented from a statistical analysis will be semaglutide 2.0 mg versus 
semaglutide 1.0 mg and results will be presented by the estimated treatment contrast with associated 
two-sided 95% confidence intervals and p-values corresponding to two-sided tests of no difference 
if not otherwise specified.
Data from all sites will be analysed and reported together. 
If no statistical analysis is specified, data will be presented using relevant summary statistics. 
Accordingly, adverse events will be summarised descriptively. Data collected before randomisation 
(V2) will only be summarised descriptively.
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
17 of 28
A partial database lock will be performed at the end of the treatment period for all subjects, i.e. after 
the date of the last patient last treatment (LPLT) visit. The database will be updated after the partial 
database lock to include remaining PK data and any additional safety information. The full database 
lock will be performed after the date of the last patient last visit (LPLV).
Novo Nordisk will become unblinded at the time of the partial database lock, whereas subjects and 
investigators will remain blinded until after last patient last visit (LPLV). The analysis of the 
primary endpoint and all other efficacy endpoints will be performed based on the data from the 
partial database lock. Analysis of safety and PK data will be performed after the full database lock. 
This approach is implemented to allow earlier availability of semaglutide 2 mg to the patient 
population expected to benefit from a higher dose and to support further development activities 
with semaglutide s.c. A detailed plan for data handling and operational aspects of the partial 
database lock and the database update will be finalised before the partial database lock.
5.2
Subject disposition
See mock TFLs.
5.3
Primary endpoint analysis
5.3.1
Main analytical approach
5.3.1.1
Primary hypothetical estimand
The primary (except US) hypothetical estimand, see Table 1, will be estimated based on FAS using 
post-baseline data collected up to and including week 40 from the ‘on-treatment without rescue 
medication’ observation period. 
Imputation of missing data will be handled by multiple imputation (MI) assuming that missing data 
are missing at random (MAR). The imputation will be performed separately within each treatment 
group defined by randomised treatment. First, intermittent missing values are imputed using a 
Markov Chain Monte Carlo (MCMC) method, to obtain a monotone missing data pattern, 
generating 500 complete data sets. Secondly, a sequential conditional linear regression approach for 
imputing monotone missing values will be implemented starting with the first visit after baseline 
and sequentially continuing to the last planned visit at week 40. The model used for imputation will 
include the baseline and post-baseline HbA1c values observed prior to the visit in question as 
covariates. 
The 500 complete datasets will be analysed using an analysis of covariance (ANCOVA) with 
treatment and stratification as fixed factors and the baseline HbA1c as covariate. Rubin’s rule1 will 
be applied to obtain inference.
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CONFIDENTIAL


Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
18 of 28
5.3.1.2
Primary treatment policy estimand
The primary (US) treatment policy estimand, see Table 1, will be estimated based on the FAS using 
week 40 data from the ‘in-trial’ observation period.
Imputation of missing data will be handled by MI assuming that missing data are missing at 
random. The imputation will be performed by imputing missing week 40 data separately within 
groups defined by randomised treatment and treatment status at week 40 (retrieved drop-out), in 
total, four groups as follows; (i) semaglutide 1.0 mg and on-treatment at week 40, (ii) semaglutide 
1.0 mg and off-treatment at week 40, (iii) semaglutide 2.0 mg and on-treatment at week 40, (iv) 
semaglutide 2.0 mg and off-treatment at week 40.
For each of the four groups an ANCOVA with baseline HbA1c as covariate will be fitted to 
observed values of the change from baseline in HbA1c at week 40. The estimated parameters for 
location and dispersion will then be used to impute 500 values for each subject with missing week 
40 data based on only baseline HbA1c.
The 500 complete datasets will be analysed using an analysis of covariance (ANCOVA) with 
treatment and stratification as fixed factors and the baseline HbA1c as covariate. Rubin’s rule1 will
be applied to obtain inference.
5.3.2
Sensitivity analyses
5.3.2.1
Primary hypothetical estimand
A tipping point sensitivity analysis will be performed for the primary (except US) hypothetical 
estimand, by repeating the ANCOVA described in section 5.3.1.1, however, prior to analysis 
subjects from the semaglutide 2.0 mg group with missing observations at week 40 will be given a 
penalty, i.e., it is assumed that subjects with missing observations who are randomised to 
semaglutide 2.0 mg will receive a treatment that is less beneficial than subjects with observed 
values who are randomised to semaglutide 2.0 mg. The addition of the penalty values and
subsequent analysis steps should be repeated with increasing penalty values until a significant result 
in the corresponding superiority analysis is no longer significant. This analysis will only be 
performed if superiority is confirmed based on the primary analysis.
5.3.2.2
Primary treatment policy estimand
A tipping point sensitivity analysis for the primary (US) treatment policy estimand will be 
performed by repeating the ANCOVA described in section 5.3.1.2, however, prior to analysis 
subjects from the semaglutide 2.0 mg group with missing observations at week 40 will be given a 
penalty. The addition of the penalty values and subsequent analysis steps should be repeated with 
increasing penalty values until a significant result in the corresponding superiority analysis is no 
longer significant. This analysis will only be performed if superiority is confirmed based on the 
primary analysis.
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CONFIDENTIAL


Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
19 of 28
In addition, a two-way tipping point sensitivity analysis will be conducted as this may be a more 
reflective of a real-world situation for missing data from both treatment arms. The ANCOVA 
described in section 5.3.1.2 is repeated, however prior to analysis penalties of opposite sign are 
added to the imputed values at week 40 in both treatment arms simultaneously. The approach is to 
explore a range of penalties for both treatment groups, and the impact these would have on the 
study conclusions. This sensitivity analysis evaluates the robustness of the superiority conclusions 
to departures from the imputed change in HbA1c in both treatment groups. The analysis will only be 
performed if superiority is confirmed based on the primary analysis.
Let (Δ2.0mg,Δ1.0mg) denote a pair of penalties to (semaglutide 2.0 mg, semaglutide 1.0 mg). Then, for 
a given superiority hypothesis that is confirmed, denote the corresponding ‘one-way’ tipping points 
with (Δ2.0mg1,0) for semaglutide 2.0 mg and (0,Δ1.0mg1) for semaglutide 1.0 mg. It follows that the 
domain of penalties in a ‘two-way’ tipping point analysis should include a grid over (0,0) to 
(Δ2.0mg1,Δ1.0mg1).
The analyses are presented as contour plots for the test probability (p-value) of superiority as a 
function of the penalties (Δ2.0mg,Δ1.0mg). In this representation the contour line corresponding to 0.05
will partition the grid of penalties into two regions: a region where superiority of semaglutide 2.0 
mg is confirmed at a 5% significance level and a region where superiority is no longer confirmed.
5.3.3
Overview of statistical analyses and intercurrent events
An overview of all analyses addressing the two primary estimands for the confirmatory endpoints is 
provided in Table 3.
Table 3
Statistical analyses of the confirmatory endpoints
Endpoint
Estimand
Analysis 
set
Observation 
period
Statistical 
model
Imputation approach
Sensitivity 
analysis
Primary endpoint
Change in 
HbA1c (%-point)
Hypothetical
FAS
On-
treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Tipping 
point 
analysis
Treatment 
policy
FAS
In-trial
ANCOVA
MAR within group
defined by randomised 
treatment and treatment 
status at week 40
One-way and 
two-way 
tipping point 
analyses
Confirmatory secondary endpoint
Change in body 
weight (kg)
Hypothetical
FAS
On-
treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Tipping 
point 
analysis
Treatment 
policy
FAS
In-trial
ANCOVA
MAR within group 
defined by randomised 
treatment and treatment 
status at week 40
One-way and 
two-way 
tipping point 
analyses
Abbreviations: ANCOVA; analysis of covariance; FAS: full analysis set; MAR: missing at random.
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
20 of 28
The following Table 4 describes how anticipated intercurrent events during the trial are handled for 
confirmatory endpoints. The different intercurrent events will be handled in the same manner for 
both confirmatory endpoints.
Table 4
Statistical handling of intercurrent events for the primary analyses of the 
confirmatory endpoints
Intercurrent event
Handling
Hypothetical estimand
Treatment policy estimand
Strategy
Data
Strategy
Data
x Change in dose
during and after the
dose escalation
period
Treatment 
policy
Assessments will be 
performed and collected 
at scheduled visits after 
the intercurrent event and 
used in the analysis
Treatment 
policy
Assessments will be 
performed and collected 
at scheduled visits after 
the intercurrent event and 
used in the analysis
x Treatment
discontinuation due
to AEs
x Initiation of rescue
(anti-diabetic)
medication
Hypothetical
Assessments for 
scheduled visits after the 
time of the intercurrent 
event are considered 
missing and will be 
imputed assuming MAR 
as described in the 
analysis
Treatment 
policy
Assessments will be
performed and collected 
at scheduled visits after 
the intercurrent event and 
used in the analysis
5.4
Secondary endpoint analysis
5.4.1
Confirmatory secondary endpoints
The confirmatory secondary endpoint is change from baseline (week 0) to week 40 in body weight 
(kg).
5.4.1.1
Main analytical approach
Secondary hypothetical estimand
Similar analyses as described in section 5.3.1.1 with body weight values instead of HbA1c values 
will be performed.
Secondary treatment policy estimand
Similar analyses as described in section 5.3.1.2 with body weight values instead of HbA1c values 
will be performed.
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
21 of 28
5.4.1.2
Sensitivity analyses
Secondary hypothetical estimand
One-way tipping point sensitivity analysis as described in section 5.3.2.1 with body weight values 
instead of HbA1c values will be performed.
Secondary treatment policy estimand
Both one-way and two-way tipping point analyses as those described in section 5.3.2.2 with body 
weight values instead of HbA1c values will be performed.
5.4.2
Supportive secondary endpoints
The supportive secondary endpoints are listed in Table 6 and all relevant estimands are described in
Table 1. A hypothetical estimand strategy will be applied for all supportive secondary endpoints. 
Continuous endpoints 
Analyses of change in FPG, BMI and waist circumference will be performed as described in section 
5.3.1.1 with values for the given parameter instead of HbA1c values based on FAS using data from 
the ‘on-treatment without rescue medication’ observation period. The analysis of change from 
baseline to week 40 in pulse rate will be based on SAS using data from the ‘on-treatment’ 
observation period, but otherwise using the same approach as described in section 5.3.1.1.
Responder endpoints
To account for missing data, the binary endpoints will be derived from the 500 imputed datasets 
described in section 5.3.1.1. Each of the complete data sets will be analysed using a logistic 
regression (LR) model with treatment and stratification as fixed effects and associated baseline 
response as covariate. Estimated odds ratios will be log-transformed and inference will be drawn 
using Rubin’s rule1. The results will be back-transformed and described by the odds ratio between 
treatments and the associated 95% CI and p-value for no treatment difference.
Overview of statistical analyses
An overview of all analyses of the supportive secondary endpoints is provided in Table 5.
Table 5
Statistical analyses of the supportive secondary endpoints
Endpoint
Estimand
Analysis 
set
Observation 
period
Statistical 
model
Imputation approach
Supportive secondary endpoints (effect related)
Change in FPG 
(mmol/)
Hypothetical
FAS
On-treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Change in BMI 
(kg/m2)
Hypothetical
FAS
On-treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
22 of 28
Endpoint
Estimand
Analysis 
set
Observation 
period
Statistical 
model
Imputation approach
Change in waist 
circumference (cm)
Hypothetical
FAS
On-treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
HbA1c < 7% (yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
HbA1c ≤ 6.5% 
(yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
Weight loss ≥ 5% 
(yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
Weight loss ≥ 10% 
(yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
Supportive secondary endpoints (safety related)
Change in pulse 
(bpm)
-
SAS
On-treatment 
ANCOVA
MAR within randomised 
treatment group
Number of 
hypoglycaemic 
episodes
-
SAS
On-treatment 
NBR
-
Abbreviations: ANCOVA; analysis of covariance; FAS: full analysis set; LR: logistic regression; MAR: missing at 
random; NBR: negative binomial regression; SAS: safety analysis set
5.5
Exploratory endpoint analysis
Not applicable.
5.6
Other safety analyses
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic 
episodes at week 40 will be analysed using a negative binomial regression (NBR) model with a 
log-link function and the logarithm of the time period covered by the subject’s ‘on-treatment’ 
observation period as offset. The model will include treatment and stratification as fixed factors and 
baseline HbA1c as a covariate. This analysis will be based on the SAS using the ‘on-treatment’ 
observation period. The results will be described by the rate ratio between treatments and the 
associated 95% CI and p-value for no treatment difference.
The binary assessment indicating whether a subject has had no treatment emergent severe or blood 
glucose confirmed symptomatic hypoglycaemic episodes at week 40 or at least one will be analysed 
using a logistic regression model. The model will include treatment and stratification as fixed 
effects and baseline HbA1c as covariate, and the analysis will be based on SAS using data from the 
‘on-treatment’ observation period. The results will be described by the odds ratio between 
treatments and the associated 95% confidence interval and p-value for no treatment difference.
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
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5.7
Other analyses
Population PK modelling and exposure-response analyses may be included to support dose 
selection and to explore the benefits of high versus lower doses of semaglutide in subjects with 
T2D. 
The modelling will include data from all randomised subjects that were exposed to semaglutide in 
this trial and might be performed as a meta-analysis including data from historical trials. Actual 
dose and date of administration of last dose before PK sampling will be registered in the CRF and 
used in the analysis, together with actual time point for PK sampling. The analysis will be further 
specified in a modelling analysis plan that is to be prepared before database lock. 
The modelling analyses will be performed by Quantitative Clinical Pharmacology at Novo Nordisk 
A/S and will be reported separately from the CTR. 
5.7.1
Subgroup analyses
Change from baseline to week 40 in HbA1c will be analysed according to the following three 
subgroup splits:
x
HbA1c < 9% and HbA1c ≥ 9% at baseline
x
BMI < 30 and BMI ≥ 30 at baseline
x
BMI < 35 and BMI ≥ 35 at baseline
The rationale for conducting these subgroup analyses is to generate evidence to support potential 
individualised treatment in clinically relevant subpopulations with high HbA1c or BMI, where 
subjects may experience even further improvement of glycaemic control from advancing to a higher 
dose of semaglutide.
From each analysis the estimated treatment differences in change from baseline to week 40 in 
HbA1c across subgroups with 95% confidence intervals will be presented.
5.7.1.1
Hypothetical strategy
The effect of randomised treatment on change from baseline to week 40 in HbA1c across subgroups 
will be analysed based on a hypothetical estimand strategy by using the same 500 imputed and 
complete data sets as described in section 5.3.1.1. On these 500 complete data sets an ANCOVA 
having baseline HbA1c level as covariate, treatment and stratification as well as the interaction 
between the relevant subgroup and treatment as fixed factors, will be applied. Rubin’s rule1 will be 
applied to obtain inference. 
5.7.1.2
Treatment policy strategy
Addressing the effect of randomised treatment on change from baseline to week 40 in HbA1c across 
subgroups by a treatment policy strategy the 500 imputed data described in section 5.3.1.2, will also 
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
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Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
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be analysed by an ANCOVA having baseline HbA1c level as covariate, treatment and stratification 
as well as the interaction between the relevant subgroup and treatment as fixed factors, will be 
applied. Rubin’s rule1 will be applied to obtain inference. 
5.7.2
Subpopulation analysis
To further support individualised treatment, an analysis of change in HbA1c from week 12 to week 
40 will be performed in the subpopulation of all randomised subjects that are on-treatment, have not 
initiated rescue medication and are adherent to semaglutide 1.0 mg at week 12, having a week 12 
HbA1c ≥ 7%.
This represents a clinically meaningful and important subpopulation of patients that are expected to 
particularly benefit from advancing to a higher dose of semaglutide.
Due to the trial design, where both treatment arms receive semaglutide unblinded for the first 12 
weeks, subpopulation membership is arguably unrelated to treatment assignment. Accordingly, an 
analysis of change from week 12 to week 40 in HbA1c in this subpopulation will still have the 
benefit of randomisation.
5.7.2.1
Hypothetical strategy
The endpoint change from week 12 to week 40 in HbA1c in the subpopulation will be analysed with 
the hypothetical estimand strategy, see Table 1 for definition of intercurrent events.
Imputation of missing data will be handled by MI assuming that missing data pattern is MAR. The 
imputation will be performed separately within each treatment group defined by randomised 
treatment. First, intermittent missing values are imputed using a Markov Chain Monte Carlo 
(MCMC) method, to obtain a monotone missing data pattern, generating 500 complete data sets.
Secondly, a sequential conditional linear regression approach for imputing monotone missing
values will be implemented starting with the first visit after week 12 and sequentially continuing to
the last planned visit at week 40. The model used for imputation will include the HbA1c at week 12
and post-baseline HbA1c values observed prior to the visit in question as covariates.
The 500 complete datasets will be analysed using an analysis of covariance (ANCOVA) with 
treatment and stratification as fixed factors and HbA1c at week 12 as covariate. Rubin’s rule1 will be 
applied to obtain inference.
5.7.2.2
Treatment policy strategy
The endpoint change from week 12 to week 40 in HbA1c in the subpopulation will be analysed with 
the treatment policy estimand strategy, see Table 1 for definition of intercurrent events.
Imputation of missing data will be handled by MI assuming that missing data pattern is MAR. The 
imputation will be performed by imputing missing week 40 data separately within groups defined 
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Statistical analysis plan
CONFIDENTIAL
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
25 of 28
by randomised treatment and treatment status at week 40 (retrieved drop-out), in total, four groups 
as follows; (i) semaglutide 1.0 mg and on-treatment at week 40, (ii) semaglutide 1.0 mg and off-
treatment at week 40, (iii) semaglutide 2.0 mg and on-treatment at week 40, (iv) semaglutide 2.0 
mg and off-treatment at week 40.
For each of the four groups an ANCOVA with HbA1c at week 12 as covariate will be fitted to 
observed values of the change from week 12 to week 40 in HbA1c. The estimated parameters for 
location and dispersion will then be used to impute 500 values for each subject with missing week 
40 data based on only HbA1c at week 12. 
The 500 complete datasets will be analysed using an analysis of covariance (ANCOVA) with 
treatment and stratification as fixed factors and HbA1c at week 12 as covariate. Rubin’s rule1 will be 
applied to obtain inference.
5.8
Interim analyses
Not applicable.
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CONFIDENTIAL


Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
26 of 28
6
Supporting documentation
6.1
Appendix 1: List of abbreviations
AE
adverse event
ANCOVA
analysis of covariance
ATC
Anatomical Therapeutic Chemical
BMI
body mass index
bpm
beats per minute
CI
confidence interval
CRF
case report form
CTR
clinical trial report
EMA
European Medicines Agency
FAS
full analysis set
FDA
US Food and Drug Administration
FPG
fasting plasma glucose
ICH
International Council on Harmonization
LR
logistic regression
LPLT
last patient last treatment
LPLV
last patient last visit
MAR
missing at random
MCMC
Markov Chain Monte Carlo
MI
multiple imputation
NBR
negative binomial regression
PK
pharmacokinetics
SAS
safety analysis set
s.c.
subcutaneous
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Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
27 of 28
SU
sulfonylureas
T2D
Type 2 diabetes 
TFL
Tables, figures and listings
w/o
without
6.2
Appendix 2: Changes to protocol-planned analyses
Corrected the end of the in-trial observation period, from end-of-treatment visit (V10) to the follow-
up visit (P11).
A schematic overview of the estimands has been provided, see Table 1.
Clarification in section 2 that statistical testing is performed for each estimand strategy separately.
A clarification of rescue medication has been included, see section 4.
A two-way tipping point sensitivity analysis has been added based on feedback from FDA, see 
sections 5.3.2.2 and 5.4.1.2.
Subgroup analyses have been included, see section 5.7.1, as well as a subpopulation analysis, see 
section 5.7.2.
6.3
Appendix 3: Definition and calculation of endpoints, assessments and derivations
Table 6
Endpoints
Type
Title
Time frame
Unit
Primary endpoint
Change from baseline (week 0) to week 40 in glycosylated 
haemoglobin (HbA1c)
From baseline 
(week 0) to week 
40
%
Confirmatory 
secondary endpoint
Change from baseline (week 0) to week 40 in body weight
From baseline 
(week 0) to week 
40
kg
Supportive 
secondary endpoint
Change from baseline (week 0) to week 40 in fasting plasma 
glucose
Week 40
mmol/L
Supportive 
secondary endpoint
Change from baseline (week 0) to week 40 in BMI
Week 40
kg/m2
Supportive 
secondary endpoint
Change from baseline (week 0) to week 40 in waist 
circumference
Week 40
cm
Supportive 
secondary endpoint
HbA1c < 7.0% (53 mmol/mol)
Week 40
Yes/no
Supportive 
secondary endpoint
HbA1c ≤ 6.5% (48 mmol/mol)
Week 40
Yes/no
Supportive 
secondary endpoint
Weight loss ≥ 5 kg
Week 40
Yes/no
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Statistical analysis plan
Date:
11 September 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EudraCT No: 2018-004529-96
Page:
28 of 28
Type
Title
Time frame
Unit
Supportive 
secondary endpoint
Weight loss ≥ 10 kg
Week 40
Yes/no
Supportive 
secondary endpoint
Number of treatment emergent severe or blood glucose 
confirmed symptomatic hypoglycaemic episodes from 
baseline (week 0) to week 40
From week 0 to 
week 40
Count
Supportive
secondary endpoint
Change from baseline (week 0) to week 40 in pulse
From week 0 to 
week 40
bpm
7
References
1.
Little RJA, Rubin DB. Statistical analysis with missing data. New York: Wiley. 1987. xiv,
278 p. p.
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CONFIDENTIAL 


 
 
 
 
 
 
 
From: 
 
To:  
Whom it may concern 
Memo 
Ref.: 
 
Date: 28-Aug .2020 
Novo Nordisk A/S 
Safety Surveillance 
Global Safety 
Telephone: 
+45 4444 8888
www.novonordisk.com
Author: 
 
E-mail: 
Mobile: 
Krogshøjvej 55 
DK-2880 
Bagsværd 
Denmark 
Identification and presentation of Areas of Special Interest for 
NN9535-4506 – Memo version [2.0] – Task 088 
This document aims to provide an overview of MedDRA queries (SMQs and NNMQs) in 
relation to CTR for the above trial 
Areas of special interest are identified as outlined in the table below in MedDRA version 
[23.0]. Please make sure that no duplicate Preferred Terms are included in any of the 
separate searches. 
If the Safety area of special interest is covered by a custom query (e.g. NNMQ) the 
text included in the table under ‘Safety Area of Special Interest’ should be included as 
the CQNAM in the SAS data set (left blank if SMQ). 
If the Safety area of special interest is covered by a SMQ, the title of the SMQ should 
be included as the SMQNAM in the SAS data.  
N 
Safety Area of Special 
Interest (if defined by 
an NNMQ, CQNAM in 
SAS dataset) 
Search criteria by NNMQ, SMQ, SOC 
and/or specific Preferred Terms (if 
defined by SMQ, SMQNAM in SAS 
dataset) 
Scope / Filter - 
include scope for 
each component 
(tick one per area) 
1 
Gastrointestinal adverse 
events 
NNMQ GI SOC 
☒Primary terms only
☐Both primary and
secondary term
2 
Cardiovascular disorders 
NNMQ Cardiovascular disorders 
☒All terms
☐Narrow term only
3 
Acute gallstone disease 
NNMQ Gallbladder related disorders 
☐All terms
☒Narrow term only
4 
Pancreatitis 
NNMQ Pancreatitis 
☐All terms
☒Narrow term only
5 
Acute renal failure 
SMQ Acute renal failure 
☐All terms
☒Narrow term only
6 
Diabetic retinopathy 
adverse events  
NNMQ Retinopathy phase 3a 
- single PTs
☒All terms
☐Narrow term only
7 
Hepatic disorders 
SMQ Drug related hepatic disorders 
Comprehensive search 
8 
Allergic reactions 
NNMQ Allergic reactions 
☐All terms
'DWD'HILQLWLRQVIRU$QDO\VLV'DWDVHWV$XJ0(02_


Page 2 of 3 
☒Narrow term only
9 
Medication 
error/overdose 
SMQ Medication error, 
NNMQ Abuse/Misuse,  
NNMQ Overdose 
☒All terms
☐Narrow term only
Duplicate terms should 
be included only once 
10 
Rare events 
NNMQ Rare 
☒All terms
☐Narrow term only
Excluding terms caught 
in other searches 
11 
Neoplasms 
NNMQ Neoplasms 
☒All terms
☐Narrow term only
12 
Malignant neoplasms 
SMQ Malignant tumours 
☐All terms
☒Narrow term only
13 
Injection site reaction 
NNMQ Injection site reaction 
☒All terms
☐Narrow term only
14 
Suspected transmission 
of an infectious agent 
NNMQ Transmission 
☒Primary terms only
☐Both primary and
secondary term
'DWD'HILQLWLRQVIRU$QDO\VLV'DWDVHWV$XJ0(02_


Page 3 of 3 
Memo 
version 
MedDRA version 
Description of change 
1.0 
23.0 
This is the first version of memo. 
To be used for task 088 
2.0 
23.0 
Memo has been updated to include the diabetic 
retinopathy phase 3a search instead of retinal 
disorders which is in agreement with a safety 
committee decision taking 2017-09-08. 
The phase 3a search is using MedRA v. 13.1 and 
it is recognised that PT terms may have been 
demoted or other changes when used in data 
coded in the current version of MedDRA is 
affecting the output. 
'DWD'HILQLWLRQVIRU$QDO\VLV'DWDVHWV$XJ0(02_


NN9535 
Date: 
04 December 2020 
Novo Nordisk 
NN9535-4506 
Version: 
1.0 
Clinical Trial Report 
Status: 
Final 
- 
Page: 
1 of 229 
Table of contents 
Page 
1: Pre-defined MedDRA search - list of preferred terms ................................................................................... 2
.
CONFIDENTIAL 


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Page: 
2 of 229 
1: Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Acute gallstone disease
AIDS cholangiopathy
Ampulla of Vater stenosis
Autoimmune cholangitis
Bile culture positive
Bile duct necrosis
Bile duct obstruction
Bile duct pressure increased
Bile duct reconstruction
Bile duct stenosis
Bile duct stenosis traumatic
Bile duct stent insertion
Bile duct stent removal
Bile duct stone
Bile output abnormal
Bile output decreased
Bile output increased
Biliary abscess
Biliary anastomosis
Biliary anastomosis complication   
Biliary ascites
Biliary cast syndrome
Biliary catheter insertion
Biliary catheter removal
Biliary cirrhosis
Biliary colic
Biliary dilatation
Biliary dyskinesia
Biliary fibrosis
Biliary fistula
Biliary fistula repair
Biliary ischaemia
Biliary sepsis
Biliary sphincterotomy
Biliary stent placement
Biliary tract dilation procedure
Biliary tract disorder
Biliary tract infection
Biliary tract operation
Biliary-bronchial fistula
Biliary-vascular fistula
Bilirubin conjugated abnormal
Bilirubin conjugated increased
Bilirubin excretion disorder
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Version: 
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3 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Acute gallstone disease
Biloma
Biloma rupture
Biopsy bile duct abnormal
Biopsy gallbladder abnormal
Blood bilirubin abnormal
Blood bilirubin increased
Cholangiectasis acquired
Cholangiogram abnormal
Cholangiolitis
Cholangiostomy
Cholangitis
Cholangitis acute
Cholangitis chronic
Cholangitis infective
Cholangitis sclerosing
Cholecystectomy
Cholecystitis
Cholecystitis acute
Cholecystitis chronic
Cholecystitis infective
Cholecystocholangitis
Cholecystoenterostomy
Cholecystogram intravenous abnormal
Cholecystogram oral abnormal
Cholecystostomy
Choledochectomy
Choledochoenterostomy
Choledocholithotomy
Choledochostomy
Choledochotomy
Cholelithiasis
Cholelithiasis migration
Cholelithiasis obstructive
Cholelithotomy
Cholelithotripsy
Cholestasis
Cholestasis of pregnancy
Dilatation intrahepatic duct acquired
Emphysematous cholecystitis
Endoscopic retrograde cholangiopancreatography
abnormal
Endoscopy biliary tract abnormal   
Gallbladder abscess
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
4 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Acute gallstone disease
Gallbladder cholesterolosis
Gallbladder disorder
Gallbladder empyema
Gallbladder enlargement
Gallbladder fibrosis
Gallbladder fistula
Gallbladder fistula repair
Gallbladder hyperfunction
Gallbladder hypofunction
Gallbladder injury
Gallbladder mucocoele
Gallbladder necrosis
Gallbladder obstruction
Gallbladder oedema
Gallbladder operation
Gallbladder palpable
Gallbladder rupture
Gallbladder varices
Gallbladder volvulus
Gallstone ileus
Haemobilia
Haemorrhagic cholecystitis
Hepatitis cholestatic
Hepatobiliary disease
Hepatobiliary infection
Hepatolithectomy
Hydrocholecystis
Hyperbilirubinaemia
Hyperplastic cholecystopathy
Immune-mediated cholangitis
Ischaemic cholecystitis
Jaundice
Jaundice cholestatic
Jaundice extrahepatic obstructive
Lemmel's syndrome
Limy bile syndrome
Malignant biliary obstruction
Pancreatobiliary sphincterotomy
Parenteral nutrition associated liver disease
Perforation bile duct
Porcelain gallbladder
Post cholecystectomy syndrome
Post procedural bile leak
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
5 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Acute gallstone disease
Primary biliary cholangitis
Pseudocholelithiasis
Recurrent pyogenic cholangitis
Reynold's syndrome
Sphincter of Oddi dysfunction
Ultrasound biliary tract abnormal
Vanishing bile duct syndrome
X-ray hepatobiliary abnormal
Acute renal failure
Acute kidney injury
Acute phosphate nephropathy
Anuria
Azotaemia
Continuous haemodiafiltration
Dialysis
Foetal renal impairment
Haemodialysis
Haemofiltration
Neonatal anuria
Nephropathy toxic
Oliguria
Peritoneal dialysis
Prerenal failure
Renal failure
Renal failure neonatal
Renal impairment
Renal impairment neonatal
Subacute kidney injury
Allergic reactions
Acquired C1 inhibitor deficiency
Acute generalised exanthematous pustulosis
Administration related reaction
Administration site dermatitis
Administration site eczema
Administration site hypersensitivity
Administration site rash
Administration site recall reaction
Administration site urticaria
Administration site vasculitis
Allergic bronchitis
Allergic colitis
Allergic cough
Allergic cystitis
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
6 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Allergic reactions
Allergic eosinophilia
Allergic gastroenteritis
Allergic hepatitis
Allergic keratitis
Allergic oedema
Allergic otitis externa
Allergic otitis media
Allergic pharyngitis
Allergic reaction to excipient
Allergic respiratory disease
Allergic respiratory symptom
Allergic sinusitis
Allergic stomatitis
Allergic transfusion reaction
Allergy alert test positive
Allergy test positive
Allergy to immunoglobulin therapy
Allergy to surgical sutures
Allergy to vaccine
Anal eczema
Anaphylactic reaction
Anaphylactic shock
Anaphylactic transfusion reaction
Anaphylactoid reaction
Anaphylactoid shock
Anaphylaxis treatment
Angioedema
Anti-neutrophil cytoplasmic antibody positive
vasculitis
Antiallergic therapy
Antiendomysial antibody positive
Application site dermatitis
Application site eczema
Application site hypersensitivity
Application site rash
Application site recall reaction
Application site urticaria
Application site vasculitis
Arthritis allergic
Aspirin-exacerbated respiratory disease
Atopic cough
Atopy
Blepharitis allergic
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
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7 of 229 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Allergic reactions
Blood immunoglobulin E abnormal
Blood immunoglobulin E increased
Bromoderma
Bronchospasm
Bullous haemorrhagic dermatosis
Catheter site dermatitis
Catheter site eczema
Catheter site hypersensitivity
Catheter site rash
Catheter site urticaria
Catheter site vasculitis
Chronic eosinophilic rhinosinusitis
Chronic hyperplastic eosinophilic sinusitis
Circulatory collapse
Circumoral oedema
Circumoral swelling
Conjunctival oedema
Conjunctivitis allergic
Contact stomatitis
Contrast media allergy
Contrast media reaction
Corneal oedema
Cutaneous vasculitis
Dennie-Morgan fold
Dermatitis
Dermatitis acneiform
Dermatitis allergic
Dermatitis atopic
Dermatitis bullous
Dermatitis contact
Dermatitis exfoliative
Dermatitis exfoliative generalised
Dermatitis herpetiformis
Dermatitis infected
Dermatitis psoriasiform
Device allergy
Dialysis membrane reaction
Distributive shock
Documented hypersensitivity to administered
product
Drug eruption
Drug hypersensitivity
Drug provocation test
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
8 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Allergic reactions
Drug reaction with eosinophilia and systemic
symptoms
Eczema
Eczema infantile
Eczema nummular
Eczema vaccinatum
Eczema vesicular
Eczema weeping
Encephalitis allergic
Encephalopathy allergic
Eosinophilic granulomatosis with polyangiitis
Epidermal necrosis
Epidermolysis
Epidermolysis bullosa
Epiglottic oedema
Erythema multiforme
Erythema nodosum
Erythrodermic atopic dermatitis
Exfoliative rash
Eye allergy
Eye oedema
Eye swelling
Eyelid oedema
Face oedema
Fixed eruption
Giant papillary conjunctivitis
Gingival oedema
Gingival swelling
Gleich's syndrome
Haemorrhagic urticaria
Hand dermatitis
Henoch-Schonlein purpura
Henoch-Schonlein purpura nephritis
Heparin-induced thrombocytopenia
Hereditary angioedema
Hereditary angioedema with C1 esterase inhibitor
deficiency
Hypersensitivity
Hypersensitivity myocarditis
Hypersensitivity pneumonitis
Hypersensitivity vasculitis
Idiopathic angioedema
Idiopathic urticaria
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
9 of 229 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Allergic reactions
Immediate post-injection reaction
Immune thrombocytopenia
Immune tolerance induction
Implant site dermatitis
Implant site hypersensitivity
Implant site rash
Implant site urticaria
Incision site dermatitis
Incision site rash
Infusion related hypersensitivity reaction
Infusion related reaction
Infusion site dermatitis
Infusion site eczema
Infusion site hypersensitivity
Infusion site rash
Infusion site recall reaction
Infusion site urticaria
Infusion site vasculitis
Injection related reaction
Injection site dermatitis
Injection site eczema
Injection site hypersensitivity
Injection site rash
Injection site recall reaction
Injection site urticaria
Injection site vasculitis
Instillation site hypersensitivity   
Instillation site rash
Instillation site urticaria
Interstitial granulomatous dermatitis
Intestinal angioedema
Iodine allergy
Kaposi's varicelliform eruption
Kounis syndrome
Laryngeal oedema
Laryngitis allergic
Laryngospasm
Laryngotracheal oedema
Limbal swelling
Lip oedema
Lip swelling
Mast cell degranulation present
Medical device site dermatitis
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
10 of 229 
 
Pre-defined MedDRA search - list of preferred terms 
  
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Allergic reactions                                 Medical device site eczema                                                                 
                                                   Medical device site hypersensitivity                                                       
                                                   Medical device site rash                                                                   
                                                   Medical device site recall reaction                                                        
                                                   Medical device site urticaria                                                              
                                                   Mouth swelling                                                                             
                                                   Mucocutaneous rash                                                                         
                                                   Multiple allergies                                                                         
                                                   Nephritis allergic                                                                         
                                                   Nikolsky's sign                                                                            
                                                   Nodular rash                                                                               
                                                   Nutritional supplement allergy                                                             
                                                   Oculomucocutaneous syndrome                                                                
                                                   Oculorespiratory syndrome                                                                  
                                                   Oedema mouth                                                                               
                                                   Oral allergy syndrome                                                                      
                                                   Oropharyngeal blistering                                                                   
                                                   Oropharyngeal oedema                                                                       
                                                   Oropharyngeal spasm                                                                        
                                                   Oropharyngeal swelling                                                                     
                                                   Palatal oedema                                                                             
                                                   Palatal swelling                                                                           
                                                   Palisaded neutrophilic granulomatous dermatitis                                            
                                                   Palpable purpura                                                                           
                                                   Pathergy reaction                                                                          
                                                   Perioral dermatitis                                                                        
                                                   Periorbital oedema                                                                         
                                                   Periorbital swelling                                                                       
                                                   Pharyngeal oedema                                                                          
                                                   Pharyngeal swelling                                                                        
                                                   Procedural shock                                                                           
                                                   Pruritus allergic                                                                          
                                                   Radioallergosorbent test positive                                                          
                                                   Rash                                                                                       
                                                   Rash erythematous                                                                          
                                                   Rash follicular                                                                            
                                                   Rash macular                                                                               
                                                   Rash maculo-papular                                                                        
                                                   Rash maculovesicular                                                                       
                                                   Rash morbilliform                                                                          
                                                   Rash neonatal                                                                              
                                                   Rash papulosquamous                                                                        
                                                   Rash pruritic                                                                              
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
11 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Allergic reactions
Rash pustular
Rash rubelliform
Rash scarlatiniform
Rash vesicular
Reaction to azo-dyes
Reaction to colouring
Reaction to excipient
Reaction to food additive
Reaction to preservatives
Red man syndrome
Rhinitis allergic
SJS-TEN overlap
Scleral oedema
Scleritis allergic
Scrotal dermatitis
Scrotal oedema
Serum sickness
Serum sickness-like reaction
Shock
Shock symptom
Skin necrosis
Skin reaction
Skin test positive
Solar urticaria
Solvent sensitivity
Stevens-Johnson syndrome
Stoma site hypersensitivity
Stoma site rash
Swelling face
Swelling of eyelid
Swollen tongue
Symmetrical drug-related intertriginous and
flexural exanthema
Target skin lesion
Therapeutic product cross-reactivity
Tongue oedema
Toxic epidermal necrolysis
Toxic skin eruption
Tracheal oedema
Type I hypersensitivity
Type II hypersensitivity
Type III immune complex mediated reaction
Type IV hypersensitivity reaction
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
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12 of 229 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Allergic reactions
Urticaria
Urticaria cholinergic
Urticaria chronic
Urticaria contact
Urticaria papular
Urticaria physical
Urticaria pigmentosa
Urticaria vesiculosa
Urticarial dermatitis
Urticarial vasculitis
Vaccination site dermatitis
Vaccination site eczema
Vaccination site exfoliation
Vaccination site hypersensitivity
Vaccination site rash
Vaccination site recall reaction
Vaccination site urticaria
Vaccination site vasculitis
Vaccination site vesicles
Vaginal ulceration
Vasculitic rash
Vernal keratoconjunctivitis
Vessel puncture site rash
Vessel puncture site vesicles
Vulval eczema
Vulval ulceration
Vulvovaginal rash
Vulvovaginal ulceration
Vulvovaginitis allergic
Cardiovascular disorders
Acute kidney injury
Anuria
Neonatal anuria
Prerenal failure
Renal failure
Renal failure neonatal
Subacute kidney injury
Administration site vasculitis
Anaphylactic reaction
Anaphylactic shock
Anaphylactic transfusion reaction
Anaphylactoid reaction
Anaphylactoid shock
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
13 of 229 
 
Pre-defined MedDRA search - list of preferred terms 
  
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Anti-neutrophil cytoplasmic antibody positive                                              
                                                   vasculitis                                                                                 
                                                   Application site vasculitis                                                                
                                                   Circulatory collapse                                                                       
                                                   Cutaneous vasculitis                                                                       
                                                   Distributive shock                                                                         
                                                   Eosinophilic granulomatosis with polyangiitis                                              
                                                   Henoch-Schonlein purpura                                                                   
                                                   Henoch-Schonlein purpura nephritis                                                         
                                                   Heparin-induced thrombocytopenia                                                           
                                                   Hypersensitivity myocarditis                                                               
                                                   Hypersensitivity vasculitis                                                                
                                                   Infusion site vasculitis                                                                   
                                                   Injection site vasculitis                                                                  
                                                   Kounis syndrome                                                                            
                                                   Palpable purpura                                                                           
                                                   Procedural shock                                                                           
                                                   Shock                                                                                      
                                                   Shock symptom                                                                              
                                                   Urticarial vasculitis                                                                      
                                                   Vaccination site vasculitis                                                                
                                                   Vasculitic rash                                                                            
                                                   Abnormal precordial movement                                                               
                                                   Accelerated idioventricular rhythm                                                         
                                                   Accessory cardiac pathway                                                                  
                                                   Acquired cardiac septal defect                                                             
                                                   Acute aortic syndrome                                                                      
                                                   Acute cardiac event                                                                        
                                                   Acute coronary syndrome                                                                    
                                                   Acute haemorrhagic oedema of infancy                                                       
                                                   Acute left ventricular failure                                                             
                                                   Acute myocardial infarction                                                                
                                                   Acute pulmonary oedema                                                                     
                                                   Acute respiratory failure                                                                  
                                                   Acute right ventricular failure                                                            
                                                   Adams-Stokes syndrome                                                                      
                                                   Administration site thrombosis                                                             
                                                   Adrenal thrombosis                                                                         
                                                   Agnosia                                                                                    
                                                   Agonal rhythm                                                                              
                                                   Alcohol septal ablation                                                                    
                                                   Amaurosis                                                                                  
                                                   Amaurosis fugax                                                                            
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Version: 
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Page: 
14 of 229 
Pre-defined MedDRA search - list of preferred terms 
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Cardiovascular disorders
Amyloid related imaging abnormalities
Amyloid related imaging
abnormality-microhaemorrhages and haemosiderin
deposits
Amyloid related imaging
abnormality-oedema/effusion
Andersen-Tawil syndrome
Angina pectoris
Angina unstable
Anginal equivalent
Angiogram abnormal
Angiogram cerebral abnormal
Angiogram peripheral abnormal
Angioplasty
Anomalous atrioventricular excitation
Anti-glomerular basement membrane disease
Antibody test abnormal
Antibody test positive
Antineutrophil cytoplasmic antibody increased
Antineutrophil cytoplasmic antibody positive
Antiphospholipid syndrome
Aortic bypass
Aortic embolus
Aortic surgery
Aortic thrombosis
Aortitis
Aortogram abnormal
Aphasia
Application site thrombosis
Arrhythmia
Arrhythmia neonatal
Arrhythmia supraventricular
Arrhythmogenic right ventricular dysplasia
Arterectomy
Arterectomy with graft replacement
Arterial angioplasty
Arterial bypass occlusion
Arterial bypass operation
Arterial bypass thrombosis
Arterial graft
Arterial occlusive disease
Arterial stent insertion
Arterial therapeutic procedure
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Version: 
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15 of 229 
 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Arterial thrombosis                                                                        
                                                   Arteriogram abnormal                                                                       
                                                   Arteriogram carotid abnormal                                                               
                                                   Arteriogram coronary abnormal                                                              
                                                   Arteriosclerosis coronary artery                                                           
                                                   Arteriospasm coronary                                                                      
                                                   Arteriotomy                                                                                
                                                   Arteriovenous fistula occlusion                                                            
                                                   Arteriovenous fistula thrombosis                                                           
                                                   Arteriovenous graft thrombosis                                                             
                                                   Arteritis                                                                                  
                                                   Arteritis coronary                                                                         
                                                   Artificial blood vessel occlusion                                                          
                                                   Artificial heart implant                                                                   
                                                   Ascites                                                                                    
                                                   Atherectomy                                                                                
                                                   Atherosclerotic plaque rupture                                                             
                                                   Atrial appendage closure                                                                   
                                                   Atrial appendage resection                                                                 
                                                   Atrial conduction time prolongation                                                        
                                                   Atrial enlargement                                                                         
                                                   Atrial fibrillation                                                                        
                                                   Atrial flutter                                                                             
                                                   Atrial hypertrophy                                                                         
                                                   Atrial natriuretic peptide abnormal                                                        
                                                   Atrial natriuretic peptide increased                                                       
                                                   Atrial parasystole                                                                         
                                                   Atrial pressure increased                                                                  
                                                   Atrial septal defect acquired                                                              
                                                   Atrial tachycardia                                                                         
                                                   Atrial thrombosis                                                                          
                                                   Atrioventricular block                                                                     
                                                   Atrioventricular block complete                                                            
                                                   Atrioventricular block first degree                                                        
                                                   Atrioventricular block second degree                                                       
                                                   Atrioventricular conduction time shortened                                                 
                                                   Atrioventricular dissociation                                                              
                                                   Atrioventricular node dispersion                                                           
                                                   Atrioventricular node dysfunction                                                          
                                                   Autoimmune myocarditis                                                                     
                                                   Axillary vein thrombosis                                                                   
                                                   BRASH syndrome                                                                             
                                                   Balint's syndrome                                                                          
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Basal ganglia haematoma                                                                    
                                                   Basal ganglia haemorrhage                                                                  
                                                   Basal ganglia infarction                                                                   
                                                   Basal ganglia stroke                                                                       
                                                   Baseline foetal heart rate variability disorder                                            
                                                   Basilar artery aneurysm                                                                    
                                                   Basilar artery occlusion                                                                   
                                                   Basilar artery perforation                                                                 
                                                   Basilar artery stenosis                                                                    
                                                   Basilar artery thrombosis                                                                  
                                                   Behcet's syndrome                                                                          
                                                   Bendopnoea                                                                                 
                                                   Bezold-Jarisch reflex                                                                      
                                                   Bifascicular block                                                                         
                                                   Biopsy heart abnormal                                                                      
                                                   Blindness transient                                                                        
                                                   Blood brain barrier defect                                                                 
                                                   Blood creatine phosphokinase MB abnormal                                                   
                                                   Blood creatine phosphokinase MB increased                                                  
                                                   Blood creatine phosphokinase abnormal                                                      
                                                   Blood creatine phosphokinase increased                                                     
                                                   Blood pressure diastolic abnormal                                                          
                                                   Blood pressure diastolic decreased                                                         
                                                   Blood pressure diastolic increased                                                         
                                                   Blood pressure fluctuation                                                                 
                                                   Blood pressure immeasurable                                                                
                                                   Blood pressure inadequately controlled                                                     
                                                   Blood pressure systolic abnormal                                                           
                                                   Blood pressure systolic decreased                                                          
                                                   Blood pressure systolic increased                                                          
                                                   Blood viscosity increased                                                                  
                                                   Bone infarction                                                                            
                                                   Brachiocephalic arteriosclerosis                                                           
                                                   Brachiocephalic artery occlusion                                                           
                                                   Brachiocephalic artery stenosis                                                            
                                                   Brachiocephalic vein occlusion                                                             
                                                   Brachiocephalic vein thrombosis                                                            
                                                   Bradyarrhythmia                                                                            
                                                   Bradycardia                                                                                
                                                   Bradycardia foetal                                                                         
                                                   Bradycardia neonatal                                                                       
                                                   Brain hypoxia                                                                              
                                                   Brain injury                                                                               
.


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Cardiovascular disorders                           Brain natriuretic peptide abnormal                                                         
                                                   Brain natriuretic peptide increased                                                        
                                                   Brain stem embolism                                                                        
                                                   Brain stem haematoma                                                                       
                                                   Brain stem haemorrhage                                                                     
                                                   Brain stem infarction                                                                      
                                                   Brain stem ischaemia                                                                       
                                                   Brain stem microhaemorrhage                                                                
                                                   Brain stem stroke                                                                          
                                                   Brain stem thrombosis                                                                      
                                                   Brain stent insertion                                                                      
                                                   Brugada syndrome                                                                           
                                                   Budd-Chiari syndrome                                                                       
                                                   Bundle branch block                                                                        
                                                   Bundle branch block bilateral                                                              
                                                   Bundle branch block left                                                                   
                                                   Bundle branch block right                                                                  
                                                   CADASIL                                                                                    
                                                   CARASIL syndrome                                                                           
                                                   CSF bilirubin positive                                                                     
                                                   CSF red blood cell count positive                                                          
                                                   CT hypotension complex                                                                     
                                                   Capillaritis                                                                               
                                                   Capsular warning syndrome                                                                  
                                                   Cardiac amyloidosis                                                                        
                                                   Cardiac aneurysm                                                                           
                                                   Cardiac arrest                                                                             
                                                   Cardiac arrest neonatal                                                                    
                                                   Cardiac asthma                                                                             
                                                   Cardiac cirrhosis                                                                          
                                                   Cardiac contractility modulation therapy                                                   
                                                   Cardiac death                                                                              
                                                   Cardiac device reprogramming                                                               
                                                   Cardiac dysfunction                                                                        
                                                   Cardiac electrophysiologic study abnormal                                                  
                                                   Cardiac failure                                                                            
                                                   Cardiac failure acute                                                                      
                                                   Cardiac failure chronic                                                                    
                                                   Cardiac failure congestive                                                                 
                                                   Cardiac failure high output                                                                
                                                   Cardiac fibrillation                                                                       
                                                   Cardiac flutter                                                                            
                                                   Cardiac function test abnormal                                                             
.


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Pre-defined MedDRA search                          Preferred term                                                                             
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Cardiovascular disorders                           Cardiac hypertrophy                                                                        
                                                   Cardiac imaging procedure abnormal                                                         
                                                   Cardiac index abnormal                                                                     
                                                   Cardiac index decreased                                                                    
                                                   Cardiac index increased                                                                    
                                                   Cardiac iron overload                                                                      
                                                   Cardiac monitoring abnormal                                                                
                                                   Cardiac operation                                                                          
                                                   Cardiac output decreased                                                                   
                                                   Cardiac perfusion defect                                                                   
                                                   Cardiac pseudoaneurysm                                                                     
                                                   Cardiac resynchronisation therapy                                                          
                                                   Cardiac sarcoidosis                                                                        
                                                   Cardiac septal hypertrophy                                                                 
                                                   Cardiac stress test abnormal                                                               
                                                   Cardiac telemetry abnormal                                                                 
                                                   Cardiac ventricular scarring                                                               
                                                   Cardiac ventricular thrombosis                                                             
                                                   Cardiac ventriculogram abnormal                                                            
                                                   Cardiac ventriculogram left abnormal                                                       
                                                   Cardiac ventriculogram right abnormal                                                      
                                                   Cardio-respiratory arrest                                                                  
                                                   Cardio-respiratory arrest neonatal                                                         
                                                   Cardio-respiratory distress                                                                
                                                   Cardiogenic shock                                                                          
                                                   Cardiohepatic syndrome                                                                     
                                                   Cardiomegaly                                                                               
                                                   Cardiomyopathy                                                                             
                                                   Cardiomyopathy acute                                                                       
                                                   Cardiomyopathy alcoholic                                                                   
                                                   Cardiomyopathy neonatal                                                                    
                                                   Cardiopulmonary exercise test abnormal                                                     
                                                   Cardiopulmonary failure                                                                    
                                                   Cardiorenal syndrome                                                                       
                                                   Cardiothoracic ratio increased                                                             
                                                   Cardiotoxicity                                                                             
                                                   Cardiovascular disorder                                                                    
                                                   Cardiovascular event prophylaxis                                                           
                                                   Cardiovascular function test abnormal                                                      
                                                   Cardiovascular insufficiency                                                               
                                                   Carotid aneurysm rupture                                                                   
                                                   Carotid angioplasty                                                                        
                                                   Carotid arterial embolus                                                                   
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Cardiovascular disorders
Carotid arteriosclerosis
Carotid artery aneurysm
Carotid artery bypass
Carotid artery disease
Carotid artery dissection
Carotid artery dolichoectasia
Carotid artery insufficiency
Carotid artery occlusion
Carotid artery perforation
Carotid artery restenosis
Carotid artery stenosis
Carotid artery stent insertion
Carotid artery stent removal
Carotid artery thrombosis
Carotid endarterectomy
Carotid revascularisation
Catheter site thrombosis
Catheterisation venous
Cavernous sinus thrombosis
Central bradycardia
Central nervous system haemorrhage
Central nervous system vasculitis
Central pain syndrome
Central venous catheterisation
Central venous pressure increased
Cerebellar artery occlusion
Cerebellar artery thrombosis
Cerebellar embolism
Cerebellar haematoma
Cerebellar haemorrhage
Cerebellar infarction
Cerebellar ischaemia
Cerebellar microhaemorrhage
Cerebellar stroke
Cerebral amyloid angiopathy
Cerebral aneurysm perforation
Cerebral aneurysm ruptured syphilitic  
Cerebral arteriosclerosis
Cerebral arteriovenous malformation haemorrhagic
Cerebral arteritis
Cerebral artery embolism
Cerebral artery occlusion
Cerebral artery perforation
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
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Cardiovascular disorders                           Cerebral artery restenosis                                                                 
                                                   Cerebral artery stenosis                                                                   
                                                   Cerebral artery stent insertion                                                            
                                                   Cerebral artery thrombosis                                                                 
                                                   Cerebral capillary telangiectasia                                                          
                                                   Cerebral cavernous malformation                                                            
                                                   Cerebral circulatory failure                                                               
                                                   Cerebral congestion                                                                        
                                                   Cerebral cyst haemorrhage                                                                  
                                                   Cerebral endovascular aneurysm repair                                                      
                                                   Cerebral gas embolism                                                                      
                                                   Cerebral haematoma                                                                         
                                                   Cerebral haemorrhage                                                                       
                                                   Cerebral haemorrhage foetal                                                                
                                                   Cerebral haemorrhage neonatal                                                              
                                                   Cerebral haemosiderin deposition                                                           
                                                   Cerebral hypoperfusion                                                                     
                                                   Cerebral infarction                                                                        
                                                   Cerebral infarction foetal                                                                 
                                                   Cerebral ischaemia                                                                         
                                                   Cerebral microangiopathy                                                                   
                                                   Cerebral microembolism                                                                     
                                                   Cerebral microhaemorrhage                                                                  
                                                   Cerebral microinfarction                                                                   
                                                   Cerebral reperfusion injury                                                                
                                                   Cerebral revascularisation                                                                 
                                                   Cerebral septic infarct                                                                    
                                                   Cerebral small vessel ischaemic disease                                                    
                                                   Cerebral thrombosis                                                                        
                                                   Cerebral vascular occlusion                                                                
                                                   Cerebral vasoconstriction                                                                  
                                                   Cerebral venous sinus thrombosis                                                           
                                                   Cerebral venous thrombosis                                                                 
                                                   Cerebral ventricular rupture                                                               
                                                   Cerebrospinal thrombotic tamponade                                                         
                                                   Cerebrovascular accident                                                                   
                                                   Cerebrovascular accident prophylaxis                                                       
                                                   Cerebrovascular arteriovenous malformation                                                 
                                                   Cerebrovascular disorder                                                                   
                                                   Cerebrovascular insufficiency                                                              
                                                   Cerebrovascular operation                                                                  
                                                   Cerebrovascular pseudoaneurysm                                                             
                                                   Cerebrovascular stenosis                                                                   
.


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Date: 
04 December 2020 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Cardiovascular disorders
Chagas' cardiomyopathy
Charcot-Bouchard microaneurysms
Chest X-ray abnormal
Chest pain
Choroidal infarction
Chronic cerebrospinal venous insufficiency
Chronic left ventricular failure
Chronic pigmented purpura
Chronic right ventricular failure
Chronotropic incompetence
Coeliac artery occlusion
Cogan's syndrome
Collateral circulation
Compression garment application
Computerised tomogram coronary artery abnormal
Computerised tomogram thorax abnormal
Conduction disorder
Congenital cerebrovascular anomaly 
Congenital hemiparesis
Congenital supraventricular tachycardia
Congestive cardiomyopathy
Congestive hepatopathy
Cor pulmonale
Cor pulmonale acute
Cor pulmonale chronic
Coronary angioplasty
Coronary arterial stent insertion
Coronary artery bypass
Coronary artery compression
Coronary artery disease
Coronary artery dissection
Coronary artery embolism
Coronary artery insufficiency
Coronary artery occlusion
Coronary artery reocclusion
Coronary artery restenosis
Coronary artery stenosis
Coronary artery surgery
Coronary artery thrombosis
Coronary brachytherapy
Coronary bypass stenosis
Coronary bypass thrombosis
Coronary endarterectomy
.


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Date: 
04 December 2020 
Status: 
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Pre-defined MedDRA search                          Preferred term                                                                             
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Cardiovascular disorders                           Coronary no-reflow phenomenon                                                              
                                                   Coronary ostial stenosis                                                                   
                                                   Coronary revascularisation                                                                 
                                                   Coronary sinus dilatation                                                                  
                                                   Coronary steal syndrome                                                                    
                                                   Coronary vascular graft occlusion                                                          
                                                   Coronary vascular graft stenosis                                                           
                                                   Coxsackie carditis                                                                         
                                                   Coxsackie myocarditis                                                                      
                                                   Cryoglobulinaemia                                                                          
                                                   Cryoglobulins present                                                                      
                                                   Cytomegalovirus myocarditis                                                                
                                                   Decreased ventricular preload                                                              
                                                   Deep vein thrombosis                                                                       
                                                   Deep vein thrombosis postoperative                                                         
                                                   Defect conduction intraventricular                                                         
                                                   Delayed ischaemic neurological deficit                                                     
                                                   Device embolisation                                                                        
                                                   Device occlusion                                                                           
                                                   Device related thrombosis                                                                  
                                                   Diabetic arteritis                                                                         
                                                   Diabetic cardiomyopathy                                                                    
                                                   Diabetic coronary microangiopathy                                                          
                                                   Diastolic dysfunction                                                                      
                                                   Diffuse vasculitis                                                                         
                                                   Dilatation atrial                                                                          
                                                   Dilatation ventricular                                                                     
                                                   Diplegia                                                                                   
                                                   Directional Doppler flow tests abnormal                                                    
                                                   Disseminated intravascular coagulation                                                     
                                                   Disseminated intravascular coagulation in newborn                                          
                                                   Dural arteriovenous fistula                                                                
                                                   Dysarthria                                                                                 
                                                   Dyspnoea                                                                                   
                                                   Dyspnoea paroxysmal nocturnal                                                              
                                                   ECG P wave inverted                                                                        
                                                   ECG electrically inactive area                                                             
                                                   ECG signs of myocardial infarction                                                         
                                                   ECG signs of myocardial ischaemia                                                          
                                                   ECG signs of ventricular hypertrophy                                                       
                                                   Echocardiogram abnormal                                                                    
                                                   Ejection fraction abnormal                                                                 
                                                   Ejection fraction decreased                                                                
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
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Cardiovascular disorders                           Elastic vessel recoil complication                                                         
                                                   Electrocardiogram P wave abnormal                                                          
                                                   Electrocardiogram PR prolongation                                                          
                                                   Electrocardiogram PR segment depression                                                    
                                                   Electrocardiogram PR shortened                                                             
                                                   Electrocardiogram Q wave abnormal                                                          
                                                   Electrocardiogram QRS complex prolonged                                                    
                                                   Electrocardiogram QT interval abnormal                                                     
                                                   Electrocardiogram QT prolonged                                                             
                                                   Electrocardiogram RR interval prolonged                                                    
                                                   Electrocardiogram ST segment abnormal                                                      
                                                   Electrocardiogram ST segment depression                                                    
                                                   Electrocardiogram ST segment elevation                                                     
                                                   Electrocardiogram ST-T segment abnormal                                                    
                                                   Electrocardiogram ST-T segment depression                                                  
                                                   Electrocardiogram ST-T segment elevation                                                   
                                                   Electrocardiogram T wave abnormal                                                          
                                                   Electrocardiogram T wave inversion                                                         
                                                   Electrocardiogram U wave inversion                                                         
                                                   Electrocardiogram U wave present                                                           
                                                   Electrocardiogram U-wave abnormality                                                       
                                                   Electrocardiogram abnormal                                                                 
                                                   Electrocardiogram ambulatory abnormal                                                      
                                                   Electrocardiogram change                                                                   
                                                   Electrocardiogram delta waves abnormal                                                     
                                                   Electrocardiogram repolarisation abnormality                                               
                                                   Embolia cutis medicamentosa                                                                
                                                   Embolic cerebellar infarction                                                              
                                                   Embolic cerebral infarction                                                                
                                                   Embolic pneumonia                                                                          
                                                   Embolic stroke                                                                             
                                                   Embolism                                                                                   
                                                   Embolism arterial                                                                          
                                                   Embolism venous                                                                            
                                                   Endarterectomy                                                                             
                                                   Endocardial fibroelastosis                                                                 
                                                   Endotoxic shock                                                                            
                                                   Enterovirus myocarditis                                                                    
                                                   Eosinophilic myocarditis                                                                   
                                                   Epidural haemorrhage                                                                       
                                                   Erythema induratum                                                                         
                                                   Exercise electrocardiogram abnormal                                                        
                                                   Exercise test abnormal                                                                     
.


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Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Pre-defined MedDRA search                          Preferred term                                                                             
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Cardiovascular disorders                           External counterpulsation                                                                  
                                                   Extra-axial haemorrhage                                                                    
                                                   Extradural haematoma                                                                       
                                                   Extradural haematoma evacuation                                                            
                                                   Extraischaemic cerebral haematoma                                                          
                                                   Extrasystoles                                                                              
                                                   Eye infarction                                                                             
                                                   Femoral artery embolism                                                                    
                                                   Fluorescence angiogram abnormal                                                            
                                                   Foetal arrhythmia                                                                          
                                                   Foetal cerebrovascular disorder                                                            
                                                   Foetal heart rate acceleration abnormality                                                 
                                                   Foetal heart rate deceleration abnormality                                                 
                                                   Foetal heart rate disorder                                                                 
                                                   Foetal tachyarrhythmia                                                                     
                                                   Foville syndrome                                                                           
                                                   Frederick's syndrome                                                                       
                                                   Giant cell myocarditis                                                                     
                                                   Gonococcal heart disease                                                                   
                                                   Goodpasture's syndrome                                                                     
                                                   Graft thrombosis                                                                           
                                                   Granulomatosis with polyangiitis                                                           
                                                   Grey syndrome neonatal                                                                     
                                                   HIV cardiomyopathy                                                                         
                                                   Haemorrhage coronary artery                                                                
                                                   Haemorrhage intracranial                                                                   
                                                   Haemorrhagic adrenal infarction                                                            
                                                   Haemorrhagic cerebral infarction                                                           
                                                   Haemorrhagic infarction                                                                    
                                                   Haemorrhagic stroke                                                                        
                                                   Haemorrhagic transformation stroke                                                         
                                                   Haemorrhagic vasculitis                                                                    
                                                   Haemorrhoids thrombosed                                                                    
                                                   Heart alternation                                                                          
                                                   Heart and lung transplant                                                                  
                                                   Heart block congenital                                                                     
                                                   Heart rate abnormal                                                                        
                                                   Heart rate decreased                                                                       
                                                   Heart rate increased                                                                       
                                                   Heart rate irregular                                                                       
                                                   Heart transplant                                                                           
                                                   Hemianaesthesia                                                                            
                                                   Hemiasomatognosia                                                                          
.


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Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Cardiovascular disorders                           Hemiataxia                                                                                 
                                                   Hemidysaesthesia                                                                           
                                                   Hemihyperaesthesia                                                                         
                                                   Hemiparaesthesia                                                                           
                                                   Hemiparesis                                                                                
                                                   Hemiplegia                                                                                 
                                                   Hepatic artery embolism                                                                    
                                                   Hepatic artery occlusion                                                                   
                                                   Hepatic artery thrombosis                                                                  
                                                   Hepatic infarction                                                                         
                                                   Hepatic vascular thrombosis                                                                
                                                   Hepatic vein dilatation                                                                    
                                                   Hepatic vein embolism                                                                      
                                                   Hepatic vein occlusion                                                                     
                                                   Hepatic vein thrombosis                                                                    
                                                   Hepatojugular reflux                                                                       
                                                   Hepatomegaly                                                                               
                                                   Hepatorenal failure                                                                        
                                                   Holiday heart syndrome                                                                     
                                                   Homans' sign positive                                                                      
                                                   Hunt and Hess scale                                                                        
                                                   Hyperdynamic left ventricle                                                                
                                                   Hypertensive cardiomyopathy                                                                
                                                   Hypertensive cerebrovascular disease                                                       
                                                   Hypertrophic cardiomyopathy                                                                
                                                   Hypoperfusion                                                                              
                                                   Hypotensive crisis                                                                         
                                                   Hypothenar hammer syndrome                                                                 
                                                   Hypovolaemic shock                                                                         
                                                   Hypoxic-ischaemic encephalopathy                                                           
                                                   Iliac artery embolism                                                                      
                                                   Iliac artery occlusion                                                                     
                                                   Iliac vein occlusion                                                                       
                                                   Immune-mediated myocarditis                                                                
                                                   Implant site thrombosis                                                                    
                                                   Implantable cardiac monitor replacement                                                    
                                                   Incision site vessel occlusion                                                             
                                                   Increased ventricular preload                                                              
                                                   Infarction                                                                                 
                                                   Inferior vena cava syndrome                                                                
                                                   Inferior vena caval occlusion                                                              
                                                   Infusion site thrombosis                                                                   
                                                   Injection site thrombosis                                                                  
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Cardiovascular disorders                           Inner ear infarction                                                                       
                                                   Instillation site thrombosis                                                               
                                                   Internal capsule infarction                                                                
                                                   Internal carotid artery deformity                                                          
                                                   Intestinal infarction                                                                      
                                                   Intra-aortic balloon placement                                                             
                                                   Intra-cerebral aneurysm operation                                                          
                                                   Intracardiac mass                                                                          
                                                   Intracardiac pressure increased                                                            
                                                   Intracardiac thrombus                                                                      
                                                   Intracerebral haematoma evacuation                                                         
                                                   Intracranial aneurysm                                                                      
                                                   Intracranial artery dissection                                                             
                                                   Intracranial haematoma                                                                     
                                                   Intracranial tumour haemorrhage                                                            
                                                   Intraoperative cerebral artery occlusion                                                   
                                                   Intraventricular haemorrhage                                                               
                                                   Intraventricular haemorrhage neonatal                                                      
                                                   Irregular breathing                                                                        
                                                   Ischaemic cardiomyopathy                                                                   
                                                   Ischaemic cerebral infarction                                                              
                                                   Ischaemic mitral regurgitation                                                             
                                                   Ischaemic stroke                                                                           
                                                   Jugular vein distension                                                                    
                                                   Jugular vein embolism                                                                      
                                                   Jugular vein occlusion                                                                     
                                                   Jugular vein thrombosis                                                                    
                                                   Junctional ectopic tachycardia                                                             
                                                   Kawasaki's disease                                                                         
                                                   Labile blood pressure                                                                      
                                                   Lacunar infarction                                                                         
                                                   Lacunar stroke                                                                             
                                                   Lambl's excrescences                                                                       
                                                   Langerhans' cell histiocytosis                                                             
                                                   Lateral medullary syndrome                                                                 
                                                   Lateropulsion                                                                              
                                                   Left atrial dilatation                                                                     
                                                   Left atrial enlargement                                                                    
                                                   Left atrial volume abnormal                                                                
                                                   Left atrial volume decreased                                                               
                                                   Left atrial volume increased                                                               
                                                   Left ventricular diastolic collapse                                                        
                                                   Left ventricular dilatation                                                                
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Left ventricular dysfunction                                                               
                                                   Left ventricular end-diastolic pressure decreased                                          
                                                   Left ventricular enlargement                                                               
                                                   Left ventricular failure                                                                   
                                                   Left ventricular heave                                                                     
                                                   Lenegre's disease                                                                          
                                                   Leriche syndrome                                                                           
                                                   Long QT syndrome                                                                           
                                                   Long QT syndrome congenital                                                                
                                                   Loss of consciousness                                                                      
                                                   Low cardiac output syndrome                                                                
                                                   Lower respiratory tract congestion                                                         
                                                   Lown-Ganong-Levine syndrome                                                                
                                                   Lung opacity                                                                               
                                                   Lupus myocarditis                                                                          
                                                   Lupus vasculitis                                                                           
                                                   Lyme carditis                                                                              
                                                   MAGIC syndrome                                                                             
                                                   Magnetic resonance imaging thoracic abnormal                                               
                                                   Mahler sign                                                                                
                                                   Malarial myocarditis                                                                       
                                                   May-Thurner syndrome                                                                       
                                                   Medical device site thrombosis                                                             
                                                   Medical device site vasculitis                                                             
                                                   Meningorrhagia                                                                             
                                                   Mental status changes                                                                      
                                                   Mesenteric arterial occlusion                                                              
                                                   Mesenteric arteriosclerosis                                                                
                                                   Mesenteric artery embolism                                                                 
                                                   Mesenteric artery stenosis                                                                 
                                                   Mesenteric artery stent insertion                                                          
                                                   Mesenteric artery thrombosis                                                               
                                                   Mesenteric vascular insufficiency                                                          
                                                   Mesenteric vascular occlusion                                                              
                                                   Mesenteric vein thrombosis                                                                 
                                                   Mesenteric venous occlusion                                                                
                                                   Metabolic cardiomyopathy                                                                   
                                                   Microembolism                                                                              
                                                   Microscopic polyangiitis                                                                   
                                                   Microvascular coronary artery disease                                                      
                                                   Migrainous infarction                                                                      
                                                   Millard-Gubler syndrome                                                                    
                                                   Modified Rankin score decreased                                                            
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Modified Rankin score increased                                                            
                                                   Monoparesis                                                                                
                                                   Monoplegia                                                                                 
                                                   Moyamoya disease                                                                           
                                                   Multiple gated acquisition scan abnormal                                                   
                                                   Multiple organ dysfunction syndrome                                                        
                                                   Myocardiac abscess                                                                         
                                                   Myocardial calcification                                                                   
                                                   Myocardial depression                                                                      
                                                   Myocardial fibrosis                                                                        
                                                   Myocardial haemorrhage                                                                     
                                                   Myocardial hypoperfusion                                                                   
                                                   Myocardial hypoxia                                                                         
                                                   Myocardial infarction                                                                      
                                                   Myocardial ischaemia                                                                       
                                                   Myocardial necrosis                                                                        
                                                   Myocardial necrosis marker increased                                                       
                                                   Myocardial reperfusion injury                                                              
                                                   Myocardial stunning                                                                        
                                                   Myocarditis                                                                                
                                                   Myocarditis bacterial                                                                      
                                                   Myocarditis helminthic                                                                     
                                                   Myocarditis infectious                                                                     
                                                   Myocarditis meningococcal                                                                  
                                                   Myocarditis mycotic                                                                        
                                                   Myocarditis post infection                                                                 
                                                   Myocarditis septic                                                                         
                                                   Myocarditis syphilitic                                                                     
                                                   Myocarditis toxoplasmal                                                                    
                                                   Myoglobinaemia                                                                             
                                                   Myoglobinuria                                                                              
                                                   N-terminal prohormone brain natriuretic peptide                                            
                                                   abnormal                                                                                   
                                                   N-terminal prohormone brain natriuretic peptide                                            
                                                   increased                                                                                  
                                                   NIH stroke scale abnormal                                                                  
                                                   NIH stroke scale score decreased                                                           
                                                   NIH stroke scale score increased                                                           
                                                   Neonatal bradyarrhythmia                                                                   
                                                   Neonatal cardiac failure                                                                   
                                                   Neonatal multi-organ failure                                                               
                                                   Neonatal respiratory failure                                                               
                                                   Neonatal sinus bradycardia                                                                 
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Neonatal sinus tachycardia                                                                 
                                                   Neonatal tachyarrhythmia                                                                   
                                                   Neonatal tachycardia                                                                       
                                                   Neurogenic shock                                                                           
                                                   Nocturia                                                                                   
                                                   Nocturnal dyspnoea                                                                         
                                                   Nodal arrhythmia                                                                           
                                                   Nodal rhythm                                                                               
                                                   Nodular vasculitis                                                                         
                                                   Non-obstructive cardiomyopathy                                                             
                                                   Nonreassuring foetal heart rate pattern                                                    
                                                   Obesity cardiomyopathy                                                                     
                                                   Obstetrical pulmonary embolism                                                             
                                                   Obstructive shock                                                                          
                                                   Ocular vasculitis                                                                          
                                                   Oedema                                                                                     
                                                   Oedema blister                                                                             
                                                   Oedema due to cardiac disease                                                              
                                                   Oedema neonatal                                                                            
                                                   Oedema peripheral                                                                          
                                                   Ophthalmic artery thrombosis                                                               
                                                   Ophthalmic vein thrombosis                                                                 
                                                   Optic nerve infarction                                                                     
                                                   Organ failure                                                                              
                                                   Orthopnoea                                                                                 
                                                   Orthostatic hypotension                                                                    
                                                   Ovarian vein thrombosis                                                                    
                                                   Pacemaker generated arrhythmia                                                             
                                                   Pacemaker syndrome                                                                         
                                                   Paget-Schroetter syndrome                                                                  
                                                   Palpitations                                                                               
                                                   Pancreatic infarction                                                                      
                                                   Papillary muscle disorder                                                                  
                                                   Papillary muscle haemorrhage                                                               
                                                   Papillary muscle infarction                                                                
                                                   Paradoxical embolism                                                                       
                                                   Paralysis                                                                                  
                                                   Paraneoplastic thrombosis                                                                  
                                                   Paraparesis                                                                                
                                                   Paraplegia                                                                                 
                                                   Parasystole                                                                                
                                                   Paresis                                                                                    
                                                   Paroxysmal arrhythmia                                                                      
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Cardiovascular disorders
Paroxysmal atrioventricular block
Pelvic venous thrombosis
Penile artery occlusion
Penile vein thrombosis
Percutaneous coronary intervention
Perinatal stroke
Peripartum cardiomyopathy
Peripheral arterial occlusive disease
Peripheral arterial reocclusion
Peripheral artery angioplasty
Peripheral artery bypass
Peripheral artery occlusion
Peripheral artery stent insertion
Peripheral artery surgery
Peripheral artery thrombosis
Peripheral embolism
Peripheral endarterectomy
Peripheral oedema neonatal
Peripheral revascularisation
Peripheral swelling
Peripheral vein occlusion
Peripheral vein thrombus extension
Periprocedural myocardial infarction
Periventricular haemorrhage neonatal
Phlebectomy
Pituitary apoplexy
Pituitary haemorrhage
Pituitary infarction
Placental infarction
Plasma viscosity abnormal
Pneumatic compression therapy
Polyarteritis nodosa
Polymyalgia rheumatica
Popliteal artery entrapment syndrome
Portal shunt procedure
Portal vein cavernous transformation
Portal vein embolism
Portal vein occlusion
Portal vein thrombosis
Portosplenomesenteric venous thrombosis
Post angioplasty restenosis
Post cardiac arrest syndrome
Post procedural myocardial infarction
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Post procedural pulmonary embolism                                                         
                                                   Post procedural stroke                                                                     
                                                   Post stroke depression                                                                     
                                                   Post thrombotic syndrome                                                                   
                                                   Posthaemorrhagic hydrocephalus                                                             
                                                   Postinfarction angina                                                                      
                                                   Postoperative thrombosis                                                                   
                                                   Postpartum thrombosis                                                                      
                                                   Postpartum venous thrombosis                                                               
                                                   Precerebral arteriosclerosis                                                               
                                                   Precerebral artery occlusion                                                               
                                                   Precerebral artery thrombosis                                                              
                                                   Primary familial brain calcification                                                       
                                                   Prinzmetal angina                                                                          
                                                   Profundaplasty                                                                             
                                                   Prohormone brain natriuretic peptide abnormal                                              
                                                   Prohormone brain natriuretic peptide increased                                             
                                                   Propofol infusion syndrome                                                                 
                                                   Prosthetic cardiac valve thrombosis                                                        
                                                   Prosthetic vessel implantation                                                             
                                                   Pseudovasculitis                                                                           
                                                   Pulmonary arterial wedge pressure increased                                                
                                                   Pulmonary artery occlusion                                                                 
                                                   Pulmonary artery therapeutic procedure                                                     
                                                   Pulmonary artery thrombosis                                                                
                                                   Pulmonary congestion                                                                       
                                                   Pulmonary embolism                                                                         
                                                   Pulmonary endarterectomy                                                                   
                                                   Pulmonary infarction                                                                       
                                                   Pulmonary microemboli                                                                      
                                                   Pulmonary oedema                                                                           
                                                   Pulmonary oedema neonatal                                                                  
                                                   Pulmonary thrombosis                                                                       
                                                   Pulmonary tumour thrombotic microangiopathy                                                
                                                   Pulmonary vasculitis                                                                       
                                                   Pulmonary vein occlusion                                                                   
                                                   Pulmonary veno-occlusive disease                                                           
                                                   Pulmonary venous thrombosis                                                                
                                                   Pulse absent                                                                               
                                                   Pulseless electrical activity                                                              
                                                   Putamen haemorrhage                                                                        
                                                   Quadriparesis                                                                              
                                                   Quadriplegia                                                                               
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Cardiovascular disorders
Radiation associated cardiac failure
Radiation myocarditis
Radiation vasculitis
Rebound tachycardia
Renal arteritis
Renal artery angioplasty
Renal artery occlusion
Renal artery thrombosis
Renal embolism
Renal infarct
Renal vascular thrombosis
Renal vasculitis
Renal vein embolism
Renal vein occlusion
Renal vein thrombosis
Reperfusion arrhythmia
Respiratory failure
Respiratory sinus arrhythmia magnitude abnormal
Respiratory sinus arrhythmia magnitude decreased
Respiratory sinus arrhythmia magnitude increased
Restenosis
Restrictive cardiomyopathy
Retinal artery embolism
Retinal artery occlusion
Retinal artery thrombosis
Retinal infarction
Retinal vascular thrombosis
Retinal vasculitis
Retinal vein occlusion
Retinal vein thrombosis
Retrograde p-waves
Revascularisation procedure
Reversible cerebral vasoconstriction syndrome
Reversible ischaemic neurological deficit
Rheumatoid vasculitis
Rhythm idioventricular
Right atrial dilatation
Right atrial enlargement
Right atrial pressure increased
Right hemisphere deficit syndrome
Right ventricle outflow tract obstruction
Right ventricular diastolic collapse
Right ventricular dilatation
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Right ventricular dysfunction                                                              
                                                   Right ventricular ejection fraction decreased                                              
                                                   Right ventricular enlargement                                                              
                                                   Right ventricular failure                                                                  
                                                   Right ventricular heave                                                                    
                                                   Right ventricular systolic pressure decreased                                              
                                                   Ruptured cerebral aneurysm                                                                 
                                                   SI QIII TIII pattern                                                                       
                                                   Scan myocardial perfusion abnormal                                                         
                                                   Segmented hyalinising vasculitis                                                           
                                                   Septic pulmonary embolism                                                                  
                                                   Septic shock                                                                               
                                                   Shock haemorrhagic                                                                         
                                                   Shock hypoglycaemic                                                                        
                                                   Shunt occlusion                                                                            
                                                   Shunt thrombosis                                                                           
                                                   Silent myocardial infarction                                                               
                                                   Sinoatrial block                                                                           
                                                   Sinus arrest                                                                               
                                                   Sinus arrhythmia                                                                           
                                                   Sinus bradycardia                                                                          
                                                   Sinus node dysfunction                                                                     
                                                   Sinus tachycardia                                                                          
                                                   Sneddon's syndrome                                                                         
                                                   Spinal artery embolism                                                                     
                                                   Spinal artery thrombosis                                                                   
                                                   Spinal cord haematoma                                                                      
                                                   Spinal cord haemorrhage                                                                    
                                                   Spinal cord infarction                                                                     
                                                   Spinal cord ischaemia                                                                      
                                                   Spinal epidural haematoma                                                                  
                                                   Spinal epidural haemorrhage                                                                
                                                   Spinal stroke                                                                              
                                                   Spinal subarachnoid haemorrhage                                                            
                                                   Spinal subdural haematoma                                                                  
                                                   Spinal subdural haemorrhage                                                                
                                                   Spinal vascular disorder                                                                   
                                                   Spinal vessel congenital anomaly                                                           
                                                   Splenic artery thrombosis                                                                  
                                                   Splenic embolism                                                                           
                                                   Splenic infarction                                                                         
                                                   Splenic thrombosis                                                                         
                                                   Splenic vein occlusion                                                                     
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Splenic vein thrombosis                                                                    
                                                   Stoma site thrombosis                                                                      
                                                   Stress cardiomyopathy                                                                      
                                                   Stress echocardiogram abnormal                                                             
                                                   Stroke in evolution                                                                        
                                                   Stroke volume decreased                                                                    
                                                   Subarachnoid haematoma                                                                     
                                                   Subarachnoid haemorrhage                                                                   
                                                   Subarachnoid haemorrhage neonatal                                                          
                                                   Subclavian artery embolism                                                                 
                                                   Subclavian artery occlusion                                                                
                                                   Subclavian artery thrombosis                                                               
                                                   Subclavian coronary steal syndrome                                                         
                                                   Subclavian steal syndrome                                                                  
                                                   Subclavian vein occlusion                                                                  
                                                   Subclavian vein thrombosis                                                                 
                                                   Subdural haematoma                                                                         
                                                   Subdural haematoma evacuation                                                              
                                                   Subdural haemorrhage                                                                       
                                                   Subdural haemorrhage neonatal                                                              
                                                   Subendocardial haemorrhage                                                                 
                                                   Subendocardial ischaemia                                                                   
                                                   Sudden cardiac death                                                                       
                                                   Sudden death                                                                               
                                                   Superficial siderosis of central nervous system                                            
                                                   Superior sagittal sinus thrombosis                                                         
                                                   Superior vena cava occlusion                                                               
                                                   Superior vena cava syndrome                                                                
                                                   Supraventricular extrasystoles                                                             
                                                   Supraventricular tachyarrhythmia                                                           
                                                   Supraventricular tachycardia                                                               
                                                   Surgical vascular shunt                                                                    
                                                   Surgical ventricular restoration                                                           
                                                   Susac's syndrome                                                                           
                                                   Syncope                                                                                    
                                                   Systolic anterior motion of mitral valve                                                   
                                                   Systolic dysfunction                                                                       
                                                   Tachyarrhythmia                                                                            
                                                   Tachycardia                                                                                
                                                   Tachycardia foetal                                                                         
                                                   Tachycardia induced cardiomyopathy                                                         
                                                   Tachycardia paroxysmal                                                                     
                                                   Takayasu's arteritis                                                                       
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Temporal arteritis                                                                         
                                                   Testicular infarction                                                                      
                                                   Thalamic infarction                                                                        
                                                   Thalamus haemorrhage                                                                       
                                                   Thrombectomy                                                                               
                                                   Thromboangiitis obliterans                                                                 
                                                   Thromboembolectomy                                                                         
                                                   Thrombolysis                                                                               
                                                   Thrombophlebitis                                                                           
                                                   Thrombophlebitis migrans                                                                   
                                                   Thrombophlebitis neonatal                                                                  
                                                   Thrombophlebitis superficial                                                               
                                                   Thrombosed varicose vein                                                                   
                                                   Thrombosis                                                                                 
                                                   Thrombosis corpora cavernosa                                                               
                                                   Thrombosis in device                                                                       
                                                   Thrombosis mesenteric vessel                                                               
                                                   Thrombosis prophylaxis                                                                     
                                                   Thrombotic cerebral infarction                                                             
                                                   Thrombotic microangiopathy                                                                 
                                                   Thrombotic stroke                                                                          
                                                   Thrombotic thrombocytopenic purpura                                                        
                                                   Thyroid infarction                                                                         
                                                   Thyrotoxic cardiomyopathy                                                                  
                                                   Torsade de pointes                                                                         
                                                   Toxic cardiomyopathy                                                                       
                                                   Toxic shock syndrome                                                                       
                                                   Toxic shock syndrome staphylococcal                                                        
                                                   Toxic shock syndrome streptococcal                                                         
                                                   Transient ischaemic attack                                                                 
                                                   Transverse sinus thrombosis                                                                
                                                   Trifascicular block                                                                        
                                                   Troponin I increased                                                                       
                                                   Troponin T increased                                                                       
                                                   Troponin increased                                                                         
                                                   Truncus coeliacus thrombosis                                                               
                                                   Tumour embolism                                                                            
                                                   Tumour thrombectomy                                                                        
                                                   Tumour thrombosis                                                                          
                                                   Type 2 lepra reaction                                                                      
                                                   Ultrasonic angiogram abnormal                                                              
                                                   Ultrasound Doppler abnormal                                                                
                                                   Umbilical cord occlusion                                                                   
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Cardiovascular disorders
Umbilical cord thrombosis
Vaccination site thrombosis
Vascular access site thrombosis
Vascular device occlusion
Vascular encephalopathy
Vascular graft
Vascular graft occlusion
Vascular graft thrombosis
Vascular operation
Vascular pseudoaneurysm thrombosis
Vascular purpura
Vascular resistance pulmonary increased
Vascular stent insertion
Vascular stent occlusion
Vascular stent stenosis
Vascular stent thrombosis
Vasculitis
Vasculitis gastrointestinal
Vasculitis necrotising
Vasodilation procedure
Vein of Galen aneurysmal malformation
Vena cava embolism
Vena cava filter insertion
Vena cava filter removal
Vena cava thrombosis
Venogram abnormal
Venoocclusive disease
Venoocclusive liver disease
Venous angioplasty
Venous occlusion
Venous operation
Venous pressure increased
Venous pressure jugular abnormal
Venous pressure jugular increased
Venous recanalisation
Venous repair
Venous stent insertion
Venous thrombosis
Venous thrombosis in pregnancy
Venous thrombosis limb
Venous thrombosis neonatal
Ventricular arrhythmia
Ventricular assist device insertion
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Cardiovascular disorders                           Ventricular asystole                                                                       
                                                   Ventricular compliance decreased                                                           
                                                   Ventricular dysfunction                                                                    
                                                   Ventricular dyskinesia                                                                     
                                                   Ventricular dyssynchrony                                                                   
                                                   Ventricular enlargement                                                                    
                                                   Ventricular extrasystoles                                                                  
                                                   Ventricular failure                                                                        
                                                   Ventricular fibrillation                                                                   
                                                   Ventricular flutter                                                                        
                                                   Ventricular hyperkinesia                                                                   
                                                   Ventricular hypertrophy                                                                    
                                                   Ventricular hypokinesia                                                                    
                                                   Ventricular parasystole                                                                    
                                                   Ventricular pre-excitation                                                                 
                                                   Ventricular remodelling                                                                    
                                                   Ventricular septal defect acquired                                                         
                                                   Ventricular tachyarrhythmia                                                                
                                                   Ventricular tachycardia                                                                    
                                                   Vertebral artery aneurysm                                                                  
                                                   Vertebral artery dissection                                                                
                                                   Vertebral artery occlusion                                                                 
                                                   Vertebral artery perforation                                                               
                                                   Vertebral artery stenosis                                                                  
                                                   Vertebral artery thrombosis                                                                
                                                   Vertebrobasilar dolichoectasia                                                             
                                                   Vertebrobasilar insufficiency                                                              
                                                   Vertebrobasilar stroke                                                                     
                                                   Vessel puncture site occlusion                                                             
                                                   Vessel puncture site thrombosis                                                            
                                                   Viral cardiomyopathy                                                                       
                                                   Viral myocarditis                                                                          
                                                   Viral vasculitis                                                                           
                                                   Visceral venous thrombosis                                                                 
                                                   Visual acuity reduced transiently                                                          
                                                   Visual agnosia                                                                             
                                                   Visual midline shift syndrome                                                              
                                                   Wall motion score index abnormal                                                           
                                                   Wandering pacemaker                                                                        
                                                   Wellens' syndrome                                                                          
                                                   Withdrawal arrhythmia                                                                      
                                                   Wolff-Parkinson-White syndrome                                                             
                                                   Wolff-Parkinson-White syndrome congenital                                                  
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Diabetic retinopathy adverse events                Amaurosis                                                                                  
                                                   Visual acuity reduced transiently                                                          
                                                   Cystoid macular oedema                                                                     
                                                   Diabetic blindness                                                                         
                                                   Diabetic eye disease                                                                       
                                                   Diabetic glaucoma                                                                          
                                                   Diabetic retinal oedema                                                                    
                                                   Diabetic retinopathy                                                                       
                                                   Diabetic uveitis                                                                           
                                                   Exudative retinopathy                                                                      
                                                   Macular ischaemia                                                                          
                                                   Macular oedema                                                                             
                                                   Macular opacity                                                                            
                                                   Macular pseudohole                                                                         
                                                   Maculopathy                                                                                
                                                   Night blindness                                                                            
                                                   Papilloedema                                                                               
                                                   Papillophlebitis                                                                           
                                                   Retinal deposits                                                                           
                                                   Retinal detachment                                                                         
                                                   Retinal exudates                                                                           
                                                   Retinal haemorrhage                                                                        
                                                   Retinal ischaemia                                                                          
                                                   Retinal neovascularisation                                                                 
                                                   Retinal oedema                                                                             
                                                   Retinal pallor                                                                             
                                                   Retinal vascular occlusion                                                                 
                                                   Retinopathy                                                                                
                                                   Retinopathy proliferative                                                                  
                                                   Sudden visual loss                                                                         
                                                   Visual acuity reduced                                                                      
                                                   Vitreal cells                                                                              
                                                   Vitreous detachment                                                                        
                                                   Vitreous haemorrhage                                                                       
                                                   Vitreous opacities                                                                         
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Bile output abnormal                                                                       
search (SMQ)                                                                                                                                  
                                                   Bile output decreased                                                                      
                                                   Biliary ascites                                                                            
                                                   Biliary cirrhosis                                                                          
                                                   Biliary fibrosis                                                                           
                                                   Bilirubin conjugated abnormal                                                              
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Bilirubin conjugated increased                                                             
search (SMQ)                                                                                                                                  
                                                   Bilirubin excretion disorder                                                               
                                                   Blood bilirubin abnormal                                                                   
                                                   Blood bilirubin increased                                                                  
                                                   Cholestasis                                                                                
                                                   Gallbladder varices                                                                        
                                                   Hepatitis cholestatic                                                                      
                                                   Hepatobiliary disease                                                                      
                                                   Hyperbilirubinaemia                                                                        
                                                   Immune-mediated cholangitis                                                                
                                                   Jaundice                                                                                   
                                                   Jaundice cholestatic                                                                       
                                                   Parenteral nutrition associated liver disease                                              
                                                   Primary biliary cholangitis                                                                
                                                   Reynold's syndrome                                                                         
                                                   X-ray hepatobiliary abnormal                                                               
                                                   Allergic hepatitis                                                                         
                                                   Ascites                                                                                    
                                                   Cardiohepatic syndrome                                                                     
                                                   Congestive hepatopathy                                                                     
                                                   Hepatomegaly                                                                               
                                                   Hepatorenal failure                                                                        
                                                   Portal shunt procedure                                                                     
                                                   Portal vein cavernous transformation                                                       
                                                   5'nucleotidase increased                                                                   
                                                   AST/ALT ratio abnormal                                                                     
                                                   Acquired antithrombin III deficiency                                                       
                                                   Acquired factor IX deficiency                                                              
                                                   Acquired factor VIII deficiency                                                            
                                                   Acquired factor XI deficiency                                                              
                                                   Acquired hepatocerebral degeneration                                                       
                                                   Acquired protein S deficiency                                                              
                                                   Acute graft versus host disease in liver                                                   
                                                   Acute hepatic failure                                                                      
                                                   Acute on chronic liver failure                                                             
                                                   Acute yellow liver atrophy                                                                 
                                                   Alanine aminotransferase abnormal                                                          
                                                   Alanine aminotransferase increased                                                         
                                                   Alloimmune hepatitis                                                                       
                                                   Ammonia abnormal                                                                           
                                                   Ammonia increased                                                                          
                                                   Anorectal varices                                                                          
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Drug related hepatic disorders - comprehensive
Anorectal varices haemorrhage
search (SMQ)
Anti factor X activity abnormal
Anti factor X activity decreased
Anti factor X activity increased
Antithrombin III decreased
Aspartate aminotransferase abnormal
Aspartate aminotransferase increased
Asterixis
Autoimmune hepatitis
Bacterascites
Benign hepatic neoplasm
Benign hepatobiliary neoplasm
Bilirubin urine present
Biopsy liver abnormal
Blood alkaline phosphatase abnormal
Blood alkaline phosphatase increased
Blood bilirubin unconjugated increased
Blood cholinesterase abnormal
Blood cholinesterase decreased
Blood fibrinogen abnormal
Blood fibrinogen decreased
Blood thrombin abnormal
Blood thrombin decreased
Blood thromboplastin abnormal
Blood thromboplastin decreased
Bromosulphthalein test abnormal
Child-Pugh-Turcotte score abnormal 
Child-Pugh-Turcotte score increased
Cholaemia
Cholangiosarcoma
Cholestatic liver injury
Cholestatic pruritus
Chronic graft versus host disease in liver
Chronic hepatic failure
Chronic hepatitis
Coagulation factor IX level abnormal 
Coagulation factor IX level decreased
Coagulation factor V level abnormal
Coagulation factor V level decreased
Coagulation factor VII level abnormal
Coagulation factor VII level decreased
Coagulation factor X level abnormal
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Coagulation factor X level decreased                                                       
search (SMQ)                                                                                                                                  
                                                   Coagulation factor decreased                                                               
                                                   Coma hepatic                                                                               
                                                   Complications of transplanted liver                                                        
                                                   Computerised tomogram liver abnormal                                                       
                                                   Cryptogenic cirrhosis                                                                      
                                                   Deficiency of bile secretion                                                               
                                                   Diabetic hepatopathy                                                                       
                                                   Drug-induced liver injury                                                                  
                                                   Duodenal varices                                                                           
                                                   Focal nodular hyperplasia                                                                  
                                                   Foetor hepaticus                                                                           
                                                   Galactose elimination capacity test abnormal                                               
                                                   Galactose elimination capacity test decreased                                              
                                                   Gamma-glutamyltransferase abnormal                                                         
                                                   Gamma-glutamyltransferase increased                                                        
                                                   Gastric variceal injection                                                                 
                                                   Gastric variceal ligation                                                                  
                                                   Gastric varices                                                                            
                                                   Gastric varices haemorrhage                                                                
                                                   Gastrooesophageal variceal haemorrhage prophylaxis                                         
                                                   Glutamate dehydrogenase increased                                                          
                                                   Glycocholic acid increased                                                                 
                                                   Graft versus host disease in liver                                                         
                                                   Granulomatous liver disease                                                                
                                                   Guanase increased                                                                          
                                                   Haemangioma of liver                                                                       
                                                   Haemorrhagic ascites                                                                       
                                                   Haemorrhagic hepatic cyst                                                                  
                                                   Hepaplastin abnormal                                                                       
                                                   Hepaplastin decreased                                                                      
                                                   Hepatectomy                                                                                
                                                   Hepatic adenoma                                                                            
                                                   Hepatic angiosarcoma                                                                       
                                                   Hepatic artery flow decreased                                                              
                                                   Hepatic atrophy                                                                            
                                                   Hepatic calcification                                                                      
                                                   Hepatic cancer                                                                             
                                                   Hepatic cancer metastatic                                                                  
                                                   Hepatic cancer recurrent                                                                   
                                                   Hepatic cancer stage I                                                                     
                                                   Hepatic cancer stage II                                                                    
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Hepatic cancer stage III                                                                   
search (SMQ)                                                                                                                                  
                                                   Hepatic cancer stage IV                                                                    
                                                   Hepatic cirrhosis                                                                          
                                                   Hepatic cyst                                                                               
                                                   Hepatic cyst ruptured                                                                      
                                                   Hepatic encephalopathy                                                                     
                                                   Hepatic encephalopathy prophylaxis                                                         
                                                   Hepatic enzyme abnormal                                                                    
                                                   Hepatic enzyme decreased                                                                   
                                                   Hepatic enzyme increased                                                                   
                                                   Hepatic failure                                                                            
                                                   Hepatic fibrosis                                                                           
                                                   Hepatic fibrosis marker abnormal                                                           
                                                   Hepatic fibrosis marker increased                                                          
                                                   Hepatic function abnormal                                                                  
                                                   Hepatic haemangioma rupture                                                                
                                                   Hepatic hamartoma                                                                          
                                                   Hepatic hydrothorax                                                                        
                                                   Hepatic hypertrophy                                                                        
                                                   Hepatic infiltration eosinophilic                                                          
                                                   Hepatic lesion                                                                             
                                                   Hepatic lymphocytic infiltration                                                           
                                                   Hepatic mass                                                                               
                                                   Hepatic necrosis                                                                           
                                                   Hepatic neoplasm                                                                           
                                                   Hepatic pain                                                                               
                                                   Hepatic perfusion disorder                                                                 
                                                   Hepatic sequestration                                                                      
                                                   Hepatic steato-fibrosis                                                                    
                                                   Hepatic steatosis                                                                          
                                                   Hepatic vascular resistance increased                                                      
                                                   Hepatic venous pressure gradient abnormal                                                  
                                                   Hepatic venous pressure gradient increased                                                 
                                                   Hepatitis                                                                                  
                                                   Hepatitis acute                                                                            
                                                   Hepatitis chronic active                                                                   
                                                   Hepatitis chronic persistent                                                               
                                                   Hepatitis fulminant                                                                        
                                                   Hepatitis toxic                                                                            
                                                   Hepatobiliary cancer                                                                       
                                                   Hepatobiliary cancer in situ                                                               
                                                   Hepatobiliary cyst                                                                         
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Hepatobiliary neoplasm                                                                     
search (SMQ)                                                                                                                                  
                                                   Hepatobiliary scan abnormal                                                                
                                                   Hepatoblastoma                                                                             
                                                   Hepatoblastoma recurrent                                                                   
                                                   Hepatocellular carcinoma                                                                   
                                                   Hepatocellular foamy cell syndrome                                                         
                                                   Hepatocellular injury                                                                      
                                                   Hepatopulmonary syndrome                                                                   
                                                   Hepatorenal syndrome                                                                       
                                                   Hepatosplenomegaly                                                                         
                                                   Hepatotoxicity                                                                             
                                                   Hyperammonaemia                                                                            
                                                   Hypercholia                                                                                
                                                   Hyperfibrinolysis                                                                          
                                                   Hypertransaminasaemia                                                                      
                                                   Hypoalbuminaemia                                                                           
                                                   Hypocoagulable state                                                                       
                                                   Hypofibrinogenaemia                                                                        
                                                   Hypoprothrombinaemia                                                                       
                                                   Hypothrombinaemia                                                                          
                                                   Hypothromboplastinaemia                                                                    
                                                   Icterus index increased                                                                    
                                                   Immune-mediated hepatic disorder                                                           
                                                   Immune-mediated hepatitis                                                                  
                                                   Increased liver stiffness                                                                  
                                                   International normalised ratio abnormal                                                    
                                                   International normalised ratio increased                                                   
                                                   Intestinal varices                                                                         
                                                   Intestinal varices haemorrhage                                                             
                                                   Intrahepatic portal hepatic venous fistula                                                 
                                                   Ischaemic hepatitis                                                                        
                                                   Jaundice hepatocellular                                                                    
                                                   Kayser-Fleischer ring                                                                      
                                                   Leucine aminopeptidase increased                                                           
                                                   Liver ablation                                                                             
                                                   Liver and pancreas transplant rejection                                                    
                                                   Liver carcinoma ruptured                                                                   
                                                   Liver dialysis                                                                             
                                                   Liver disorder                                                                             
                                                   Liver function test abnormal                                                               
                                                   Liver function test decreased                                                              
                                                   Liver function test increased                                                              
.


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04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Liver induration                                                                           
search (SMQ)                                                                                                                                  
                                                   Liver injury                                                                               
                                                   Liver iron concentration abnormal                                                          
                                                   Liver iron concentration increased                                                         
                                                   Liver opacity                                                                              
                                                   Liver operation                                                                            
                                                   Liver palpable                                                                             
                                                   Liver sarcoidosis                                                                          
                                                   Liver scan abnormal                                                                        
                                                   Liver tenderness                                                                           
                                                   Liver transplant                                                                           
                                                   Liver transplant failure                                                                   
                                                   Liver transplant rejection                                                                 
                                                   Lupoid hepatic cirrhosis                                                                   
                                                   Lupus hepatitis                                                                            
                                                   Magnetic resonance imaging liver abnormal                                                  
                                                   Magnetic resonance proton density fat fraction                                             
                                                   measurement                                                                                
                                                   Minimal hepatic encephalopathy                                                             
                                                   Mitochondrial aspartate aminotransferase increased                                         
                                                   Mixed hepatocellular cholangiocarcinoma                                                    
                                                   Mixed liver injury                                                                         
                                                   Model for end stage liver disease score abnormal                                           
                                                   Model for end stage liver disease score increased                                          
                                                   Molar ratio of total branched-chain amino acid to                                          
                                                   tyrosine                                                                                   
                                                   Multivisceral transplantation                                                              
                                                   Nodular regenerative hyperplasia                                                           
                                                   Non-alcoholic steatohepatitis                                                              
                                                   Non-cirrhotic portal hypertension                                                          
                                                   Nonalcoholic fatty liver disease                                                           
                                                   Ocular icterus                                                                             
                                                   Oedema due to hepatic disease                                                              
                                                   Oesophageal varices haemorrhage                                                            
                                                   Perihepatic discomfort                                                                     
                                                   Peripancreatic varices                                                                     
                                                   Periportal oedema                                                                          
                                                   Peritoneal fluid protein abnormal                                                          
                                                   Peritoneal fluid protein decreased                                                         
                                                   Peritoneal fluid protein increased                                                         
                                                   Peritoneovenous shunt                                                                      
                                                   Pneumobilia                                                                                
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Portal fibrosis                                                                            
search (SMQ)                                                                                                                                  
                                                   Portal hypertension                                                                        
                                                   Portal hypertensive colopathy                                                              
                                                   Portal hypertensive enteropathy                                                            
                                                   Portal hypertensive gastropathy                                                            
                                                   Portal shunt                                                                               
                                                   Portal tract inflammation                                                                  
                                                   Portal vein dilatation                                                                     
                                                   Portal vein flow decreased                                                                 
                                                   Portal vein pressure increased                                                             
                                                   Portopulmonary hypertension                                                                
                                                   Protein C decreased                                                                        
                                                   Protein S abnormal                                                                         
                                                   Protein S decreased                                                                        
                                                   Prothrombin level abnormal                                                                 
                                                   Prothrombin level decreased                                                                
                                                   Prothrombin time abnormal                                                                  
                                                   Prothrombin time prolonged                                                                 
                                                   Prothrombin time ratio abnormal                                                            
                                                   Prothrombin time ratio increased                                                           
                                                   Radiation hepatitis                                                                        
                                                   Regenerative siderotic hepatic nodule                                                      
                                                   Renal and liver transplant                                                                 
                                                   Retinol binding protein decreased                                                          
                                                   Retrograde portal vein flow                                                                
                                                   Reye's syndrome                                                                            
                                                   Small-for-size liver syndrome                                                              
                                                   Spider naevus                                                                              
                                                   Splenic artery embolisation                                                                
                                                   Splenic varices                                                                            
                                                   Splenic varices haemorrhage                                                                
                                                   Splenorenal shunt                                                                          
                                                   Splenorenal shunt procedure                                                                
                                                   Spontaneous intrahepatic portosystemic venous                                              
                                                   shunt                                                                                      
                                                   Steatohepatitis                                                                            
                                                   Stomal varices                                                                             
                                                   Subacute hepatic failure                                                                   
                                                   Sugiura procedure                                                                          
                                                   Thrombin time abnormal                                                                     
                                                   Thrombin time prolonged                                                                    
                                                   Total bile acids increased                                                                 
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Drug related hepatic disorders - comprehensive     Transaminases abnormal                                                                     
search (SMQ)                                                                                                                                  
                                                   Transaminases increased                                                                    
                                                   Ultrasound liver abnormal                                                                  
                                                   Urine bilirubin increased                                                                  
                                                   Urobilinogen urine decreased                                                               
                                                   Urobilinogen urine increased                                                               
                                                   Varices oesophageal                                                                        
                                                   Varicose veins of abdominal wall                                                           
                                                   White nipple sign                                                                          
                                                   Yellow skin                                                                                
                                                                                                                                              
Gastrointestinal adverse events                    Biliary ascites                                                                            
                                                   Gallstone ileus                                                                            
                                                   Allergic colitis                                                                           
                                                   Allergic gastroenteritis                                                                   
                                                   Allergic stomatitis                                                                        
                                                   Anal eczema                                                                                
                                                   Contact stomatitis                                                                         
                                                   Gingival oedema                                                                            
                                                   Gingival swelling                                                                          
                                                   Intestinal angioedema                                                                      
                                                   Lip oedema                                                                                 
                                                   Lip swelling                                                                               
                                                   Mouth swelling                                                                             
                                                   Oedema mouth                                                                               
                                                   Palatal oedema                                                                             
                                                   Palatal swelling                                                                           
                                                   Swollen tongue                                                                             
                                                   Tongue oedema                                                                              
                                                   Ascites                                                                                    
                                                   Haemorrhoids thrombosed                                                                    
                                                   Intestinal infarction                                                                      
                                                   Mesenteric arterial occlusion                                                              
                                                   Mesenteric arteriosclerosis                                                                
                                                   Mesenteric artery embolism                                                                 
                                                   Mesenteric artery stenosis                                                                 
                                                   Mesenteric artery thrombosis                                                               
                                                   Mesenteric vascular insufficiency                                                          
                                                   Mesenteric vascular occlusion                                                              
                                                   Mesenteric vein thrombosis                                                                 
                                                   Mesenteric venous occlusion                                                                
                                                   Pancreatic infarction                                                                      
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Thrombosis mesenteric vessel
Truncus coeliacus thrombosis
Vasculitis gastrointestinal
Visceral venous thrombosis
Anorectal varices
Anorectal varices haemorrhage
Duodenal varices
Gastric varices
Gastric varices haemorrhage
Haemorrhagic ascites
Intestinal varices
Intestinal varices haemorrhage
Oesophageal varices haemorrhage
Peripancreatic varices
Portal hypertensive colopathy
Portal hypertensive enteropathy
Portal hypertensive gastropathy
Varices oesophageal
Varicose veins of abdominal wall   
White nipple sign
Abdominal adhesions
Abdominal compartment syndrome
Abdominal discomfort
Abdominal distension
Abdominal fat apron
Abdominal hernia
Abdominal hernia obstructive
Abdominal hernia perforation
Abdominal incarcerated hernia
Abdominal mass
Abdominal migraine
Abdominal pain
Abdominal pain lower
Abdominal pain upper
Abdominal rebound tenderness
Abdominal rigidity
Abdominal strangulated hernia
Abdominal symptom
Abdominal tenderness
Abdominal wall cyst
Abdominal wall disorder
Abdominal wall haematoma
Abdominal wall haemorrhage
.


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Date: 
04 December 2020 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Abdominal wall mass                                                                        
                                                   Abdominal wall oedema                                                                      
                                                   Abnormal faeces                                                                            
                                                   Acetonaemic vomiting                                                                       
                                                   Achlorhydria                                                                               
                                                   Acid peptic disease                                                                        
                                                   Acquired enamel hypoplasia                                                                 
                                                   Acquired macroglossia                                                                      
                                                   Acquired oesophageal web                                                                   
                                                   Acute abdomen                                                                              
                                                   Acute haemorrhagic ulcerative colitis                                                      
                                                   Acute oesophageal mucosal lesion                                                           
                                                   Aerophagia                                                                                 
                                                   Alcoholic pancreatitis                                                                     
                                                   Alcoholic pancreopathy                                                                     
                                                   Alveolar bone resorption                                                                   
                                                   Amalgam tattoo                                                                             
                                                   Ampullary polyp                                                                            
                                                   Anaesthesia oral                                                                           
                                                   Anal blister                                                                               
                                                   Anal dilatation                                                                            
                                                   Anal erosion                                                                               
                                                   Anal fissure                                                                               
                                                   Anal fissure haemorrhage                                                                   
                                                   Anal fistula                                                                               
                                                   Anal haemorrhage                                                                           
                                                   Anal hypoaesthesia                                                                         
                                                   Anal incontinence                                                                          
                                                   Anal inflammation                                                                          
                                                   Anal leukoplakia                                                                           
                                                   Anal paraesthesia                                                                          
                                                   Anal polyp                                                                                 
                                                   Anal prolapse                                                                              
                                                   Anal pruritus                                                                              
                                                   Anal skin tags                                                                             
                                                   Anal spasm                                                                                 
                                                   Anal sphincter atony                                                                       
                                                   Anal sphincter hypertonia                                                                  
                                                   Anal stenosis                                                                              
                                                   Anal trichiasis                                                                            
                                                   Anal ulcer                                                                                 
                                                   Anal ulcer haemorrhage                                                                     
                                                   Anastomotic ulcer perforation                                                              
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Anastomotic ulcer, obstructive
Angina bullosa haemorrhagica
Angular cheilitis
Ankyloglossia acquired
Anogenital dysplasia
Anorectal discomfort
Anorectal disorder
Anorectal sensory loss
Anorectal squamous cell metaplasia
Anorectal stenosis
Anorectal swelling
Anorectal ulcer
Anovulvar fistula
Aorto-oesophageal fistula
Aortoenteric fistula
Aphthous ulcer
Apical granuloma
Apoptotic colonopathy
Appendiceal mucocoele
Appendicitis noninfective
Appendicolith
Appendix disorder
Aptyalism
Atrophic glossitis
Auriculotemporal syndrome
Autoimmune colitis
Autoimmune enteropathy
Autoimmune pancreatitis
Barrett's oesophagus
Bezoar
Bile acid malabsorption
Bloody peritoneal effluent
Bowel movement irregularity
Breath odour
Brunner's gland hyperplasia
Buccal polyp
Buccoglossal syndrome
Burning mouth syndrome
Cannabinoid hyperemesis syndrome
Cardiospasm
Cascade stomach
Cemento osseous dysplasia
Change of bowel habit
.


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Date: 
04 December 2020 
Status: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Chapped lips                                                                               
                                                   Cheilitis                                                                                  
                                                   Cheilitis granulomatosa                                                                    
                                                   Cheilosis                                                                                  
                                                   Chilaiditi's syndrome                                                                      
                                                   Chronic cheek biting                                                                       
                                                   Chronic gastritis                                                                          
                                                   Chronic gastrointestinal bleeding                                                          
                                                   Coating in mouth                                                                           
                                                   Cobble stone tongue                                                                        
                                                   Coeliac artery aneurysm                                                                    
                                                   Coeliac artery compression syndrome                                                        
                                                   Coeliac artery stenosis                                                                    
                                                   Coeliac disease                                                                            
                                                   Colitis                                                                                    
                                                   Colitis cystica profunda                                                                   
                                                   Colitis erosive                                                                            
                                                   Colitis ischaemic                                                                          
                                                   Colitis microscopic                                                                        
                                                   Colitis ulcerative                                                                         
                                                   Colon dysplasia                                                                            
                                                   Colonic fistula                                                                            
                                                   Colonic haematoma                                                                          
                                                   Constipation                                                                               
                                                   Constipation neonatal                                                                      
                                                   Creatorrhoea                                                                               
                                                   Cricopharyngeal achalasia                                                                  
                                                   Crohn's disease                                                                            
                                                   Cronkhite-Canada syndrome                                                                  
                                                   Cryptitis                                                                                  
                                                   Cyclic vomiting syndrome                                                                   
                                                   Defaecation disorder                                                                       
                                                   Defaecation urgency                                                                        
                                                   Dental abfraction                                                                          
                                                   Dental alveolar anomaly                                                                    
                                                   Dental attrition                                                                           
                                                   Dental caries                                                                              
                                                   Dental cyst                                                                                
                                                   Dental discomfort                                                                          
                                                   Dental dysaesthesia                                                                        
                                                   Dental necrosis                                                                            
                                                   Dental paraesthesia                                                                        
                                                   Dental plaque                                                                              
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Dental pulp disorder                                                                       
                                                   Diabetic enteropathy                                                                       
                                                   Diabetic gastroenteropathy                                                                 
                                                   Diabetic gastroparesis                                                                     
                                                   Diabetic gastropathy                                                                       
                                                   Diaphragmatic hernia                                                                       
                                                   Diaphragmatic hernia, obstructive                                                          
                                                   Diarrhoea                                                                                  
                                                   Diarrhoea haemorrhagic                                                                     
                                                   Diarrhoea neonatal                                                                         
                                                   Diastema                                                                                   
                                                   Dieulafoy's vascular malformation                                                          
                                                   Discoloured vomit                                                                          
                                                   Distal intestinal obstruction syndrome                                                     
                                                   Diverticular fistula                                                                       
                                                   Diverticular hernia                                                                        
                                                   Diverticular perforation                                                                   
                                                   Diverticulitis oesophageal                                                                 
                                                   Diverticuloma                                                                              
                                                   Diverticulum                                                                               
                                                   Diverticulum gastric                                                                       
                                                   Diverticulum intestinal                                                                    
                                                   Diverticulum intestinal haemorrhagic                                                       
                                                   Diverticulum oesophageal                                                                   
                                                   Dolichocolon acquired                                                                      
                                                   Douglas' pouch mass                                                                        
                                                   Dry mouth                                                                                  
                                                   Dumping syndrome                                                                           
                                                   Duodenal obstruction                                                                       
                                                   Duodenal papillitis                                                                        
                                                   Duodenal perforation                                                                       
                                                   Duodenal polyp                                                                             
                                                   Duodenal stenosis                                                                          
                                                   Duodenal ulcer                                                                             
                                                   Duodenal ulcer haemorrhage                                                                 
                                                   Duodenal ulcer perforation                                                                 
                                                   Duodenal ulcer perforation, obstructive                                                    
                                                   Duodenal ulcer, obstructive                                                                
                                                   Duodenal vascular ectasia                                                                  
                                                   Duodenitis                                                                                 
                                                   Duodenitis haemorrhagic                                                                    
                                                   Duodenogastric reflux                                                                      
                                                   Dysbiosis                                                                                  
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Dyschezia                                                                                  
                                                   Dyskinesia oesophageal                                                                     
                                                   Dyspepsia                                                                                  
                                                   Dysphagia                                                                                  
                                                   Dysphagia lusoria                                                                          
                                                   Ectopic gastric mucosa                                                                     
                                                   Enamel anomaly                                                                             
                                                   Encapsulating peritoneal sclerosis                                                         
                                                   Enlarged uvula                                                                             
                                                   Enteric neuropathy                                                                         
                                                   Enteritis                                                                                  
                                                   Enteritis leukopenic                                                                       
                                                   Enterocele                                                                                 
                                                   Enterochromaffin cell hyperplasia                                                          
                                                   Enterocolitis                                                                              
                                                   Enterocolitis haemorrhagic                                                                 
                                                   Enterocolonic fistula                                                                      
                                                   Enterocutaneous fistula                                                                    
                                                   Enterovesical fistula                                                                      
                                                   Eosinophilic colitis                                                                       
                                                   Eosinophilic gastritis                                                                     
                                                   Eosinophilic oesophagitis                                                                  
                                                   Epigastric discomfort                                                                      
                                                   Epiploic appendagitis                                                                      
                                                   Epulis                                                                                     
                                                   Erosive duodenitis                                                                         
                                                   Erosive oesophagitis                                                                       
                                                   Eructation                                                                                 
                                                   Faecal vomiting                                                                            
                                                   Faecalith                                                                                  
                                                   Faecaloma                                                                                  
                                                   Faeces discoloured                                                                         
                                                   Faeces hard                                                                                
                                                   Faeces pale                                                                                
                                                   Faeces soft                                                                                
                                                   Feline oesophagus                                                                          
                                                   Femoral hernia                                                                             
                                                   Femoral hernia incarcerated                                                                
                                                   Femoral hernia strangulated                                                                
                                                   Femoral hernia, obstructive                                                                
                                                   Fibrosing colonopathy                                                                      
                                                   Fistula of small intestine                                                                 
                                                   Fixed bowel loop                                                                           
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Flatulence                                                                                 
                                                   Fluorosis dental                                                                           
                                                   Food poisoning                                                                             
                                                   Frequent bowel movements                                                                   
                                                   Functional gastrointestinal disorder                                                       
                                                   Gastric antral vascular ectasia                                                            
                                                   Gastric atony                                                                              
                                                   Gastric cyst                                                                               
                                                   Gastric dilatation                                                                         
                                                   Gastric disorder                                                                           
                                                   Gastric dysplasia                                                                          
                                                   Gastric fibrosis                                                                           
                                                   Gastric fistula                                                                            
                                                   Gastric haemorrhage                                                                        
                                                   Gastric hypermotility                                                                      
                                                   Gastric hypertonia                                                                         
                                                   Gastric hypomotility                                                                       
                                                   Gastric ileus                                                                              
                                                   Gastric mucosa erythema                                                                    
                                                   Gastric mucosal calcinosis                                                                 
                                                   Gastric mucosal hypertrophy                                                                
                                                   Gastric mucosal lesion                                                                     
                                                   Gastric perforation                                                                        
                                                   Gastric pneumatosis                                                                        
                                                   Gastric polyps                                                                             
                                                   Gastric prolapse                                                                           
                                                   Gastric stenosis                                                                           
                                                   Gastric ulcer                                                                              
                                                   Gastric ulcer haemorrhage                                                                  
                                                   Gastric ulcer haemorrhage, obstructive                                                     
                                                   Gastric ulcer perforation                                                                  
                                                   Gastric ulcer perforation, obstructive                                                     
                                                   Gastric ulcer, obstructive                                                                 
                                                   Gastric volvulus                                                                           
                                                   Gastric xanthoma                                                                           
                                                   Gastritis                                                                                  
                                                   Gastritis alcoholic                                                                        
                                                   Gastritis alcoholic haemorrhagic                                                           
                                                   Gastritis erosive                                                                          
                                                   Gastritis haemorrhagic                                                                     
                                                   Gastritis hypertrophic                                                                     
                                                   Gastrocoele                                                                                
                                                   Gastroduodenal haemorrhage                                                                 
.


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Gastrointestinal adverse events                    Gastroduodenal ulcer                                                                       
                                                   Gastroenteritis eosinophilic                                                               
                                                   Gastrointestinal amyloidosis                                                               
                                                   Gastrointestinal angiectasia                                                               
                                                   Gastrointestinal angiodysplasia                                                            
                                                   Gastrointestinal disorder                                                                  
                                                   Gastrointestinal dysplasia                                                                 
                                                   Gastrointestinal erosion                                                                   
                                                   Gastrointestinal fistula                                                                   
                                                   Gastrointestinal haemorrhage                                                               
                                                   Gastrointestinal hypermotility                                                             
                                                   Gastrointestinal hypomotility                                                              
                                                   Gastrointestinal inflammation                                                              
                                                   Gastrointestinal ischaemia                                                                 
                                                   Gastrointestinal melanosis                                                                 
                                                   Gastrointestinal motility disorder                                                         
                                                   Gastrointestinal mucocoele                                                                 
                                                   Gastrointestinal mucosa hyperaemia                                                         
                                                   Gastrointestinal mucosal disorder                                                          
                                                   Gastrointestinal mucosal exfoliation                                                       
                                                   Gastrointestinal mucosal necrosis                                                          
                                                   Gastrointestinal necrosis                                                                  
                                                   Gastrointestinal obstruction                                                               
                                                   Gastrointestinal oedema                                                                    
                                                   Gastrointestinal pain                                                                      
                                                   Gastrointestinal perforation                                                               
                                                   Gastrointestinal polyp                                                                     
                                                   Gastrointestinal polyp haemorrhage                                                         
                                                   Gastrointestinal scarring                                                                  
                                                   Gastrointestinal sounds abnormal                                                           
                                                   Gastrointestinal stenosis                                                                  
                                                   Gastrointestinal toxicity                                                                  
                                                   Gastrointestinal tract irritation                                                          
                                                   Gastrointestinal tract mucosal discolouration                                              
                                                   Gastrointestinal tract mucosal pigmentation                                                
                                                   Gastrointestinal ulcer                                                                     
                                                   Gastrointestinal ulcer haemorrhage                                                         
                                                   Gastrointestinal ulcer perforation                                                         
                                                   Gastrointestinal vascular malformation                                                     
                                                   Gastrointestinal vascular malformation                                                     
                                                   haemorrhagic                                                                               
                                                   Gastrointestinal wall abnormal                                                             
                                                   Gastrointestinal wall thickening                                                           
.


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Pre-defined MedDRA search                          Preferred term                                                                             
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Gastrointestinal adverse events                    Gastrointestinal wall thinning                                                             
                                                   Gastrolithiasis                                                                            
                                                   Gastrooesophageal reflux disease                                                           
                                                   Gastrooesophageal sphincter insufficiency                                                  
                                                   Gastropleural fistula                                                                      
                                                   Gastroptosis                                                                               
                                                   Gastrosplenic fistula                                                                      
                                                   Giant cell epulis                                                                          
                                                   Gingival atrophy                                                                           
                                                   Gingival bleeding                                                                          
                                                   Gingival blister                                                                           
                                                   Gingival cyst                                                                              
                                                   Gingival discolouration                                                                    
                                                   Gingival discomfort                                                                        
                                                   Gingival disorder                                                                          
                                                   Gingival erosion                                                                           
                                                   Gingival erythema                                                                          
                                                   Gingival hyperpigmentation                                                                 
                                                   Gingival hypertrophy                                                                       
                                                   Gingival hypoplasia                                                                        
                                                   Gingival pain                                                                              
                                                   Gingival polyp                                                                             
                                                   Gingival pruritus                                                                          
                                                   Gingival recession                                                                         
                                                   Gingival ulceration                                                                        
                                                   Gingivitis ulcerative                                                                      
                                                   Glossitis                                                                                  
                                                   Glossodynia                                                                                
                                                   Glossoptosis                                                                               
                                                   Glycogenic acanthosis                                                                      
                                                   Gut fermentation syndrome                                                                  
                                                   Haematemesis                                                                               
                                                   Haematochezia                                                                              
                                                   Haemoperitoneum                                                                            
                                                   Haemorrhagic erosive gastritis                                                             
                                                   Haemorrhagic necrotic pancreatitis                                                         
                                                   Haemorrhoidal haemorrhage                                                                  
                                                   Haemorrhoids                                                                               
                                                   Hernial eventration                                                                        
                                                   Heyde's syndrome                                                                           
                                                   Hiatus hernia                                                                              
                                                   Hiatus hernia strangulated                                                                 
                                                   Hiatus hernia, obstructive                                                                 
.


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Pre-defined MedDRA search                          Preferred term                                                                             
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Gastrointestinal adverse events                    Hyperaesthesia teeth                                                                       
                                                   Hypercementosis                                                                            
                                                   Hyperchlorhydria                                                                           
                                                   Hypergastrinaemia                                                                          
                                                   Hypertrophic anal papilla                                                                  
                                                   Hypertrophy of tongue papillae                                                             
                                                   Hypoaesthesia oral                                                                         
                                                   Hypoaesthesia teeth                                                                        
                                                   Ileal perforation                                                                          
                                                   Ileal stenosis                                                                             
                                                   Ileal ulcer                                                                                
                                                   Ileal ulcer perforation                                                                    
                                                   Ileus                                                                                      
                                                   Ileus paralytic                                                                            
                                                   Ileus spastic                                                                              
                                                   Immune-mediated enterocolitis                                                              
                                                   Immune-mediated pancreatitis                                                               
                                                   Impaired gastric emptying                                                                  
                                                   Incarcerated hiatus hernia                                                                 
                                                   Incarcerated inguinal hernia                                                               
                                                   Incarcerated umbilical hernia                                                              
                                                   Increased intraperitoneal volume                                                           
                                                   Infant dyschezia                                                                           
                                                   Infantile colic                                                                            
                                                   Infantile spitting up                                                                      
                                                   Infantile vomiting                                                                         
                                                   Inflammatory bowel disease                                                                 
                                                   Infrequent bowel movements                                                                 
                                                   Inguinal hernia                                                                            
                                                   Inguinal hernia perforation                                                                
                                                   Inguinal hernia strangulated                                                               
                                                   Inguinal hernia, obstructive                                                               
                                                   Internal hernia                                                                            
                                                   Intestinal angina                                                                          
                                                   Intestinal atony                                                                           
                                                   Intestinal calcification                                                                   
                                                   Intestinal congestion                                                                      
                                                   Intestinal cyst                                                                            
                                                   Intestinal diaphragm disease                                                               
                                                   Intestinal dilatation                                                                      
                                                   Intestinal fibrosis                                                                        
                                                   Intestinal fistula                                                                         
                                                   Intestinal haematoma                                                                       
.


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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Intestinal haemorrhage
Intestinal ischaemia
Intestinal mass
Intestinal metaplasia
Intestinal mucosal atrophy
Intestinal mucosal hypertrophy
Intestinal mucosal tear
Intestinal obstruction
Intestinal perforation
Intestinal polyp
Intestinal prolapse
Intestinal pseudo-obstruction
Intestinal smooth muscle hypertrophy
Intestinal steatosis
Intestinal stenosis
Intestinal strangulation
Intestinal ulcer
Intestinal ulcer perforation
Intestinal villi atrophy
Intra-abdominal fluid collection
Intra-abdominal haematoma
Intra-abdominal haemorrhage
Intrinsic factor deficiency
Intussusception
Irritable bowel syndrome
Ischaemic enteritis
Ischaemic gastritis
Ischaemic pancreatitis
Ischiatic hernia
Ischiorectal hernia
Jejunal perforation
Jejunal stenosis
Jejunal ulcer
Jejunal ulcer perforation
Large intestinal haemorrhage
Large intestinal obstruction
Large intestinal stenosis
Large intestinal ulcer
Large intestinal ulcer haemorrhage
Large intestinal ulcer perforation
Large intestine erosion
Large intestine perforation
Large intestine polyp
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
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Gastrointestinal adverse events                    Leukoplakia oesophageal                                                                    
                                                   Leukoplakia oral                                                                           
                                                   Levator syndrome                                                                           
                                                   Lichenoid dysplasia                                                                        
                                                   Lip blister                                                                                
                                                   Lip discolouration                                                                         
                                                   Lip disorder                                                                               
                                                   Lip dry                                                                                    
                                                   Lip erosion                                                                                
                                                   Lip erythema                                                                               
                                                   Lip exfoliation                                                                            
                                                   Lip haematoma                                                                              
                                                   Lip haemorrhage                                                                            
                                                   Lip pain                                                                                   
                                                   Lip pruritus                                                                               
                                                   Lip scab                                                                                   
                                                   Lip ulceration                                                                             
                                                   Loose tooth                                                                                
                                                   Lower gastrointestinal haemorrhage                                                         
                                                   Lower gastrointestinal perforation                                                         
                                                   Lumbar hernia                                                                              
                                                   Lupus enteritis                                                                            
                                                   Lupus pancreatitis                                                                         
                                                   Lymphangiectasia intestinal                                                                
                                                   Lymphocytic oesophagitis                                                                   
                                                   Lymphoid hyperplasia of intestine                                                          
                                                   Malabsorption                                                                              
                                                   Malacoplakia gastrointestinal                                                              
                                                   Malignant dysphagia                                                                        
                                                   Malignant gastrointestinal obstruction                                                     
                                                   Mallory-Weiss syndrome                                                                     
                                                   Malocclusion                                                                               
                                                   Malpositioned teeth                                                                        
                                                   Mastocytic enterocolitis                                                                   
                                                   Mechanical ileus                                                                           
                                                   Meconium cyst                                                                              
                                                   Meconium ileus                                                                             
                                                   Meconium peritonitis                                                                       
                                                   Meconium plug syndrome                                                                     
                                                   Megacolon                                                                                  
                                                   Melaena                                                                                    
                                                   Melaena neonatal                                                                           
                                                   Melanoplakia oral                                                                          
.


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Pre-defined MedDRA search                          Preferred term                                                                             
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Gastrointestinal adverse events                    Mesenteric artery aneurysm                                                                 
                                                   Mesenteric cyst                                                                            
                                                   Mesenteric fibrosis                                                                        
                                                   Mesenteric haematoma                                                                       
                                                   Mesenteric haemorrhage                                                                     
                                                   Mesenteric panniculitis                                                                    
                                                   Mesenteric phlebosclerosis                                                                 
                                                   Mesenteritis                                                                               
                                                   Mikulicz's disease                                                                         
                                                   Mikulicz's syndrome                                                                        
                                                   Mouth cyst                                                                                 
                                                   Mouth haemorrhage                                                                          
                                                   Mouth ulceration                                                                           
                                                   Mucosal prolapse syndrome                                                                  
                                                   Mucous stools                                                                              
                                                   Myochosis                                                                                  
                                                   Narcotic bowel syndrome                                                                    
                                                   Nausea                                                                                     
                                                   Necrotising colitis                                                                        
                                                   Necrotising enterocolitis neonatal                                                         
                                                   Necrotising gastritis                                                                      
                                                   Necrotising oesophagitis                                                                   
                                                   Neonatal gastrointestinal disorder                                                         
                                                   Neonatal gastrointestinal haemorrhage                                                      
                                                   Neonatal intestinal dilatation                                                             
                                                   Neonatal intestinal obstruction                                                            
                                                   Neonatal intestinal perforation                                                            
                                                   Neurogenic bowel                                                                           
                                                   Neutropenic colitis                                                                        
                                                   Nicotinic stomatitis                                                                       
                                                   Noninfectious peritonitis                                                                  
                                                   Noninfective gingivitis                                                                    
                                                   Noninfective sialoadenitis                                                                 
                                                   Obstruction gastric                                                                        
                                                   Obstructive defaecation                                                                    
                                                   Obstructive pancreatitis                                                                   
                                                   Obturator hernia                                                                           
                                                   Odynophagia                                                                                
                                                   Oedematous pancreatitis                                                                    
                                                   Oesophageal achalasia                                                                      
                                                   Oesophageal atony                                                                          
                                                   Oesophageal compression                                                                    
                                                   Oesophageal dilatation                                                                     
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
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Gastrointestinal adverse events                    Oesophageal discomfort                                                                     
                                                   Oesophageal disorder                                                                       
                                                   Oesophageal dysplasia                                                                      
                                                   Oesophageal fibrosis                                                                       
                                                   Oesophageal fistula                                                                        
                                                   Oesophageal food impaction                                                                 
                                                   Oesophageal haemorrhage                                                                    
                                                   Oesophageal hypomotility                                                                   
                                                   Oesophageal intramural haematoma                                                           
                                                   Oesophageal irritation                                                                     
                                                   Oesophageal mass                                                                           
                                                   Oesophageal motility disorder                                                              
                                                   Oesophageal mucosa erythema                                                                
                                                   Oesophageal mucosal blister                                                                
                                                   Oesophageal mucosal dissection                                                             
                                                   Oesophageal mucosal hyperplasia                                                            
                                                   Oesophageal mucosal tear                                                                   
                                                   Oesophageal obstruction                                                                    
                                                   Oesophageal oedema                                                                         
                                                   Oesophageal pain                                                                           
                                                   Oesophageal perforation                                                                    
                                                   Oesophageal polyp                                                                          
                                                   Oesophageal rupture                                                                        
                                                   Oesophageal spasm                                                                          
                                                   Oesophageal stenosis                                                                       
                                                   Oesophageal stent stenosis                                                                 
                                                   Oesophageal ulcer                                                                          
                                                   Oesophageal ulcer haemorrhage                                                              
                                                   Oesophageal ulcer perforation                                                              
                                                   Oesophageal-pulmonary fistula                                                              
                                                   Oesophagitis                                                                               
                                                   Oesophagitis haemorrhagic                                                                  
                                                   Oesophagitis ulcerative                                                                    
                                                   Oesophagomediastinal fistula                                                               
                                                   Oesophagopleural fistula                                                                   
                                                   Omental infarction                                                                         
                                                   Omental necrosis                                                                           
                                                   Oral blood blister                                                                         
                                                   Oral cavity fistula                                                                        
                                                   Oral discharge                                                                             
                                                   Oral discomfort                                                                            
                                                   Oral disorder                                                                              
                                                   Oral dysaesthesia                                                                          
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Oral hyperaesthesia                                                                        
                                                   Oral hyperkeratosis                                                                        
                                                   Oral leukoedema                                                                            
                                                   Oral lichen planus                                                                         
                                                   Oral lichenoid reaction                                                                    
                                                   Oral macule                                                                                
                                                   Oral mucosa atrophy                                                                        
                                                   Oral mucosa erosion                                                                        
                                                   Oral mucosa haematoma                                                                      
                                                   Oral mucosal blistering                                                                    
                                                   Oral mucosal discolouration                                                                
                                                   Oral mucosal eruption                                                                      
                                                   Oral mucosal erythema                                                                      
                                                   Oral mucosal exfoliation                                                                   
                                                   Oral mucosal hypertrophy                                                                   
                                                   Oral mucosal roughening                                                                    
                                                   Oral mucosal scab                                                                          
                                                   Oral pain                                                                                  
                                                   Oral papule                                                                                
                                                   Oral pigmentation                                                                          
                                                   Oral pruritus                                                                              
                                                   Oral purpura                                                                               
                                                   Oral submucosal fibrosis                                                                   
                                                   Oral toxicity                                                                              
                                                   Oroantral fistula                                                                          
                                                   Palatal disorder                                                                           
                                                   Palatal dysplasia                                                                          
                                                   Palatal polyp                                                                              
                                                   Palatal ulcer                                                                              
                                                   Pancreatic atrophy                                                                         
                                                   Pancreatic calcification                                                                   
                                                   Pancreatic cyst                                                                            
                                                   Pancreatic cyst rupture                                                                    
                                                   Pancreatic disorder                                                                        
                                                   Pancreatic duct dilatation                                                                 
                                                   Pancreatic duct obstruction                                                                
                                                   Pancreatic duct stenosis                                                                   
                                                   Pancreatic enlargement                                                                     
                                                   Pancreatic enzyme abnormality                                                              
                                                   Pancreatic failure                                                                         
                                                   Pancreatic fibrosis                                                                        
                                                   Pancreatic fistula                                                                         
                                                   Pancreatic haemorrhage                                                                     
.


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Gastrointestinal adverse events                    Pancreatic mass                                                                            
                                                   Pancreatic necrosis                                                                        
                                                   Pancreatic phlegmon                                                                        
                                                   Pancreatic pseudoaneurysm                                                                  
                                                   Pancreatic pseudocyst                                                                      
                                                   Pancreatic pseudocyst haemorrhage                                                          
                                                   Pancreatic pseudocyst rupture                                                              
                                                   Pancreatic steatosis                                                                       
                                                   Pancreatic toxicity                                                                        
                                                   Pancreatitis                                                                               
                                                   Pancreatitis acute                                                                         
                                                   Pancreatitis chronic                                                                       
                                                   Pancreatitis haemorrhagic                                                                  
                                                   Pancreatitis necrotising                                                                   
                                                   Pancreatitis relapsing                                                                     
                                                   Pancreatolithiasis                                                                         
                                                   Papilla of Vater stenosis                                                                  
                                                   Paraesthesia oral                                                                          
                                                   Paresis anal sphincter                                                                     
                                                   Parotid duct obstruction                                                                   
                                                   Parotid gland enlargement                                                                  
                                                   Parotid gland haemorrhage                                                                  
                                                   Parotid lipomatosis                                                                        
                                                   Pathological tooth fracture                                                                
                                                   Pelvic floor dysfunction                                                                   
                                                   Peptic ulcer                                                                               
                                                   Peptic ulcer haemorrhage                                                                   
                                                   Peptic ulcer perforation                                                                   
                                                   Peptic ulcer perforation, obstructive                                                      
                                                   Peptic ulcer, obstructive                                                                  
                                                   Perianal erythema                                                                          
                                                   Periodontal disease                                                                        
                                                   Periodontal inflammation                                                                   
                                                   Peristalsis visible                                                                        
                                                   Peritoneal adhesions                                                                       
                                                   Peritoneal cloudy effluent                                                                 
                                                   Peritoneal cyst                                                                            
                                                   Peritoneal disorder                                                                        
                                                   Peritoneal fibrosis                                                                        
                                                   Peritoneal haematoma                                                                       
                                                   Peritoneal hernia                                                                          
                                                   Peritoneal lesion                                                                          
                                                   Peritoneal mesothelial hyperplasia                                                         
.


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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Peritoneal necrosis
Peritoneal perforation
Peritoneocutaneous fistula
Peritonitis lupus
Pharyngo-oesophageal diverticulum
Pigmentation lip
Plicated tongue
Pneumatosis intestinalis
Pneumoperitoneum
Pneumoretroperitoneum
Poor dental condition
Portal venous gas
Post-tussive vomiting
Pouchitis
Precancerous lesion of digestive tract
Prepyloric stenosis
Presbyoesophagus
Proctalgia
Proctitis
Proctitis haemorrhagic
Proctitis ulcerative
Proctoparalysis
Protein-losing gastroenteropathy
Protrusion tongue
Pseudoachalasia
Pseudodiverticular disease
Pseudopolyposis
Pudendal hernia
Pulpless tooth
Pyloric sphincter insufficiency
Pylorospasm
Pylorus dilatation
Pyostomatitis vegetans
Ranula 
Rebound acid hypersecretion
Rectal discharge
Rectal dysplasia
Rectal fissure
Rectal haemorrhage
Rectal lesion
Rectal obstruction
Rectal perforation
Rectal polyp
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Rectal prolapse
Rectal spasm
Rectal stenosis
Rectal tenesmus
Rectal ulcer
Rectal ulcer haemorrhage
Rectourethral fistula
Reflux gastritis
Regurgitation
Retained deciduous tooth
Retching
Retroperitoneal effusion
Retroperitoneal fibrosis
Retroperitoneal haematoma
Retroperitoneal haemorrhage
Retroperitoneal hernia
Retroperitoneal mass
Retroperitoneal oedema
Retroperitoneum cyst
Richter's hernia
Saliva altered
Saliva discolouration
Salivary duct inflammation
Salivary duct obstruction
Salivary duct stenosis
Salivary gland atrophy
Salivary gland calculus
Salivary gland cyst
Salivary gland disorder
Salivary gland enlargement
Salivary gland fistula
Salivary gland induration
Salivary gland mass
Salivary gland mucocoele
Salivary gland pain
Salivary hypersecretion
Sandifer's syndrome
Scalloped tongue
Scaphoid abdomen
Sciatic hernia
Segmental diverticular colitis
Short-bowel syndrome
Sialadenosis
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Sialectasia
Sialocele
Sialodochitis fibrinosa
Sialometaplasia
Sideropenic dysphagia
Sigmoid mesocolon hernia
Small intestinal haemorrhage
Small intestinal obstruction
Small intestinal perforation
Small intestinal stenosis
Small intestinal ulcer haemorrhage
Small intestinal ulcer perforation
Small intestine polyp
Small intestine ulcer
Sordes
Spigelian hernia
Splenic artery aneurysm
Splenic vein aneurysm
Sprue-like enteropathy
Stasis syndrome
Steatorrhoea
Stiff tongue
Stomach granuloma
Stomach mass
Stomatitis
Stomatitis haemorrhagic
Stomatitis necrotising
Strangulated umbilical hernia
Strawberry tongue
Stress ulcer
Subileus
Submaxillary gland enlargement
Superior mesenteric artery syndrome
Supernumerary teeth
Teeth brittle
Teething
Terminal ileitis
Tongue amyloidosis
Tongue atrophy
Tongue blistering
Tongue coated
Tongue cyst
Tongue discolouration
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Gastrointestinal adverse events                    Tongue discomfort                                                                          
                                                   Tongue disorder                                                                            
                                                   Tongue dry                                                                                 
                                                   Tongue dysplasia                                                                           
                                                   Tongue eruption                                                                            
                                                   Tongue erythema                                                                            
                                                   Tongue exfoliation                                                                         
                                                   Tongue geographic                                                                          
                                                   Tongue haematoma                                                                           
                                                   Tongue haemorrhage                                                                         
                                                   Tongue infarction                                                                          
                                                   Tongue movement disturbance                                                                
                                                   Tongue necrosis                                                                            
                                                   Tongue pigmentation                                                                        
                                                   Tongue polyp                                                                               
                                                   Tongue pruritus                                                                            
                                                   Tongue rough                                                                               
                                                   Tongue spasm                                                                               
                                                   Tongue thrust                                                                              
                                                   Tongue ulceration                                                                          
                                                   Tooth ankylosis                                                                            
                                                   Tooth delamination                                                                         
                                                   Tooth demineralisation                                                                     
                                                   Tooth deposit                                                                              
                                                   Tooth development disorder                                                                 
                                                   Tooth discolouration                                                                       
                                                   Tooth disorder                                                                             
                                                   Tooth erosion                                                                              
                                                   Tooth impacted                                                                             
                                                   Tooth loss                                                                                 
                                                   Tooth malformation                                                                         
                                                   Tooth pulp haemorrhage                                                                     
                                                   Tooth resorption                                                                           
                                                   Tooth socket haemorrhage                                                                   
                                                   Toothache                                                                                  
                                                   Toxic dilatation of intestine                                                              
                                                   Transient lingual papillitis                                                               
                                                   Traumatic occlusion                                                                        
                                                   Traumatic ulcerative granuloma with stromal                                                
                                                   eosinophilia                                                                               
                                                   Trichoglossia                                                                              
                                                   Ulcerative duodenitis                                                                      
                                                   Ulcerative gastritis                                                                       
.


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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Gastrointestinal adverse events
Ultrafiltration failure
Umbilical hernia
Umbilical hernia perforation
Umbilical hernia, obstructive
Upper gastrointestinal haemorrhage
Upper gastrointestinal perforation
Uraemic gastropathy
Urinary ascites
Uvulitis
Varicose veins sublingual
Visceroptosis
Volvulus
Volvulus of small bowel
Vomiting
Vomiting projectile
Wischnewsky spots
Injection site reactions
Administration site dermatitis
Administration site eczema
Administration site hypersensitivity
Administration site rash
Administration site recall reaction
Administration site urticaria
Administration site vasculitis
Application site dermatitis
Application site eczema
Application site hypersensitivity
Application site rash
Application site recall reaction
Application site urticaria
Application site vasculitis
Infusion site dermatitis
Infusion site eczema
Infusion site hypersensitivity
Infusion site rash
Infusion site recall reaction
Infusion site urticaria
Infusion site vasculitis
Injection site dermatitis
Injection site eczema
Injection site hypersensitivity
Injection site rash
Injection site recall reaction
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Injection site reactions                           Injection site urticaria                                                                   
                                                   Injection site vasculitis                                                                  
                                                   Instillation site hypersensitivity                                                         
                                                   Instillation site rash                                                                     
                                                   Instillation site urticaria                                                                
                                                   Vessel puncture site rash                                                                  
                                                   Vessel puncture site vesicles                                                              
                                                   Administration site thrombosis                                                             
                                                   Application site thrombosis                                                                
                                                   Embolia cutis medicamentosa                                                                
                                                   Infusion site thrombosis                                                                   
                                                   Injection site thrombosis                                                                  
                                                   Instillation site thrombosis                                                               
                                                   Vessel puncture site occlusion                                                             
                                                   Vessel puncture site thrombosis                                                            
                                                   Administration site abscess                                                                
                                                   Administration site abscess sterile                                                        
                                                   Administration site acne                                                                   
                                                   Administration site anaesthesia                                                            
                                                   Administration site atrophy                                                                
                                                   Administration site bruise                                                                 
                                                   Administration site calcification                                                          
                                                   Administration site cellulitis                                                             
                                                   Administration site coldness                                                               
                                                   Administration site cyst                                                                   
                                                   Administration site discharge                                                              
                                                   Administration site discolouration                                                         
                                                   Administration site discomfort                                                             
                                                   Administration site dryness                                                                
                                                   Administration site dysaesthesia                                                           
                                                   Administration site erosion                                                                
                                                   Administration site erythema                                                               
                                                   Administration site exfoliation                                                            
                                                   Administration site extravasation                                                          
                                                   Administration site fibrosis                                                               
                                                   Administration site granuloma                                                              
                                                   Administration site haematoma                                                              
                                                   Administration site haemorrhage                                                            
                                                   Administration site hyperaesthesia                                                         
                                                   Administration site hypertrichosis                                                         
                                                   Administration site hypertrophy                                                            
                                                   Administration site hypoaesthesia                                                          
                                                   Administration site indentation                                                            
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Injection site reactions                           Administration site induration                                                             
                                                   Administration site infection                                                              
                                                   Administration site inflammation                                                           
                                                   Administration site injury                                                                 
                                                   Administration site irritation                                                             
                                                   Administration site ischaemia                                                              
                                                   Administration site joint discomfort                                                       
                                                   Administration site joint effusion                                                         
                                                   Administration site joint erythema                                                         
                                                   Administration site joint infection                                                        
                                                   Administration site joint inflammation                                                     
                                                   Administration site joint movement impairment                                              
                                                   Administration site joint pain                                                             
                                                   Administration site joint warmth                                                           
                                                   Administration site laceration                                                             
                                                   Administration site lymphadenopathy                                                        
                                                   Administration site macule                                                                 
                                                   Administration site mass                                                                   
                                                   Administration site movement impairment                                                    
                                                   Administration site necrosis                                                               
                                                   Administration site nerve damage                                                           
                                                   Administration site nodule                                                                 
                                                   Administration site odour                                                                  
                                                   Administration site oedema                                                                 
                                                   Administration site pain                                                                   
                                                   Administration site pallor                                                                 
                                                   Administration site papule                                                                 
                                                   Administration site paraesthesia                                                           
                                                   Administration site phlebitis                                                              
                                                   Administration site photosensitivity reaction                                              
                                                   Administration site plaque                                                                 
                                                   Administration site pruritus                                                               
                                                   Administration site pustule                                                                
                                                   Administration site reaction                                                               
                                                   Administration site reaction neonatal                                                      
                                                   Administration site scab                                                                   
                                                   Administration site scar                                                                   
                                                   Administration site streaking                                                              
                                                   Administration site swelling                                                               
                                                   Administration site ulcer                                                                  
                                                   Administration site vesicles                                                               
                                                   Administration site warmth                                                                 
                                                   Administration site wound                                                                  
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
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Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Injection site reactions                           Application site abscess                                                                   
                                                   Application site abscess sterile                                                           
                                                   Application site acne                                                                      
                                                   Application site alopecia                                                                  
                                                   Application site anaesthesia                                                               
                                                   Application site atrophy                                                                   
                                                   Application site bruise                                                                    
                                                   Application site burn                                                                      
                                                   Application site calcification                                                             
                                                   Application site cellulitis                                                                
                                                   Application site coldness                                                                  
                                                   Application site cyst                                                                      
                                                   Application site discharge                                                                 
                                                   Application site discolouration                                                            
                                                   Application site discomfort                                                                
                                                   Application site dryness                                                                   
                                                   Application site dysaesthesia                                                              
                                                   Application site erosion                                                                   
                                                   Application site erythema                                                                  
                                                   Application site exfoliation                                                               
                                                   Application site extravasation                                                             
                                                   Application site fibrosis                                                                  
                                                   Application site fissure                                                                   
                                                   Application site folliculitis                                                              
                                                   Application site granuloma                                                                 
                                                   Application site haematoma                                                                 
                                                   Application site haemorrhage                                                               
                                                   Application site hyperaesthesia                                                            
                                                   Application site hypertrichosis                                                            
                                                   Application site hypertrophy                                                               
                                                   Application site hypoaesthesia                                                             
                                                   Application site induration                                                                
                                                   Application site infection                                                                 
                                                   Application site inflammation                                                              
                                                   Application site injury                                                                    
                                                   Application site irritation                                                                
                                                   Application site ischaemia                                                                 
                                                   Application site joint discomfort                                                          
                                                   Application site joint effusion                                                            
                                                   Application site joint erythema                                                            
                                                   Application site joint infection                                                           
                                                   Application site joint inflammation                                                        
                                                   Application site joint movement impairment                                                 
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
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Page: 
71 of 229 
 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Injection site reactions                           Application site joint pain                                                                
                                                   Application site joint swelling                                                            
                                                   Application site joint warmth                                                              
                                                   Application site laceration                                                                
                                                   Application site lymphadenopathy                                                           
                                                   Application site macule                                                                    
                                                   Application site mass                                                                      
                                                   Application site movement impairment                                                       
                                                   Application site necrosis                                                                  
                                                   Application site nerve damage                                                              
                                                   Application site nodule                                                                    
                                                   Application site odour                                                                     
                                                   Application site oedema                                                                    
                                                   Application site pain                                                                      
                                                   Application site pallor                                                                    
                                                   Application site papules                                                                   
                                                   Application site paraesthesia                                                              
                                                   Application site perspiration                                                              
                                                   Application site phlebitis                                                                 
                                                   Application site photosensitivity reaction                                                 
                                                   Application site plaque                                                                    
                                                   Application site pruritus                                                                  
                                                   Application site purpura                                                                   
                                                   Application site pustules                                                                  
                                                   Application site reaction                                                                  
                                                   Application site scab                                                                      
                                                   Application site scar                                                                      
                                                   Application site streaking                                                                 
                                                   Application site swelling                                                                  
                                                   Application site telangiectasia                                                            
                                                   Application site ulcer                                                                     
                                                   Application site vesicles                                                                  
                                                   Application site warmth                                                                    
                                                   Application site wound                                                                     
                                                   Challenge site reaction                                                                    
                                                   Infusion site abscess                                                                      
                                                   Infusion site abscess sterile                                                              
                                                   Infusion site anaesthesia                                                                  
                                                   Infusion site atrophy                                                                      
                                                   Infusion site bruising                                                                     
                                                   Infusion site calcification                                                                
                                                   Infusion site cellulitis                                                                   
                                                   Infusion site coldness                                                                     
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
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Version: 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Injection site reactions
Infusion site cyst
Infusion site discharge
Infusion site discolouration
Infusion site discomfort
Infusion site dryness
Infusion site dysaesthesia
Infusion site erosion
Infusion site erythema
Infusion site eschar
Infusion site exfoliation
Infusion site extravasation
Infusion site fibrosis
Infusion site granuloma
Infusion site haematoma
Infusion site haemorrhage
Infusion site hyperaesthesia
Infusion site hypertrichosis
Infusion site hypertrophy
Infusion site hypoaesthesia
Infusion site induration
Infusion site infection
Infusion site inflammation
Infusion site injury
Infusion site irritation
Infusion site ischaemia
Infusion site joint discomfort
Infusion site joint effusion
Infusion site joint erythema
Infusion site joint infection
Infusion site joint inflammation
Infusion site joint movement impairment
Infusion site joint pain
Infusion site joint swelling
Infusion site joint warmth
Infusion site laceration
Infusion site lymphadenopathy
Infusion site macule
Infusion site mass
Infusion site mobility decreased
Infusion site necrosis
Infusion site nerve damage
Infusion site nodule
Infusion site oedema
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Injection site reactions                           Infusion site pain                                                                         
                                                   Infusion site pallor                                                                       
                                                   Infusion site papule                                                                       
                                                   Infusion site paraesthesia                                                                 
                                                   Infusion site phlebitis                                                                    
                                                   Infusion site photosensitivity reaction                                                    
                                                   Infusion site plaque                                                                       
                                                   Infusion site pruritus                                                                     
                                                   Infusion site pustule                                                                      
                                                   Infusion site reaction                                                                     
                                                   Infusion site scab                                                                         
                                                   Infusion site scar                                                                         
                                                   Infusion site streaking                                                                    
                                                   Infusion site swelling                                                                     
                                                   Infusion site ulcer                                                                        
                                                   Infusion site vesicles                                                                     
                                                   Infusion site warmth                                                                       
                                                   Injected limb mobility decreased                                                           
                                                   Injection site abscess                                                                     
                                                   Injection site abscess sterile                                                             
                                                   Injection site alopecia                                                                    
                                                   Injection site anaesthesia                                                                 
                                                   Injection site atrophy                                                                     
                                                   Injection site bruising                                                                    
                                                   Injection site calcification                                                               
                                                   Injection site cellulitis                                                                  
                                                   Injection site coldness                                                                    
                                                   Injection site cyst                                                                        
                                                   Injection site deformation                                                                 
                                                   Injection site discharge                                                                   
                                                   Injection site discolouration                                                              
                                                   Injection site discomfort                                                                  
                                                   Injection site dryness                                                                     
                                                   Injection site dysaesthesia                                                                
                                                   Injection site erosion                                                                     
                                                   Injection site erythema                                                                    
                                                   Injection site exfoliation                                                                 
                                                   Injection site extravasation                                                               
                                                   Injection site fibrosis                                                                    
                                                   Injection site granuloma                                                                   
                                                   Injection site haematoma                                                                   
                                                   Injection site haemorrhage                                                                 
                                                   Injection site hyperaesthesia                                                              
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
74 of 229 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Injection site reactions
Injection site hypertrichosis
Injection site hypertrophy
Injection site hypoaesthesia
Injection site indentation
Injection site induration
Injection site infection
Injection site inflammation
Injection site injury
Injection site irritation
Injection site ischaemia
Injection site joint discomfort
Injection site joint effusion
Injection site joint erythema
Injection site joint infection
Injection site joint inflammation
Injection site joint movement impairment
Injection site joint pain
Injection site joint swelling
Injection site joint warmth
Injection site laceration
Injection site lymphadenopathy
Injection site macule
Injection site mass
Injection site movement impairment
Injection site necrosis
Injection site nerve damage
Injection site nodule
Injection site oedema
Injection site pain
Injection site pallor
Injection site panniculitis
Injection site papule
Injection site paraesthesia
Injection site phlebitis
Injection site photosensitivity reaction
Injection site plaque
Injection site pruritus
Injection site pustule
Injection site reaction
Injection site scab
Injection site scar
Injection site streaking
Injection site swelling
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Injection site reactions                           Injection site telangiectasia                                                              
                                                   Injection site ulcer                                                                       
                                                   Injection site vesicles                                                                    
                                                   Injection site warmth                                                                      
                                                   Instillation site abscess                                                                  
                                                   Instillation site anaesthesia                                                              
                                                   Instillation site atrophy                                                                  
                                                   Instillation site bruise                                                                   
                                                   Instillation site burn                                                                     
                                                   Instillation site coldness                                                                 
                                                   Instillation site complication                                                             
                                                   Instillation site discharge                                                                
                                                   Instillation site discolouration                                                           
                                                   Instillation site discomfort                                                               
                                                   Instillation site dryness                                                                  
                                                   Instillation site erosion                                                                  
                                                   Instillation site erythema                                                                 
                                                   Instillation site exfoliation                                                              
                                                   Instillation site foreign body sensation                                                   
                                                   Instillation site haematoma                                                                
                                                   Instillation site haemorrhage                                                              
                                                   Instillation site hyperaesthesia                                                           
                                                   Instillation site hypoaesthesia                                                            
                                                   Instillation site induration                                                               
                                                   Instillation site infection                                                                
                                                   Instillation site inflammation                                                             
                                                   Instillation site irritation                                                               
                                                   Instillation site lacrimation                                                              
                                                   Instillation site necrosis                                                                 
                                                   Instillation site nodule                                                                   
                                                   Instillation site odour                                                                    
                                                   Instillation site oedema                                                                   
                                                   Instillation site pain                                                                     
                                                   Instillation site papules                                                                  
                                                   Instillation site paraesthesia                                                             
                                                   Instillation site pruritus                                                                 
                                                   Instillation site pustules                                                                 
                                                   Instillation site reaction                                                                 
                                                   Instillation site scab                                                                     
                                                   Instillation site swelling                                                                 
                                                   Instillation site ulcer                                                                    
                                                   Instillation site vesicles                                                                 
                                                   Instillation site warmth                                                                   
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
76 of 229 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Injection site reactions
Malabsorption from administration site
Malabsorption from application site
Malabsorption from injection site  
Oral administration complication
Puncture site abscess
Puncture site bruise
Puncture site discharge
Puncture site erythema
Puncture site haematoma
Puncture site haemorrhage
Puncture site hernia
Puncture site hypoaesthesia
Puncture site induration
Puncture site infection
Puncture site injury
Puncture site oedema
Puncture site pain
Puncture site pruritus
Puncture site reaction
Puncture site swelling
Systemic leakage
Vessel puncture site anaesthesia
Vessel puncture site bruise
Vessel puncture site cellulitis
Vessel puncture site discharge
Vessel puncture site erythema
Vessel puncture site haematoma
Vessel puncture site haemorrhage
Vessel puncture site hypoaesthesia
Vessel puncture site induration
Vessel puncture site infection
Vessel puncture site inflammation
Vessel puncture site injury
Vessel puncture site pain
Vessel puncture site paraesthesia
Vessel puncture site phlebitis
Vessel puncture site pruritus
Vessel puncture site reaction
Vessel puncture site swelling
Malignant tumours (SMQ)
Cholangiosarcoma
Hepatic angiosarcoma
Hepatic cancer
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Hepatic cancer metastatic                                                                  
                                                   Hepatic cancer recurrent                                                                   
                                                   Hepatic cancer stage I                                                                     
                                                   Hepatic cancer stage II                                                                    
                                                   Hepatic cancer stage III                                                                   
                                                   Hepatic cancer stage IV                                                                    
                                                   Hepatobiliary cancer                                                                       
                                                   Hepatobiliary cancer in situ                                                               
                                                   Hepatoblastoma                                                                             
                                                   Hepatoblastoma recurrent                                                                   
                                                   Hepatocellular carcinoma                                                                   
                                                   Mixed hepatocellular cholangiocarcinoma                                                    
                                                   5q minus syndrome                                                                          
                                                   Abdominal wall neoplasm malignant                                                          
                                                   Acinar cell carcinoma of pancreas                                                          
                                                   Acinic cell carcinoma of salivary gland                                                    
                                                   Acral lentiginous melanoma                                                                 
                                                   Acral lentiginous melanoma stage I                                                         
                                                   Acral lentiginous melanoma stage II                                                        
                                                   Acral lentiginous melanoma stage III                                                       
                                                   Acral lentiginous melanoma stage IV                                                        
                                                   Acute bilineal leukaemia                                                                   
                                                   Acute biphenotypic leukaemia                                                               
                                                   Acute erythroid leukaemia                                                                  
                                                   Acute leukaemia                                                                            
                                                   Acute leukaemia in remission                                                               
                                                   Acute lymphocytic leukaemia                                                                
                                                   Acute lymphocytic leukaemia (in remission)                                                 
                                                   Acute lymphocytic leukaemia recurrent                                                      
                                                   Acute lymphocytic leukaemia refractory                                                     
                                                   Acute megakaryocytic leukaemia                                                             
                                                   Acute megakaryocytic leukaemia (in remission)                                              
                                                   Acute monocytic leukaemia                                                                  
                                                   Acute monocytic leukaemia (in remission)                                                   
                                                   Acute myeloid leukaemia                                                                    
                                                   Acute myeloid leukaemia (in remission)                                                     
                                                   Acute myeloid leukaemia recurrent                                                          
                                                   Acute myeloid leukaemia refractory                                                         
                                                   Acute myelomonocytic leukaemia                                                             
                                                   Acute promyelocytic leukaemia                                                              
                                                   Acute undifferentiated leukaemia                                                           
                                                   Adenocarcinoma                                                                             
                                                   Adenocarcinoma gastric                                                                     
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
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Page: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Adenocarcinoma metastatic                                                                  
                                                   Adenocarcinoma of appendix                                                                 
                                                   Adenocarcinoma of colon                                                                    
                                                   Adenocarcinoma of salivary gland                                                           
                                                   Adenocarcinoma of the cervix                                                               
                                                   Adenocarcinoma pancreas                                                                    
                                                   Adenoid cystic carcinoma                                                                   
                                                   Adenoid cystic carcinoma of salivary gland                                                 
                                                   Adenosquamous carcinoma of the cervix                                                      
                                                   Adenosquamous carcinoma of vagina                                                          
                                                   Adenosquamous cell carcinoma                                                               
                                                   Adenosquamous cell lung cancer                                                             
                                                   Adenosquamous cell lung cancer recurrent                                                   
                                                   Adenosquamous cell lung cancer stage 0                                                     
                                                   Adenosquamous cell lung cancer stage I                                                     
                                                   Adenosquamous cell lung cancer stage II                                                    
                                                   Adenosquamous cell lung cancer stage III                                                   
                                                   Adenosquamous cell lung cancer stage IV                                                    
                                                   Adrenal gland cancer                                                                       
                                                   Adrenal gland cancer metastatic                                                            
                                                   Adrenocortical carcinoma                                                                   
                                                   Adult T-cell lymphoma/leukaemia                                                            
                                                   Adult T-cell lymphoma/leukaemia recurrent                                                  
                                                   Adult T-cell lymphoma/leukaemia refractory                                                 
                                                   Adult T-cell lymphoma/leukaemia stage I                                                    
                                                   Adult T-cell lymphoma/leukaemia stage II                                                   
                                                   Adult T-cell lymphoma/leukaemia stage III                                                  
                                                   Adult T-cell lymphoma/leukaemia stage IV                                                   
                                                   Aesthesioneuroblastoma                                                                     
                                                   Aleukaemic leukaemia                                                                       
                                                   Alveolar rhabdomyosarcoma                                                                  
                                                   Alveolar soft part sarcoma                                                                 
                                                   Alveolar soft part sarcoma metastatic                                                      
                                                   Alveolar soft part sarcoma recurrent                                                       
                                                   Ameloblastic carcinoma                                                                     
                                                   Anal cancer                                                                                
                                                   Anal cancer metastatic                                                                     
                                                   Anal cancer recurrent                                                                      
                                                   Anal cancer stage 0                                                                        
                                                   Anal cancer stage I                                                                        
                                                   Anal cancer stage II                                                                       
                                                   Anal cancer stage III                                                                      
                                                   Anal cancer stage IV                                                                       
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
79 of 229 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Anal squamous cell carcinoma
Anaplastic astrocytoma
Anaplastic large cell lymphoma T- and null-cell
types  
Anaplastic large cell lymphoma T- and null-cell
types recurrent
Anaplastic large cell lymphoma T- and null-cell
types refractory
Anaplastic large cell lymphoma T- and null-cell
types stage I
Anaplastic large cell lymphoma T- and null-cell
types stage II
Anaplastic large cell lymphoma T- and null-cell
types stage III
Anaplastic large cell lymphoma T- and null-cell
types stage IV
Anaplastic large-cell lymphoma
Anaplastic meningioma
Anaplastic oligodendroglioma
Anaplastic thyroid cancer
Angiocentric glioma
Angiocentric lymphoma
Angiocentric lymphoma recurrent
Angiocentric lymphoma refractory
Angiocentric lymphoma stage I
Angiocentric lymphoma stage II
Angiocentric lymphoma stage III
Angiocentric lymphoma stage IV
Angioimmunoblastic T-cell lymphoma
Angioimmunoblastic T-cell lymphoma recurrent
Angioimmunoblastic T-cell lymphoma refractory
Angioimmunoblastic T-cell lymphoma stage I
Angioimmunoblastic T-cell lymphoma stage II
Angioimmunoblastic T-cell lymphoma stage III
Angioimmunoblastic T-cell lymphoma stage IV
Angiosarcoma
Angiosarcoma metastatic
Angiosarcoma non-metastatic
Angiosarcoma recurrent
Apocrine breast carcinoma
Appendix cancer
Astrocytoma
Astrocytoma malignant
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Atypical teratoid/rhabdoid tumour of CNS                                                   
                                                   B precursor type acute leukaemia                                                           
                                                   B-cell lymphoma                                                                            
                                                   B-cell lymphoma recurrent                                                                  
                                                   B-cell lymphoma refractory                                                                 
                                                   B-cell lymphoma stage I                                                                    
                                                   B-cell lymphoma stage II                                                                   
                                                   B-cell lymphoma stage III                                                                  
                                                   B-cell lymphoma stage IV                                                                   
                                                   B-cell prolymphocytic leukaemia                                                            
                                                   B-cell small lymphocytic lymphoma                                                          
                                                   B-cell small lymphocytic lymphoma recurrent                                                
                                                   B-cell small lymphocytic lymphoma refractory                                               
                                                   B-cell small lymphocytic lymphoma stage I                                                  
                                                   B-cell small lymphocytic lymphoma stage II                                                 
                                                   B-cell small lymphocytic lymphoma stage III                                                
                                                   B-cell small lymphocytic lymphoma stage IV                                                 
                                                   B-cell type acute leukaemia                                                                
                                                   B-cell unclassifiable lymphoma high grade                                                  
                                                   B-cell unclassifiable lymphoma low grade                                                   
                                                   Basal cell carcinoma                                                                       
                                                   Basal cell carcinoma metastatic                                                            
                                                   Basosquamous carcinoma                                                                     
                                                   Basosquamous carcinoma of skin                                                             
                                                   Bile duct adenocarcinoma                                                                   
                                                   Bile duct adenosquamous carcinoma                                                          
                                                   Bile duct cancer                                                                           
                                                   Bile duct cancer recurrent                                                                 
                                                   Bile duct cancer stage 0                                                                   
                                                   Bile duct cancer stage I                                                                   
                                                   Bile duct cancer stage II                                                                  
                                                   Bile duct cancer stage III                                                                 
                                                   Bile duct cancer stage IV                                                                  
                                                   Bile duct squamous cell carcinoma                                                          
                                                   Biliary cancer metastatic                                                                  
                                                   Biphasic mesothelioma                                                                      
                                                   Bladder adenocarcinoma recurrent                                                           
                                                   Bladder adenocarcinoma stage 0                                                             
                                                   Bladder adenocarcinoma stage I                                                             
                                                   Bladder adenocarcinoma stage II                                                            
                                                   Bladder adenocarcinoma stage III                                                           
                                                   Bladder adenocarcinoma stage IV                                                            
                                                   Bladder adenocarcinoma stage unspecified                                                   
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Bladder cancer                                                                             
                                                   Bladder cancer recurrent                                                                   
                                                   Bladder cancer stage 0, with cancer in situ                                                
                                                   Bladder cancer stage 0, without cancer in situ                                             
                                                   Bladder cancer stage I, with cancer in situ                                                
                                                   Bladder cancer stage I, without cancer in situ                                             
                                                   Bladder cancer stage II                                                                    
                                                   Bladder cancer stage III                                                                   
                                                   Bladder cancer stage IV                                                                    
                                                   Bladder squamous cell carcinoma recurrent                                                  
                                                   Bladder squamous cell carcinoma stage 0                                                    
                                                   Bladder squamous cell carcinoma stage I                                                    
                                                   Bladder squamous cell carcinoma stage II                                                   
                                                   Bladder squamous cell carcinoma stage III                                                  
                                                   Bladder squamous cell carcinoma stage IV                                                   
                                                   Bladder squamous cell carcinoma stage unspecified                                          
                                                   Bladder transitional cell carcinoma                                                        
                                                   Bladder transitional cell carcinoma metastatic                                             
                                                   Bladder transitional cell carcinoma recurrent                                              
                                                   Bladder transitional cell carcinoma stage 0                                                
                                                   Bladder transitional cell carcinoma stage I                                                
                                                   Bladder transitional cell carcinoma stage II                                               
                                                   Bladder transitional cell carcinoma stage III                                              
                                                   Bladder transitional cell carcinoma stage IV                                               
                                                   Blast cell crisis                                                                          
                                                   Blast crisis in myelogenous leukaemia                                                      
                                                   Blastic plasmacytoid dendritic cell neoplasia                                              
                                                   Bone cancer                                                                                
                                                   Bone cancer metastatic                                                                     
                                                   Bone giant cell tumour malignant                                                           
                                                   Bone marrow leukaemic cell infiltration                                                    
                                                   Bone marrow tumour cell infiltration                                                       
                                                   Bone sarcoma                                                                               
                                                   Bowen's disease                                                                            
                                                   Brain cancer metastatic                                                                    
                                                   Brain neoplasm malignant                                                                   
                                                   Brain sarcoma                                                                              
                                                   Brain stem glioma                                                                          
                                                   Breast angiosarcoma                                                                        
                                                   Breast angiosarcoma metastatic                                                             
                                                   Breast cancer                                                                              
                                                   Breast cancer female                                                                       
                                                   Breast cancer in situ                                                                      
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Breast cancer male
Breast cancer metastatic
Breast cancer recurrent
Breast cancer stage I
Breast cancer stage II
Breast cancer stage III
Breast cancer stage IV
Breast implant-associated anaplastic large cell
lymphoma
Breast sarcoma
Breast sarcoma metastatic
Breast sarcoma recurrent
Bronchial carcinoma
Bronchioloalveolar carcinoma
Burkitt's leukaemia
Burkitt's lymphoma
Burkitt's lymphoma recurrent
Burkitt's lymphoma refractory
Burkitt's lymphoma stage I
Burkitt's lymphoma stage II
Burkitt's lymphoma stage III
Burkitt's lymphoma stage IV
Buschke-Lowenstein's tumour
CNS germinoma
Cancer in remission
Carcinoid tumour
Carcinoid tumour of the appendix
Carcinoid tumour of the caecum
Carcinoid tumour of the duodenum
Carcinoid tumour of the gastrointestinal tract
Carcinoid tumour of the liver
Carcinoid tumour of the ovary
Carcinoid tumour of the pancreas
Carcinoid tumour of the prostate
Carcinoid tumour of the small bowel
Carcinoid tumour of the stomach
Carcinoid tumour pulmonary
Carcinoma ex-pleomorphic adenoma
Carcinoma in situ
Carcinoma in situ of eye
Carcinoma in situ of penis
Carcinoma in situ of skin
Carcinoma in situ of trachea
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Cardiac neoplasm malignant                                                                 
                                                   Central nervous system leukaemia                                                           
                                                   Central nervous system lymphoma                                                            
                                                   Central nervous system melanoma                                                            
                                                   Central nervous system neuroblastoma                                                       
                                                   Cervix cancer metastatic                                                                   
                                                   Cervix carcinoma                                                                           
                                                   Cervix carcinoma recurrent                                                                 
                                                   Cervix carcinoma stage 0                                                                   
                                                   Cervix carcinoma stage I                                                                   
                                                   Cervix carcinoma stage II                                                                  
                                                   Cervix carcinoma stage III                                                                 
                                                   Cervix carcinoma stage IV                                                                  
                                                   Chloroma                                                                                   
                                                   Chloroma (in remission)                                                                    
                                                   Cholangiocarcinoma                                                                         
                                                   Chondrosarcoma                                                                             
                                                   Chondrosarcoma metastatic                                                                  
                                                   Chondrosarcoma recurrent                                                                   
                                                   Chordoma                                                                                   
                                                   Choriocarcinoma                                                                            
                                                   Choroid melanoma                                                                           
                                                   Choroid plexus carcinoma                                                                   
                                                   Chromophobe renal cell carcinoma                                                           
                                                   Chronic eosinophilic leukaemia                                                             
                                                   Chronic leukaemia                                                                          
                                                   Chronic leukaemia in remission                                                             
                                                   Chronic lymphocytic leukaemia                                                              
                                                   Chronic lymphocytic leukaemia (in remission)                                               
                                                   Chronic lymphocytic leukaemia recurrent                                                    
                                                   Chronic lymphocytic leukaemia refractory                                                   
                                                   Chronic lymphocytic leukaemia stage 0                                                      
                                                   Chronic lymphocytic leukaemia stage 1                                                      
                                                   Chronic lymphocytic leukaemia stage 2                                                      
                                                   Chronic lymphocytic leukaemia stage 3                                                      
                                                   Chronic lymphocytic leukaemia stage 4                                                      
                                                   Chronic lymphocytic leukaemia transformation                                               
                                                   Chronic myeloid leukaemia                                                                  
                                                   Chronic myeloid leukaemia (in remission)                                                   
                                                   Chronic myeloid leukaemia recurrent                                                        
                                                   Chronic myeloid leukaemia transformation                                                   
                                                   Chronic myelomonocytic leukaemia                                                           
                                                   Chronic myelomonocytic leukaemia (in remission)                                            
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Ciliary body melanoma                                                                      
                                                   Clear cell carcinoma of cervix                                                             
                                                   Clear cell endometrial carcinoma                                                           
                                                   Clear cell renal cell carcinoma                                                            
                                                   Clear cell sarcoma of soft tissue                                                          
                                                   Clear cell sarcoma of the kidney                                                           
                                                   Colon cancer                                                                               
                                                   Colon cancer metastatic                                                                    
                                                   Colon cancer recurrent                                                                     
                                                   Colon cancer stage 0                                                                       
                                                   Colon cancer stage I                                                                       
                                                   Colon cancer stage II                                                                      
                                                   Colon cancer stage III                                                                     
                                                   Colon cancer stage IV                                                                      
                                                   Colorectal adenocarcinoma                                                                  
                                                   Colorectal cancer                                                                          
                                                   Colorectal cancer metastatic                                                               
                                                   Colorectal cancer recurrent                                                                
                                                   Colorectal cancer stage I                                                                  
                                                   Colorectal cancer stage II                                                                 
                                                   Colorectal cancer stage III                                                                
                                                   Colorectal cancer stage IV                                                                 
                                                   Colorectal carcinoma stage 0                                                               
                                                   Composite lymphoma                                                                         
                                                   Congenital fibrosarcoma                                                                    
                                                   Congenital malignant neoplasm                                                              
                                                   Congenital retinoblastoma                                                                  
                                                   Conjunctival melanoma                                                                      
                                                   Cutaneous T-cell lymphoma                                                                  
                                                   Cutaneous T-cell lymphoma recurrent                                                        
                                                   Cutaneous T-cell lymphoma refractory                                                       
                                                   Cutaneous T-cell lymphoma stage I                                                          
                                                   Cutaneous T-cell lymphoma stage II                                                         
                                                   Cutaneous T-cell lymphoma stage III                                                        
                                                   Cutaneous T-cell lymphoma stage IV                                                         
                                                   Cutaneous lymphoma                                                                         
                                                   Cystadenocarcinoma ovary                                                                   
                                                   Cystadenocarcinoma pancreas                                                                
                                                   Dedifferentiated liposarcoma                                                               
                                                   Dermatofibrosarcoma protuberans                                                            
                                                   Dermatofibrosarcoma protuberans metastatic                                                 
                                                   Desmoplastic melanoma                                                                      
                                                   Desmoplastic mesothelioma                                                                  
.


NN9535 
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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Desmoplastic small round cell tumour
Diffuse large B-cell lymphoma
Diffuse large B-cell lymphoma recurrent
Diffuse large B-cell lymphoma refractory
Diffuse large B-cell lymphoma stage I
Diffuse large B-cell lymphoma stage II
Diffuse large B-cell lymphoma stage III
Diffuse large B-cell lymphoma stage IV
Disseminated large cell lymphoma
Double hit lymphoma
Ductal adenocarcinoma of pancreas
Ear neoplasm malignant
Eccrine carcinoma
Embryonal rhabdomyosarcoma
Endocrine neoplasm malignant
Endometrial adenocarcinoma
Endometrial cancer
Endometrial cancer metastatic
Endometrial cancer recurrent
Endometrial cancer stage 0
Endometrial cancer stage I
Endometrial cancer stage II
Endometrial cancer stage III
Endometrial cancer stage IV
Endometrial sarcoma
Endometrial sarcoma metastatic
Endometrial sarcoma recurrent
Endometrial stromal sarcoma
Endotheliomatosis
Enteropathy-associated T-cell lymphoma
Eosinophilic leukaemia
Ependymoma malignant
Epididymal cancer
Epiglottic cancer
Epithelioid mesothelioma
Epithelioid sarcoma
Epithelioid sarcoma metastatic
Epithelioid sarcoma recurrent
Epstein-Barr virus associated lymphoma
Erythraemic myelosis (in remission)
Ewing's sarcoma
Ewing's sarcoma metastatic
Ewing's sarcoma recurrent
.


NN9535 
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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Ewing-like sarcoma                                                                         
                                                   External ear neoplasm malignant                                                            
                                                   Extra-osseous Ewing's sarcoma                                                              
                                                   Extra-osseous Ewing's sarcoma metastatic                                                   
                                                   Extra-osseous Ewing's sarcoma recurrent                                                    
                                                   Extragonadal primary embryonal carcinoma                                                   
                                                   Extragonadal primary germ cell tumour                                                      
                                                   Extragonadal primary germ cell tumour mixed                                                
                                                   Extragonadal primary germ cell tumour mixed stage                                          
                                                   I                                                                                          
                                                   Extragonadal primary germ cell tumour mixed stage                                          
                                                   II                                                                                         
                                                   Extragonadal primary germ cell tumour mixed stage                                          
                                                   III                                                                                        
                                                   Extragonadal primary malignant teratoma                                                    
                                                   Extragonadal primary non-seminoma                                                          
                                                   Extragonadal primary non-seminoma stage I                                                  
                                                   Extragonadal primary non-seminoma stage II                                                 
                                                   Extragonadal primary non-seminoma stage III                                                
                                                   Extragonadal primary non-seminoma stage IV                                                 
                                                   Extragonadal primary seminoma (pure)                                                       
                                                   Extragonadal primary seminoma (pure) stage I                                               
                                                   Extragonadal primary seminoma (pure) stage II                                              
                                                   Extragonadal primary seminoma (pure) stage III                                             
                                                   Extragonadal primary seminoma (pure) stage IV                                              
                                                   Extramammary Paget's disease                                                               
                                                   Extranodal marginal zone B-cell lymphoma (BALT                                             
                                                   type)                                                                                      
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type)                                                                                      
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type) recurrent                                                                            
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type) refractory                                                                           
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type) stage I                                                                              
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type) stage II                                                                             
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type) stage III                                                                            
                                                   Extranodal marginal zone B-cell lymphoma (MALT                                             
                                                   type) stage IV                                                                             
                                                   Extraocular retinoblastoma                                                                 
.


NN9535 
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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Extraskeletal chondrosarcoma metastatic
Extraskeletal chondrosarcoma recurrent
Extraskeletal myxoid chondrosarcoma
Extraskeletal osteosarcoma
Extraskeletal osteosarcoma metastatic
Extraskeletal osteosarcoma recurrent
Fallopian tube cancer
Fallopian tube cancer metastatic
Fallopian tube cancer stage I
Fallopian tube cancer stage II
Fallopian tube cancer stage III
Fallopian tube cancer stage IV
Familial medullary thyroid cancer
Female reproductive tract carcinoma in situ
Fibrosarcoma
Fibrosarcoma metastatic
Follicle centre lymphoma diffuse small cell
lymphoma
Follicle centre lymphoma diffuse small cell
lymphoma recurrent
Follicle centre lymphoma diffuse small cell
lymphoma refractory
Follicle centre lymphoma diffuse small cell
lymphoma stage I
Follicle centre lymphoma diffuse small cell
lymphoma stage II
Follicle centre lymphoma diffuse small cell
lymphoma stage III
Follicle centre lymphoma diffuse small cell
lymphoma stage IV
Follicle centre lymphoma, follicular grade I, II,
III
Follicle centre lymphoma, follicular grade I, II,
III recurrent
Follicle centre lymphoma, follicular grade I, II,
III refractory
Follicle centre lymphoma, follicular grade I, II,
III stage I
Follicle centre lymphoma, follicular grade I, II,
III stage II
Follicle centre lymphoma, follicular grade I, II,
III stage III
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Follicle centre lymphoma, follicular grade I, II,
III stage IV
Follicular dendritic cell sarcoma
Follicular thyroid cancer
Gallbladder adenocarcinoma
Gallbladder adenosquamous carcinoma
Gallbladder cancer
Gallbladder cancer metastatic
Gallbladder cancer recurrent
Gallbladder cancer stage 0
Gallbladder cancer stage I
Gallbladder cancer stage II
Gallbladder cancer stage III
Gallbladder cancer stage IV
Gallbladder squamous cell carcinoma
Ganglioglioma
Ganglioneuroblastoma
Gastric cancer
Gastric cancer recurrent
Gastric cancer stage 0
Gastric cancer stage I
Gastric cancer stage II
Gastric cancer stage III
Gastric cancer stage IV
Gastric sarcoma
Gastrinoma malignant
Gastroenteropancreatic neuroendocrine tumour
disease
Gastrointestinal adenocarcinoma
Gastrointestinal cancer metastatic
Gastrointestinal carcinoma
Gastrointestinal carcinoma in situ
Gastrointestinal lymphoma
Gastrointestinal melanoma
Gastrointestinal stromal tumour
Gastrooesophageal cancer
Gastrooesophageal cancer recurrent
Genital cancer male
Genital cancer male in situ
Genital neoplasm malignant female
Genitourinary melanoma
Germ cell cancer
Germ cell cancer metastatic
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Gestational trophoblastic tumour                                                           
                                                   Gingival cancer                                                                            
                                                   Glioblastoma                                                                               
                                                   Glioblastoma multiforme                                                                    
                                                   Glioma                                                                                     
                                                   Gliomatosis cerebri                                                                        
                                                   Glioneuronal tumour                                                                        
                                                   Gliosarcoma                                                                                
                                                   Glomangiopericytoma                                                                        
                                                   Glottis carcinoma                                                                          
                                                   Glucagonoma                                                                                
                                                   HER2 negative breast cancer                                                                
                                                   HER2 positive breast cancer                                                                
                                                   HER2 positive gastric cancer                                                               
                                                   Haemangiopericytoma                                                                        
                                                   Haemangiopericytoma of meninges                                                            
                                                   Haematological malignancy                                                                  
                                                   Hairy cell leukaemia                                                                       
                                                   Hairy cell leukaemia recurrent                                                             
                                                   Head and neck cancer                                                                       
                                                   Head and neck cancer metastatic                                                            
                                                   Head and neck cancer stage I                                                               
                                                   Head and neck cancer stage II                                                              
                                                   Head and neck cancer stage III                                                             
                                                   Head and neck cancer stage IV                                                              
                                                   Hepatosplenic T-cell lymphoma                                                              
                                                   Hereditary leiomyomatosis renal cell carcinoma                                             
                                                   Hereditary papillary renal carcinoma                                                       
                                                   Hidradenocarcinoma                                                                         
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   recurrent                                                                                  
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   refractory                                                                                 
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage I                                                                                    
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage II                                                                                   
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage III                                                                                  
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage IV                                                                                   
                                                   High-grade B-cell lymphoma                                                                 
.


NN9535 
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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Histiocytic medullary reticulosis                                                          
                                                   Histiocytic sarcoma                                                                        
                                                   Hodgkin's disease                                                                          
                                                   Hodgkin's disease lymphocyte depletion stage I                                             
                                                   site unspecified                                                                           
                                                   Hodgkin's disease lymphocyte depletion stage I                                             
                                                   subdiaphragm                                                                               
                                                   Hodgkin's disease lymphocyte depletion stage I                                             
                                                   supradiaphragm                                                                             
                                                   Hodgkin's disease lymphocyte depletion stage II                                            
                                                   site unspecified                                                                           
                                                   Hodgkin's disease lymphocyte depletion stage II                                            
                                                   subdiaphragm                                                                               
                                                   Hodgkin's disease lymphocyte depletion stage II                                            
                                                   supradiaphragm                                                                             
                                                   Hodgkin's disease lymphocyte depletion type                                                
                                                   recurrent                                                                                  
                                                   Hodgkin's disease lymphocyte depletion type                                                
                                                   refractory                                                                                 
                                                   Hodgkin's disease lymphocyte depletion type stage                                          
                                                   III                                                                                        
                                                   Hodgkin's disease lymphocyte depletion type stage                                          
                                                   IV                                                                                         
                                                   Hodgkin's disease lymphocyte depletion type stage                                          
                                                   unspecified                                                                                
                                                   Hodgkin's disease lymphocyte predominance stage I                                          
                                                   site unspec                                                                                
                                                   Hodgkin's disease lymphocyte predominance stage I                                          
                                                   subdiaphragm                                                                               
                                                   Hodgkin's disease lymphocyte predominance stage I                                          
                                                   supradiaphragm                                                                             
                                                   Hodgkin's disease lymphocyte predominance stage                                            
                                                   II site unspec                                                                             
                                                   Hodgkin's disease lymphocyte predominance stage                                            
                                                   II subdiaphragm                                                                            
                                                   Hodgkin's disease lymphocyte predominance stage                                            
                                                   II supradiaphragm                                                                          
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   recurrent                                                                                  
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   refractory                                                                                 
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   stage III                                                                                  
.


NN9535 
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Date: 
04 December 2020 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Hodgkin's disease lymphocyte predominance type                                             
                                                   stage IV                                                                                   
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   stage unspecified                                                                          
                                                   Hodgkin's disease mixed cellularity recurrent                                              
                                                   Hodgkin's disease mixed cellularity refractory                                             
                                                   Hodgkin's disease mixed cellularity stage I site                                           
                                                   unspecified                                                                                
                                                   Hodgkin's disease mixed cellularity stage I                                                
                                                   subdiaphragmatic                                                                           
                                                   Hodgkin's disease mixed cellularity stage I                                                
                                                   supradiaphragmatic                                                                         
                                                   Hodgkin's disease mixed cellularity stage II                                               
                                                   subdiaphragmatic                                                                           
                                                   Hodgkin's disease mixed cellularity stage II                                               
                                                   supradiaphragmatic                                                                         
                                                   Hodgkin's disease mixed cellularity stage III                                              
                                                   Hodgkin's disease mixed cellularity stage IV                                               
                                                   Hodgkin's disease mixed cellularity stage                                                  
                                                   unspecified                                                                                
                                                   Hodgkin's disease nodular sclerosis                                                        
                                                   Hodgkin's disease nodular sclerosis recurrent                                              
                                                   Hodgkin's disease nodular sclerosis refractory                                             
                                                   Hodgkin's disease nodular sclerosis stage I                                                
                                                   Hodgkin's disease nodular sclerosis stage II                                               
                                                   Hodgkin's disease nodular sclerosis stage III                                              
                                                   Hodgkin's disease nodular sclerosis stage IV                                               
                                                   Hodgkin's disease recurrent                                                                
                                                   Hodgkin's disease refractory                                                               
                                                   Hodgkin's disease stage I                                                                  
                                                   Hodgkin's disease stage II                                                                 
                                                   Hodgkin's disease stage III                                                                
                                                   Hodgkin's disease stage IV                                                                 
                                                   Hodgkin's disease unclassifiable                                                           
                                                   Hormone receptor positive breast cancer                                                    
                                                   Hormone refractory breast cancer                                                           
                                                   Hormone-dependent prostate cancer                                                          
                                                   Hormone-refractory prostate cancer                                                         
                                                   Huerthle cell carcinoma                                                                    
                                                   Hypopharyngeal cancer                                                                      
                                                   Hypopharyngeal cancer recurrent                                                            
                                                   Hypopharyngeal cancer stage 0                                                              
                                                   Hypopharyngeal cancer stage I                                                              
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Hypopharyngeal cancer stage II
Hypopharyngeal cancer stage III
Hypopharyngeal cancer stage IV
Immune reconstitution inflammatory syndrome
associated Kaposi's sarcoma
Immunoblastic lymphoma
Inflammatory carcinoma of breast recurrent
Inflammatory carcinoma of breast stage III
Inflammatory carcinoma of breast stage IV
Inflammatory carcinoma of the breast
Inflammatory malignant fibrous histiocytoma
Inflammatory myofibroblastic tumour  
Intestinal T-cell lymphoma recurrent
Intestinal T-cell lymphoma refractory
Intestinal T-cell lymphoma stage I
Intestinal T-cell lymphoma stage II
Intestinal T-cell lymphoma stage III
Intestinal T-cell lymphoma stage IV
Intestinal adenocarcinoma
Intestinal metastasis
Intracranial germ cell tumour
Intracranial meningioma malignant
Intraductal papillary breast neoplasm
Intraductal papillary-mucinous carcinoma of
pancreas
Intraductal proliferative breast lesion
Intraocular melanoma
Invasive breast carcinoma
Invasive ductal breast carcinoma
Invasive lobular breast carcinoma
Invasive papillary breast carcinoma
Iris melanoma
Juvenile chronic myelomonocytic leukaemia
Kaposi's sarcoma
Kaposi's sarcoma AIDS related
Kaposi's sarcoma classical type
Keratinising squamous cell carcinoma of
nasopharynx
Keratoacanthoma
Langerhans cell sarcoma
Large cell lung cancer
Large cell lung cancer metastatic
Large cell lung cancer recurrent
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Large cell lung cancer stage 0
Large cell lung cancer stage I
Large cell lung cancer stage II
Large cell lung cancer stage III
Large cell lung cancer stage IV
Laryngeal cancer
Laryngeal cancer metastatic
Laryngeal cancer recurrent
Laryngeal cancer stage 0
Laryngeal cancer stage I
Laryngeal cancer stage II
Laryngeal cancer stage III
Laryngeal cancer stage IV
Laryngeal squamous cell carcinoma
Leiomyosarcoma
Leiomyosarcoma metastatic
Leiomyosarcoma recurrent
Lentigo maligna
Lentigo maligna recurrent
Lentigo maligna stage I
Lentigo maligna stage II
Lentigo maligna stage III
Lentigo maligna stage IV
Leptomeningeal myelomatosis
Leukaemia
Leukaemia basophilic
Leukaemia cutis
Leukaemia granulocytic
Leukaemia in remission
Leukaemia monocytic
Leukaemia recurrent
Leukaemic cardiac infiltration
Leukaemic infiltration
Leukaemic infiltration extramedullary
Leukaemic infiltration gingiva
Leukaemic infiltration hepatic
Leukaemic infiltration ovary
Leukaemic infiltration pulmonary
Leukaemic infiltration renal
Leukaemic lymphoma
Leukaemic retinopathy
Leydig cell tumour of the testis   
Linitis plastica
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Lip and/or oral cavity cancer
Lip and/or oral cavity cancer recurrent
Lip and/or oral cavity cancer stage 0
Lip and/or oral cavity cancer stage I
Lip and/or oral cavity cancer stage II
Lip and/or oral cavity cancer stage III
Lip and/or oral cavity cancer stage IV
Lip neoplasm malignant stage unspecified
Lip squamous cell carcinoma
Liposarcoma
Liposarcoma metastatic
Liposarcoma recurrent
Lobular breast carcinoma in situ
Lung adenocarcinoma
Lung adenocarcinoma recurrent
Lung adenocarcinoma stage 0
Lung adenocarcinoma stage I
Lung adenocarcinoma stage II
Lung adenocarcinoma stage III
Lung adenocarcinoma stage IV
Lung cancer metastatic
Lung carcinoma cell type unspecified recurrent
Lung carcinoma cell type unspecified stage 0
Lung carcinoma cell type unspecified stage I
Lung carcinoma cell type unspecified stage II
Lung carcinoma cell type unspecified stage III
Lung carcinoma cell type unspecified stage IV
Lung infiltration malignant
Lung neoplasm malignant
Lung squamous cell carcinoma metastatic
Lung squamous cell carcinoma recurrent
Lung squamous cell carcinoma stage 0
Lung squamous cell carcinoma stage I
Lung squamous cell carcinoma stage II
Lung squamous cell carcinoma stage III
Lung squamous cell carcinoma stage IV
Lymphangiosarcoma
Lymphangiosis carcinomatosa
Lymphocytic leukaemia
Lymphocytic lymphoma
Lymphoid leukaemia (in remission)
Lymphoma   
Lymphoma AIDS related
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Lymphoma transformation                                                                    
                                                   Lymphoplasmacytoid lymphoma/immunocytoma                                                   
                                                   Lymphoplasmacytoid lymphoma/immunocytoma recurrent                                         
                                                   Lymphoplasmacytoid lymphoma/immunocytoma                                                   
                                                   refractory                                                                                 
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage I                                           
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage II                                          
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage III                                         
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage IV                                          
                                                   Malignant anorectal neoplasm                                                               
                                                   Malignant blue naevus                                                                      
                                                   Malignant connective tissue neoplasm                                                       
                                                   Malignant cranial nerve neoplasm                                                           
                                                   Malignant fibrous histiocytoma                                                             
                                                   Malignant fibrous histiocytoma metastatic                                                  
                                                   Malignant fibrous histiocytoma of bone                                                     
                                                   Malignant fibrous histiocytoma recurrent                                                   
                                                   Malignant genitourinary tract neoplasm                                                     
                                                   Malignant giant cell fibrous histiocytoma                                                  
                                                   Malignant glioma                                                                           
                                                   Malignant haemangiopericytoma                                                              
                                                   Malignant haemangiopericytoma metastatic                                                   
                                                   Malignant haemangiopericytoma recurrent                                                    
                                                   Malignant histiocytosis                                                                    
                                                   Malignant hydatidiform mole                                                                
                                                   Malignant joint neoplasm                                                                   
                                                   Malignant lymphoid neoplasm                                                                
                                                   Malignant lymphoma unclassifiable high grade                                               
                                                   Malignant lymphoma unclassifiable low grade                                                
                                                   Malignant mast cell neoplasm                                                               
                                                   Malignant mediastinal neoplasm                                                             
                                                   Malignant melanoma                                                                         
                                                   Malignant melanoma in situ                                                                 
                                                   Malignant melanoma of eyelid                                                               
                                                   Malignant melanoma of sites other than skin                                                
                                                   Malignant melanoma stage I                                                                 
                                                   Malignant melanoma stage II                                                                
                                                   Malignant melanoma stage III                                                               
                                                   Malignant melanoma stage IV                                                                
                                                   Malignant meningioma metastatic                                                            
                                                   Malignant mesenchymoma                                                                     
                                                   Malignant mesenchymoma metastatic                                                          
                                                   Malignant mesenchymoma recurrent                                                           
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Malignant mesenteric neoplasm                                                              
                                                   Malignant middle ear neoplasm                                                              
                                                   Malignant muscle neoplasm                                                                  
                                                   Malignant neoplasm of ampulla of Vater                                                     
                                                   Malignant neoplasm of choroid                                                              
                                                   Malignant neoplasm of conjunctiva                                                          
                                                   Malignant neoplasm of cornea                                                               
                                                   Malignant neoplasm of eye                                                                  
                                                   Malignant neoplasm of eyelid                                                               
                                                   Malignant neoplasm of islets of Langerhans                                                 
                                                   Malignant neoplasm of lacrimal duct                                                        
                                                   Malignant neoplasm of lacrimal gland                                                       
                                                   Malignant neoplasm of orbit                                                                
                                                   Malignant neoplasm of paraurethral glands                                                  
                                                   Malignant neoplasm of placenta                                                             
                                                   Malignant neoplasm of pleura                                                               
                                                   Malignant neoplasm of pleura metastatic                                                    
                                                   Malignant neoplasm of renal pelvis                                                         
                                                   Malignant neoplasm of retina                                                               
                                                   Malignant neoplasm of seminal vesicle                                                      
                                                   Malignant neoplasm of spermatic cord                                                       
                                                   Malignant neoplasm of spinal cord                                                          
                                                   Malignant neoplasm of thorax                                                               
                                                   Malignant neoplasm of thymus                                                               
                                                   Malignant neoplasm of unknown primary site                                                 
                                                   Malignant neoplasm of uterine adnexa                                                       
                                                   Malignant neoplasm papilla of Vater                                                        
                                                   Malignant nervous system neoplasm                                                          
                                                   Malignant nipple neoplasm                                                                  
                                                   Malignant nipple neoplasm female                                                           
                                                   Malignant nipple neoplasm male                                                             
                                                   Malignant oligodendroglioma                                                                
                                                   Malignant ovarian cyst                                                                     
                                                   Malignant palate neoplasm                                                                  
                                                   Malignant pericardial neoplasm                                                             
                                                   Malignant peritoneal neoplasm                                                              
                                                   Malignant pituitary tumour                                                                 
                                                   Malignant polyp                                                                            
                                                   Malignant respiratory tract neoplasm                                                       
                                                   Malignant splenic neoplasm                                                                 
                                                   Malignant sweat gland neoplasm                                                             
                                                   Malignant transformation                                                                   
                                                   Malignant urinary tract neoplasm                                                           
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Mantle cell lymphoma                                                                       
                                                   Mantle cell lymphoma recurrent                                                             
                                                   Mantle cell lymphoma refractory                                                            
                                                   Mantle cell lymphoma stage I                                                               
                                                   Mantle cell lymphoma stage II                                                              
                                                   Mantle cell lymphoma stage III                                                             
                                                   Mantle cell lymphoma stage IV                                                              
                                                   Marginal zone lymphoma                                                                     
                                                   Marginal zone lymphoma recurrent                                                           
                                                   Marginal zone lymphoma refractory                                                          
                                                   Marginal zone lymphoma stage I                                                             
                                                   Marginal zone lymphoma stage II                                                            
                                                   Marginal zone lymphoma stage III                                                           
                                                   Marginal zone lymphoma stage IV                                                            
                                                   Marjolin's ulcer                                                                           
                                                   Mastocytic leukaemia                                                                       
                                                   Maternal cancer in pregnancy                                                               
                                                   Mature B-cell type acute leukaemia                                                         
                                                   Medullary carcinoma of breast                                                              
                                                   Medullary thyroid cancer                                                                   
                                                   Medulloblastoma                                                                            
                                                   Medulloblastoma recurrent                                                                  
                                                   Melanoma recurrent                                                                         
                                                   Meningioma malignant                                                                       
                                                   Mesothelioma malignant                                                                     
                                                   Mesothelioma malignant recurrent                                                           
                                                   Metaplastic breast carcinoma                                                               
                                                   Metastases to Eustachian tube                                                              
                                                   Metastases to abdominal cavity                                                             
                                                   Metastases to abdominal wall                                                               
                                                   Metastases to adrenals                                                                     
                                                   Metastases to biliary tract                                                                
                                                   Metastases to bladder                                                                      
                                                   Metastases to bone                                                                         
                                                   Metastases to bone marrow                                                                  
                                                   Metastases to breast                                                                       
                                                   Metastases to central nervous system                                                       
                                                   Metastases to chest wall                                                                   
                                                   Metastases to diaphragm                                                                    
                                                   Metastases to eye                                                                          
                                                   Metastases to fallopian tube                                                               
                                                   Metastases to gallbladder                                                                  
                                                   Metastases to gastrointestinal tract                                                       
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Metastases to heart                                                                        
                                                   Metastases to kidney                                                                       
                                                   Metastases to larynx                                                                       
                                                   Metastases to liver                                                                        
                                                   Metastases to lung                                                                         
                                                   Metastases to lymph nodes                                                                  
                                                   Metastases to meninges                                                                     
                                                   Metastases to mouth                                                                        
                                                   Metastases to muscle                                                                       
                                                   Metastases to nasal sinuses                                                                
                                                   Metastases to neck                                                                         
                                                   Metastases to nervous system                                                               
                                                   Metastases to oesophagus                                                                   
                                                   Metastases to ovary                                                                        
                                                   Metastases to pancreas                                                                     
                                                   Metastases to pelvis                                                                       
                                                   Metastases to penis                                                                        
                                                   Metastases to perineum                                                                     
                                                   Metastases to peripheral nervous system                                                    
                                                   Metastases to peripheral vascular system                                                   
                                                   Metastases to peritoneum                                                                   
                                                   Metastases to pharynx                                                                      
                                                   Metastases to pituitary gland                                                              
                                                   Metastases to placenta                                                                     
                                                   Metastases to pleura                                                                       
                                                   Metastases to prostate                                                                     
                                                   Metastases to rectum                                                                       
                                                   Metastases to reproductive organ                                                           
                                                   Metastases to retroperitoneum                                                              
                                                   Metastases to salivary gland                                                               
                                                   Metastases to skin                                                                         
                                                   Metastases to soft tissue                                                                  
                                                   Metastases to spinal cord                                                                  
                                                   Metastases to spine                                                                        
                                                   Metastases to spleen                                                                       
                                                   Metastases to stomach                                                                      
                                                   Metastases to testicle                                                                     
                                                   Metastases to the mediastinum                                                              
                                                   Metastases to the respiratory system                                                       
                                                   Metastases to thorax                                                                       
                                                   Metastases to thyroid                                                                      
                                                   Metastases to tonsils                                                                      
                                                   Metastases to trachea                                                                      
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Metastases to urinary tract                                                                
                                                   Metastases to uterus                                                                       
                                                   Metastases to vagina                                                                       
                                                   Metastasis                                                                                 
                                                   Metastatic bronchial carcinoma                                                             
                                                   Metastatic carcinoid tumour                                                                
                                                   Metastatic carcinoma of the bladder                                                        
                                                   Metastatic choriocarcinoma                                                                 
                                                   Metastatic gastric cancer                                                                  
                                                   Metastatic glioma                                                                          
                                                   Metastatic glucagonoma                                                                     
                                                   Metastatic lymphoma                                                                        
                                                   Metastatic malignant melanoma                                                              
                                                   Metastatic neoplasm                                                                        
                                                   Metastatic nervous system neoplasm                                                         
                                                   Metastatic ocular melanoma                                                                 
                                                   Metastatic renal cell carcinoma                                                            
                                                   Metastatic salivary gland cancer                                                           
                                                   Metastatic squamous cell carcinoma                                                         
                                                   Metastatic uterine cancer                                                                  
                                                   Microsatellite instability cancer                                                          
                                                   Minimal residual disease                                                                   
                                                   Mismatch repair cancer syndrome                                                            
                                                   Mixed adenoneuroendocrine carcinoma                                                        
                                                   Mixed-type liposarcoma                                                                     
                                                   Monocytic leukaemia in remission                                                           
                                                   Mucinous adenocarcinoma of appendix                                                        
                                                   Mucinous breast carcinoma                                                                  
                                                   Mucinous cystadenocarcinoma ovary                                                          
                                                   Mucinous endometrial carcinoma                                                             
                                                   Mucoepidermoid carcinoma                                                                   
                                                   Mucoepidermoid carcinoma of salivary gland                                                 
                                                   Musculoskeletal cancer                                                                     
                                                   Myeloblastoma                                                                              
                                                   Myeloid leukaemia                                                                          
                                                   Myeloid leukaemia in remission                                                             
                                                   Myxofibrosarcoma                                                                           
                                                   Myxoid liposarcoma                                                                         
                                                   NUT midline carcinoma                                                                      
                                                   Naevoid melanoma                                                                           
                                                   Nasal cavity cancer                                                                        
                                                   Nasal sinus cancer                                                                         
                                                   Nasopharyngeal cancer                                                                      
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Nasopharyngeal cancer metastatic                                                           
                                                   Nasopharyngeal cancer recurrent                                                            
                                                   Nasopharyngeal cancer stage 0                                                              
                                                   Nasopharyngeal cancer stage I                                                              
                                                   Nasopharyngeal cancer stage II                                                             
                                                   Nasopharyngeal cancer stage III                                                            
                                                   Nasopharyngeal cancer stage IV                                                             
                                                   Natural killer-cell leukaemia                                                              
                                                   Natural killer-cell lymphoblastic lymphoma                                                 
                                                   Neonatal leukaemia                                                                         
                                                   Neonatal neuroblastoma                                                                     
                                                   Neoplasm malignant                                                                         
                                                   Nephroblastoma                                                                             
                                                   Neuroblastoma                                                                              
                                                   Neuroblastoma recurrent                                                                    
                                                   Neuroendocrine breast tumour                                                               
                                                   Neuroendocrine carcinoma                                                                   
                                                   Neuroendocrine carcinoma metastatic                                                        
                                                   Neuroendocrine carcinoma of prostate                                                       
                                                   Neuroendocrine carcinoma of the bladder                                                    
                                                   Neuroendocrine carcinoma of the skin                                                       
                                                   Neuroendocrine tumour                                                                      
                                                   Neuroendocrine tumour of the lung                                                          
                                                   Neuroendocrine tumour of the lung metastatic                                               
                                                   Neurofibrosarcoma                                                                          
                                                   Neurofibrosarcoma metastatic                                                               
                                                   Neurofibrosarcoma recurrent                                                                
                                                   Nodal marginal zone B-cell lymphoma                                                        
                                                   Nodal marginal zone B-cell lymphoma recurrent                                              
                                                   Nodal marginal zone B-cell lymphoma refractory                                             
                                                   Nodal marginal zone B-cell lymphoma stage I                                                
                                                   Nodal marginal zone B-cell lymphoma stage II                                               
                                                   Nodal marginal zone B-cell lymphoma stage III                                              
                                                   Nodal marginal zone B-cell lymphoma stage IV                                               
                                                   Nodular lymphocyte predominant Hodgkin lymphoma                                            
                                                   Nodular melanoma                                                                           
                                                   Non-Hodgkin's lymphoma                                                                     
                                                   Non-Hodgkin's lymphoma metastatic                                                          
                                                   Non-Hodgkin's lymphoma recurrent                                                           
                                                   Non-Hodgkin's lymphoma refractory                                                          
                                                   Non-Hodgkin's lymphoma stage I                                                             
                                                   Non-Hodgkin's lymphoma stage II                                                            
                                                   Non-Hodgkin's lymphoma stage III                                                           
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Non-Hodgkin's lymphoma stage IV
Non-Hodgkin's lymphoma transformed recurrent
Non-Hodgkin's lymphoma unspecified histology
aggressive
Non-Hodgkin's lymphoma unspecified histology
aggressive recurrent
Non-Hodgkin's lymphoma unspecified histology
aggressive refractory
Non-Hodgkin's lymphoma unspecified histology
aggressive stage I
Non-Hodgkin's lymphoma unspecified histology
aggressive stage II
Non-Hodgkin's lymphoma unspecified histology
aggressive stage III
Non-Hodgkin's lymphoma unspecified histology
aggressive stage IV
Non-Hodgkin's lymphoma unspecified histology
indolent
Non-Hodgkin's lymphoma unspecified histology
indolent stage I
Non-Hodgkin's lymphoma unspecified histology
indolent stage II
Non-Hodgkin's lymphoma unspecified histology
indolent stage III
Non-Hodgkin's lymphoma unspecified histology
indolent stage IV
Non-renal cell carcinoma of kidney 
Non-small cell lung cancer
Non-small cell lung cancer metastatic
Non-small cell lung cancer recurrent
Non-small cell lung cancer stage 0
Non-small cell lung cancer stage I
Non-small cell lung cancer stage II
Non-small cell lung cancer stage III
Non-small cell lung cancer stage IIIA
Non-small cell lung cancer stage IIIB
Non-small cell lung cancer stage IV
Nongerminomatous germ cell tumour of the CNS
Nonkeratinising carcinoma of nasopharynx
Ocular cancer metastatic
Ocular haemangiopericytoma
Ocular lymphoma
Oesophageal adenocarcinoma
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Oesophageal adenocarcinoma recurrent                                                       
                                                   Oesophageal adenocarcinoma stage 0                                                         
                                                   Oesophageal adenocarcinoma stage I                                                         
                                                   Oesophageal adenocarcinoma stage II                                                        
                                                   Oesophageal adenocarcinoma stage III                                                       
                                                   Oesophageal adenocarcinoma stage IV                                                        
                                                   Oesophageal adenosquamous carcinoma                                                        
                                                   Oesophageal cancer metastatic                                                              
                                                   Oesophageal carcinoma                                                                      
                                                   Oesophageal carcinoma recurrent                                                            
                                                   Oesophageal carcinoma stage 0                                                              
                                                   Oesophageal squamous cell carcinoma                                                        
                                                   Oesophageal squamous cell carcinoma metastatic                                             
                                                   Oesophageal squamous cell carcinoma recurrent                                              
                                                   Oesophageal squamous cell carcinoma stage 0                                                
                                                   Oesophageal squamous cell carcinoma stage I                                                
                                                   Oesophageal squamous cell carcinoma stage II                                               
                                                   Oesophageal squamous cell carcinoma stage III                                              
                                                   Oesophageal squamous cell carcinoma stage IV                                               
                                                   Oligoastrocytoma                                                                           
                                                   Oligodendroglioma                                                                          
                                                   Optic glioma                                                                               
                                                   Oral cavity cancer metastatic                                                              
                                                   Oropharyngeal cancer                                                                       
                                                   Oropharyngeal cancer recurrent                                                             
                                                   Oropharyngeal cancer stage 0                                                               
                                                   Oropharyngeal cancer stage I                                                               
                                                   Oropharyngeal cancer stage II                                                              
                                                   Oropharyngeal cancer stage III                                                             
                                                   Oropharyngeal cancer stage IV                                                              
                                                   Oropharyngeal lymphoepithelioma                                                            
                                                   Oropharyngeal squamous cell carcinoma                                                      
                                                   Osteosarcoma                                                                               
                                                   Osteosarcoma metastatic                                                                    
                                                   Osteosarcoma recurrent                                                                     
                                                   Otic cancer metastatic                                                                     
                                                   Ovarian cancer                                                                             
                                                   Ovarian cancer metastatic                                                                  
                                                   Ovarian cancer recurrent                                                                   
                                                   Ovarian cancer stage I                                                                     
                                                   Ovarian cancer stage II                                                                    
                                                   Ovarian cancer stage III                                                                   
                                                   Ovarian cancer stage IV                                                                    
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Ovarian clear cell carcinoma                                                               
                                                   Ovarian dysgerminoma stage I                                                               
                                                   Ovarian dysgerminoma stage II                                                              
                                                   Ovarian dysgerminoma stage III                                                             
                                                   Ovarian dysgerminoma stage IV                                                              
                                                   Ovarian dysgerminoma stage unspecified                                                     
                                                   Ovarian embryonal carcinoma                                                                
                                                   Ovarian endometrioid carcinoma                                                             
                                                   Ovarian epithelial cancer                                                                  
                                                   Ovarian epithelial cancer metastatic                                                       
                                                   Ovarian epithelial cancer recurrent                                                        
                                                   Ovarian epithelial cancer stage I                                                          
                                                   Ovarian epithelial cancer stage II                                                         
                                                   Ovarian epithelial cancer stage III                                                        
                                                   Ovarian epithelial cancer stage IV                                                         
                                                   Ovarian germ cell cancer                                                                   
                                                   Ovarian germ cell cancer stage I                                                           
                                                   Ovarian germ cell cancer stage II                                                          
                                                   Ovarian germ cell cancer stage III                                                         
                                                   Ovarian germ cell cancer stage IV                                                          
                                                   Ovarian germ cell choriocarcinoma                                                          
                                                   Ovarian germ cell choriocarcinoma stage I                                                  
                                                   Ovarian germ cell choriocarcinoma stage II                                                 
                                                   Ovarian germ cell choriocarcinoma stage III                                                
                                                   Ovarian germ cell choriocarcinoma stage IV                                                 
                                                   Ovarian germ cell embryonal carcinoma stage I                                              
                                                   Ovarian germ cell embryonal carcinoma stage II                                             
                                                   Ovarian germ cell embryonal carcinoma stage III                                            
                                                   Ovarian germ cell embryonal carcinoma stage IV                                             
                                                   Ovarian germ cell endodermal sinus tumour                                                  
                                                   Ovarian germ cell endodermal sinus tumour stage I                                          
                                                   Ovarian germ cell endodermal sinus tumour stage II                                         
                                                   Ovarian germ cell endodermal sinus tumour stage                                            
                                                   III                                                                                        
                                                   Ovarian germ cell endodermal sinus tumour stage IV                                         
                                                   Ovarian germ cell polyembryoma                                                             
                                                   Ovarian germ cell polyembryoma stage I                                                     
                                                   Ovarian germ cell polyembryoma stage II                                                    
                                                   Ovarian germ cell polyembryoma stage III                                                   
                                                   Ovarian germ cell polyembryoma stage IV                                                    
                                                   Ovarian germ cell teratoma                                                                 
                                                   Ovarian germ cell teratoma stage I                                                         
                                                   Ovarian germ cell teratoma stage II                                                        
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Ovarian germ cell teratoma stage III
Ovarian germ cell teratoma stage IV
Ovarian germ cell tumour mixed
Ovarian granulosa-theca cell tumour
Ovarian low malignant potential tumour
Ovarian melanoma
Ovarian stromal cancer
Paget's disease of nipple
Paget's disease of penis
Paget's disease of the vulva
Pancoast's tumour
Pancreatic carcinoma
Pancreatic carcinoma metastatic
Pancreatic carcinoma recurrent
Pancreatic carcinoma stage 0
Pancreatic carcinoma stage I
Pancreatic carcinoma stage II
Pancreatic carcinoma stage III
Pancreatic carcinoma stage IV
Pancreatic neuroendocrine tumour
Pancreatic neuroendocrine tumour metastatic
Pancreatic sarcoma
Pancreatoblastoma
Papillary renal cell carcinoma
Papillary serous endometrial carcinoma
Papillary thyroid cancer
Paraganglion neoplasm malignant
Paranasal sinus and nasal cavity malignant
neoplasm
Paranasal sinus and nasal cavity malignant
neoplasm recurrent
Paranasal sinus and nasal cavity malignant
neoplasm stage 0
Paranasal sinus and nasal cavity malignant
neoplasm stage I
Paranasal sinus and nasal cavity malignant
neoplasm stage II
Paranasal sinus and nasal cavity malignant
neoplasm stage III
Paranasal sinus and nasal cavity malignant
neoplasm stage IV
Parathyroid tumour malignant
Penile cancer
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Penile squamous cell carcinoma
Penis carcinoma metastatic
Penis carcinoma recurrent
Penis carcinoma stage I
Penis carcinoma stage II
Penis carcinoma stage III
Penis carcinoma stage IV
Pericardial mesothelioma malignant
Pericardial mesothelioma malignant recurrent
Peripheral T-cell lymphoma unspecified
Peripheral T-cell lymphoma unspecified recurrent
Peripheral T-cell lymphoma unspecified refractory
Peripheral T-cell lymphoma unspecified stage I
Peripheral T-cell lymphoma unspecified stage II
Peripheral T-cell lymphoma unspecified stage III
Peripheral T-cell lymphoma unspecified stage IV
Peripheral neuroepithelioma of bone
Peripheral neuroepithelioma of bone metastatic
Peripheral neuroepithelioma of bone recurrent
Peripheral neuroepithelioma of soft tissue
Peripheral primitive neuroectodermal bone tumour
Peripheral primitive neuroectodermal tumour of
soft tissue
Peritoneal carcinoma metastatic
Peritoneal mesothelioma malignant
Peritoneal mesothelioma malignant recurrent
Peritoneal sarcoma
Phaeochromocytoma malignant
Pharyngeal cancer
Pharyngeal cancer metastatic
Pharyngeal cancer recurrent
Pharyngeal cancer stage 0
Pharyngeal cancer stage I
Pharyngeal cancer stage II
Pharyngeal cancer stage III
Pharyngeal cancer stage IV
Pilomatrix carcinoma
Pineal germinoma
Pineal parenchymal neoplasm malignant
Pinealoblastoma
Pituitary cancer metastatic
Pituitary neoplasm malignant recurrent
Plasma cell leukaemia
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Plasma cell leukaemia in remission
Plasma cell myeloma
Plasma cell myeloma in remission
Plasma cell myeloma recurrent
Plasma cell myeloma refractory
Plasmablastic lymphoma
Plasmacytoma
Pleomorphic leiomyosarcoma
Pleomorphic liposarcoma
Pleomorphic malignant fibrous histiocytoma
Pleural mesothelioma
Pleural mesothelioma malignant
Pleural mesothelioma malignant recurrent
Pleural sarcoma
Pleuropulmonary blastoma
Poorly differentiated thyroid carcinoma
Porocarcinoma
Postcricoid cancer
Precursor B-lymphoblastic lymphoma 
Precursor B-lymphoblastic lymphoma recurrent
Precursor B-lymphoblastic lymphoma refractory
Precursor B-lymphoblastic lymphoma stage I
Precursor B-lymphoblastic lymphoma stage II
Precursor B-lymphoblastic lymphoma stage III
Precursor B-lymphoblastic lymphoma stage IV
Precursor T-lymphoblastic leukaemia acute
Precursor T-lymphoblastic lymphoma/leukaemia
Precursor T-lymphoblastic lymphoma/leukaemia
recurrent
Precursor T-lymphoblastic lymphoma/leukaemia
refractory
Precursor T-lymphoblastic lymphoma/leukaemia
stage I
Precursor T-lymphoblastic lymphoma/leukaemia
stage II
Precursor T-lymphoblastic lymphoma/leukaemia
stage III
Precursor T-lymphoblastic lymphoma/leukaemia
stage IV
Primary breast lymphoma
Primary cardiac lymphoma
Primary effusion lymphoma
Primary gastrointestinal follicular lymphoma
.


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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Primary mediastinal large B-cell lymphoma                                                  
                                                   Primary mediastinal large B-cell lymphoma                                                  
                                                   recurrent                                                                                  
                                                   Primary mediastinal large B-cell lymphoma                                                  
                                                   refractory                                                                                 
                                                   Primary mediastinal large B-cell lymphoma stage I                                          
                                                   Primary mediastinal large B-cell lymphoma stage II                                         
                                                   Primary mediastinal large B-cell lymphoma stage                                            
                                                   III                                                                                        
                                                   Primary mediastinal large B-cell lymphoma stage IV                                         
                                                   Primary pulmonary melanoma                                                                 
                                                   Primitive neuroectodermal tumour                                                           
                                                   Primitive neuroectodermal tumour metastatic                                                
                                                   Prolymphocytic leukaemia                                                                   
                                                   Prostate cancer                                                                            
                                                   Prostate cancer metastatic                                                                 
                                                   Prostate cancer recurrent                                                                  
                                                   Prostate cancer stage 0                                                                    
                                                   Prostate cancer stage I                                                                    
                                                   Prostate cancer stage II                                                                   
                                                   Prostate cancer stage III                                                                  
                                                   Prostate cancer stage IV                                                                   
                                                   Pseudosarcoma                                                                              
                                                   Queyrat erythroplasia                                                                      
                                                   Rectal adenocarcinoma                                                                      
                                                   Rectal cancer                                                                              
                                                   Rectal cancer metastatic                                                                   
                                                   Rectal cancer recurrent                                                                    
                                                   Rectal cancer stage 0                                                                      
                                                   Rectal cancer stage I                                                                      
                                                   Rectal cancer stage II                                                                     
                                                   Rectal cancer stage III                                                                    
                                                   Rectal cancer stage IV                                                                     
                                                   Rectosigmoid cancer                                                                        
                                                   Rectosigmoid cancer metastatic                                                             
                                                   Rectosigmoid cancer recurrent                                                              
                                                   Rectosigmoid cancer stage 0                                                                
                                                   Rectosigmoid cancer stage I                                                                
                                                   Rectosigmoid cancer stage II                                                               
                                                   Rectosigmoid cancer stage III                                                              
                                                   Rectosigmoid cancer stage IV                                                               
                                                   Recurrent cancer                                                                           
                                                   Refractory cancer                                                                          
.


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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Renal cancer
Renal cancer metastatic
Renal cancer recurrent
Renal cancer stage I
Renal cancer stage II
Renal cancer stage III
Renal cancer stage IV
Renal cell carcinoma
Renal cell carcinoma recurrent
Renal cell carcinoma stage I
Renal cell carcinoma stage II
Renal cell carcinoma stage III
Renal cell carcinoma stage IV
Respiratory tract carcinoma in situ
Retinal melanoma
Retinoblastoma
Retroperitoneal cancer
Retroperitoneal neoplasm metastatic
Rhabdoid tumour
Rhabdoid tumour of the kidney
Rhabdomyosarcoma
Rhabdomyosarcoma recurrent
Richter's syndrome
Round cell liposarcoma
Salivary gland cancer
Salivary gland cancer recurrent
Salivary gland cancer stage 0
Salivary gland cancer stage I
Salivary gland cancer stage II
Salivary gland cancer stage III
Salivary gland cancer stage IV
Sarcoma
Sarcoma metastatic
Sarcoma of skin
Sarcoma uterus
Sarcomatoid carcinoma
Sarcomatoid carcinoma of the lung
Sarcomatoid mesothelioma
Sarcomatosis
Scrotal cancer
Sebaceous carcinoma
Second primary malignancy
Seminoma
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Serous cystadenocarcinoma ovary                                                            
                                                   Signet-ring cell carcinoma                                                                 
                                                   Sinus cancer metastatic                                                                    
                                                   Skin angiosarcoma                                                                          
                                                   Skin cancer                                                                                
                                                   Skin cancer metastatic                                                                     
                                                   Skin squamous cell carcinoma metastatic                                                    
                                                   Skin squamous cell carcinoma recurrent                                                     
                                                   Small cell carcinoma                                                                       
                                                   Small cell carcinoma of the cervix                                                         
                                                   Small cell lung cancer                                                                     
                                                   Small cell lung cancer extensive stage                                                     
                                                   Small cell lung cancer limited stage                                                       
                                                   Small cell lung cancer metastatic                                                          
                                                   Small cell lung cancer recurrent                                                           
                                                   Small intestine adenocarcinoma                                                             
                                                   Small intestine carcinoma                                                                  
                                                   Small intestine carcinoma metastatic                                                       
                                                   Small intestine carcinoma recurrent                                                        
                                                   Small intestine carcinoma stage 0                                                          
                                                   Small intestine carcinoma stage I                                                          
                                                   Small intestine carcinoma stage II                                                         
                                                   Small intestine carcinoma stage III                                                        
                                                   Small intestine carcinoma stage IV                                                         
                                                   Small intestine leiomyosarcoma                                                             
                                                   Soft tissue sarcoma                                                                        
                                                   Solid pseudopapillary tumour of the pancreas                                               
                                                   Spermatocytic seminoma                                                                     
                                                   Spinal meningioma malignant                                                                
                                                   Spindle cell sarcoma                                                                       
                                                   Splenic marginal zone lymphoma                                                             
                                                   Splenic marginal zone lymphoma recurrent                                                   
                                                   Splenic marginal zone lymphoma refractory                                                  
                                                   Splenic marginal zone lymphoma stage I                                                     
                                                   Splenic marginal zone lymphoma stage II                                                    
                                                   Splenic marginal zone lymphoma stage III                                                   
                                                   Splenic marginal zone lymphoma stage IV                                                    
                                                   Squamous cell breast carcinoma                                                             
                                                   Squamous cell carcinoma                                                                    
                                                   Squamous cell carcinoma of head and neck                                                   
                                                   Squamous cell carcinoma of lung                                                            
                                                   Squamous cell carcinoma of pharynx                                                         
                                                   Squamous cell carcinoma of skin                                                            
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Squamous cell carcinoma of the cervix                                                      
                                                   Squamous cell carcinoma of the hypopharynx                                                 
                                                   Squamous cell carcinoma of the oral cavity                                                 
                                                   Squamous cell carcinoma of the parotid gland                                               
                                                   Squamous cell carcinoma of the tongue                                                      
                                                   Squamous cell carcinoma of the vagina                                                      
                                                   Squamous cell carcinoma of the vulva                                                       
                                                   Squamous endometrial carcinoma                                                             
                                                   Stewart-Treves syndrome                                                                    
                                                   Superficial spreading melanoma stage I                                                     
                                                   Superficial spreading melanoma stage II                                                    
                                                   Superficial spreading melanoma stage III                                                   
                                                   Superficial spreading melanoma stage IV                                                    
                                                   Superficial spreading melanoma stage unspecified                                           
                                                   Synovial sarcoma                                                                           
                                                   Synovial sarcoma metastatic                                                                
                                                   Synovial sarcoma recurrent                                                                 
                                                   T-cell chronic lymphocytic leukaemia                                                       
                                                   T-cell lymphoma                                                                            
                                                   T-cell lymphoma recurrent                                                                  
                                                   T-cell lymphoma refractory                                                                 
                                                   T-cell lymphoma stage I                                                                    
                                                   T-cell lymphoma stage II                                                                   
                                                   T-cell lymphoma stage III                                                                  
                                                   T-cell lymphoma stage IV                                                                   
                                                   T-cell prolymphocytic leukaemia                                                            
                                                   T-cell type acute leukaemia                                                                
                                                   T-cell unclassifiable lymphoma high grade                                                  
                                                   T-cell unclassifiable lymphoma low grade                                                   
                                                   Testicular cancer metastatic                                                               
                                                   Testicular choriocarcinoma                                                                 
                                                   Testicular choriocarcinoma recurrent                                                       
                                                   Testicular choriocarcinoma stage I                                                         
                                                   Testicular choriocarcinoma stage II                                                        
                                                   Testicular choriocarcinoma stage III                                                       
                                                   Testicular embryonal carcinoma                                                             
                                                   Testicular embryonal carcinoma stage I                                                     
                                                   Testicular embryonal carcinoma stage II                                                    
                                                   Testicular embryonal carcinoma stage III                                                   
                                                   Testicular germ cell cancer                                                                
                                                   Testicular germ cell cancer metastatic                                                     
                                                   Testicular germ cell tumour mixed                                                          
                                                   Testicular germ cell tumour mixed stage I                                                  
.


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Date: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Malignant tumours (SMQ)                            Testicular germ cell tumour mixed stage II                                                 
                                                   Testicular germ cell tumour mixed stage III                                                
                                                   Testicular leiomyosarcoma                                                                  
                                                   Testicular malignant teratoma                                                              
                                                   Testicular malignant teratoma stage I                                                      
                                                   Testicular malignant teratoma stage II                                                     
                                                   Testicular malignant teratoma stage III                                                    
                                                   Testicular seminoma (pure)                                                                 
                                                   Testicular seminoma (pure) stage I                                                         
                                                   Testicular seminoma (pure) stage II                                                        
                                                   Testicular seminoma (pure) stage III                                                       
                                                   Testicular yolk sac tumour                                                                 
                                                   Testicular yolk sac tumour stage I                                                         
                                                   Testicular yolk sac tumour stage II                                                        
                                                   Testicular yolk sac tumour stage III                                                       
                                                   Testis cancer                                                                              
                                                   Testis cancer recurrent                                                                    
                                                   Throat cancer                                                                              
                                                   Thymic cancer metastatic                                                                   
                                                   Thymoma malignant                                                                          
                                                   Thymoma malignant recurrent                                                                
                                                   Thyroid B-cell lymphoma                                                                    
                                                   Thyroid cancer                                                                             
                                                   Thyroid cancer metastatic                                                                  
                                                   Thyroid cancer recurrent                                                                   
                                                   Thyroid cancer stage 0                                                                     
                                                   Thyroid cancer stage I                                                                     
                                                   Thyroid cancer stage II                                                                    
                                                   Thyroid cancer stage III                                                                   
                                                   Thyroid cancer stage IV                                                                    
                                                   Tongue cancer metastatic                                                                   
                                                   Tongue cancer recurrent                                                                    
                                                   Tongue carcinoma stage 0                                                                   
                                                   Tongue carcinoma stage I                                                                   
                                                   Tongue carcinoma stage II                                                                  
                                                   Tongue carcinoma stage III                                                                 
                                                   Tongue carcinoma stage IV                                                                  
                                                   Tongue neoplasm malignant stage unspecified                                                
                                                   Tonsil cancer                                                                              
                                                   Tonsil cancer metastatic                                                                   
                                                   Tracheal cancer                                                                            
                                                   Transformation to acute myeloid leukaemia                                                  
.


NN9535 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Transitional cell cancer of renal pelvis and
ureter metastatic
Transitional cell cancer of the renal pelvis and
ureter
Transitional cell cancer of the renal pelvis and
ureter localised
Transitional cell cancer of the renal pelvis and
ureter recurrent
Transitional cell cancer of the renal pelvis and
ureter regional
Transitional cell carcinoma
Transitional cell carcinoma metastatic
Transitional cell carcinoma recurrent
Transitional cell carcinoma urethra
Trichoblastic carcinoma
Triple hit lymphoma
Triple negative breast cancer
Triple positive breast cancer
Tubular breast carcinoma
Tumour budding
Undifferentiated carcinoma of colon
Undifferentiated nasopharyngeal carcinoma
Undifferentiated sarcoma
Ureteric cancer
Ureteric cancer local
Ureteric cancer metastatic
Ureteric cancer recurrent
Ureteric cancer regional
Urethral cancer
Urethral cancer metastatic
Urethral cancer recurrent
Urethral melanoma metastatic
Urinary bladder sarcoma
Urinary tract carcinoma in situ
Uterine cancer
Uterine carcinoma in situ
Uterine leiomyosarcoma
Uveal melanoma
Vaginal adenocarcinoma
Vaginal cancer
Vaginal cancer metastatic
Vaginal cancer recurrent
Vaginal cancer stage 0
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Malignant tumours (SMQ)
Vaginal cancer stage I
Vaginal cancer stage II
Vaginal cancer stage III
Vaginal cancer stage IVA
Vaginal cancer stage IVB
Vulval cancer
Vulval cancer metastatic
Vulval cancer recurrent
Vulval cancer stage 0
Vulval cancer stage I
Vulval cancer stage II
Vulval cancer stage III
Vulval cancer stage IV
Vulvar adenocarcinoma
Vulvar basal cell carcinoma
Waldenstrom's macroglobulinaemia
Waldenstrom's macroglobulinaemia recurrent
Waldenstrom's macroglobulinaemia refractory
Waldenstrom's macroglobulinaemia stage I
Waldenstrom's macroglobulinaemia stage II
Waldenstrom's macroglobulinaemia stage III
Waldenstrom's macroglobulinaemia stage IV
Medication error overdose
Documented hypersensitivity to administered
product
Accidental device ingestion
Accidental device ingestion by a child
Accidental exposure to product
Accidental exposure to product by child
Accidental exposure to product packaging
Accidental exposure to product packaging by child
Accidental overdose
Accidental poisoning
Accidental underdose
Accidental use of placebo
Assisted suicide
Booster dose missed
Circumstance or information capable of leading to
device use error
Circumstance or information capable of leading to
medication error
Completed suicide
Contraindicated device used
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Medication error overdose
Contraindicated product administered
Contraindicated product prescribed
Contraindication to medical treatment
Contraindication to vaccination
Deprescribing error
Device adhesion issue
Device connection issue
Device difficult to use
Device dispensing error
Device infusion issue
Device maintenance issue
Device malfunction
Device monitoring procedure not performed
Device placement issue
Device programming error
Device use confusion
Device use error
Device use issue
Device-device incompatibility
Dietary supplement prescribing error
Discontinued product administered
Dopamine dysregulation syndrome
Dose calculation error
Drug abuse
Drug abuser
Drug administered in wrong device
Drug delivery system issue
Drug delivery system malfunction
Drug dependence
Drug dependence, antepartum
Drug dependence, postpartum
Drug dispensed to wrong patient
Drug dose omission by device
Drug dose titration not performed
Drug monitoring procedure incorrectly performed
Drug monitoring procedure not performed
Drug titration error
Drug use disorder
Drug use disorder, antepartum
Drug use disorder, postpartum
Duplicate therapy error
Expired device used
Expired product administered
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Medication error overdose
Exposure to contaminated device
Exposure via contaminated device
Exposure via direct contact
Exposure via eye contact
Exposure via ingestion
Exposure via inhalation
Exposure via partner
Exposure via skin contact
Exposure via unknown route
Extra dose administered
Failure of child resistant product closure
Failure to suspend medication
Inadequate aseptic technique in use of product
Inappropriate schedule of product administration
Incomplete course of vaccination
Incorrect disposal of product
Incorrect dosage administered
Incorrect dose administered
Incorrect dose administered by device
Incorrect dose administered by product
Incorrect drug administration rate
Incorrect product administration duration
Incorrect product dosage form administered
Incorrect product formulation administered
Incorrect route of product administration
Injury associated with device
Intentional device misuse
Intentional dose omission
Intentional misuse of drug delivery system
Intentional overdose
Intentional product misuse
Intentional self-injury
Intercepted accidental exposure to product by
child
Intercepted medication error
Intercepted product administration error
Intercepted product dispensing error
Intercepted product monitoring error
Intercepted product preparation error
Intercepted product prescribing error
Intercepted product selection error
Intercepted product storage error
Intercepted wrong patient selected
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Medication error overdose
Interchange of vaccine products
Labelled drug-disease interaction medication error
Labelled drug-drug interaction medication error
Labelled drug-food interaction medication error
Lack of administration site rotation
Lack of application site rotation
Lack of infusion site rotation
Lack of injection site rotation
Lack of vaccination site rotation
Maternal use of illicit drugs
Medical device monitoring error
Medication error
Multiple use of single-use product
Needle issue
Neonatal complications of substance abuse
Occupational exposure to product
Occupational exposure to radiation
Out of specification product use
Overdose
Paravenous drug administration
Performance enhancing product use
Poisoning deliberate
Poor quality device used
Poor quality product administered
Prescribed overdose
Prescribed underdose
Product adhesion issue
Product administered at inappropriate site
Product administered to patient of inappropriate
age
Product administration error
Product administration interrupted
Product appearance confusion
Product barcode issue
Product commingling
Product communication issue
Product compounding quality issue
Product confusion
Product design confusion
Product dispensing error
Product dispensing issue
Product dosage form confusion
Product dosage form issue
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Medication error overdose
Product dose omission
Product dropper issue
Product identification number issue
Product label confusion
Product label issue
Product label on wrong product
Product lot number issue
Product monitoring error
Product name confusion
Product packaging confusion
Product packaging difficult to open
Product packaging issue
Product preparation error
Product preparation issue
Product prescribing error
Product prescribing issue
Product reconstitution quality issue
Product selection error
Product storage error
Product substitution error
Product use complaint
Product use in unapproved indication
Product use in unapproved therapeutic environment
Product use issue
Radiation overdose
Radiation underdose
Recalled product administered
Single component of a two-component product
administered
Substance abuse
Substance abuser
Substance dependence
Substance use disorder
Suicide attempt
Suspected suicide
Suspected suicide attempt
Syringe issue
Therapeutic drug monitoring analysis incorrectly
performed
Therapeutic drug monitoring analysis not performed
Transcription medication error
Transfusion with incompatible blood
Underdose
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Medication error overdose                          Unintentional medical device removal                                                       
                                                   Unintentional use for unapproved indication                                                
                                                   Vaccination error                                                                          
                                                   Wrong device used                                                                          
                                                   Wrong dosage form                                                                          
                                                   Wrong dosage formulation                                                                   
                                                   Wrong dose                                                                                 
                                                   Wrong drug                                                                                 
                                                   Wrong patient received product                                                             
                                                   Wrong product administered                                                                 
                                                   Wrong product procured                                                                     
                                                   Wrong product stored                                                                       
                                                   Wrong rate                                                                                 
                                                   Wrong schedule                                                                             
                                                   Wrong strength                                                                             
                                                   Wrong technique in device usage process                                                    
                                                   Wrong technique in product usage process                                                   
                                                                                                                                              
Neoplasm                                           Biopsy bile duct abnormal                                                                  
                                                   Biopsy gallbladder abnormal                                                                
                                                   Malignant biliary obstruction                                                              
                                                   Acquired C1 inhibitor deficiency                                                           
                                                   Biopsy heart abnormal                                                                      
                                                   Cerebral cyst haemorrhage                                                                  
                                                   Inferior vena cava syndrome                                                                
                                                   Intracranial tumour haemorrhage                                                            
                                                   Langerhans' cell histiocytosis                                                             
                                                   Multiple gated acquisition scan abnormal                                                   
                                                   Paraneoplastic thrombosis                                                                  
                                                   Pulmonary tumour thrombotic microangiopathy                                                
                                                   Scan myocardial perfusion abnormal                                                         
                                                   Superior vena cava occlusion                                                               
                                                   Superior vena cava syndrome                                                                
                                                   Thrombophlebitis migrans                                                                   
                                                   Tumour embolism                                                                            
                                                   Tumour thrombectomy                                                                        
                                                   Tumour thrombosis                                                                          
                                                   Benign hepatic neoplasm                                                                    
                                                   Benign hepatobiliary neoplasm                                                              
                                                   Biopsy liver abnormal                                                                      
                                                   Cholangiosarcoma                                                                           
                                                   Computerised tomogram liver abnormal                                                       
                                                   Focal nodular hyperplasia                                                                  
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Haemangioma of liver                                                                       
                                                   Haemorrhagic hepatic cyst                                                                  
                                                   Hepatectomy                                                                                
                                                   Hepatic adenoma                                                                            
                                                   Hepatic angiosarcoma                                                                       
                                                   Hepatic cancer                                                                             
                                                   Hepatic cancer metastatic                                                                  
                                                   Hepatic cancer recurrent                                                                   
                                                   Hepatic cancer stage I                                                                     
                                                   Hepatic cancer stage II                                                                    
                                                   Hepatic cancer stage III                                                                   
                                                   Hepatic cancer stage IV                                                                    
                                                   Hepatic cyst                                                                               
                                                   Hepatic cyst ruptured                                                                      
                                                   Hepatic haemangioma rupture                                                                
                                                   Hepatic hamartoma                                                                          
                                                   Hepatic neoplasm                                                                           
                                                   Hepatobiliary cancer                                                                       
                                                   Hepatobiliary cancer in situ                                                               
                                                   Hepatobiliary cyst                                                                         
                                                   Hepatobiliary neoplasm                                                                     
                                                   Hepatoblastoma                                                                             
                                                   Hepatoblastoma recurrent                                                                   
                                                   Hepatocellular carcinoma                                                                   
                                                   Liver ablation                                                                             
                                                   Liver carcinoma ruptured                                                                   
                                                   Liver scan abnormal                                                                        
                                                   Mixed hepatocellular cholangiocarcinoma                                                    
                                                   Peritoneal fluid protein increased                                                         
                                                   Splenic artery embolisation                                                                
                                                   Abdominal wall cyst                                                                        
                                                   Ampullary polyp                                                                            
                                                   Anal leukoplakia                                                                           
                                                   Anal polyp                                                                                 
                                                   Anogenital dysplasia                                                                       
                                                   Barrett's oesophagus                                                                       
                                                   Buccal polyp                                                                               
                                                   Colon dysplasia                                                                            
                                                   Crohn's disease                                                                            
                                                   Cronkhite-Canada syndrome                                                                  
                                                   Dental cyst                                                                                
                                                   Duodenal polyp                                                                             
                                                   Epulis                                                                                     
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Gastric cyst                                                                               
                                                   Gastric dysplasia                                                                          
                                                   Gastric polyps                                                                             
                                                   Gastrointestinal dysplasia                                                                 
                                                   Gastrointestinal polyp                                                                     
                                                   Gastrointestinal polyp haemorrhage                                                         
                                                   Giant cell epulis                                                                          
                                                   Gingival cyst                                                                              
                                                   Gingival polyp                                                                             
                                                   Intestinal cyst                                                                            
                                                   Intestinal polyp                                                                           
                                                   Large intestine polyp                                                                      
                                                   Leukoplakia oesophageal                                                                    
                                                   Leukoplakia oral                                                                           
                                                   Lichenoid dysplasia                                                                        
                                                   Malignant dysphagia                                                                        
                                                   Malignant gastrointestinal obstruction                                                     
                                                   Melanoplakia oral                                                                          
                                                   Mesenteric cyst                                                                            
                                                   Mouth cyst                                                                                 
                                                   Oesophageal dysplasia                                                                      
                                                   Oesophageal polyp                                                                          
                                                   Palatal polyp                                                                              
                                                   Pancreatic cyst                                                                            
                                                   Pancreatic cyst rupture                                                                    
                                                   Peritoneal cyst                                                                            
                                                   Precancerous lesion of digestive tract                                                     
                                                   Pseudoachalasia                                                                            
                                                   Rectal dysplasia                                                                           
                                                   Rectal polyp                                                                               
                                                   Retroperitoneum cyst                                                                       
                                                   Salivary gland cyst                                                                        
                                                   Salivary gland induration                                                                  
                                                   Small intestine polyp                                                                      
                                                   Terminal ileitis                                                                           
                                                   Tongue cyst                                                                                
                                                   Tongue dysplasia                                                                           
                                                   Tongue polyp                                                                               
                                                   Administration site cyst                                                                   
                                                   Application site cyst                                                                      
                                                   Infusion site cyst                                                                         
                                                   Injection site cyst                                                                        
                                                   5q minus syndrome                                                                          
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Abdominal wall neoplasm malignant
Acinar cell carcinoma of pancreas
Acinic cell carcinoma of salivary gland
Acral lentiginous melanoma
Acral lentiginous melanoma stage I
Acral lentiginous melanoma stage II
Acral lentiginous melanoma stage III
Acral lentiginous melanoma stage IV
Acute bilineal leukaemia
Acute biphenotypic leukaemia
Acute erythroid leukaemia
Acute leukaemia
Acute leukaemia in remission
Acute lymphocytic leukaemia
Acute lymphocytic leukaemia (in remission)
Acute lymphocytic leukaemia recurrent
Acute lymphocytic leukaemia refractory
Acute megakaryocytic leukaemia
Acute megakaryocytic leukaemia (in remission)
Acute monocytic leukaemia
Acute monocytic leukaemia (in remission)
Acute myeloid leukaemia
Acute myeloid leukaemia (in remission)
Acute myeloid leukaemia recurrent
Acute myeloid leukaemia refractory
Acute myelomonocytic leukaemia
Acute promyelocytic leukaemia
Acute undifferentiated leukaemia
Adenocarcinoma
Adenocarcinoma gastric
Adenocarcinoma metastatic
Adenocarcinoma of appendix
Adenocarcinoma of colon
Adenocarcinoma of salivary gland   
Adenocarcinoma of the cervix
Adenocarcinoma pancreas
Adenoid cystic carcinoma
Adenoid cystic carcinoma of salivary gland
Adenosquamous carcinoma of the cervix
Adenosquamous carcinoma of vagina
Adenosquamous cell carcinoma
Adenosquamous cell lung cancer
Adenosquamous cell lung cancer recurrent
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Adenosquamous cell lung cancer stage 0  
Adenosquamous cell lung cancer stage I
Adenosquamous cell lung cancer stage II
Adenosquamous cell lung cancer stage III
Adenosquamous cell lung cancer stage IV
Adrenal gland cancer
Adrenal gland cancer metastatic
Adrenocortical carcinoma
Adult T-cell lymphoma/leukaemia
Adult T-cell lymphoma/leukaemia recurrent
Adult T-cell lymphoma/leukaemia refractory
Adult T-cell lymphoma/leukaemia stage I
Adult T-cell lymphoma/leukaemia stage II
Adult T-cell lymphoma/leukaemia stage III
Adult T-cell lymphoma/leukaemia stage IV
Aesthesioneuroblastoma
Aleukaemic leukaemia
Alveolar rhabdomyosarcoma
Alveolar soft part sarcoma
Alveolar soft part sarcoma metastatic
Alveolar soft part sarcoma recurrent
Ameloblastic carcinoma
Anal cancer
Anal cancer metastatic
Anal cancer recurrent
Anal cancer stage 0
Anal cancer stage I
Anal cancer stage II
Anal cancer stage III
Anal cancer stage IV
Anal squamous cell carcinoma
Anaplastic astrocytoma
Anaplastic large cell lymphoma T- and null-cell
types
Anaplastic large cell lymphoma T- and null-cell
types recurrent
Anaplastic large cell lymphoma T- and null-cell
types refractory
Anaplastic large cell lymphoma T- and null-cell
types stage I
Anaplastic large cell lymphoma T- and null-cell
types stage II
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Anaplastic large cell lymphoma T- and null-cell
types stage III
Anaplastic large cell lymphoma T- and null-cell
types stage IV
Anaplastic large-cell lymphoma
Anaplastic meningioma
Anaplastic oligodendroglioma
Anaplastic thyroid cancer
Angiocentric glioma
Angiocentric lymphoma
Angiocentric lymphoma recurrent
Angiocentric lymphoma refractory
Angiocentric lymphoma stage I
Angiocentric lymphoma stage II
Angiocentric lymphoma stage III
Angiocentric lymphoma stage IV
Angioimmunoblastic T-cell lymphoma
Angioimmunoblastic T-cell lymphoma recurrent
Angioimmunoblastic T-cell lymphoma refractory
Angioimmunoblastic T-cell lymphoma stage I
Angioimmunoblastic T-cell lymphoma stage II
Angioimmunoblastic T-cell lymphoma stage III
Angioimmunoblastic T-cell lymphoma stage IV
Angiosarcoma
Angiosarcoma metastatic
Angiosarcoma non-metastatic
Angiosarcoma recurrent
Apocrine breast carcinoma
Appendix cancer
Astrocytoma
Astrocytoma malignant
Atypical teratoid/rhabdoid tumour of CNS
B precursor type acute leukaemia
B-cell lymphoma
B-cell lymphoma recurrent
B-cell lymphoma refractory
B-cell lymphoma stage I
B-cell lymphoma stage II
B-cell lymphoma stage III
B-cell lymphoma stage IV
B-cell prolymphocytic leukaemia
B-cell small lymphocytic lymphoma
B-cell small lymphocytic lymphoma recurrent
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           B-cell small lymphocytic lymphoma refractory                                               
                                                   B-cell small lymphocytic lymphoma stage I                                                  
                                                   B-cell small lymphocytic lymphoma stage II                                                 
                                                   B-cell small lymphocytic lymphoma stage III                                                
                                                   B-cell small lymphocytic lymphoma stage IV                                                 
                                                   B-cell type acute leukaemia                                                                
                                                   B-cell unclassifiable lymphoma high grade                                                  
                                                   B-cell unclassifiable lymphoma low grade                                                   
                                                   Basal cell carcinoma                                                                       
                                                   Basal cell carcinoma metastatic                                                            
                                                   Basosquamous carcinoma                                                                     
                                                   Basosquamous carcinoma of skin                                                             
                                                   Bile duct adenocarcinoma                                                                   
                                                   Bile duct adenosquamous carcinoma                                                          
                                                   Bile duct cancer                                                                           
                                                   Bile duct cancer recurrent                                                                 
                                                   Bile duct cancer stage 0                                                                   
                                                   Bile duct cancer stage I                                                                   
                                                   Bile duct cancer stage II                                                                  
                                                   Bile duct cancer stage III                                                                 
                                                   Bile duct cancer stage IV                                                                  
                                                   Bile duct squamous cell carcinoma                                                          
                                                   Biliary cancer metastatic                                                                  
                                                   Biphasic mesothelioma                                                                      
                                                   Bladder adenocarcinoma recurrent                                                           
                                                   Bladder adenocarcinoma stage 0                                                             
                                                   Bladder adenocarcinoma stage I                                                             
                                                   Bladder adenocarcinoma stage II                                                            
                                                   Bladder adenocarcinoma stage III                                                           
                                                   Bladder adenocarcinoma stage IV                                                            
                                                   Bladder adenocarcinoma stage unspecified                                                   
                                                   Bladder cancer                                                                             
                                                   Bladder cancer recurrent                                                                   
                                                   Bladder cancer stage 0, with cancer in situ                                                
                                                   Bladder cancer stage 0, without cancer in situ                                             
                                                   Bladder cancer stage I, with cancer in situ                                                
                                                   Bladder cancer stage I, without cancer in situ                                             
                                                   Bladder cancer stage II                                                                    
                                                   Bladder cancer stage III                                                                   
                                                   Bladder cancer stage IV                                                                    
                                                   Bladder squamous cell carcinoma recurrent                                                  
                                                   Bladder squamous cell carcinoma stage 0                                                    
                                                   Bladder squamous cell carcinoma stage I                                                    
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Bladder squamous cell carcinoma stage II                                                   
                                                   Bladder squamous cell carcinoma stage III                                                  
                                                   Bladder squamous cell carcinoma stage IV                                                   
                                                   Bladder squamous cell carcinoma stage unspecified                                          
                                                   Bladder transitional cell carcinoma                                                        
                                                   Bladder transitional cell carcinoma metastatic                                             
                                                   Bladder transitional cell carcinoma recurrent                                              
                                                   Bladder transitional cell carcinoma stage 0                                                
                                                   Bladder transitional cell carcinoma stage I                                                
                                                   Bladder transitional cell carcinoma stage II                                               
                                                   Bladder transitional cell carcinoma stage III                                              
                                                   Bladder transitional cell carcinoma stage IV                                               
                                                   Blast cell crisis                                                                          
                                                   Blast crisis in myelogenous leukaemia                                                      
                                                   Blastic plasmacytoid dendritic cell neoplasia                                              
                                                   Bone cancer                                                                                
                                                   Bone cancer metastatic                                                                     
                                                   Bone giant cell tumour malignant                                                           
                                                   Bone marrow leukaemic cell infiltration                                                    
                                                   Bone marrow tumour cell infiltration                                                       
                                                   Bone sarcoma                                                                               
                                                   Bowen's disease                                                                            
                                                   Brain cancer metastatic                                                                    
                                                   Brain neoplasm malignant                                                                   
                                                   Brain sarcoma                                                                              
                                                   Brain stem glioma                                                                          
                                                   Breast angiosarcoma                                                                        
                                                   Breast angiosarcoma metastatic                                                             
                                                   Breast cancer                                                                              
                                                   Breast cancer female                                                                       
                                                   Breast cancer in situ                                                                      
                                                   Breast cancer male                                                                         
                                                   Breast cancer metastatic                                                                   
                                                   Breast cancer recurrent                                                                    
                                                   Breast cancer stage I                                                                      
                                                   Breast cancer stage II                                                                     
                                                   Breast cancer stage III                                                                    
                                                   Breast cancer stage IV                                                                     
                                                   Breast implant-associated anaplastic large cell                                            
                                                   lymphoma                                                                                   
                                                   Breast sarcoma                                                                             
                                                   Breast sarcoma metastatic                                                                  
                                                   Breast sarcoma recurrent                                                                   
.


NN9535 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Bronchial carcinoma
Bronchioloalveolar carcinoma
Burkitt's leukaemia
Burkitt's lymphoma
Burkitt's lymphoma recurrent
Burkitt's lymphoma refractory
Burkitt's lymphoma stage I
Burkitt's lymphoma stage II
Burkitt's lymphoma stage III
Burkitt's lymphoma stage IV
Buschke-Lowenstein's tumour
CNS germinoma
Cancer in remission
Carcinoid tumour
Carcinoid tumour of the appendix
Carcinoid tumour of the caecum
Carcinoid tumour of the duodenum
Carcinoid tumour of the gastrointestinal tract
Carcinoid tumour of the liver
Carcinoid tumour of the ovary
Carcinoid tumour of the pancreas   
Carcinoid tumour of the prostate
Carcinoid tumour of the small bowel
Carcinoid tumour of the stomach
Carcinoid tumour pulmonary
Carcinoma ex-pleomorphic adenoma
Carcinoma in situ
Carcinoma in situ of eye
Carcinoma in situ of penis
Carcinoma in situ of skin
Carcinoma in situ of trachea
Cardiac neoplasm malignant
Central nervous system leukaemia
Central nervous system lymphoma
Central nervous system melanoma
Central nervous system neuroblastoma
Cervix cancer metastatic
Cervix carcinoma
Cervix carcinoma recurrent
Cervix carcinoma stage 0
Cervix carcinoma stage I
Cervix carcinoma stage II
Cervix carcinoma stage III
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Cervix carcinoma stage IV
Chloroma
Chloroma (in remission)
Cholangiocarcinoma
Chondrosarcoma
Chondrosarcoma metastatic
Chondrosarcoma recurrent
Chordoma
Choriocarcinoma
Choroid melanoma
Choroid plexus carcinoma
Chromophobe renal cell carcinoma
Chronic eosinophilic leukaemia
Chronic leukaemia
Chronic leukaemia in remission
Chronic lymphocytic leukaemia
Chronic lymphocytic leukaemia (in remission)
Chronic lymphocytic leukaemia recurrent
Chronic lymphocytic leukaemia refractory
Chronic lymphocytic leukaemia stage 0
Chronic lymphocytic leukaemia stage 1
Chronic lymphocytic leukaemia stage 2
Chronic lymphocytic leukaemia stage 3
Chronic lymphocytic leukaemia stage 4
Chronic lymphocytic leukaemia transformation
Chronic myeloid leukaemia
Chronic myeloid leukaemia (in remission)
Chronic myeloid leukaemia recurrent
Chronic myeloid leukaemia transformation
Chronic myelomonocytic leukaemia   
Chronic myelomonocytic leukaemia (in remission)
Ciliary body melanoma
Clear cell carcinoma of cervix
Clear cell endometrial carcinoma
Clear cell renal cell carcinoma
Clear cell sarcoma of soft tissue
Clear cell sarcoma of the kidney
Colon cancer
Colon cancer metastatic
Colon cancer recurrent
Colon cancer stage 0
Colon cancer stage I
Colon cancer stage II
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Colon cancer stage III                                                                     
                                                   Colon cancer stage IV                                                                      
                                                   Colorectal adenocarcinoma                                                                  
                                                   Colorectal cancer                                                                          
                                                   Colorectal cancer metastatic                                                               
                                                   Colorectal cancer recurrent                                                                
                                                   Colorectal cancer stage I                                                                  
                                                   Colorectal cancer stage II                                                                 
                                                   Colorectal cancer stage III                                                                
                                                   Colorectal cancer stage IV                                                                 
                                                   Colorectal carcinoma stage 0                                                               
                                                   Composite lymphoma                                                                         
                                                   Congenital fibrosarcoma                                                                    
                                                   Congenital malignant neoplasm                                                              
                                                   Congenital retinoblastoma                                                                  
                                                   Conjunctival melanoma                                                                      
                                                   Cutaneous T-cell lymphoma                                                                  
                                                   Cutaneous T-cell lymphoma recurrent                                                        
                                                   Cutaneous T-cell lymphoma refractory                                                       
                                                   Cutaneous T-cell lymphoma stage I                                                          
                                                   Cutaneous T-cell lymphoma stage II                                                         
                                                   Cutaneous T-cell lymphoma stage III                                                        
                                                   Cutaneous T-cell lymphoma stage IV                                                         
                                                   Cutaneous lymphoma                                                                         
                                                   Cystadenocarcinoma ovary                                                                   
                                                   Cystadenocarcinoma pancreas                                                                
                                                   Dedifferentiated liposarcoma                                                               
                                                   Dermatofibrosarcoma protuberans                                                            
                                                   Dermatofibrosarcoma protuberans metastatic                                                 
                                                   Desmoplastic melanoma                                                                      
                                                   Desmoplastic mesothelioma                                                                  
                                                   Desmoplastic small round cell tumour                                                       
                                                   Diffuse large B-cell lymphoma                                                              
                                                   Diffuse large B-cell lymphoma recurrent                                                    
                                                   Diffuse large B-cell lymphoma refractory                                                   
                                                   Diffuse large B-cell lymphoma stage I                                                      
                                                   Diffuse large B-cell lymphoma stage II                                                     
                                                   Diffuse large B-cell lymphoma stage III                                                    
                                                   Diffuse large B-cell lymphoma stage IV                                                     
                                                   Disseminated large cell lymphoma                                                           
                                                   Double hit lymphoma                                                                        
                                                   Ductal adenocarcinoma of pancreas                                                          
                                                   Ear neoplasm malignant                                                                     
.


NN9535 
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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Eccrine carcinoma                                                                          
                                                   Embryonal rhabdomyosarcoma                                                                 
                                                   Endocrine neoplasm malignant                                                               
                                                   Endometrial adenocarcinoma                                                                 
                                                   Endometrial cancer                                                                         
                                                   Endometrial cancer metastatic                                                              
                                                   Endometrial cancer recurrent                                                               
                                                   Endometrial cancer stage 0                                                                 
                                                   Endometrial cancer stage I                                                                 
                                                   Endometrial cancer stage II                                                                
                                                   Endometrial cancer stage III                                                               
                                                   Endometrial cancer stage IV                                                                
                                                   Endometrial sarcoma                                                                        
                                                   Endometrial sarcoma metastatic                                                             
                                                   Endometrial sarcoma recurrent                                                              
                                                   Endometrial stromal sarcoma                                                                
                                                   Endotheliomatosis                                                                          
                                                   Enteropathy-associated T-cell lymphoma                                                     
                                                   Eosinophilic leukaemia                                                                     
                                                   Ependymoma malignant                                                                       
                                                   Epididymal cancer                                                                          
                                                   Epiglottic cancer                                                                          
                                                   Epithelioid mesothelioma                                                                   
                                                   Epithelioid sarcoma                                                                        
                                                   Epithelioid sarcoma metastatic                                                             
                                                   Epithelioid sarcoma recurrent                                                              
                                                   Epstein-Barr virus associated lymphoma                                                     
                                                   Erythraemic myelosis (in remission)                                                        
                                                   Ewing's sarcoma                                                                            
                                                   Ewing's sarcoma metastatic                                                                 
                                                   Ewing's sarcoma recurrent                                                                  
                                                   Ewing-like sarcoma                                                                         
                                                   External ear neoplasm malignant                                                            
                                                   Extra-osseous Ewing's sarcoma                                                              
                                                   Extra-osseous Ewing's sarcoma metastatic                                                   
                                                   Extra-osseous Ewing's sarcoma recurrent                                                    
                                                   Extragonadal primary embryonal carcinoma                                                   
                                                   Extragonadal primary germ cell tumour                                                      
                                                   Extragonadal primary germ cell tumour mixed                                                
                                                   Extragonadal primary germ cell tumour mixed stage                                          
                                                   I                                                                                          
                                                   Extragonadal primary germ cell tumour mixed stage                                          
                                                   II                                                                                         
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Extragonadal primary germ cell tumour mixed stage
III
Extragonadal primary malignant teratoma
Extragonadal primary non-seminoma
Extragonadal primary non-seminoma stage I
Extragonadal primary non-seminoma stage II
Extragonadal primary non-seminoma stage III
Extragonadal primary non-seminoma stage IV
Extragonadal primary seminoma (pure) 
Extragonadal primary seminoma (pure) stage I
Extragonadal primary seminoma (pure) stage II
Extragonadal primary seminoma (pure) stage III
Extragonadal primary seminoma (pure) stage IV
Extramammary Paget's disease
Extranodal marginal zone B-cell lymphoma (BALT
type)
Extranodal marginal zone B-cell lymphoma (MALT
type)
Extranodal marginal zone B-cell lymphoma (MALT
type) recurrent
Extranodal marginal zone B-cell lymphoma (MALT
type) refractory
Extranodal marginal zone B-cell lymphoma (MALT
type) stage I
Extranodal marginal zone B-cell lymphoma (MALT
type) stage II
Extranodal marginal zone B-cell lymphoma (MALT
type) stage III
Extranodal marginal zone B-cell lymphoma (MALT
type) stage IV
Extraocular retinoblastoma
Extraskeletal chondrosarcoma metastatic
Extraskeletal chondrosarcoma recurrent
Extraskeletal myxoid chondrosarcoma
Extraskeletal osteosarcoma
Extraskeletal osteosarcoma metastatic
Extraskeletal osteosarcoma recurrent 
Fallopian tube cancer
Fallopian tube cancer metastatic
Fallopian tube cancer stage I
Fallopian tube cancer stage II
Fallopian tube cancer stage III
Fallopian tube cancer stage IV
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Familial medullary thyroid cancer
Female reproductive tract carcinoma in situ
Fibrosarcoma
Fibrosarcoma metastatic
Follicle centre lymphoma diffuse small cell
lymphoma
Follicle centre lymphoma diffuse small cell
lymphoma recurrent
Follicle centre lymphoma diffuse small cell
lymphoma refractory
Follicle centre lymphoma diffuse small cell
lymphoma stage I
Follicle centre lymphoma diffuse small cell
lymphoma stage II
Follicle centre lymphoma diffuse small cell
lymphoma stage III
Follicle centre lymphoma diffuse small cell
lymphoma stage IV
Follicle centre lymphoma, follicular grade I, II,
III
Follicle centre lymphoma, follicular grade I, II,
III recurrent
Follicle centre lymphoma, follicular grade I, II,
III refractory
Follicle centre lymphoma, follicular grade I, II,
III stage I
Follicle centre lymphoma, follicular grade I, II,
III stage II
Follicle centre lymphoma, follicular grade I, II,
III stage III
Follicle centre lymphoma, follicular grade I, II,
III stage IV
Follicular dendritic cell sarcoma
Follicular thyroid cancer
Gallbladder adenocarcinoma
Gallbladder adenosquamous carcinoma
Gallbladder cancer
Gallbladder cancer metastatic
Gallbladder cancer recurrent
Gallbladder cancer stage 0
Gallbladder cancer stage I
Gallbladder cancer stage II
Gallbladder cancer stage III
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Gallbladder cancer stage IV
Gallbladder squamous cell carcinoma
Ganglioglioma
Ganglioneuroblastoma
Gastric cancer
Gastric cancer recurrent
Gastric cancer stage 0
Gastric cancer stage I
Gastric cancer stage II
Gastric cancer stage III
Gastric cancer stage IV
Gastric sarcoma
Gastrinoma malignant
Gastroenteropancreatic neuroendocrine tumour
disease
Gastrointestinal adenocarcinoma
Gastrointestinal cancer metastatic
Gastrointestinal carcinoma
Gastrointestinal carcinoma in situ
Gastrointestinal lymphoma
Gastrointestinal melanoma
Gastrointestinal stromal tumour
Gastrooesophageal cancer
Gastrooesophageal cancer recurrent
Genital cancer male
Genital cancer male in situ
Genital neoplasm malignant female
Genitourinary melanoma
Germ cell cancer
Germ cell cancer metastatic
Gestational trophoblastic tumour
Gingival cancer
Glioblastoma
Glioblastoma multiforme
Glioma
Gliomatosis cerebri
Glioneuronal tumour
Gliosarcoma
Glomangiopericytoma
Glottis carcinoma
Glucagonoma
HER2 negative breast cancer
HER2 positive breast cancer
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           HER2 positive gastric cancer                                                               
                                                   Haemangiopericytoma                                                                        
                                                   Haemangiopericytoma of meninges                                                            
                                                   Haematological malignancy                                                                  
                                                   Hairy cell leukaemia                                                                       
                                                   Hairy cell leukaemia recurrent                                                             
                                                   Head and neck cancer                                                                       
                                                   Head and neck cancer metastatic                                                            
                                                   Head and neck cancer stage I                                                               
                                                   Head and neck cancer stage II                                                              
                                                   Head and neck cancer stage III                                                             
                                                   Head and neck cancer stage IV                                                              
                                                   Hepatosplenic T-cell lymphoma                                                              
                                                   Hereditary leiomyomatosis renal cell carcinoma                                             
                                                   Hereditary papillary renal carcinoma                                                       
                                                   Hidradenocarcinoma                                                                         
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   recurrent                                                                                  
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   refractory                                                                                 
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage I                                                                                    
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage II                                                                                   
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage III                                                                                  
                                                   High grade B-cell lymphoma Burkitt-like lymphoma                                           
                                                   stage IV                                                                                   
                                                   High-grade B-cell lymphoma                                                                 
                                                   Histiocytic medullary reticulosis                                                          
                                                   Histiocytic sarcoma                                                                        
                                                   Hodgkin's disease                                                                          
                                                   Hodgkin's disease lymphocyte depletion stage I                                             
                                                   site unspecified                                                                           
                                                   Hodgkin's disease lymphocyte depletion stage I                                             
                                                   subdiaphragm                                                                               
                                                   Hodgkin's disease lymphocyte depletion stage I                                             
                                                   supradiaphragm                                                                             
                                                   Hodgkin's disease lymphocyte depletion stage II                                            
                                                   site unspecified                                                                           
                                                   Hodgkin's disease lymphocyte depletion stage II                                            
                                                   subdiaphragm                                                                               
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Hodgkin's disease lymphocyte depletion stage II                                            
                                                   supradiaphragm                                                                             
                                                   Hodgkin's disease lymphocyte depletion type                                                
                                                   recurrent                                                                                  
                                                   Hodgkin's disease lymphocyte depletion type                                                
                                                   refractory                                                                                 
                                                   Hodgkin's disease lymphocyte depletion type stage                                          
                                                   III                                                                                        
                                                   Hodgkin's disease lymphocyte depletion type stage                                          
                                                   IV                                                                                         
                                                   Hodgkin's disease lymphocyte depletion type stage                                          
                                                   unspecified                                                                                
                                                   Hodgkin's disease lymphocyte predominance stage I                                          
                                                   site unspec                                                                                
                                                   Hodgkin's disease lymphocyte predominance stage I                                          
                                                   subdiaphragm                                                                               
                                                   Hodgkin's disease lymphocyte predominance stage I                                          
                                                   supradiaphragm                                                                             
                                                   Hodgkin's disease lymphocyte predominance stage                                            
                                                   II site unspec                                                                             
                                                   Hodgkin's disease lymphocyte predominance stage                                            
                                                   II subdiaphragm                                                                            
                                                   Hodgkin's disease lymphocyte predominance stage                                            
                                                   II supradiaphragm                                                                          
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   recurrent                                                                                  
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   refractory                                                                                 
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   stage III                                                                                  
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   stage IV                                                                                   
                                                   Hodgkin's disease lymphocyte predominance type                                             
                                                   stage unspecified                                                                          
                                                   Hodgkin's disease mixed cellularity recurrent                                              
                                                   Hodgkin's disease mixed cellularity refractory                                             
                                                   Hodgkin's disease mixed cellularity stage I site                                           
                                                   unspecified                                                                                
                                                   Hodgkin's disease mixed cellularity stage I                                                
                                                   subdiaphragmatic                                                                           
                                                   Hodgkin's disease mixed cellularity stage I                                                
                                                   supradiaphragmatic                                                                         
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Hodgkin's disease mixed cellularity stage II
subdiaphragmatic
Hodgkin's disease mixed cellularity stage II
supradiaphragmatic
Hodgkin's disease mixed cellularity stage III
Hodgkin's disease mixed cellularity stage IV
Hodgkin's disease mixed cellularity stage
unspecified
Hodgkin's disease nodular sclerosis
Hodgkin's disease nodular sclerosis recurrent
Hodgkin's disease nodular sclerosis refractory
Hodgkin's disease nodular sclerosis stage I
Hodgkin's disease nodular sclerosis stage II
Hodgkin's disease nodular sclerosis stage III
Hodgkin's disease nodular sclerosis stage IV
Hodgkin's disease recurrent
Hodgkin's disease refractory
Hodgkin's disease stage I
Hodgkin's disease stage II
Hodgkin's disease stage III
Hodgkin's disease stage IV
Hodgkin's disease unclassifiable
Hormone receptor positive breast cancer
Hormone refractory breast cancer
Hormone-dependent prostate cancer
Hormone-refractory prostate cancer
Huerthle cell carcinoma
Hypopharyngeal cancer
Hypopharyngeal cancer recurrent
Hypopharyngeal cancer stage 0
Hypopharyngeal cancer stage I
Hypopharyngeal cancer stage II
Hypopharyngeal cancer stage III
Hypopharyngeal cancer stage IV
Immune reconstitution inflammatory syndrome
associated Kaposi's sarcoma
Immunoblastic lymphoma
Inflammatory carcinoma of breast recurrent
Inflammatory carcinoma of breast stage III
Inflammatory carcinoma of breast stage IV
Inflammatory carcinoma of the breast   
Inflammatory malignant fibrous histiocytoma
Inflammatory myofibroblastic tumour
.


NN9535 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Intestinal T-cell lymphoma recurrent
Intestinal T-cell lymphoma refractory
Intestinal T-cell lymphoma stage I
Intestinal T-cell lymphoma stage II   
Intestinal T-cell lymphoma stage III
Intestinal T-cell lymphoma stage IV
Intestinal adenocarcinoma
Intestinal metastasis
Intracranial germ cell tumour
Intracranial meningioma malignant
Intraductal papillary breast neoplasm
Intraductal papillary-mucinous carcinoma of
pancreas
Intraductal proliferative breast lesion
Intraocular melanoma
Invasive breast carcinoma
Invasive ductal breast carcinoma
Invasive lobular breast carcinoma
Invasive papillary breast carcinoma
Iris melanoma
Juvenile chronic myelomonocytic leukaemia
Kaposi's sarcoma
Kaposi's sarcoma AIDS related
Kaposi's sarcoma classical type
Keratinising squamous cell carcinoma of
nasopharynx
Keratoacanthoma
Langerhans cell sarcoma
Large cell lung cancer
Large cell lung cancer metastatic
Large cell lung cancer recurrent
Large cell lung cancer stage 0
Large cell lung cancer stage I
Large cell lung cancer stage II
Large cell lung cancer stage III
Large cell lung cancer stage IV
Laryngeal cancer
Laryngeal cancer metastatic
Laryngeal cancer recurrent
Laryngeal cancer stage 0
Laryngeal cancer stage I
Laryngeal cancer stage II
Laryngeal cancer stage III
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Laryngeal cancer stage IV
Laryngeal squamous cell carcinoma
Leiomyosarcoma
Leiomyosarcoma metastatic
Leiomyosarcoma recurrent
Lentigo maligna
Lentigo maligna recurrent
Lentigo maligna stage I
Lentigo maligna stage II
Lentigo maligna stage III
Lentigo maligna stage IV
Leptomeningeal myelomatosis
Leukaemia
Leukaemia basophilic
Leukaemia cutis
Leukaemia granulocytic
Leukaemia in remission
Leukaemia monocytic
Leukaemia recurrent
Leukaemic cardiac infiltration
Leukaemic infiltration
Leukaemic infiltration extramedullary
Leukaemic infiltration gingiva
Leukaemic infiltration hepatic
Leukaemic infiltration ovary
Leukaemic infiltration pulmonary
Leukaemic infiltration renal
Leukaemic lymphoma
Leukaemic retinopathy
Leydig cell tumour of the testis
Linitis plastica
Lip and/or oral cavity cancer
Lip and/or oral cavity cancer recurrent
Lip and/or oral cavity cancer stage 0
Lip and/or oral cavity cancer stage I
Lip and/or oral cavity cancer stage II
Lip and/or oral cavity cancer stage III
Lip and/or oral cavity cancer stage IV
Lip neoplasm malignant stage unspecified
Lip squamous cell carcinoma
Liposarcoma
Liposarcoma metastatic
Liposarcoma recurrent
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Lobular breast carcinoma in situ                                                           
                                                   Lung adenocarcinoma                                                                        
                                                   Lung adenocarcinoma recurrent                                                              
                                                   Lung adenocarcinoma stage 0                                                                
                                                   Lung adenocarcinoma stage I                                                                
                                                   Lung adenocarcinoma stage II                                                               
                                                   Lung adenocarcinoma stage III                                                              
                                                   Lung adenocarcinoma stage IV                                                               
                                                   Lung cancer metastatic                                                                     
                                                   Lung carcinoma cell type unspecified recurrent                                             
                                                   Lung carcinoma cell type unspecified stage 0                                               
                                                   Lung carcinoma cell type unspecified stage I                                               
                                                   Lung carcinoma cell type unspecified stage II                                              
                                                   Lung carcinoma cell type unspecified stage III                                             
                                                   Lung carcinoma cell type unspecified stage IV                                              
                                                   Lung infiltration malignant                                                                
                                                   Lung neoplasm malignant                                                                    
                                                   Lung squamous cell carcinoma metastatic                                                    
                                                   Lung squamous cell carcinoma recurrent                                                     
                                                   Lung squamous cell carcinoma stage 0                                                       
                                                   Lung squamous cell carcinoma stage I                                                       
                                                   Lung squamous cell carcinoma stage II                                                      
                                                   Lung squamous cell carcinoma stage III                                                     
                                                   Lung squamous cell carcinoma stage IV                                                      
                                                   Lymphangiosarcoma                                                                          
                                                   Lymphangiosis carcinomatosa                                                                
                                                   Lymphocytic leukaemia                                                                      
                                                   Lymphocytic lymphoma                                                                       
                                                   Lymphoid leukaemia (in remission)                                                          
                                                   Lymphoma                                                                                   
                                                   Lymphoma AIDS related                                                                      
                                                   Lymphoma transformation                                                                    
                                                   Lymphoplasmacytoid lymphoma/immunocytoma                                                   
                                                   Lymphoplasmacytoid lymphoma/immunocytoma recurrent                                         
                                                   Lymphoplasmacytoid lymphoma/immunocytoma                                                   
                                                   refractory                                                                                 
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage I                                           
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage II                                          
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage III                                         
                                                   Lymphoplasmacytoid lymphoma/immunocytoma stage IV                                          
                                                   Malignant anorectal neoplasm                                                               
                                                   Malignant blue naevus                                                                      
                                                   Malignant connective tissue neoplasm                                                       
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Malignant cranial nerve neoplasm                                                           
                                                   Malignant fibrous histiocytoma                                                             
                                                   Malignant fibrous histiocytoma metastatic                                                  
                                                   Malignant fibrous histiocytoma of bone                                                     
                                                   Malignant fibrous histiocytoma recurrent                                                   
                                                   Malignant genitourinary tract neoplasm                                                     
                                                   Malignant giant cell fibrous histiocytoma                                                  
                                                   Malignant glioma                                                                           
                                                   Malignant haemangiopericytoma                                                              
                                                   Malignant haemangiopericytoma metastatic                                                   
                                                   Malignant haemangiopericytoma recurrent                                                    
                                                   Malignant histiocytosis                                                                    
                                                   Malignant hydatidiform mole                                                                
                                                   Malignant joint neoplasm                                                                   
                                                   Malignant lymphoid neoplasm                                                                
                                                   Malignant lymphoma unclassifiable high grade                                               
                                                   Malignant lymphoma unclassifiable low grade                                                
                                                   Malignant mast cell neoplasm                                                               
                                                   Malignant mediastinal neoplasm                                                             
                                                   Malignant melanoma                                                                         
                                                   Malignant melanoma in situ                                                                 
                                                   Malignant melanoma of eyelid                                                               
                                                   Malignant melanoma of sites other than skin                                                
                                                   Malignant melanoma stage I                                                                 
                                                   Malignant melanoma stage II                                                                
                                                   Malignant melanoma stage III                                                               
                                                   Malignant melanoma stage IV                                                                
                                                   Malignant meningioma metastatic                                                            
                                                   Malignant mesenchymoma                                                                     
                                                   Malignant mesenchymoma metastatic                                                          
                                                   Malignant mesenchymoma recurrent                                                           
                                                   Malignant mesenteric neoplasm                                                              
                                                   Malignant middle ear neoplasm                                                              
                                                   Malignant muscle neoplasm                                                                  
                                                   Malignant neoplasm of ampulla of Vater                                                     
                                                   Malignant neoplasm of choroid                                                              
                                                   Malignant neoplasm of conjunctiva                                                          
                                                   Malignant neoplasm of cornea                                                               
                                                   Malignant neoplasm of eye                                                                  
                                                   Malignant neoplasm of eyelid                                                               
                                                   Malignant neoplasm of islets of Langerhans                                                 
                                                   Malignant neoplasm of lacrimal duct                                                        
                                                   Malignant neoplasm of lacrimal gland                                                       
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Malignant neoplasm of orbit
Malignant neoplasm of paraurethral glands
Malignant neoplasm of placenta
Malignant neoplasm of pleura
Malignant neoplasm of pleura metastatic
Malignant neoplasm of renal pelvis
Malignant neoplasm of retina
Malignant neoplasm of seminal vesicle
Malignant neoplasm of spermatic cord
Malignant neoplasm of spinal cord
Malignant neoplasm of thorax
Malignant neoplasm of thymus
Malignant neoplasm of unknown primary site
Malignant neoplasm of uterine adnexa
Malignant neoplasm papilla of Vater
Malignant nervous system neoplasm
Malignant nipple neoplasm
Malignant nipple neoplasm female
Malignant nipple neoplasm male
Malignant oligodendroglioma
Malignant ovarian cyst
Malignant palate neoplasm
Malignant pericardial neoplasm
Malignant peritoneal neoplasm
Malignant pituitary tumour
Malignant polyp
Malignant respiratory tract neoplasm
Malignant splenic neoplasm
Malignant sweat gland neoplasm
Malignant transformation
Malignant urinary tract neoplasm
Mantle cell lymphoma
Mantle cell lymphoma recurrent
Mantle cell lymphoma refractory
Mantle cell lymphoma stage I
Mantle cell lymphoma stage II
Mantle cell lymphoma stage III
Mantle cell lymphoma stage IV
Marginal zone lymphoma
Marginal zone lymphoma recurrent
Marginal zone lymphoma refractory
Marginal zone lymphoma stage I
Marginal zone lymphoma stage II
.


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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Marginal zone lymphoma stage III
Marginal zone lymphoma stage IV
Marjolin's ulcer
Mastocytic leukaemia
Maternal cancer in pregnancy
Mature B-cell type acute leukaemia
Medullary carcinoma of breast
Medullary thyroid cancer
Medulloblastoma
Medulloblastoma recurrent
Melanoma recurrent
Meningioma malignant
Mesothelioma malignant
Mesothelioma malignant recurrent
Metaplastic breast carcinoma
Metastases to Eustachian tube
Metastases to abdominal cavity
Metastases to abdominal wall
Metastases to adrenals
Metastases to biliary tract
Metastases to bladder
Metastases to bone
Metastases to bone marrow
Metastases to breast
Metastases to central nervous system
Metastases to chest wall
Metastases to diaphragm
Metastases to eye
Metastases to fallopian tube
Metastases to gallbladder
Metastases to gastrointestinal tract 
Metastases to heart
Metastases to kidney
Metastases to larynx
Metastases to liver
Metastases to lung
Metastases to lymph nodes
Metastases to meninges
Metastases to mouth
Metastases to muscle
Metastases to nasal sinuses
Metastases to neck
Metastases to nervous system
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Metastases to oesophagus
Metastases to ovary
Metastases to pancreas
Metastases to pelvis
Metastases to penis
Metastases to perineum
Metastases to peripheral nervous system
Metastases to peripheral vascular system
Metastases to peritoneum
Metastases to pharynx
Metastases to pituitary gland
Metastases to placenta
Metastases to pleura
Metastases to prostate
Metastases to rectum
Metastases to reproductive organ
Metastases to retroperitoneum
Metastases to salivary gland
Metastases to skin
Metastases to soft tissue
Metastases to spinal cord
Metastases to spine
Metastases to spleen
Metastases to stomach
Metastases to testicle
Metastases to the mediastinum
Metastases to the respiratory system
Metastases to thorax
Metastases to thyroid
Metastases to tonsils
Metastases to trachea
Metastases to urinary tract
Metastases to uterus
Metastases to vagina
Metastasis
Metastatic bronchial carcinoma
Metastatic carcinoid tumour
Metastatic carcinoma of the bladder
Metastatic choriocarcinoma
Metastatic gastric cancer
Metastatic glioma
Metastatic glucagonoma
Metastatic lymphoma
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Metastatic malignant melanoma                                                              
                                                   Metastatic neoplasm                                                                        
                                                   Metastatic nervous system neoplasm                                                         
                                                   Metastatic ocular melanoma                                                                 
                                                   Metastatic renal cell carcinoma                                                            
                                                   Metastatic salivary gland cancer                                                           
                                                   Metastatic squamous cell carcinoma                                                         
                                                   Metastatic uterine cancer                                                                  
                                                   Microsatellite instability cancer                                                          
                                                   Minimal residual disease                                                                   
                                                   Mismatch repair cancer syndrome                                                            
                                                   Mixed adenoneuroendocrine carcinoma                                                        
                                                   Mixed-type liposarcoma                                                                     
                                                   Monocytic leukaemia in remission                                                           
                                                   Mucinous adenocarcinoma of appendix                                                        
                                                   Mucinous breast carcinoma                                                                  
                                                   Mucinous cystadenocarcinoma ovary                                                          
                                                   Mucinous endometrial carcinoma                                                             
                                                   Mucoepidermoid carcinoma                                                                   
                                                   Mucoepidermoid carcinoma of salivary gland                                                 
                                                   Musculoskeletal cancer                                                                     
                                                   Myeloblastoma                                                                              
                                                   Myeloid leukaemia                                                                          
                                                   Myeloid leukaemia in remission                                                             
                                                   Myxofibrosarcoma                                                                           
                                                   Myxoid liposarcoma                                                                         
                                                   NUT midline carcinoma                                                                      
                                                   Naevoid melanoma                                                                           
                                                   Nasal cavity cancer                                                                        
                                                   Nasal sinus cancer                                                                         
                                                   Nasopharyngeal cancer                                                                      
                                                   Nasopharyngeal cancer metastatic                                                           
                                                   Nasopharyngeal cancer recurrent                                                            
                                                   Nasopharyngeal cancer stage 0                                                              
                                                   Nasopharyngeal cancer stage I                                                              
                                                   Nasopharyngeal cancer stage II                                                             
                                                   Nasopharyngeal cancer stage III                                                            
                                                   Nasopharyngeal cancer stage IV                                                             
                                                   Natural killer-cell leukaemia                                                              
                                                   Natural killer-cell lymphoblastic lymphoma                                                 
                                                   Neonatal leukaemia                                                                         
                                                   Neonatal neuroblastoma                                                                     
                                                   Neoplasm malignant                                                                         
.


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Date: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Nephroblastoma                                                                             
                                                   Neuroblastoma                                                                              
                                                   Neuroblastoma recurrent                                                                    
                                                   Neuroendocrine breast tumour                                                               
                                                   Neuroendocrine carcinoma                                                                   
                                                   Neuroendocrine carcinoma metastatic                                                        
                                                   Neuroendocrine carcinoma of prostate                                                       
                                                   Neuroendocrine carcinoma of the bladder                                                    
                                                   Neuroendocrine carcinoma of the skin                                                       
                                                   Neuroendocrine tumour                                                                      
                                                   Neuroendocrine tumour of the lung                                                          
                                                   Neuroendocrine tumour of the lung metastatic                                               
                                                   Neurofibrosarcoma                                                                          
                                                   Neurofibrosarcoma metastatic                                                               
                                                   Neurofibrosarcoma recurrent                                                                
                                                   Nodal marginal zone B-cell lymphoma                                                        
                                                   Nodal marginal zone B-cell lymphoma recurrent                                              
                                                   Nodal marginal zone B-cell lymphoma refractory                                             
                                                   Nodal marginal zone B-cell lymphoma stage I                                                
                                                   Nodal marginal zone B-cell lymphoma stage II                                               
                                                   Nodal marginal zone B-cell lymphoma stage III                                              
                                                   Nodal marginal zone B-cell lymphoma stage IV                                               
                                                   Nodular lymphocyte predominant Hodgkin lymphoma                                            
                                                   Nodular melanoma                                                                           
                                                   Non-Hodgkin's lymphoma                                                                     
                                                   Non-Hodgkin's lymphoma metastatic                                                          
                                                   Non-Hodgkin's lymphoma recurrent                                                           
                                                   Non-Hodgkin's lymphoma refractory                                                          
                                                   Non-Hodgkin's lymphoma stage I                                                             
                                                   Non-Hodgkin's lymphoma stage II                                                            
                                                   Non-Hodgkin's lymphoma stage III                                                           
                                                   Non-Hodgkin's lymphoma stage IV                                                            
                                                   Non-Hodgkin's lymphoma transformed recurrent                                               
                                                   Non-Hodgkin's lymphoma unspecified histology                                               
                                                   aggressive                                                                                 
                                                   Non-Hodgkin's lymphoma unspecified histology                                               
                                                   aggressive recurrent                                                                       
                                                   Non-Hodgkin's lymphoma unspecified histology                                               
                                                   aggressive refractory                                                                      
                                                   Non-Hodgkin's lymphoma unspecified histology                                               
                                                   aggressive stage I                                                                         
                                                   Non-Hodgkin's lymphoma unspecified histology                                               
                                                   aggressive stage II                                                                        
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Non-Hodgkin's lymphoma unspecified histology
aggressive stage III
Non-Hodgkin's lymphoma unspecified histology
aggressive stage IV
Non-Hodgkin's lymphoma unspecified histology
indolent
Non-Hodgkin's lymphoma unspecified histology
indolent stage I
Non-Hodgkin's lymphoma unspecified histology
indolent stage II
Non-Hodgkin's lymphoma unspecified histology
indolent stage III
Non-Hodgkin's lymphoma unspecified histology
indolent stage IV
Non-renal cell carcinoma of kidney
Non-small cell lung cancer
Non-small cell lung cancer metastatic
Non-small cell lung cancer recurrent
Non-small cell lung cancer stage 0
Non-small cell lung cancer stage I
Non-small cell lung cancer stage II
Non-small cell lung cancer stage III
Non-small cell lung cancer stage IIIA
Non-small cell lung cancer stage IIIB
Non-small cell lung cancer stage IV
Nongerminomatous germ cell tumour of the CNS
Nonkeratinising carcinoma of nasopharynx
Ocular cancer metastatic
Ocular haemangiopericytoma
Ocular lymphoma
Oesophageal adenocarcinoma
Oesophageal adenocarcinoma recurrent
Oesophageal adenocarcinoma stage 0
Oesophageal adenocarcinoma stage I
Oesophageal adenocarcinoma stage II
Oesophageal adenocarcinoma stage III
Oesophageal adenocarcinoma stage IV
Oesophageal adenosquamous carcinoma
Oesophageal cancer metastatic
Oesophageal carcinoma
Oesophageal carcinoma recurrent
Oesophageal carcinoma stage 0
Oesophageal squamous cell carcinoma
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Oesophageal squamous cell carcinoma metastatic
Oesophageal squamous cell carcinoma recurrent
Oesophageal squamous cell carcinoma stage 0
Oesophageal squamous cell carcinoma stage I
Oesophageal squamous cell carcinoma stage II
Oesophageal squamous cell carcinoma stage III
Oesophageal squamous cell carcinoma stage IV
Oligoastrocytoma
Oligodendroglioma
Optic glioma
Oral cavity cancer metastatic
Oropharyngeal cancer
Oropharyngeal cancer recurrent
Oropharyngeal cancer stage 0
Oropharyngeal cancer stage I
Oropharyngeal cancer stage II
Oropharyngeal cancer stage III
Oropharyngeal cancer stage IV
Oropharyngeal lymphoepithelioma
Oropharyngeal squamous cell carcinoma
Osteosarcoma
Osteosarcoma metastatic
Osteosarcoma recurrent
Otic cancer metastatic
Ovarian cancer
Ovarian cancer metastatic
Ovarian cancer recurrent
Ovarian cancer stage I
Ovarian cancer stage II
Ovarian cancer stage III
Ovarian cancer stage IV
Ovarian clear cell carcinoma
Ovarian dysgerminoma stage I
Ovarian dysgerminoma stage II
Ovarian dysgerminoma stage III
Ovarian dysgerminoma stage IV
Ovarian dysgerminoma stage unspecified
Ovarian embryonal carcinoma
Ovarian endometrioid carcinoma
Ovarian epithelial cancer
Ovarian epithelial cancer metastatic
Ovarian epithelial cancer recurrent
Ovarian epithelial cancer stage I
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Ovarian epithelial cancer stage II
Ovarian epithelial cancer stage III
Ovarian epithelial cancer stage IV
Ovarian germ cell cancer
Ovarian germ cell cancer stage I
Ovarian germ cell cancer stage II
Ovarian germ cell cancer stage III
Ovarian germ cell cancer stage IV  
Ovarian germ cell choriocarcinoma
Ovarian germ cell choriocarcinoma stage I
Ovarian germ cell choriocarcinoma stage II
Ovarian germ cell choriocarcinoma stage III
Ovarian germ cell choriocarcinoma stage IV
Ovarian germ cell embryonal carcinoma stage I
Ovarian germ cell embryonal carcinoma stage II
Ovarian germ cell embryonal carcinoma stage III
Ovarian germ cell embryonal carcinoma stage IV
Ovarian germ cell endodermal sinus tumour
Ovarian germ cell endodermal sinus tumour stage I
Ovarian germ cell endodermal sinus tumour stage II
Ovarian germ cell endodermal sinus tumour stage
III
Ovarian germ cell endodermal sinus tumour stage IV
Ovarian germ cell polyembryoma
Ovarian germ cell polyembryoma stage I
Ovarian germ cell polyembryoma stage II
Ovarian germ cell polyembryoma stage III
Ovarian germ cell polyembryoma stage IV
Ovarian germ cell teratoma
Ovarian germ cell teratoma stage I
Ovarian germ cell teratoma stage II  
Ovarian germ cell teratoma stage III
Ovarian germ cell teratoma stage IV
Ovarian germ cell tumour mixed
Ovarian granulosa-theca cell tumour
Ovarian low malignant potential tumour
Ovarian melanoma
Ovarian stromal cancer
Paget's disease of nipple
Paget's disease of penis
Paget's disease of the vulva
Pancoast's tumour
Pancreatic carcinoma
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Pancreatic carcinoma metastatic
Pancreatic carcinoma recurrent
Pancreatic carcinoma stage 0
Pancreatic carcinoma stage I
Pancreatic carcinoma stage II
Pancreatic carcinoma stage III
Pancreatic carcinoma stage IV
Pancreatic neuroendocrine tumour
Pancreatic neuroendocrine tumour metastatic
Pancreatic sarcoma
Pancreatoblastoma
Papillary renal cell carcinoma
Papillary serous endometrial carcinoma
Papillary thyroid cancer
Paraganglion neoplasm malignant
Paranasal sinus and nasal cavity malignant
neoplasm
Paranasal sinus and nasal cavity malignant
neoplasm recurrent
Paranasal sinus and nasal cavity malignant
neoplasm stage 0
Paranasal sinus and nasal cavity malignant
neoplasm stage I
Paranasal sinus and nasal cavity malignant
neoplasm stage II
Paranasal sinus and nasal cavity malignant
neoplasm stage III
Paranasal sinus and nasal cavity malignant
neoplasm stage IV
Parathyroid tumour malignant
Penile cancer
Penile squamous cell carcinoma
Penis carcinoma metastatic
Penis carcinoma recurrent
Penis carcinoma stage I
Penis carcinoma stage II
Penis carcinoma stage III
Penis carcinoma stage IV
Pericardial mesothelioma malignant
Pericardial mesothelioma malignant recurrent
Peripheral T-cell lymphoma unspecified
Peripheral T-cell lymphoma unspecified recurrent
Peripheral T-cell lymphoma unspecified refractory
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Peripheral T-cell lymphoma unspecified stage I                                             
                                                   Peripheral T-cell lymphoma unspecified stage II                                            
                                                   Peripheral T-cell lymphoma unspecified stage III                                           
                                                   Peripheral T-cell lymphoma unspecified stage IV                                            
                                                   Peripheral neuroepithelioma of bone                                                        
                                                   Peripheral neuroepithelioma of bone metastatic                                             
                                                   Peripheral neuroepithelioma of bone recurrent                                              
                                                   Peripheral neuroepithelioma of soft tissue                                                 
                                                   Peripheral primitive neuroectodermal bone tumour                                           
                                                   Peripheral primitive neuroectodermal tumour of                                             
                                                   soft tissue                                                                                
                                                   Peritoneal carcinoma metastatic                                                            
                                                   Peritoneal mesothelioma malignant                                                          
                                                   Peritoneal mesothelioma malignant recurrent                                                
                                                   Peritoneal sarcoma                                                                         
                                                   Phaeochromocytoma malignant                                                                
                                                   Pharyngeal cancer                                                                          
                                                   Pharyngeal cancer metastatic                                                               
                                                   Pharyngeal cancer recurrent                                                                
                                                   Pharyngeal cancer stage 0                                                                  
                                                   Pharyngeal cancer stage I                                                                  
                                                   Pharyngeal cancer stage II                                                                 
                                                   Pharyngeal cancer stage III                                                                
                                                   Pharyngeal cancer stage IV                                                                 
                                                   Pilomatrix carcinoma                                                                       
                                                   Pineal germinoma                                                                           
                                                   Pineal parenchymal neoplasm malignant                                                      
                                                   Pinealoblastoma                                                                            
                                                   Pituitary cancer metastatic                                                                
                                                   Pituitary neoplasm malignant recurrent                                                     
                                                   Plasma cell leukaemia                                                                      
                                                   Plasma cell leukaemia in remission                                                         
                                                   Plasma cell myeloma                                                                        
                                                   Plasma cell myeloma in remission                                                           
                                                   Plasma cell myeloma recurrent                                                              
                                                   Plasma cell myeloma refractory                                                             
                                                   Plasmablastic lymphoma                                                                     
                                                   Plasmacytoma                                                                               
                                                   Pleomorphic leiomyosarcoma                                                                 
                                                   Pleomorphic liposarcoma                                                                    
                                                   Pleomorphic malignant fibrous histiocytoma                                                 
                                                   Pleural mesothelioma                                                                       
                                                   Pleural mesothelioma malignant                                                             
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Pleural mesothelioma malignant recurrent                                                   
                                                   Pleural sarcoma                                                                            
                                                   Pleuropulmonary blastoma                                                                   
                                                   Poorly differentiated thyroid carcinoma                                                    
                                                   Porocarcinoma                                                                              
                                                   Postcricoid cancer                                                                         
                                                   Precursor B-lymphoblastic lymphoma                                                         
                                                   Precursor B-lymphoblastic lymphoma recurrent                                               
                                                   Precursor B-lymphoblastic lymphoma refractory                                              
                                                   Precursor B-lymphoblastic lymphoma stage I                                                 
                                                   Precursor B-lymphoblastic lymphoma stage II                                                
                                                   Precursor B-lymphoblastic lymphoma stage III                                               
                                                   Precursor B-lymphoblastic lymphoma stage IV                                                
                                                   Precursor T-lymphoblastic leukaemia acute                                                  
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   recurrent                                                                                  
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   refractory                                                                                 
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   stage I                                                                                    
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   stage II                                                                                   
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   stage III                                                                                  
                                                   Precursor T-lymphoblastic lymphoma/leukaemia                                               
                                                   stage IV                                                                                   
                                                   Primary breast lymphoma                                                                    
                                                   Primary cardiac lymphoma                                                                   
                                                   Primary effusion lymphoma                                                                  
                                                   Primary gastrointestinal follicular lymphoma                                               
                                                   Primary mediastinal large B-cell lymphoma                                                  
                                                   Primary mediastinal large B-cell lymphoma                                                  
                                                   recurrent                                                                                  
                                                   Primary mediastinal large B-cell lymphoma                                                  
                                                   refractory                                                                                 
                                                   Primary mediastinal large B-cell lymphoma stage I                                          
                                                   Primary mediastinal large B-cell lymphoma stage II                                         
                                                   Primary mediastinal large B-cell lymphoma stage                                            
                                                   III                                                                                        
                                                   Primary mediastinal large B-cell lymphoma stage IV                                         
                                                   Primary pulmonary melanoma                                                                 
                                                   Primitive neuroectodermal tumour                                                           
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Primitive neuroectodermal tumour metastatic
Prolymphocytic leukaemia
Prostate cancer
Prostate cancer metastatic
Prostate cancer recurrent
Prostate cancer stage 0
Prostate cancer stage I
Prostate cancer stage II
Prostate cancer stage III
Prostate cancer stage IV
Pseudosarcoma
Queyrat erythroplasia
Rectal adenocarcinoma
Rectal cancer
Rectal cancer metastatic
Rectal cancer recurrent
Rectal cancer stage 0
Rectal cancer stage I
Rectal cancer stage II
Rectal cancer stage III
Rectal cancer stage IV
Rectosigmoid cancer
Rectosigmoid cancer metastatic
Rectosigmoid cancer recurrent
Rectosigmoid cancer stage 0
Rectosigmoid cancer stage I
Rectosigmoid cancer stage II
Rectosigmoid cancer stage III
Rectosigmoid cancer stage IV
Recurrent cancer
Refractory cancer
Renal cancer
Renal cancer metastatic
Renal cancer recurrent
Renal cancer stage I
Renal cancer stage II
Renal cancer stage III
Renal cancer stage IV
Renal cell carcinoma
Renal cell carcinoma recurrent
Renal cell carcinoma stage I
Renal cell carcinoma stage II
Renal cell carcinoma stage III
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Renal cell carcinoma stage IV
Respiratory tract carcinoma in situ   
Retinal melanoma
Retinoblastoma
Retroperitoneal cancer
Retroperitoneal neoplasm metastatic
Rhabdoid tumour
Rhabdoid tumour of the kidney
Rhabdomyosarcoma
Rhabdomyosarcoma recurrent
Richter's syndrome
Round cell liposarcoma
Salivary gland cancer
Salivary gland cancer recurrent
Salivary gland cancer stage 0
Salivary gland cancer stage I
Salivary gland cancer stage II
Salivary gland cancer stage III
Salivary gland cancer stage IV
Sarcoma
Sarcoma metastatic
Sarcoma of skin
Sarcoma uterus
Sarcomatoid carcinoma
Sarcomatoid carcinoma of the lung
Sarcomatoid mesothelioma
Sarcomatosis
Scrotal cancer
Sebaceous carcinoma
Second primary malignancy
Seminoma
Serous cystadenocarcinoma ovary
Signet-ring cell carcinoma
Sinus cancer metastatic
Skin angiosarcoma
Skin cancer
Skin cancer metastatic
Skin squamous cell carcinoma metastatic
Skin squamous cell carcinoma recurrent
Small cell carcinoma
Small cell carcinoma of the cervix
Small cell lung cancer
Small cell lung cancer extensive stage
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Small cell lung cancer limited stage                                                       
                                                   Small cell lung cancer metastatic                                                          
                                                   Small cell lung cancer recurrent                                                           
                                                   Small intestine adenocarcinoma                                                             
                                                   Small intestine carcinoma                                                                  
                                                   Small intestine carcinoma metastatic                                                       
                                                   Small intestine carcinoma recurrent                                                        
                                                   Small intestine carcinoma stage 0                                                          
                                                   Small intestine carcinoma stage I                                                          
                                                   Small intestine carcinoma stage II                                                         
                                                   Small intestine carcinoma stage III                                                        
                                                   Small intestine carcinoma stage IV                                                         
                                                   Small intestine leiomyosarcoma                                                             
                                                   Soft tissue sarcoma                                                                        
                                                   Solid pseudopapillary tumour of the pancreas                                               
                                                   Spermatocytic seminoma                                                                     
                                                   Spinal meningioma malignant                                                                
                                                   Spindle cell sarcoma                                                                       
                                                   Splenic marginal zone lymphoma                                                             
                                                   Splenic marginal zone lymphoma recurrent                                                   
                                                   Splenic marginal zone lymphoma refractory                                                  
                                                   Splenic marginal zone lymphoma stage I                                                     
                                                   Splenic marginal zone lymphoma stage II                                                    
                                                   Splenic marginal zone lymphoma stage III                                                   
                                                   Splenic marginal zone lymphoma stage IV                                                    
                                                   Squamous cell breast carcinoma                                                             
                                                   Squamous cell carcinoma                                                                    
                                                   Squamous cell carcinoma of head and neck                                                   
                                                   Squamous cell carcinoma of lung                                                            
                                                   Squamous cell carcinoma of pharynx                                                         
                                                   Squamous cell carcinoma of skin                                                            
                                                   Squamous cell carcinoma of the cervix                                                      
                                                   Squamous cell carcinoma of the hypopharynx                                                 
                                                   Squamous cell carcinoma of the oral cavity                                                 
                                                   Squamous cell carcinoma of the parotid gland                                               
                                                   Squamous cell carcinoma of the tongue                                                      
                                                   Squamous cell carcinoma of the vagina                                                      
                                                   Squamous cell carcinoma of the vulva                                                       
                                                   Squamous endometrial carcinoma                                                             
                                                   Stewart-Treves syndrome                                                                    
                                                   Superficial spreading melanoma stage I                                                     
                                                   Superficial spreading melanoma stage II                                                    
                                                   Superficial spreading melanoma stage III                                                   
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Superficial spreading melanoma stage IV                                                    
                                                   Superficial spreading melanoma stage unspecified                                           
                                                   Synovial sarcoma                                                                           
                                                   Synovial sarcoma metastatic                                                                
                                                   Synovial sarcoma recurrent                                                                 
                                                   T-cell chronic lymphocytic leukaemia                                                       
                                                   T-cell lymphoma                                                                            
                                                   T-cell lymphoma recurrent                                                                  
                                                   T-cell lymphoma refractory                                                                 
                                                   T-cell lymphoma stage I                                                                    
                                                   T-cell lymphoma stage II                                                                   
                                                   T-cell lymphoma stage III                                                                  
                                                   T-cell lymphoma stage IV                                                                   
                                                   T-cell prolymphocytic leukaemia                                                            
                                                   T-cell type acute leukaemia                                                                
                                                   T-cell unclassifiable lymphoma high grade                                                  
                                                   T-cell unclassifiable lymphoma low grade                                                   
                                                   Testicular cancer metastatic                                                               
                                                   Testicular choriocarcinoma                                                                 
                                                   Testicular choriocarcinoma recurrent                                                       
                                                   Testicular choriocarcinoma stage I                                                         
                                                   Testicular choriocarcinoma stage II                                                        
                                                   Testicular choriocarcinoma stage III                                                       
                                                   Testicular embryonal carcinoma                                                             
                                                   Testicular embryonal carcinoma stage I                                                     
                                                   Testicular embryonal carcinoma stage II                                                    
                                                   Testicular embryonal carcinoma stage III                                                   
                                                   Testicular germ cell cancer                                                                
                                                   Testicular germ cell cancer metastatic                                                     
                                                   Testicular germ cell tumour mixed                                                          
                                                   Testicular germ cell tumour mixed stage I                                                  
                                                   Testicular germ cell tumour mixed stage II                                                 
                                                   Testicular germ cell tumour mixed stage III                                                
                                                   Testicular leiomyosarcoma                                                                  
                                                   Testicular malignant teratoma                                                              
                                                   Testicular malignant teratoma stage I                                                      
                                                   Testicular malignant teratoma stage II                                                     
                                                   Testicular malignant teratoma stage III                                                    
                                                   Testicular seminoma (pure)                                                                 
                                                   Testicular seminoma (pure) stage I                                                         
                                                   Testicular seminoma (pure) stage II                                                        
                                                   Testicular seminoma (pure) stage III                                                       
                                                   Testicular yolk sac tumour                                                                 
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Testicular yolk sac tumour stage I
Testicular yolk sac tumour stage II
Testicular yolk sac tumour stage III
Testis cancer
Testis cancer recurrent
Throat cancer
Thymic cancer metastatic
Thymoma malignant
Thymoma malignant recurrent
Thyroid B-cell lymphoma
Thyroid cancer
Thyroid cancer metastatic
Thyroid cancer recurrent
Thyroid cancer stage 0
Thyroid cancer stage I
Thyroid cancer stage II
Thyroid cancer stage III
Thyroid cancer stage IV
Tongue cancer metastatic
Tongue cancer recurrent
Tongue carcinoma stage 0
Tongue carcinoma stage I
Tongue carcinoma stage II
Tongue carcinoma stage III
Tongue carcinoma stage IV
Tongue neoplasm malignant stage unspecified
Tonsil cancer
Tonsil cancer metastatic
Tracheal cancer
Transformation to acute myeloid leukaemia
Transitional cell cancer of renal pelvis and
ureter metastatic
Transitional cell cancer of the renal pelvis and
ureter   
Transitional cell cancer of the renal pelvis and
ureter localised
Transitional cell cancer of the renal pelvis and
ureter recurrent
Transitional cell cancer of the renal pelvis and
ureter regional
Transitional cell carcinoma
Transitional cell carcinoma metastatic
Transitional cell carcinoma recurrent
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Transitional cell carcinoma urethra
Trichoblastic carcinoma
Triple hit lymphoma
Triple negative breast cancer
Triple positive breast cancer
Tubular breast carcinoma
Tumour budding
Undifferentiated carcinoma of colon
Undifferentiated nasopharyngeal carcinoma
Undifferentiated sarcoma
Ureteric cancer
Ureteric cancer local
Ureteric cancer metastatic
Ureteric cancer recurrent
Ureteric cancer regional
Urethral cancer
Urethral cancer metastatic
Urethral cancer recurrent
Urethral melanoma metastatic
Urinary bladder sarcoma
Urinary tract carcinoma in situ
Uterine cancer
Uterine carcinoma in situ
Uterine leiomyosarcoma
Uveal melanoma
Vaginal adenocarcinoma
Vaginal cancer
Vaginal cancer metastatic
Vaginal cancer recurrent
Vaginal cancer stage 0
Vaginal cancer stage I
Vaginal cancer stage II
Vaginal cancer stage III
Vaginal cancer stage IVA
Vaginal cancer stage IVB
Vulval cancer
Vulval cancer metastatic
Vulval cancer recurrent
Vulval cancer stage 0
Vulval cancer stage I
Vulval cancer stage II
Vulval cancer stage III
Vulval cancer stage IV
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Vulvar adenocarcinoma                                                                      
                                                   Vulvar basal cell carcinoma                                                                
                                                   Waldenstrom's macroglobulinaemia                                                           
                                                   Waldenstrom's macroglobulinaemia recurrent                                                 
                                                   Waldenstrom's macroglobulinaemia refractory                                                
                                                   Waldenstrom's macroglobulinaemia stage I                                                   
                                                   Waldenstrom's macroglobulinaemia stage II                                                  
                                                   Waldenstrom's macroglobulinaemia stage III                                                 
                                                   Waldenstrom's macroglobulinaemia stage IV                                                  
                                                   ACTH-producing pituitary tumour                                                            
                                                   APUDoma                                                                                    
                                                   Abdominal neoplasm                                                                         
                                                   Abdominal wall neoplasm                                                                    
                                                   Abdominal wall neoplasm benign                                                             
                                                   Acanthoma                                                                                  
                                                   Acanthosis nigricans                                                                       
                                                   Acoustic neuroma                                                                           
                                                   Acquired bronchial cyst                                                                    
                                                   Acquired chromosomal abnormality                                                           
                                                   Acquired cystic kidney disease                                                             
                                                   Acquired thalassaemia                                                                      
                                                   Acrochordon                                                                                
                                                   Acrokeratosis paraneoplastica                                                              
                                                   Actinic keratosis                                                                          
                                                   Adenolipoma                                                                                
                                                   Adenolymphoma                                                                              
                                                   Adenoma benign                                                                             
                                                   Adenomatous polyposis coli                                                                 
                                                   Adnexa uteri cyst                                                                          
                                                   Adrenal adenoma                                                                            
                                                   Adrenal cyst                                                                               
                                                   Adrenal neoplasm                                                                           
                                                   Adrenal rest tumour of the testis                                                          
                                                   Alcoholisation procedure                                                                   
                                                   Allogenic stem cell transplantation                                                        
                                                   Alpha 1 foetoprotein abnormal                                                              
                                                   Alpha 1 foetoprotein increased                                                             
                                                   Alpha interferon therapy                                                                   
                                                   Alpha-L-fucosidase increased                                                               
                                                   Ameloblastoma                                                                              
                                                   Amputation of penis                                                                        
                                                   Amyloidoma                                                                                 
                                                   Anal neoplasm                                                                              
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Anal polypectomy                                                                           
                                                   Anaplastic lymphoma kinase gene and nucleophosmin                                          
                                                   gene fusion overexpression                                                                 
                                                   Androgen therapy                                                                           
                                                   Aneurysmal bone cyst                                                                       
                                                   Angiofibroma                                                                               
                                                   Angiogenesis biomarker increased                                                           
                                                   Angiolipoma                                                                                
                                                   Angiomyofibroblastoma                                                                      
                                                   Angiomyolipoma                                                                             
                                                   Angiomyxoma                                                                                
                                                   Anogenital warts                                                                           
                                                   Anorectal haemangioma                                                                      
                                                   Anti-NMDA antibody positive                                                                
                                                   Anti-VGCC antibody positive                                                                
                                                   Anti-androgen withdrawal syndrome                                                          
                                                   Antiandrogen therapy                                                                       
                                                   Antioestrogen therapy                                                                      
                                                   Appendix adenoma                                                                           
                                                   Arachnoid cyst                                                                             
                                                   Arsenical keratosis                                                                        
                                                   Aspiration bone marrow abnormal                                                            
                                                   Astroblastoma                                                                              
                                                   Astrocytoma, low grade                                                                     
                                                   Atypical fibroxanthoma                                                                     
                                                   Aural cystadenoma                                                                          
                                                   Aural polyp                                                                                
                                                   Autologous bone marrow transplantation therapy                                             
                                                   Autologous haematopoietic stem cell transplant                                             
                                                   Axillary lymphadenectomy                                                                   
                                                   B-cell depletion therapy                                                                   
                                                   Bannayan-Riley-Ruvalcaba syndrome                                                          
                                                   Bartholin's cyst                                                                           
                                                   Basal cell naevus syndrome                                                                 
                                                   Becker's naevus                                                                            
                                                   Bence Jones proteinuria                                                                    
                                                   Benign abdominal neoplasm                                                                  
                                                   Benign anorectal neoplasm                                                                  
                                                   Benign biliary neoplasm                                                                    
                                                   Benign bone neoplasm                                                                       
                                                   Benign breast neoplasm                                                                     
                                                   Benign cardiac neoplasm                                                                    
                                                   Benign cartilage neoplasm                                                                  
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Benign connective tissue neoplasm
Benign duodenal neoplasm
Benign ear neoplasm
Benign endocrine neoplasm
Benign fallopian tube neoplasm
Benign female reproductive tract neoplasm
Benign gastric neoplasm
Benign gastrointestinal neoplasm
Benign genitourinary tract neoplasm  
Benign hydatidiform mole
Benign joint neoplasm
Benign laryngeal neoplasm
Benign lung neoplasm
Benign lymph node neoplasm
Benign male reproductive tract neoplasm
Benign mediastinal neoplasm
Benign mesenteric neoplasm
Benign mesothelioma
Benign middle ear neoplasm
Benign muscle neoplasm
Benign neoplasm
Benign neoplasm of adrenal gland
Benign neoplasm of ampulla of Vater
Benign neoplasm of bladder
Benign neoplasm of cervix uteri
Benign neoplasm of choroid
Benign neoplasm of conjunctiva
Benign neoplasm of cornea
Benign neoplasm of epididymis
Benign neoplasm of eye
Benign neoplasm of eyelid
Benign neoplasm of islets of Langerhans
Benign neoplasm of lacrimal duct
Benign neoplasm of lacrimal gland
Benign neoplasm of optic nerve
Benign neoplasm of orbit
Benign neoplasm of pineal gland
Benign neoplasm of prostate
Benign neoplasm of retina
Benign neoplasm of scrotum
Benign neoplasm of seminal vesicle
Benign neoplasm of skin
Benign neoplasm of spinal cord
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Benign neoplasm of testis
Benign neoplasm of thymus
Benign neoplasm of thyroid gland
Benign neoplasm of ureter
Benign neoplasm of urethra
Benign nipple neoplasm
Benign oesophageal neoplasm
Benign ovarian tumour
Benign pancreatic neoplasm
Benign penile neoplasm
Benign pericardium neoplasm
Benign peritoneal neoplasm
Benign pleural mesothelioma
Benign pleural neoplasm
Benign renal neoplasm
Benign respiratory tract neoplasm
Benign salivary gland neoplasm
Benign small intestinal neoplasm
Benign soft tissue neoplasm
Benign spleen tumour
Benign tracheal neoplasm
Benign urinary tract neoplasm
Benign uterine neoplasm
Benign vaginal neoplasm
Benign vascular neoplasm
Benign vulval neoplasm
Beta interferon therapy
Biliary adenoma
Biliary cyst
Biliary hamartoma
Biliary neoplasm
Biliary polyp
Bing-Neel syndrome
Biopsy abdominal wall abnormal
Biopsy adrenal gland abnormal
Biopsy anus abnormal
Biopsy artery abnormal
Biopsy bladder abnormal
Biopsy blood vessel abnormal
Biopsy bone abnormal
Biopsy bone marrow abnormal
Biopsy brain abnormal
Biopsy breast abnormal
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Biopsy bronchus abnormal                                                                   
                                                   Biopsy cartilage abnormal                                                                  
                                                   Biopsy cervix abnormal                                                                     
                                                   Biopsy chest wall abnormal                                                                 
                                                   Biopsy chorionic villous abnormal                                                          
                                                   Biopsy colon abnormal                                                                      
                                                   Biopsy conjunctiva abnormal                                                                
                                                   Biopsy cornea abnormal                                                                     
                                                   Biopsy diaphragm abnormal                                                                  
                                                   Biopsy ear abnormal                                                                        
                                                   Biopsy endometrium abnormal                                                                
                                                   Biopsy epididymis abnormal                                                                 
                                                   Biopsy eyelid abnormal                                                                     
                                                   Biopsy fallopian tube abnormal                                                             
                                                   Biopsy foetal abnormal                                                                     
                                                   Biopsy intestine abnormal                                                                  
                                                   Biopsy kidney abnormal                                                                     
                                                   Biopsy larynx abnormal                                                                     
                                                   Biopsy ligament abnormal                                                                   
                                                   Biopsy lip abnormal                                                                        
                                                   Biopsy lung abnormal                                                                       
                                                   Biopsy lymph gland abnormal                                                                
                                                   Biopsy mucosa abnormal                                                                     
                                                   Biopsy muscle abnormal                                                                     
                                                   Biopsy oesophagus abnormal                                                                 
                                                   Biopsy ovary abnormal                                                                      
                                                   Biopsy palate abnormal                                                                     
                                                   Biopsy pancreas abnormal                                                                   
                                                   Biopsy parathyroid gland abnormal                                                          
                                                   Biopsy penis abnormal                                                                      
                                                   Biopsy pericardium abnormal                                                                
                                                   Biopsy peripheral nerve abnormal                                                           
                                                   Biopsy peritoneum abnormal                                                                 
                                                   Biopsy pharynx abnormal                                                                    
                                                   Biopsy pleura abnormal                                                                     
                                                   Biopsy prostate abnormal                                                                   
                                                   Biopsy rectum abnormal                                                                     
                                                   Biopsy retina abnormal                                                                     
                                                   Biopsy salivary gland abnormal                                                             
                                                   Biopsy sclera abnormal                                                                     
                                                   Biopsy seminal vesicle abnormal                                                            
                                                   Biopsy site unspecified abnormal                                                           
                                                   Biopsy skin abnormal                                                                       
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Biopsy small intestine abnormal                                                            
                                                   Biopsy spinal cord abnormal                                                                
                                                   Biopsy spleen abnormal                                                                     
                                                   Biopsy stomach abnormal                                                                    
                                                   Biopsy tendon abnormal                                                                     
                                                   Biopsy testes abnormal                                                                     
                                                   Biopsy thymus gland abnormal                                                               
                                                   Biopsy thyroid gland abnormal                                                              
                                                   Biopsy tongue abnormal                                                                     
                                                   Biopsy trachea abnormal                                                                    
                                                   Biopsy urethra abnormal                                                                    
                                                   Biopsy uterus abnormal                                                                     
                                                   Biopsy vagina abnormal                                                                     
                                                   Biopsy vocal cord abnormal                                                                 
                                                   Biopsy vulva abnormal                                                                      
                                                   Biotherapy                                                                                 
                                                   Birt-Hogg-Dube syndrome                                                                    
                                                   Bladder cyst                                                                               
                                                   Bladder dysplasia                                                                          
                                                   Bladder leukoplakia                                                                        
                                                   Bladder mapping                                                                            
                                                   Bladder neck resection                                                                     
                                                   Bladder neoplasm                                                                           
                                                   Bladder neoplasm surgery                                                                   
                                                   Bladder papilloma                                                                          
                                                   Bladder polypectomy                                                                        
                                                   Blast cell count increased                                                                 
                                                   Blast cell proliferation                                                                   
                                                   Blast cells present                                                                        
                                                   Blepharal papilloma                                                                        
                                                   Blood chromogranin A increased                                                             
                                                   Bone cyst                                                                                  
                                                   Bone giant cell tumour                                                                     
                                                   Bone giant cell tumour benign                                                              
                                                   Bone marrow infiltration                                                                   
                                                   Bone marrow reticulin fibrosis                                                             
                                                   Bone neoplasm                                                                              
                                                   Bone scan abnormal                                                                         
                                                   Borderline mucinous tumour of ovary                                                        
                                                   Borderline ovarian tumour                                                                  
                                                   Borderline serous tumour of ovary                                                          
                                                   Bowenoid papulosis                                                                         
                                                   Brachytherapy                                                                              
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Brachytherapy to eye
Brachytherapy to penis
Brachytherapy to tongue
Brachytherapy to tonsil
Brain neoplasm
Brain neoplasm benign
Brain scan abnormal
Brain stem glioma benign
Brain teratoma
Brain tumour operation
Branchial cyst
Breakthrough pain
Breast adenoma
Breast calcifications
Breast capsulotomy
Breast conserving surgery
Breast cyst
Breast cyst rupture
Breast dysplasia
Breast fibroma
Breast neoplasm
Breast proliferative changes
Breast reconstruction
Breast tumour excision
Brenner tumour
Bronchial neoplasm
Bronchial neoplasm benign
Bronchial polyp
C-kit gene negative
CD20 antigen positive
CD25 antigen positive
CD30 expression
CLOVES syndrome
CSF lymphocyte count abnormal
CSF lymphocyte count increased
Cachexia
Calcifying fibrous pseudotumour
Cancer fatigue
Cancer hormonal therapy
Cancer pain
Cancer staging
Cancer surgery
Carbohydrate antigen 125 increased
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Carbohydrate antigen 15-3 increased
Carbohydrate antigen 19-9 increased
Carbohydrate antigen 27.29 increased
Carbohydrate antigen 50 increased
Carbohydrate antigen 549 increased
Carbohydrate antigen 72-4
Carbohydrate antigen 72-4 increased
Carcinoembryonic antigen decreased
Carcinoembryonic antigen increased
Carcinogenic effect in offspring
Carcinoid crisis
Carcinoid heart disease
Carcinoid syndrome
Carcinomatous polyarthritis
Cardiac fibroma
Cardiac haemangioma benign
Cardiac lymphangioma
Cardiac myxoma
Cardiac neoplasm unspecified
Cardiac neurofibroma
Cardiac teratoma
Cardiac valve fibroelastoma
Carney complex
Cartilage neoplasm
Castleman's disease
Cell marker increased
Cell-free and concentrated ascites reinfusion
therapy
Cementoblastoma
Cementoplasty
Central nervous system dermoid tumour
Central nervous system neoplasm
Cerebellar haemangioma
Cerebellar tumour
Cerebellopontine angle tumour
Cerebral cyst
Cerebral haemangioma
Cervical cyst
Cervical dysplasia
Cervical polyp
Cervix adenomatous polyp
Cervix cryotherapy
Cervix neoplasm
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Cervix tumour excision                                                                     
                                                   Cervix warts                                                                               
                                                   Chemical peel of skin                                                                      
                                                   Chemotherapy                                                                               
                                                   Chemotherapy cardiotoxicity attenuation                                                    
                                                   Chemotherapy cytokine prophylaxis                                                          
                                                   Chemotherapy extravasation management                                                      
                                                   Chemotherapy multiple agents systemic                                                      
                                                   Chemotherapy neurotoxicity attenuation                                                     
                                                   Chemotherapy sensitivity and resistance assay                                              
                                                   Chemotherapy side effect prophylaxis                                                       
                                                   Chemotherapy single agent systemic                                                         
                                                   Chemotherapy toxicity attenuation                                                          
                                                   Chemotherapy urothelial toxicity attenuation                                               
                                                   Chest wall cyst                                                                            
                                                   Chest wall tumour                                                                          
                                                   Chiasma syndrome                                                                           
                                                   Cholangioadenoma                                                                           
                                                   Cholangiojejunostomy                                                                       
                                                   Choledochal cyst                                                                           
                                                   Cholesteatoma                                                                              
                                                   Cholesterin granuloma of middle ear                                                        
                                                   Cholesterol granuloma                                                                      
                                                   Chondroblastoma                                                                            
                                                   Chondroma                                                                                  
                                                   Chondromatosis                                                                             
                                                   Choroid fissure cyst                                                                       
                                                   Choroid neoplasm                                                                           
                                                   Choroid plexus papilloma                                                                   
                                                   Choroid tumour excision                                                                    
                                                   Choroidal haemangioma                                                                      
                                                   Chronic rhinosinusitis with nasal polyps                                                   
                                                   Clonal evolution                                                                           
                                                   Colectomy                                                                                  
                                                   Colectomy total                                                                            
                                                   Colloid brain cyst                                                                         
                                                   Colon adenoma                                                                              
                                                   Colon neoplasm                                                                             
                                                   Colony stimulating factor therapy                                                          
                                                   Computerised tomogram breast abnormal                                                      
                                                   Computerised tomogram pancreas abnormal                                                    
                                                   Congenital LUMBAR syndrome                                                                 
                                                   Congenital acrochordon                                                                     
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Congenital benign neoplasm                                                                 
                                                   Congenital cerebral cyst                                                                   
                                                   Congenital cerebral haemangioma                                                            
                                                   Congenital choroid plexus cyst                                                             
                                                   Congenital cyst                                                                            
                                                   Congenital cystic kidney disease                                                           
                                                   Congenital eye naevus                                                                      
                                                   Congenital melanocytic naevus                                                              
                                                   Congenital naevus                                                                          
                                                   Congenital neoplasm                                                                        
                                                   Congenital renal cyst                                                                      
                                                   Congenital teratoma                                                                        
                                                   Congenital vaginal cyst                                                                    
                                                   Conjunctival cyst                                                                          
                                                   Conjunctival neoplasm                                                                      
                                                   Conjunctival primary acquired melanosis                                                    
                                                   Connective tissue neoplasm                                                                 
                                                   Corneal cyst                                                                               
                                                   Cowden's disease                                                                           
                                                   Cranial nerve neoplasm benign                                                              
                                                   Craniopharyngioma                                                                          
                                                   Craniopharyngioma benign                                                                   
                                                   Cutaneous T-cell dyscrasia                                                                 
                                                   Cyclotron therapy                                                                          
                                                   Cyst                                                                                       
                                                   Cyst rupture                                                                               
                                                   Cystadenofibroma of fallopian tube                                                         
                                                   Cystic angiomatosis                                                                        
                                                   Cystic eyeball, congenital                                                                 
                                                   Cystic lymphangioma                                                                        
                                                   Cystoprostatectomy                                                                         
                                                   Cytokeratin 18 increased                                                                   
                                                   Cytokeratin 19 increased                                                                   
                                                   Denys-Drash syndrome                                                                       
                                                   Dermal cyst                                                                                
                                                   Dermoid cyst                                                                               
                                                   Desmoid tumour                                                                             
                                                   Desmoplastic fibroblastoma                                                                 
                                                   Diaphragm neoplasm                                                                         
                                                   Differentiation syndrome                                                                   
                                                   Diffuse uveal melanocytic proliferation                                                    
                                                   Duodenal neoplasm                                                                          
                                                   Duodenectomy                                                                               
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Dysplasia
Dysplastic naevus
Dysplastic naevus syndrome
Ear neoplasm
Eastern Cooperative Oncology Group performance
status improved
Eastern Cooperative Oncology Group performance
status worsened
Ectopic ACTH syndrome
Ectopic aldosterone secretion
Ectopic antidiuretic hormone secretion
Ectopic calcitonin production
Ectopic chorionic gonadotrophin secretion
Ectopic growth hormone secretion
Ectopic hormone secretion
Ectopic parathyroid hormone production
Ectopic prolactin secretion
Ectopic renin secretion
Elastofibroma
Electron radiation therapy
Electron radiation therapy to bladder
Electron radiation therapy to blood
Electron radiation therapy to bone
Electron radiation therapy to brain
Electron radiation therapy to breast
Electron radiation therapy to colon
Electron radiation therapy to ear, nose, or throat
Electron radiation therapy to liver
Electron radiation therapy to lung
Electron radiation therapy to pancreas
Electron radiation therapy to prostate
Electron radiation therapy to skin
Electron radiation therapy to soft tissue
Electron radiation therapy to uterus
Elephantiasis nostras verrucosa
Encephalitis autoimmune
Enchondromatosis
Endobronchial lipoma
Endocervical mucosal thickening
Endocrine neoplasm
Endometrial adenoma
Endometrial dysplasia
Endometrial hyperplasia
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Endometrial neoplasm
Ependymoma
Ependymoma benign
Epidermal naevus syndrome
Epidermodysplasia verruciformis
Epididymal cyst
Epididymal neoplasm
Epiglottic cyst
Epiglottic mass
Epiglottidectomy
Epithelioma adenoides cysticum
Epstein Barr virus positive mucocutaneous ulcer
Epstein-Barr virus associated lymphoproliferative
disorder
Erdheim-Chester disease
Erythroplasia
Erythroplasia of lip
Erythroplasia of penis
Erythroplasia of vulva
Essential thrombocythaemia
Ex vivo gene therapy
Exploratory operation
Extended radical mastectomy
Extradural neoplasm
Eye haemangioma
Eye naevus
Eyelid haemangioma
Eyelid naevus
Eyelid seborrhoeic keratosis
Eyelid tumour
Fallopian tube cyst
Fallopian tube leiomyoma
Fallopian tube neoplasm
Familial acromegaly
Familial gigantiform cementoma
Familial haemophagocytic lymphohistiocytosis
Familial multiple lipomatosis
Female reproductive neoplasm
Fibroadenoma of breast
Fibrocystic breast disease
Fibroma
Fibromatosis
Fibromatosis colli of infancy
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Fibrous cortical defect                                                                    
                                                   Fibrous histiocytoma                                                                       
                                                   Fiducial marker placement                                                                  
                                                   Fms-like tyrosine kinase 3 positive                                                        
                                                   Foetal cystic hygroma                                                                      
                                                   Follicular cystitis                                                                        
                                                   Frasier syndrome                                                                           
                                                   Free prostate-specific antigen increased                                                   
                                                   Free prostate-specific antigen positive                                                    
                                                   Fungating wound                                                                            
                                                   Gallbladder adenoma                                                                        
                                                   Gallbladder neoplasm                                                                       
                                                   Gallbladder papilloma                                                                      
                                                   Gallbladder polyp                                                                          
                                                   Gamma interferon therapy                                                                   
                                                   Gamma radiation therapy                                                                    
                                                   Gamma radiation therapy to bladder                                                         
                                                   Gamma radiation therapy to blood                                                           
                                                   Gamma radiation therapy to bone                                                            
                                                   Gamma radiation therapy to brain                                                           
                                                   Gamma radiation therapy to breast                                                          
                                                   Gamma radiation therapy to colon                                                           
                                                   Gamma radiation therapy to ear, nose, or throat                                            
                                                   Gamma radiation therapy to liver                                                           
                                                   Gamma radiation therapy to lung                                                            
                                                   Gamma radiation therapy to pancreas                                                        
                                                   Gamma radiation therapy to pleura                                                          
                                                   Gamma radiation therapy to prostate                                                        
                                                   Gamma radiation therapy to skin                                                            
                                                   Gamma radiation therapy to soft tissue                                                     
                                                   Gamma radiation therapy to thyroid                                                         
                                                   Gamma radiation therapy to uterus                                                          
                                                   Gammopathy                                                                                 
                                                   Ganglioneuroma                                                                             
                                                   Garcin syndrome                                                                            
                                                   Gastrectomy                                                                                
                                                   Gastric adenoma                                                                            
                                                   Gastric haemangioma                                                                        
                                                   Gastric leiomyoma                                                                          
                                                   Gastric neoplasm                                                                           
                                                   Gastric polypectomy                                                                        
                                                   Gastric stent insertion                                                                    
                                                   Gastrin-releasing peptide precursor increased                                              
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Gastrinoma  
Gastrointestinal neoplasm
Gastrointestinal submucosal tumour
Gastrointestinal tract adenoma
Genital cyst
Genitourinary tract neoplasm
Germ cell neoplasm
Giant cell tumour of tendon sheath
Glomus tumour
Glossectomy
Good syndrome
Gorham's disease
Granular cell tumour
Granulosa cell tumour of the testis
Growth hormone-producing pituitary tumour
Haemangioblastoma
Haemangioma
Haemangioma congenital
Haemangioma of bone
Haemangioma of breast
Haemangioma of retina
Haemangioma of skin
Haemangioma of spleen
Haemangioma rupture
Haemangioma-thrombocytopenia syndrome
Haematopoietic neoplasm
Haemophagocytic lymphohistiocytosis
Haemophilic pseudotumour
Haemorrhagic breast cyst
Haemorrhagic cyst
Haemorrhagic ovarian cyst
Haemorrhagic thyroid cyst
Haemorrhagic tumour necrosis
Hair follicle tumour benign
Hamartoma
Hamartoma vascular
Heavy chain disease
Hemicorporectomy
Hemipelvectomy
Hepatic cyst infection
Hereditary multiple osteochondromas
Hereditary non-polyposis colorectal cancer
syndrome
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
High frequency ablation
High intensity focused ultrasound
Histiocytic necrotising lymphadenitis
Histiocytosis
Hormone suppression therapy
Hormone therapy
Hormone-secreting ovarian tumour
Horner's syndrome
Human chorionic gonadotropin increased
Human chorionic gonadotropin positive
Human epidermal growth factor receptor increased
Hygroma colli
Hypercalcaemia of malignancy
Hypercalcitoninaemia
Hypergammaglobulinaemia benign monoclonal
Hyperleukocytosis
Hyperreactio luteinalis
Hyperthermia therapy
Hyperthermic chemotherapy
Hypertrophic osteoarthropathy
Hypopharyngeal neoplasm
Hypopharyngeal neoplasm benign
Hypophosphataemic osteomalacia
Hypophysectomy
Hypothalamic hamartoma
Hysterectomy
Hysterosalpingectomy
Hysterosalpingo-oophorectomy
Iatrogenic metastasis
Ileectomy
Ileocaecal resection
Ileocolectomy
Imaging procedure abnormal
Immune enhancement therapy
Immunochemotherapy
Immunoglobulin clonality assay
Implant site cyst
In vivo gene therapy
Infantile fibromatosis
Infantile haemangioma
Infantile septic granulomatosis
Infected cyst
Infected dermal cyst
.


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Date: 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Infected lymphocele
Infected naevus
Infected neoplasm
Inflammatory pseudotumour
Insulinoma
Interleukin therapy
Intestinal angioma
Intestinal polypectomy
Intestinal resection
Intra-abdominal haemangioma
Intracranial haemangioma
Intracystic breast papilloma
Intraductal papillary mucinous neoplasm
Intraductal papilloma of breast
Intraneural cyst
Intraosseous angioma
Intraosseous meningioma
Intratumoural aneurysm
Intravascular lipoma
Intravascular papillary endothelial hyperplasia
Intravenous leiomyomatosis
Intravesical immunotherapy
Iris cyst
Iris hamartoma
Iris neoplasm
Irreversible electroporation
Isocitrate dehydrogenase gene mutation
Jaw cyst
Jejunectomy
Joint neoplasm
Juvenile angiofibroma
Juvenile melanoma benign
Knuckle pads
Lacrimal cyst
Lacrimal duct neoplasm
Lacrimal gland neoplasm
Large granular lymphocytosis
Large intestinal polypectomy
Large intestine benign neoplasm
Large intestine fibroma
Laryngeal cyst
Laryngeal dysplasia
Laryngeal leukoplakia
.


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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Laryngeal neoplasm                                                                         
                                                   Laryngeal papilloma                                                                        
                                                   Laryngeal polyp                                                                            
                                                   Laryngeal polypectomy                                                                      
                                                   Laryngectomy                                                                               
                                                   Laryngopharyngectomy                                                                       
                                                   Laser brain ablation                                                                       
                                                   Leiomyoma                                                                                  
                                                   Leser-Trelat sign                                                                          
                                                   Leukoerythroblastosis                                                                      
                                                   Leukoplakia                                                                                
                                                   Leukoplakia of penis                                                                       
                                                   Leukostasis syndrome                                                                       
                                                   Light chain disease                                                                        
                                                   Limbic encephalitis                                                                        
                                                   Lip neoplasm                                                                               
                                                   Lip neoplasm benign                                                                        
                                                   Lipoblastoma                                                                               
                                                   Lipodermoid tumour                                                                         
                                                   Lipofibroma                                                                                
                                                   Lipoma                                                                                     
                                                   Lipoma of breast                                                                           
                                                   Lung cyst                                                                                  
                                                   Lung lobectomy                                                                             
                                                   Lung neoplasm                                                                              
                                                   Lung neoplasm surgery                                                                      
                                                   Lymph nodes scan abnormal                                                                  
                                                   Lymphadenectomy                                                                            
                                                   Lymphangioma                                                                               
                                                   Lymphatic mapping                                                                          
                                                   Lymphatic system neoplasm                                                                  
                                                   Lymphocele                                                                                 
                                                   Lymphocyte adoptive therapy                                                                
                                                   Lymphocyte morphology abnormal                                                             
                                                   Lymphoid tissue operation                                                                  
                                                   Lymphoma operation                                                                         
                                                   Lymphoproliferative disorder                                                               
                                                   Lymphoproliferative disorder in remission                                                  
                                                   Maffucci syndrome                                                                          
                                                   Male reproductive tract neoplasm                                                           
                                                   Malignant ascites                                                                          
                                                   Malignant exophthalmos                                                                     
                                                   Malignant neoplasm progression                                                             
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Malignant pleural effusion
Malignant psoas syndrome
Malignant urinary tract obstruction
Marrow hyperplasia
Mastectomy
Mastocytoma
Mastoid cyst
Mastoidectomy
Maxillofacial sinus neoplasm
Mazabraud's syndrome
Mediastinal biopsy abnormal
Mediastinal cyst
Mediastinum neoplasm
Medical device site cyst
Megaloblasts increased
Meigs' syndrome
Melanocytic naevus
Meningeal neoplasm
Meningioma
Meningioma benign
Meniscus cyst
Mesenteric neoplasm
Mesoblastic nephroma
Mesonephric duct cyst
Mesothelioma
Metastatic bone disease prophylaxis
Metastatic pulmonary embolism
Micrographic skin surgery
Modified radical mastectomy
Monoclonal gammopathy
Mucosal cyst of postmastoidectomy cavity
Mueller's mixed tumour
Muir-Torre syndrome
Multicentric reticulohistiocytosis
Multilocular cystic nephroma
Multinucleate cell angiohistiocytoma
Multiple cutaneous and uterine leiomyomatosis
Multiple endocrine neoplasia
Multiple endocrine neoplasia Type 1
Multiple endocrine neoplasia Type 2
Multiple endocrine neoplasia Type 2A
Multiple endocrine neoplasia Type 2B
Muscle neoplasm
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Myasthenic syndrome
Myectomy
Myeloblast present
Myelodysplastic syndrome
Myelodysplastic syndrome transformation
Myelodysplastic syndrome unclassifiable
Myelofibrosis
Myeloid metaplasia
Myelolipoma
Myeloma cast nephropathy
Myeloproliferative neoplasm
Myolipoma
Myopericytoma
NMP22 test abnormal
Naevus haemorrhage
Naevus lipomatosus cutaneous superficialis
Nasal cyst
Nasal neoplasm
Nasal neoplasm benign
Nasal polyps
Nasopharyngeal neoplasm benign
Nasopharyngeal polyp
Nasopharyngeal tumour
Neck dissection
Necrolytic migratory erythema
Needle biopsy site unspecified abnormal
Neoadjuvant therapy
Neobladder surgery
Neoplasm
Neoplasm of appendix
Neoplasm of cornea unspecified malignancy
Neoplasm of orbit
Neoplasm of thymus
Neoplasm progression
Neoplasm prostate
Neoplasm recurrence
Neoplasm skin
Neoplasm swelling
Nephrectomy
Nephroureterectomy
Nervous system cyst
Nervous system neoplasm
Nervous system neoplasm benign
.


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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Nervous system neoplasm surgery
Neurilemmoma benign
Neuroectodermal neoplasm
Neuroendoscopy
Neurofibroma
Neurofibromatosis
Neurogenic tumour
Neuroma
Neuromyotonia
Neurotensinoma
Nipple neoplasm
Nipple resection
Nodular fasciitis
Non-secretory adenoma of pituitary
Numb chin syndrome
Ocular neoplasm
Ocular surface squamous neoplasia
Odontogenic cyst
Odontoma
Oesophageal cyst
Oesophageal neoplasm
Oesophageal papilloma
Oesophageal polypectomy
Oesophageal prosthesis insertion
Oesophagectomy
Oesophagogastrectomy
Oestrogen receptor assay positive
Oligodendroglioma benign
Omenn syndrome
Omentectomy
Oncocytoma
Oncologic complication
Oophorectomy
Oophorectomy bilateral
Optic nerve neoplasm
Oral cavity neoplasm surgery
Oral fibroma
Oral haemangioma
Oral hairy leukoplakia
Oral neoplasm
Oral neoplasm benign
Oral papilloma
Oral polypectomy
.


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Date: 
04 December 2020 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Orbital exenteration                                                                       
                                                   Orchidectomy                                                                               
                                                   Orchidotomy                                                                                
                                                   Oropharyngeal dysplasia                                                                    
                                                   Oropharyngeal neoplasm                                                                     
                                                   Oropharyngeal neoplasm benign                                                              
                                                   Ostectomy                                                                                  
                                                   Osteochondroma                                                                             
                                                   Osteofibroma                                                                               
                                                   Osteoma                                                                                    
                                                   Osteoma cutis                                                                              
                                                   Ota's naevus                                                                               
                                                   Ovarian Sertoli-Leydig cell tumour                                                         
                                                   Ovarian adenoma                                                                            
                                                   Ovarian cyst                                                                               
                                                   Ovarian cyst ruptured                                                                      
                                                   Ovarian cyst torsion                                                                       
                                                   Ovarian dysplasia                                                                          
                                                   Ovarian fibroma                                                                            
                                                   Ovarian germ cell teratoma benign                                                          
                                                   Ovarian germ cell tumour                                                                   
                                                   Ovarian granulosa cell tumour                                                              
                                                   Ovarian neoplasm                                                                           
                                                   Ovarian neoplasm surgery                                                                   
                                                   Ovarian stromal hyperplasia                                                                
                                                   Ovarian theca cell tumour                                                                  
                                                   PHACES syndrome                                                                            
                                                   PML/RAR alpha expression                                                                   
                                                   POEMS syndrome                                                                             
                                                   Pachydermodactyly                                                                          
                                                   Palliative care                                                                            
                                                   Palmar fasciitis                                                                           
                                                   Pancoast's syndrome                                                                        
                                                   Pancreastatin abnormal                                                                     
                                                   Pancreastatin increased                                                                    
                                                   Pancreatectomy                                                                             
                                                   Pancreatic neoplasm                                                                        
                                                   Pancreaticoduodenectomy                                                                    
                                                   Pancreaticosplenectomy                                                                     
                                                   Papillary cystadenoma lymphomatosum                                                        
                                                   Papillary tumour of renal pelvis                                                           
                                                   Papilloma                                                                                  
                                                   Papilloma conjunctival                                                                     
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Paracancerous pneumonia                                                                    
                                                   Paraganglion neoplasm                                                                      
                                                   Paraganglion neoplasm benign                                                               
                                                   Paranasal biopsy abnormal                                                                  
                                                   Paranasal cyst                                                                             
                                                   Paranasal sinus benign neoplasm                                                            
                                                   Paranasal sinus neoplasm                                                                   
                                                   Paraneoplastic arthritis                                                                   
                                                   Paraneoplastic dermatomyositis                                                             
                                                   Paraneoplastic dermatosis                                                                  
                                                   Paraneoplastic encephalomyelitis                                                           
                                                   Paraneoplastic glomerulonephritis                                                          
                                                   Paraneoplastic hypoglycaemia                                                               
                                                   Paraneoplastic myelopathy                                                                  
                                                   Paraneoplastic nephrotic syndrome                                                          
                                                   Paraneoplastic neurological syndrome                                                       
                                                   Paraneoplastic pemphigus                                                                   
                                                   Paraneoplastic pleural effusion                                                            
                                                   Paraneoplastic rash                                                                        
                                                   Paraneoplastic retinopathy                                                                 
                                                   Paraneoplastic syndrome                                                                    
                                                   Paraproteinaemia                                                                           
                                                   Parapsoriasis                                                                              
                                                   Parathyroid cyst                                                                           
                                                   Parathyroid scan abnormal                                                                  
                                                   Parathyroid tumour                                                                         
                                                   Parathyroid tumour benign                                                                  
                                                   Parathyroidectomy                                                                          
                                                   Parotidectomy                                                                              
                                                   Partial cystectomy                                                                         
                                                   Pathological fracture                                                                      
                                                   Pearly penile papules                                                                      
                                                   Pelvic cyst                                                                                
                                                   Pelvic neoplasm                                                                            
                                                   Penile dysplasia                                                                           
                                                   Penile neoplasm                                                                            
                                                   Penile operation                                                                           
                                                   Penile wart                                                                                
                                                   Penile warts excision                                                                      
                                                   Pepsinogen test positive                                                                   
                                                   Percutaneous ethanol injection therapy                                                     
                                                   Pericardial cyst                                                                           
                                                   Pericardial effusion malignant                                                             
.


NN9535 
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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Pericardial lipoma
Pericardial neoplasm
Pericarditis malignant
Perineal cyst
Perineurial cyst
Peripheral nervous system neoplasm
Peritoneal gliomatosis
Peritoneal neoplasm
Peritonectomy
Peritumoural oedema
Peutz-Jeghers syndrome
Phaeochromocytoma
Phaeochromocytoma crisis
Phaeochromocytoma excision
Phakomatosis
Pharyngeal cyst
Pharyngeal leukoplakia
Pharyngeal mass
Pharyngeal neoplasm
Pharyngeal neoplasm benign
Pharyngeal polyp
Pharyngectomy
Philadelphia chromosome positive   
Phosphaturic mesenchymal tumour
Photodynamic diagnostic procedure
Photon radiation therapy
Photon radiation therapy to bladder
Photon radiation therapy to blood
Photon radiation therapy to bone
Photon radiation therapy to brain
Photon radiation therapy to breast
Photon radiation therapy to colon
Photon radiation therapy to ear, nose, or throat
Photon radiation therapy to liver
Photon radiation therapy to lung   
Photon radiation therapy to pancreas
Photon radiation therapy to pleura
Photon radiation therapy to prostate
Photon radiation therapy to skin
Photon radiation therapy to soft tissue
Photon radiation therapy to thyroid
Photon radiation therapy to uterus
Phyllodes tumour
.


NN9535 
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Date: 
04 December 2020 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Pineal gland cyst
Pineal neoplasm
Pinealoma
Pineocytoma 
Pituitary cyst
Pituitary gland radiotherapy
Pituitary scan abnormal
Pituitary tumour
Pituitary tumour benign
Pituitary tumour recurrent
Placental chorioangioma
Placental cyst
Placental neoplasm
Placental polyp
Pleomorphic adenoma
Pleural cyst
Pleural neoplasm
Pleurectomy
Pneumonectomy
Polycythaemia vera
Polyneuropathy in malignant disease
Polyp
Portal vein embolisation
Post breast therapy pain syndrome
Post transplant lymphoproliferative disorder
Posterior fossa syndrome
Postmastectomy lymphoedema syndrome
Precancerous condition
Precancerous lesion excision
Precancerous mucosal lesion
Precancerous skin lesion
Primary myelofibrosis
Proctectomy
Proctocolectomy
Progesterone receptor assay positive
Prolactin-producing pituitary tumour
Prophylactic chemotherapy
Prostate ablation
Prostate cryoablation
Prostate interstitial hyperthermia therapy
Prostatectomy
Prostatic adenoma
Prostatic cyst
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Prostatic dysplasia                                                                        
                                                   Prostatic polyp                                                                            
                                                   Prostatic specific antigen abnormal                                                        
                                                   Prostatic specific antigen increased                                                       
                                                   Pseudocirrhosis                                                                            
                                                   Pseudomyxoma peritonei                                                                     
                                                   Pulmonary resection                                                                        
                                                   Pylorectomy                                                                                
                                                   Pyoderma gangrenosum                                                                       
                                                   Pyogenic granuloma                                                                         
                                                   Radiation therapy to ear, nose, or throat                                                  
                                                   Radical cystectomy                                                                         
                                                   Radical hysterectomy                                                                       
                                                   Radical mastectomy                                                                         
                                                   Radical parametrectomy                                                                     
                                                   Radical prostatectomy                                                                      
                                                   Radioactive iodine therapy                                                                 
                                                   Radioembolisation                                                                          
                                                   Radiofrequency ablation of oesophagus                                                      
                                                   Radiofrequency-induced thermochemotherapeutic                                              
                                                   effect                                                                                     
                                                   Radioisotope scan abnormal                                                                 
                                                   Radiosensitisation therapy                                                                 
                                                   Radiotherapy                                                                               
                                                   Radiotherapy to abdomen                                                                    
                                                   Radiotherapy to adrenal gland                                                              
                                                   Radiotherapy to blood                                                                      
                                                   Radiotherapy to bone                                                                       
                                                   Radiotherapy to brain                                                                      
                                                   Radiotherapy to breast                                                                     
                                                   Radiotherapy to colon                                                                      
                                                   Radiotherapy to ear                                                                        
                                                   Radiotherapy to eye                                                                        
                                                   Radiotherapy to gallbladder                                                                
                                                   Radiotherapy to gastrointestinal tract                                                     
                                                   Radiotherapy to head and neck                                                              
                                                   Radiotherapy to joint                                                                      
                                                   Radiotherapy to kidney                                                                     
                                                   Radiotherapy to liver                                                                      
                                                   Radiotherapy to lung                                                                       
                                                   Radiotherapy to lymph nodes                                                                
                                                   Radiotherapy to mediastinum                                                                
                                                   Radiotherapy to nose                                                                       
.


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Date: 
04 December 2020 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Neoplasm                                           Radiotherapy to oesophagus                                                                 
                                                   Radiotherapy to oral cavity                                                                
                                                   Radiotherapy to ovary                                                                      
                                                   Radiotherapy to pancreas                                                                   
                                                   Radiotherapy to pharynx                                                                    
                                                   Radiotherapy to pleura                                                                     
                                                   Radiotherapy to prostate                                                                   
                                                   Radiotherapy to rectum                                                                     
                                                   Radiotherapy to skin                                                                       
                                                   Radiotherapy to soft tissue                                                                
                                                   Radiotherapy to spleen                                                                     
                                                   Radiotherapy to stomach                                                                    
                                                   Radiotherapy to thymus                                                                     
                                                   Radiotherapy to thyroid                                                                    
                                                   Radiotherapy to tongue                                                                     
                                                   Radiotherapy to urinary bladder                                                            
                                                   Radiotherapy to uterus                                                                     
                                                   Radiotherapy to vagina                                                                     
                                                   Radiotherapy toxicity attenuation                                                          
                                                   Rectal adenoma                                                                             
                                                   Rectal neoplasm                                                                            
                                                   Rectal polypectomy                                                                         
                                                   Refractory anaemia with an excess of blasts                                                
                                                   Refractory anaemia with ringed sideroblasts                                                
                                                   Refractory cytopenia with multilineage dysplasia                                           
                                                   Refractory cytopenia with unilineage dysplasia                                             
                                                   Regional chemotherapy                                                                      
                                                   Renal adenoma                                                                              
                                                   Renal artery embolisation                                                                  
                                                   Renal cell dysplasia                                                                       
                                                   Renal cyst                                                                                 
                                                   Renal cyst haemorrhage                                                                     
                                                   Renal cyst infection                                                                       
                                                   Renal cyst ruptured                                                                        
                                                   Renal haemangioma                                                                          
                                                   Renal hamartoma                                                                            
                                                   Renal neoplasm                                                                             
                                                   Renal oncocytoma                                                                           
                                                   Renal scan abnormal                                                                        
                                                   Renal tumour excision                                                                      
                                                   Respiratory papilloma                                                                      
                                                   Respiratory tract neoplasm                                                                 
                                                   Retention cyst                                                                             
.


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04 December 2020 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Retinal melanocytoma
Retinal neoplasm
Retinal tumour excision
Retro-orbital neoplasm
Retro-pubic prostatectomy
Retroperitoneal neoplasm
Rhabdomyoma
Rosai-Dorfman syndrome
Sacrectomy
Salivary bypass tube insertion
Salivary gland adenoma
Salivary gland neoplasm
Salivary gland resection
Salivary gland scan abnormal
Salpingectomy
Salpingo-oophorectomy
Salpingo-oophorectomy bilateral
Salpingo-oophorectomy unilateral
Sarcoma excision
Scan abdomen abnormal
Scan abnormal
Scan adrenal gland abnormal
Scan bone marrow abnormal
Scan gallium abnormal
Scan with contrast abnormal
Schwannoma
Sclerosing pneumocytoma
Scrotal cyst
Sebaceous adenoma
Sebaceous naevus
Seborrhoeic keratosis
Secondary cerebellar degeneration
Secretory adenoma of pituitary
Seminal vesicular cyst
Senior-Loken syndrome
Sertoli cell testicular tumour
Sezary cells increased
Sigmoidectomy
Silicon granuloma
Simple mastectomy
Sinonasal papilloma
Sinus polyp
Sinus polyp degeneration
.


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04 December 2020 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Skin cryotherapy
Skin neoplasm bleeding
Skin neoplasm excision
Skin papilloma
Small intestinal polypectomy
Small intestinal resection
Smooth muscle cell neoplasm
Soft tissue neoplasm
Solitary epithelioid histiocytoma
Solitary fibrous tumour
Somatostatin receptor scan abnormal
Somatostatinoma
Spermatic cord cyst
Spermatocele
Spinal cord lipoma
Spinal cord neoplasm
Spinal meningeal cyst
Spinal meningioma benign
Spinal synovial cyst
Spleen scan abnormal
Splenectomy
Splenic cyst
Splenic hamartoma
Splenic neoplasm malignancy unspecified
Squamous cell carcinoma antigen increased
Stauffer's syndrome
Steatocystoma multiplex
Stem cell therapy
Stem cell transplant
Stoma site polyp
Stomach scan abnormal
Suprapubic prostatectomy
Sweat gland tumour
Synovial cyst
Systemic mastocytosis
TEMPI syndrome
Targeted cancer therapy
Tendon neoplasm
Teratoma
Teratoma benign
Testicle adenoma
Testicular cyst
Testicular germ cell tumour
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Testicular neoplasm
Testicular papilloma
Testicular scan abnormal
Testicular teratoma benign
Therapeutic ovarian suppression
Thymic cyst
Thymoma
Thyroglossal cyst
Thyroid C-cell hyperplasia
Thyroid adenoma
Thyroid cyst
Thyroid electron radiation therapy
Thyroid gland scan abnormal
Thyroid neoplasm
Thyroid stimulating hormone-producing pituitary
tumour
Thyroidectomy
Tissue polypeptide antigen increased
Tongue neoplasm
Tongue neoplasm benign
Tonsillar cyst
Tonsillar neoplasm
Tonsillar neoplasm benign
Tornwaldt cyst
Total adrenalectomy
Tracheal neoplasm
Tracheal papilloma
Tracheal polyp
Tracheal resection
Transcatheter arterial chemoembolisation
Transcranial electrical motor evoked potential
monitoring abnormal
Transdifferentiation of neoplasm
Transurethral bladder resection
Transurethral prostatectomy
Trisomy 12
Tuberous sclerosis complex
Tumour ablation
Tumour associated fever
Tumour cavitation
Tumour cell mobilisation
Tumour compression
Tumour excision
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Tumour exudation
Tumour fistulisation
Tumour flare
Tumour haemorrhage
Tumour hyperprogression
Tumour inflammation
Tumour invasion
Tumour lysis syndrome
Tumour marker abnormal
Tumour marker decreased
Tumour marker increased
Tumour necrosis
Tumour obstruction
Tumour of ampulla of Vater
Tumour pain
Tumour perforation
Tumour pruritus
Tumour pseudoprogression
Tumour rupture
Tumour treating fields therapy
Tumour ulceration
Tumour vaccine therapy
Ulcerated haemangioma
Ultrasound pancreas abnormal
Ultrasound scan abnormal
Ultrasound scan vagina abnormal
Umbilical cord cyst
Ureteral cyst
Ureteral neoplasm
Ureteral polyp
Ureteric papilloma
Urethral adenoma
Urethral cyst
Urethral neoplasm
Urethral papilloma
Urethral polyp
Urethrectomy
Urinary bladder adenoma
Urinary bladder polyp
Urinary cystectomy
Urinary tract neoplasm
Urinary tract polyp
Uterine cyst
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
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Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Neoplasm
Uterine leiomyoma
Uterine myoma expulsion
Uterine neoplasm
Uterine polyp
Uterine tumour excision
Uvulectomy
Vaccination site cyst
Vaginal cyst
Vaginal dysplasia
Vaginal neoplasm
Vaginal polyp
Vaginectomy
Vascular neoplasm
Venous angioma of brain
Vipoma
Viral acanthoma
Vitreous cyst
Vocal cord cyst
Vocal cord leukoplakia
Vocal cord neoplasm
Vocal cord polyp
Vocal cordectomy
Vulva cyst
Vulval neoplasm
Vulval operation
Vulval polyp
Vulval warts removal
Vulvar dysplasia
Vulvectomy
Vulvovaginal adenosis
Vulvovaginal warts
Warty dyskeratoma
White sponge naevus
X-linked lymphoproliferative syndrome
X-ray therapy to bladder
X-ray therapy to blood
X-ray therapy to bone
X-ray therapy to brain
X-ray therapy to breast
X-ray therapy to colon
X-ray therapy to ear, nose, or throat
X-ray therapy to joint
X-ray therapy to liver
.


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Neoplasm                                           X-ray therapy to lung                                                                      
                                                   X-ray therapy to pancreas                                                                  
                                                   X-ray therapy to pleura                                                                    
                                                   X-ray therapy to prostate                                                                  
                                                   X-ray therapy to skin                                                                      
                                                   X-ray therapy to soft tissue                                                               
                                                   X-ray therapy to thyroid                                                                   
                                                   X-ray therapy to uterus                                                                    
                                                   X-ray treatment                                                                            
                                                   Xanthogranuloma                                                                            
                                                   Yolk sac tumour site unspecified                                                           
                                                                                                                                              
Pancreatitis                                       Alcoholic pancreatitis                                                                     
                                                   Alcoholic pancreopathy                                                                     
                                                   Autoimmune pancreatitis                                                                    
                                                   Haemorrhagic necrotic pancreatitis                                                         
                                                   Immune-mediated pancreatitis                                                               
                                                   Ischaemic pancreatitis                                                                     
                                                   Lupus pancreatitis                                                                         
                                                   Obstructive pancreatitis                                                                   
                                                   Oedematous pancreatitis                                                                    
                                                   Pancreatic haemorrhage                                                                     
                                                   Pancreatic necrosis                                                                        
                                                   Pancreatic phlegmon                                                                        
                                                   Pancreatic pseudoaneurysm                                                                  
                                                   Pancreatic pseudocyst                                                                      
                                                   Pancreatic pseudocyst haemorrhage                                                          
                                                   Pancreatic pseudocyst rupture                                                              
                                                   Pancreatitis                                                                               
                                                   Pancreatitis acute                                                                         
                                                   Pancreatitis chronic                                                                       
                                                   Pancreatitis haemorrhagic                                                                  
                                                   Pancreatitis necrotising                                                                   
                                                   Pancreatitis relapsing                                                                     
                                                   Cullen's sign                                                                              
                                                   Cytomegalovirus pancreatitis                                                               
                                                   Grey Turner's sign                                                                         
                                                   Hereditary pancreatitis                                                                    
                                                   Pancreas infection                                                                         
                                                   Pancreatic abscess                                                                         
                                                   Pancreatic cyst drainage                                                                   
                                                   Pancreatic pseudocyst drainage                                                             
                                                   Pancreatitis bacterial                                                                     
.


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Date: 
04 December 2020 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Pancreatitis                                       Pancreatitis fungal                                                                        
                                                   Pancreatitis helminthic                                                                    
                                                   Pancreatitis mumps                                                                         
                                                   Pancreatitis viral                                                                         
                                                   Pancreatorenal syndrome                                                                    
                                                   Radiation pancreatitis                                                                     
                                                   Traumatic pancreatitis                                                                     
                                                                                                                                              
Rare events                                        11-beta-hydroxylase deficiency                                                             
                                                   17,20-desmolase deficiency                                                                 
                                                   17-alpha-hydroxylase deficiency                                                            
                                                   18q minus syndrome                                                                         
                                                   1p36 deletion syndrome                                                                     
                                                   2-Hydroxyglutaric aciduria                                                                 
                                                   20,22-desmolase deficiency                                                                 
                                                   21-hydroxylase deficiency                                                                  
                                                   3-hydroxyacetyl-coenzyme A dehydrogenase                                                   
                                                   deficiency                                                                                 
                                                   3M syndrome                                                                                
                                                   5-alpha-reductase deficiency                                                               
                                                   ABO haemolytic disease of newborn                                                          
                                                   ACAD9 deficiency                                                                           
                                                   ADCY5-related dyskinesia                                                                   
                                                   ADNP syndrome                                                                              
                                                   AIDS dysmorphic syndrome                                                                   
                                                   ASAH1 related disorder                                                                     
                                                   Aase syndrome                                                                              
                                                   Abdominal transposition                                                                    
                                                   Abdominal wall anomaly                                                                     
                                                   Aberrant aortic arch                                                                       
                                                   Abetalipoproteinaemia                                                                      
                                                   Ablepharon macrostomia syndrome                                                            
                                                   Abnormal palmar/plantar creases                                                            
                                                   Acardia                                                                                    
                                                   Accessory auricle                                                                          
                                                   Accessory breast                                                                           
                                                   Accessory carpal bone                                                                      
                                                   Accessory kidney                                                                           
                                                   Accessory liver lobe                                                                       
                                                   Accessory muscle                                                                           
                                                   Accessory navicular syndrome                                                               
                                                   Accessory renal artery                                                                     
                                                   Accessory salivary gland                                                                   
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Accessory spleen
Acetylcholinesterase deficiency
Achard Thiers syndrome
Achromotrichia congenital
Acquired amegakaryocytic thrombocytopenia
Acquired gene mutation
Acquired mitochondrial DNA deletion
Acquired mitochondrial DNA mutation
Acral peeling skin syndrome
Acrocallosal syndrome
Acrocephalosyndactyly
Acrodermatitis enteropathica
Acrodysostosis
Acrokeratosis verruciformis
Acromesomelic dysplasia
Acromicric dysplasia
Activated PI3 kinase delta syndrome
Acute interstitial pneumonitis
Acute motor axonal neuropathy
Acute motor-sensory axonal neuropathy
Adactyly
Adams-Oliver syndrome
Adenine phosphoribosyl transferase deficiency
Adenylosuccinate lyase deficiency
Adrenal insufficiency neonatal
Adrenogenital syndrome
Adrenoleukodystrophy
Adult polyglucosan body disease
Aglossia
Agranulocytosis
Aicardi's syndrome
Aicardi-Goutieres syndrome
Alagille syndrome
Albinism 
Albright's disease
Alexander disease
Alkaptonuria
Allan-Herndon-Dudley syndrome
Alpers disease
Alpha-1 antitrypsin deficiency
Alpha-mannosidosis
Alpha-thalassaemia-intellectual deficit syndrome
Alport's syndrome
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Rare events                                        Alstroem syndrome                                                                          
                                                   Alternating hemiplegia of childhood                                                        
                                                   Alveolar capillary dysplasia                                                               
                                                   Alveolar lung disease                                                                      
                                                   Alveolar proteinosis                                                                       
                                                   Alveolitis                                                                                 
                                                   Alveolitis necrotising                                                                     
                                                   Amblyopia congenital                                                                       
                                                   Amegakaryocytic thrombocytopenia                                                           
                                                   Aminoaciduria                                                                              
                                                   Amniotic band syndrome                                                                     
                                                   Amyotrophic lateral sclerosis gene carrier                                                 
                                                   Anal atresia                                                                               
                                                   Anaplastic lymphoma kinase gene mutation                                                   
                                                   Androgen insensitivity syndrome                                                            
                                                   Androgen receptor gene overexpression                                                      
                                                   Anencephaly                                                                                
                                                   Angelman's syndrome                                                                        
                                                   Angiotensin converting enzyme inhibitor foetopathy                                         
                                                   Aniridia                                                                                   
                                                   Aniridia-cerebellar ataxia-mental deficiency                                               
                                                   Ankyloglossia congenital                                                                   
                                                   Annular pancreas                                                                           
                                                   Anodontia                                                                                  
                                                   Anomalous arrangement of pancreaticobiliary duct                                           
                                                   Anomalous pulmonary venous connection                                                      
                                                   Anomaly of external ear congenital                                                         
                                                   Anomaly of middle ear congenital                                                           
                                                   Anomaly of orbit, congenital                                                               
                                                   Anophthalmos                                                                               
                                                   Anorchism                                                                                  
                                                   Anorectal agenesis                                                                         
                                                   Anorectal malformation                                                                     
                                                   Anotia                                                                                     
                                                   Anterior chamber cleavage syndrome                                                         
                                                   Anterior displaced anus                                                                    
                                                   Antibiotic associated colitis                                                              
                                                   Antithrombin III deficiency                                                                
                                                   Antley-Bixler syndrome                                                                     
                                                   Aorta hypoplasia                                                                           
                                                   Aortic valve atresia                                                                       
                                                   Aorticopulmonary septal defect                                                             
                                                   Aphakia congenital                                                                         
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Aplasia
Aplasia cutis congenita
Aplastic anaemia
Apolipoprotein E e4 gene carrier
Apparent mineralocorticoid excess
Arachnodactyly
Arcuate foramen
Arginase deficiency
Argininosuccinate lyase deficiency
Argininosuccinate synthetase deficiency
Arnold-Chiari malformation
Aromatic L-amino acid decarboxylase deficiency
Arterial tortuosity syndrome
Arteriovenous malformation
Ash leaf macule
Aspartate-glutamate-transporter deficiency
Aspartylglucosaminuria
Asphyxiating thoracic dystrophy
Asplenia
Asymptomatic gene carrier
Ataxia telangiectasia
Atrial septal defect
Atrioventricular septal defect
Auditory neuropathy spectrum disorder
Autoimmune aplastic anaemia
Autoimmune lung disease
Autoimmune lymphoproliferative syndrome
Autoimmune nephritis
Autosomal chromosome anomaly
Autosomal recessive megaloblastic anaemia
Azygos lobe
B-lymphocyte abnormalities
B-lymphocyte count abnormal
B-lymphocyte count decreased
BLyS polymorphism
BPES syndrome
BRAF gene mutation
BRCA1 gene mutation
BRCA2 gene mutation
Baller-Gerold syndrome
Baltic myoclonic epilepsy
Band neutrophil count decreased
Band neutrophil percentage decreased
.


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Date: 
04 December 2020 
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Novo Nordisk 
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Rare events                                        Baraitser Rodeck Garner syndrome                                                           
                                                   Barakat syndrome                                                                           
                                                   Barth syndrome                                                                             
                                                   Bartter's syndrome                                                                         
                                                   Basophil count abnormal                                                                    
                                                   Basophil count decreased                                                                   
                                                   Basophil percentage decreased                                                              
                                                   Basophilopenia                                                                             
                                                   Becker's muscular dystrophy                                                                
                                                   Beckwith-Wiedemann syndrome                                                                
                                                   Benign congenital hypotonia                                                                
                                                   Benign familial haematuria                                                                 
                                                   Benign familial neonatal convulsions                                                       
                                                   Benign familial pemphigus                                                                  
                                                   Benjamin syndrome                                                                          
                                                   Berdon's syndrome                                                                          
                                                   Bergmeister's papilla                                                                      
                                                   Beta ketothiolase deficiency                                                               
                                                   Bickerstaff's encephalitis                                                                 
                                                   Bicuspid aortic valve                                                                      
                                                   Bicuspid pulmonary valve                                                                   
                                                   Bicytopenia                                                                                
                                                   Biotinidase deficiency                                                                     
                                                   Birth mark                                                                                 
                                                   Bladder agenesis                                                                           
                                                   Blau syndrome                                                                              
                                                   Blepharophimosis congenital                                                                
                                                   Blindness congenital                                                                       
                                                   Bloch-Sulzberger syndrome                                                                  
                                                   Blood count abnormal                                                                       
                                                   Blood disorder                                                                             
                                                   Blood incompatibility haemolytic anaemia of                                                
                                                   newborn                                                                                    
                                                   Bloom syndrome                                                                             
                                                   Bone marrow disorder                                                                       
                                                   Bone marrow failure                                                                        
                                                   Bone marrow myelogram abnormal                                                             
                                                   Bone marrow necrosis                                                                       
                                                   Bone marrow toxicity                                                                       
                                                   Bosch-Boonstra-Schaaf optic atrophy syndrome                                               
                                                   Brachycephaly                                                                              
                                                   Brachydactyly                                                                              
                                                   Brachymetatarsia                                                                           
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Brachyolmia
Brain malformation
Branchial cleft sinus
Branchio-oto-renal syndrome
Branchiogenic syndrome
Breast malformation
Bronchial atresia
Bronchiolitis
Bronchogenic cyst
Brown-Vialetto-Van Laere syndrome
Brunner syndrome
Bruton's agammaglobulinaemia
Bulbospinal muscular atrophy congenital 
Buried penis syndrome
C-kit gene mutation
C-kit gene overexpression
C1q nephropathy
C3 glomerulopathy
CANDLE syndrome
CARD9 deficiency
CDKL5 deficiency disorder
CEC syndrome
CFTR gene mutation
CHARGE syndrome
CHILD syndrome
COPA syndrome
CTLA4 deficiency
CYP1A2 polymorphism
CYP2B6 polymorphism
CYP2C19 polymorphism
CYP2C9 polymorphism
CYP2D6 polymorphism
CYP3A4 polymorphism
CYP3A5 polymorphism
Campomelic syndrome
Camptodactyly congenital
Camptodactyly-arthropathy-coxa vara-pericarditis
syndrome
Camptomelia
Canavan disease
Cancer gene carrier
Carbamoyl phosphate synthetase deficiency
Carbohydrate metabolism disorder
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Rare events                                        Carbonic anhydrase gene mutation                                                           
                                                   Cardiac malposition                                                                        
                                                   Cardiac septal defect                                                                      
                                                   Cardiofaciocutaneous syndrome                                                              
                                                   Carnitine palmitoyltransferase deficiency                                                  
                                                   Carnitine-acylcarnitine translocase deficiency                                             
                                                   Carpenter syndrome                                                                         
                                                   Carpus curvus                                                                              
                                                   Cartilage-hair hypoplasia                                                                  
                                                   Cataract congenital                                                                        
                                                   Catel Manzke syndrome                                                                      
                                                   Caudal regression syndrome                                                                 
                                                   Central core disease                                                                       
                                                   Cerebellar dysplasia                                                                       
                                                   Cerebellar hypoplasia                                                                      
                                                   Cerebral atrophy congenital                                                                
                                                   Cerebral dysgenesis                                                                        
                                                   Cerebral palsy                                                                             
                                                   Cerebrohepatorenal syndrome                                                                
                                                   Cervical auricle                                                                           
                                                   Cervical rib                                                                               
                                                   Checkpoint kinase 2 gene mutation                                                          
                                                   Chediak-Higashi syndrome                                                                   
                                                   Chiari network                                                                             
                                                   Chimerism                                                                                  
                                                   Choanal atresia                                                                            
                                                   Choanal stenosis                                                                           
                                                   Cholangiectasis congenital                                                                 
                                                   Chondrodystrophy                                                                           
                                                   Chondroectodermal dysplasia                                                                
                                                   Chordee                                                                                    
                                                   Chorea-acanthocytosis                                                                      
                                                   Chorioretinal degeneration congenital                                                      
                                                   Choroidal coloboma                                                                         
                                                   Chromosomal deletion                                                                       
                                                   Chromosomal mutation                                                                       
                                                   Chronic autoimmune glomerulonephritis                                                      
                                                   Chronic granulomatous disease                                                              
                                                   Chronic infantile neurological cutaneous and                                               
                                                   articular syndrome                                                                         
                                                   Chronic inflammatory demyelinating                                                         
                                                   polyradiculoneuropathy                                                                     
                                                   Citrate transporter deficiency                                                             
.


NN9535 
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Date: 
04 December 2020 
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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Cleft lip
Cleft lip and palate
Cleft palate
Cleft uvula
Cleidocranial dysostosis
Clinodactyly
Cloacal exstrophy
Clostridial infection
Clostridial sepsis
Clostridium bacteraemia
Clostridium colitis
Clostridium difficile colitis
Clostridium difficile infection
Clostridium test positive
Coagulation factor mutation
Coarctation of the aorta
Cobb syndrome
Cockayne's syndrome
Coffin Siris syndrome
Coffin-Lowry syndrome
Cohen syndrome
Collodion baby
Coloboma
Colour blindness
Combined immunodeficiency
Combined pulmonary fibrosis and emphysema
Complement deficiency disease
Cone dystrophy
Confined placental mosaicism
Congenital Ebola virus infection
Congenital Eustachian tube anomaly   
Congenital HIV infection
Congenital Horner's syndrome
Congenital Zika syndrome
Congenital abdominal hernia
Congenital absence of bile ducts
Congenital absence of cranial vault
Congenital absence of vertebra
Congenital adrenal gland hypoplasia
Congenital amputation
Congenital anaemia
Congenital androgen deficiency
Congenital anomalies of ear ossicles
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Congenital anomaly
Congenital anomaly in offspring
Congenital anomaly of adrenal gland
Congenital anomaly of inner ear
Congenital anosmia
Congenital aortic anomaly
Congenital aortic atresia
Congenital aortic dilatation
Congenital aortic stenosis
Congenital aortic valve incompetence
Congenital aortic valve stenosis
Congenital aplastic anaemia
Congenital aqueductal stenosis
Congenital arterial malformation
Congenital arterial occlusion
Congenital arteriovenous fistula
Congenital astigmatism
Congenital aural fistula
Congenital bilateral perisylvian syndrome
Congenital bladder anomaly
Congenital bladder diverticulum
Congenital bladder neck obstruction
Congenital bowing of long bones
Congenital brain damage
Congenital bronchiectasis
Congenital bronchomalacia
Congenital calyceal diverticulum
Congenital cardiovascular anomaly
Congenital carnitine deficiency
Congenital central diabetes insipidus
Congenital central hypoventilation syndrome
Congenital central nervous system anomaly
Congenital cerebellar agenesis
Congenital choroidal anomaly
Congenital chylothorax
Congenital clavicular agenesis
Congenital claw toe
Congenital coagulopathy
Congenital condyloma
Congenital corneal anomaly
Congenital coronary artery malformation
Congenital cranial nerve paralysis
Congenital cutis laxa
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Version: 
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Rare events                                        Congenital cystic lung                                                                     
                                                   Congenital cytomegalovirus infection                                                       
                                                   Congenital deformity of clavicle                                                           
                                                   Congenital dengue disease                                                                  
                                                   Congenital dermal sinus                                                                    
                                                   Congenital diaphragmatic anomaly                                                           
                                                   Congenital diaphragmatic eventration                                                       
                                                   Congenital diaphragmatic hernia                                                            
                                                   Congenital disorder of glycosylation                                                       
                                                   Congenital dyserythropoietic anaemia                                                       
                                                   Congenital dysfibrinogenaemia                                                              
                                                   Congenital dyskeratosis                                                                    
                                                   Congenital ectodermal dysplasia                                                            
                                                   Congenital ectopic bladder                                                                 
                                                   Congenital ectopic pancreas                                                                
                                                   Congenital elevation of scapula                                                            
                                                   Congenital emphysema                                                                       
                                                   Congenital endocrine anomaly                                                               
                                                   Congenital epiblepharon                                                                    
                                                   Congenital epiglottal anomaly                                                              
                                                   Congenital eye disorder                                                                    
                                                   Congenital eyelid malformation                                                             
                                                   Congenital facial nerve hypoplasia                                                         
                                                   Congenital fallopian tube anomaly                                                          
                                                   Congenital flaccid paralysis                                                               
                                                   Congenital flat feet                                                                       
                                                   Congenital floppy infant                                                                   
                                                   Congenital foot malformation                                                               
                                                   Congenital gastric anomaly                                                                 
                                                   Congenital gastrointestinal vessel anomaly                                                 
                                                   Congenital generalised lipodystrophy                                                       
                                                   Congenital genital malformation                                                            
                                                   Congenital genital malformation female                                                     
                                                   Congenital genital malformation male                                                       
                                                   Congenital genitourinary abnormality                                                       
                                                   Congenital great vessel anomaly                                                            
                                                   Congenital growth hormone deficiency                                                       
                                                   Congenital haematological disorder                                                         
                                                   Congenital hair disorder                                                                   
                                                   Congenital hand malformation                                                               
                                                   Congenital hearing disorder                                                                
                                                   Congenital heart valve disorder                                                            
                                                   Congenital heart valve incompetence                                                        
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Rare events                                        Congenital hepatic fibrosis                                                                
                                                   Congenital hepatitis B infection                                                           
                                                   Congenital hepatobiliary anomaly                                                           
                                                   Congenital hepatomegaly                                                                    
                                                   Congenital herpes simplex infection                                                        
                                                   Congenital hiatus hernia                                                                   
                                                   Congenital high airway obstruction syndrome                                                
                                                   Congenital hydrocele renalis                                                               
                                                   Congenital hydrocephalus                                                                   
                                                   Congenital hydronephrosis                                                                  
                                                   Congenital hypercoagulation                                                                
                                                   Congenital hyperextension of knee                                                          
                                                   Congenital hyperextension of spine                                                         
                                                   Congenital hyperinsulinaemic hypoglycaemia                                                 
                                                   Congenital hyperthyroidism                                                                 
                                                   Congenital hypertrichosis                                                                  
                                                   Congenital hypogammaglobulinaemia                                                          
                                                   Congenital hypogonadotropic hypogonadism                                                   
                                                   Congenital hypoparathyroidism                                                              
                                                   Congenital hypoplasia of depressor angularis oris                                          
                                                   muscle                                                                                     
                                                   Congenital hypothyroidism                                                                  
                                                   Congenital hypotransferrinaemia                                                            
                                                   Congenital infection                                                                       
                                                   Congenital inguinal hernia                                                                 
                                                   Congenital intestinal malformation                                                         
                                                   Congenital intestinal obstruction                                                          
                                                   Congenital intrinsic factor deficiency                                                     
                                                   Congenital iris anomaly                                                                    
                                                   Congenital jaw malformation                                                                
                                                   Congenital joint malformation                                                              
                                                   Congenital knee deformity                                                                  
                                                   Congenital knee dislocation                                                                
                                                   Congenital kyphoscoliosis                                                                  
                                                   Congenital labia pudendi adhesions                                                         
                                                   Congenital lacrimal gland anomaly                                                          
                                                   Congenital lacrimal passage anomaly                                                        
                                                   Congenital large intestinal atresia                                                        
                                                   Congenital laryngeal stridor                                                               
                                                   Congenital lenticonus                                                                      
                                                   Congenital limb hyperextension                                                             
                                                   Congenital lip fistula                                                                     
                                                   Congenital lymphoedema                                                                     
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Congenital malaria                                                                         
                                                   Congenital megacolon                                                                       
                                                   Congenital megaureter                                                                      
                                                   Congenital melanosis                                                                       
                                                   Congenital methaemoglobinaemia                                                             
                                                   Congenital midline defect                                                                  
                                                   Congenital mitochondrial cytopathy                                                         
                                                   Congenital mitral valve incompetence                                                       
                                                   Congenital mitral valve stenosis                                                           
                                                   Congenital monorchidism                                                                    
                                                   Congenital multiplex arthrogryposis                                                        
                                                   Congenital muscle absence                                                                  
                                                   Congenital musculoskeletal anomaly                                                         
                                                   Congenital myasthenic syndrome                                                             
                                                   Congenital myopathy                                                                        
                                                   Congenital myopia                                                                          
                                                   Congenital nail disorder                                                                   
                                                   Congenital nasal septum deviation                                                          
                                                   Congenital nephrogenic diabetes insipidus                                                  
                                                   Congenital nephrotic syndrome                                                              
                                                   Congenital neurological degeneration                                                       
                                                   Congenital neurological disorder                                                           
                                                   Congenital neuropathy                                                                      
                                                   Congenital night blindness                                                                 
                                                   Congenital nipple anomaly                                                                  
                                                   Congenital nipple inversion                                                                
                                                   Congenital nose malformation                                                               
                                                   Congenital nystagmus                                                                       
                                                   Congenital oculomotor apraxia                                                              
                                                   Congenital oesophageal anomaly                                                             
                                                   Congenital oesophageal stenosis                                                            
                                                   Congenital oesophageal web                                                                 
                                                   Congenital optic nerve anomaly                                                             
                                                   Congenital oral malformation                                                               
                                                   Congenital osteodystrophy                                                                  
                                                   Congenital ovarian anomaly                                                                 
                                                   Congenital oxalosis                                                                        
                                                   Congenital pancreatic anomaly                                                              
                                                   Congenital perforated nasal septum                                                         
                                                   Congenital pharyngeal anomaly                                                              
                                                   Congenital pigmentation disorder                                                           
                                                   Congenital pneumonia                                                                       
                                                   Congenital poikiloderma                                                                    
.


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Status: 
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Rare events                                        Congenital pseudarthrosis                                                                  
                                                   Congenital pulmonary artery anomaly                                                        
                                                   Congenital pulmonary hypertension                                                          
                                                   Congenital pulmonary valve atresia                                                         
                                                   Congenital pulmonary valve disorder                                                        
                                                   Congenital pyelocaliectasis                                                                
                                                   Congenital renal disorder                                                                  
                                                   Congenital rubella infection                                                               
                                                   Congenital rubella syndrome                                                                
                                                   Congenital salivary gland anomaly                                                          
                                                   Congenital scleral disorder                                                                
                                                   Congenital scoliosis                                                                       
                                                   Congenital scrotal hypertrophy                                                             
                                                   Congenital skin dimples                                                                    
                                                   Congenital skin disorder                                                                   
                                                   Congenital small intestinal atresia                                                        
                                                   Congenital spinal cord anomaly                                                             
                                                   Congenital spinal fusion                                                                   
                                                   Congenital spinal stenosis                                                                 
                                                   Congenital spondylolisthesis                                                               
                                                   Congenital spondylolysis                                                                   
                                                   Congenital syphilis                                                                        
                                                   Congenital syphilitic encephalitis                                                         
                                                   Congenital syphilitic meningitis                                                           
                                                   Congenital syphilitic osteochondritis                                                      
                                                   Congenital thrombocyte disorder                                                            
                                                   Congenital thrombocytopenia                                                                
                                                   Congenital thymus absence                                                                  
                                                   Congenital thyroid disorder                                                                
                                                   Congenital tongue anomaly                                                                  
                                                   Congenital torticollis                                                                     
                                                   Congenital toxoplasmosis                                                                   
                                                   Congenital tracheomalacia                                                                  
                                                   Congenital trichomegaly                                                                    
                                                   Congenital tricuspid valve atresia                                                         
                                                   Congenital tricuspid valve incompetence                                                    
                                                   Congenital tricuspid valve stenosis                                                        
                                                   Congenital tuberculosis                                                                    
                                                   Congenital umbilical hernia                                                                
                                                   Congenital ureteric anomaly                                                                
                                                   Congenital ureterocele                                                                     
                                                   Congenital ureteropelvic junction obstruction                                              
                                                   Congenital ureterovesical junction anomaly                                                 
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Congenital urethral anomaly                                                                
                                                   Congenital urinary tract obstruction                                                       
                                                   Congenital uterine anomaly                                                                 
                                                   Congenital varicella infection                                                             
                                                   Congenital varicocele                                                                      
                                                   Congenital vas deferens absence                                                            
                                                   Congenital vesicoureteric reflux                                                           
                                                   Congenital visual acuity reduced                                                           
                                                   Congenital vitreous anomaly                                                                
                                                   Congenital white blood cell disorder                                                       
                                                   Conjoined twins                                                                            
                                                   Conjunctivitis gonococcal neonatal                                                         
                                                   Connective tissue dysplasia                                                                
                                                   Conradi-Huenermann syndrome                                                                
                                                   Constricted ear deformity                                                                  
                                                   Cor biloculare                                                                             
                                                   Cor triatriatum                                                                            
                                                   Corneal dystrophy                                                                          
                                                   Corneal opacity congenital                                                                 
                                                   Cornelia de Lange syndrome                                                                 
                                                   Corrected transposition of great vessels                                                   
                                                   Cortical dysplasia                                                                         
                                                   Costello syndrome                                                                          
                                                   Craniofacial deformity                                                                     
                                                   Craniofacial dysostosis                                                                    
                                                   Craniolacunia                                                                              
                                                   Craniorachischisis                                                                         
                                                   Craniosynostosis                                                                           
                                                   Craniotabes                                                                                
                                                   Creatine deficiency syndrome                                                               
                                                   Cri du Chat syndrome                                                                       
                                                   Crigler-Najjar syndrome                                                                    
                                                   Cryopyrin associated periodic syndrome                                                     
                                                   Cryptophthalmos                                                                            
                                                   Cryptorchism                                                                               
                                                   Currarino syndrome                                                                         
                                                   Cutaneovisceral angiomatosis with thrombocytopenia                                         
                                                   Cyclic neutropenia                                                                         
                                                   Cyclopia                                                                                   
                                                   Cystathionine beta-synthase deficiency                                                     
                                                   Cystic fibrosis                                                                            
                                                   Cystic fibrosis carrier                                                                    
                                                   Cystic fibrosis gastrointestinal disease                                                   
.


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Date: 
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Status: 
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Novo Nordisk 
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Rare events                                        Cystic fibrosis hepatic disease                                                            
                                                   Cystic fibrosis lung                                                                       
                                                   Cystic fibrosis pancreatic                                                                 
                                                   Cystic fibrosis related diabetes                                                           
                                                   Cystinosis                                                                                 
                                                   Cystinuria                                                                                 
                                                   Cytogenetic abnormality                                                                    
                                                   Cytomegalovirus nephritis                                                                  
                                                   Cytopenia                                                                                  
                                                   DNA mismatch repair protein gene mutation                                                  
                                                   DOOR syndrome                                                                              
                                                   Dacryocystocoele                                                                           
                                                   Dacryostenosis congenital                                                                  
                                                   Dandy-Walker syndrome                                                                      
                                                   De Barsy syndrome                                                                          
                                                   Deaf mutism                                                                                
                                                   Deafness congenital                                                                        
                                                   Deficiency of the interleukin-1 receptor                                                   
                                                   antagonist                                                                                 
                                                   Deficiency of the interleukin-36 receptor                                                  
                                                   antagonist                                                                                 
                                                   Delayed foetal renal development                                                           
                                                   Delta-beta thalassaemia                                                                    
                                                   Demyelinating polyneuropathy                                                               
                                                   Dent's disease                                                                             
                                                   Dentatorubral-pallidoluysian atrophy                                                       
                                                   Dentofacial anomaly                                                                        
                                                   Dermatofibrosis lenticularis disseminata                                                   
                                                   Dermatoglyphic anomaly                                                                     
                                                   Desmin myopathy                                                                            
                                                   Developmental glaucoma                                                                     
                                                   Developmental hip dysplasia                                                                
                                                   Dextrocardia                                                                               
                                                   DiGeorge's syndrome                                                                        
                                                   Diabetic foetopathy                                                                        
                                                   Diaphragmatic aplasia                                                                      
                                                   Diastematomyelia                                                                           
                                                   Diastrophic dysplasia                                                                      
                                                   Diencephalic syndrome of infancy                                                           
                                                   Diethylstilboestrol syndrome                                                               
                                                   Differential white blood cell count abnormal                                               
                                                   Diffuse alveolar damage                                                                    
                                                   Dihydropyrimidine dehydrogenase deficiency                                                 
.


NN9535 
Clinical Trial Report 
Date: 
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Status: 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Dilatation intrahepatic duct congenital
Disorder of sex development
Disseminated neonatal herpes simplex
Distichiasis
Diverticulitis Meckel's
Diverticulum of pharynx, congenital
Dolichocolon
Donohue syndrome
Dopa-responsive dystonia
Double cortex syndrome
Double heterozygous sickling disorders
Double inlet left ventricle
Double outlet left ventricle
Double outlet right ventricle
Double ureter
Dowling-Degos disease
Duane's syndrome
Dubin-Johnson syndrome
Dubowitz syndrome
Duchenne muscular dystrophy
Duchenne muscular dystrophy gene carrier
Ductus arteriosus premature closure
Ductus arteriosus stenosis foetal
Ductus venosus agenesis
Duodenal atresia
Duplex appendix
Duplication of inferior vena cava
Dyke-Davidoff-Masson syndrome
Dyschondrosteosis
Dyschromatosis
Dysgnathia
Dysmorphism
Dysmyelination
EGFR gene mutation
EGFR gene overexpression
Eagle Barrett syndrome
Ear malformation
Early onset familial Alzheimer's disease
Early onset primary dystonia
Ebstein's anomaly
Ectonucleotide pyrophosphatase/phosphodiesterase
1 deficiency
Ectopia cordis
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
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Version: 
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Page: 
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Rare events                                        Ectopic kidney                                                                             
                                                   Ectopic ovary                                                                              
                                                   Ectopic posterior pituitary gland                                                          
                                                   Ectopic thyroid                                                                            
                                                   Ectopic ureter                                                                             
                                                   Ectrodactyly                                                                               
                                                   Ehlers-Danlos syndrome                                                                     
                                                   Elbow synostosis                                                                           
                                                   Elliptocytosis hereditary                                                                  
                                                   Ellis-van Creveld syndrome                                                                 
                                                   Emanuel syndrome                                                                           
                                                   Emery-Dreifuss muscular dystrophy                                                          
                                                   Encephalocele                                                                              
                                                   Encephalocutaneous angiomatosis                                                            
                                                   Endothelial protein C receptor polymorphism                                                
                                                   Enteric duplication                                                                        
                                                   Entropion congenital                                                                       
                                                   Eosinopenia                                                                                
                                                   Eosinophil count abnormal                                                                  
                                                   Eosinophil count decreased                                                                 
                                                   Eosinophil percentage decreased                                                            
                                                   Eosinophilia myalgia syndrome                                                              
                                                   Eosinophilic pneumonia                                                                     
                                                   Eosinophilic pneumonia acute                                                               
                                                   Eosinophilic pneumonia chronic                                                             
                                                   Epidermal naevus                                                                           
                                                   Epilepsy congenital                                                                        
                                                   Epilepsy with myoclonic-atonic seizures                                                    
                                                   Epispadias                                                                                 
                                                   Erythroblastosis foetalis                                                                  
                                                   Erythrokeratodermia variabilis                                                             
                                                   Essential fructosuria                                                                      
                                                   Exomphalos                                                                                 
                                                   Exophthalmos congenital                                                                    
                                                   External auditory canal atresia                                                            
                                                   Extrarenal pelvis                                                                          
                                                   Eye anterior chamber congenital anomaly                                                    
                                                   Eyelid ptosis congenital                                                                   
                                                   Fabry's disease                                                                            
                                                   Faciodigitogenital dysplasia                                                               
                                                   Facioscapulohumeral muscular dystrophy                                                     
                                                   Factor I deficiency                                                                        
                                                   Factor II deficiency                                                                       
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Rare events                                        Factor II mutation                                                                         
                                                   Factor III deficiency                                                                      
                                                   Factor IX deficiency                                                                       
                                                   Factor V Leiden carrier                                                                    
                                                   Factor V Leiden mutation                                                                   
                                                   Factor V deficiency                                                                        
                                                   Factor VII deficiency                                                                      
                                                   Factor VIII deficiency                                                                     
                                                   Factor X deficiency                                                                        
                                                   Factor XI deficiency                                                                       
                                                   Factor XII deficiency                                                                      
                                                   Factor XIII deficiency                                                                     
                                                   Fallot's pentalogy                                                                         
                                                   Fallot's tetralogy                                                                         
                                                   Fallot's trilogy                                                                           
                                                   Familial amyloidosis                                                                       
                                                   Familial amyotrophic lateral sclerosis                                                     
                                                   Familial cold autoinflammatory syndrome                                                    
                                                   Familial glucocorticoid deficiency                                                         
                                                   Familial hemiplegic migraine                                                               
                                                   Familial high density lipoprotein deficiency                                               
                                                   Familial hypertriglyceridaemia                                                             
                                                   Familial hypocalciuric hypercalcaemia                                                      
                                                   Familial infantile bilateral striatal necrosis                                             
                                                   Familial isolated hyperparathyroidism                                                      
                                                   Familial mediterranean fever                                                               
                                                   Familial periodic paralysis                                                                
                                                   Familial polycythaemia                                                                     
                                                   Familial renal glycosuria                                                                  
                                                   Familial scaphocephaly syndrome                                                            
                                                   Familial tremor                                                                            
                                                   Fanconi syndrome                                                                           
                                                   Fatal familial insomnia                                                                    
                                                   Fatty acid oxidation disorder                                                              
                                                   Febrile bone marrow aplasia                                                                
                                                   Febrile neutropenia                                                                        
                                                   Femoral anteversion                                                                        
                                                   Femoral facial syndrome                                                                    
                                                   Femoral retroversion                                                                       
                                                   Femur-fibula-ulna complex                                                                  
                                                   Fibrillary glomerulonephritis                                                              
                                                   Fibrodysplasia ossificans progressiva                                                      
                                                   Fibrous dysplasia of bone                                                                  
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
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Version: 
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Page: 
207 of 229 
 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Fibrous dysplasia of jaw                                                                   
                                                   Fibula agenesis                                                                            
                                                   Filippi syndrome                                                                           
                                                   Fissure of tongue, congenital                                                              
                                                   Floating-Harbor syndrome                                                                   
                                                   Focal segmental glomerulosclerosis                                                         
                                                   Foetal alcohol syndrome                                                                    
                                                   Foetal anticonvulsant syndrome                                                             
                                                   Foetal chromosome abnormality                                                              
                                                   Foetal malformation                                                                        
                                                   Foetal megacystis                                                                          
                                                   Foetal methotrexate syndrome                                                               
                                                   Foetal retinoid syndrome                                                                   
                                                   Foetal warfarin syndrome                                                                   
                                                   Foramen magnum stenosis                                                                    
                                                   Fountain syndrome                                                                          
                                                   Fragile X carrier                                                                          
                                                   Fragile X syndrome                                                                         
                                                   Fraser syndrome                                                                            
                                                   Freeman-Sheldon syndrome                                                                   
                                                   Frenulum breve                                                                             
                                                   Friedreich's ataxia                                                                        
                                                   Fructose-1,6-bisphosphatase deficiency                                                     
                                                   Fryns syndrome                                                                             
                                                   Full blood count abnormal                                                                  
                                                   Full blood count decreased                                                                 
                                                   GM2 gangliosidosis                                                                         
                                                   GNE myopathy                                                                               
                                                   GRACILE syndrome                                                                           
                                                   Galactosaemia                                                                              
                                                   Galactosialidosis                                                                          
                                                   Gallbladder agenesis                                                                       
                                                   Gallbladder anomaly congenital                                                             
                                                   Gap junction protein beta 2 gene mutation                                                  
                                                   Gastroenteritis clostridial                                                                
                                                   Gastrointestinal arteriovenous malformation                                                
                                                   Gastrointestinal disorder congenital                                                       
                                                   Gastrointestinal malformation                                                              
                                                   Gastroschisis                                                                              
                                                   Gatad2b associated neurodevelopmental disorder                                             
                                                   Gaucher's disease                                                                          
                                                   Gaucher's disease type I                                                                   
                                                   Gaucher's disease type II                                                                  
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Version: 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Gaucher's disease type III
Gelatinous transformation of the bone marrow
Gene mutation
Generalised resistance to thyroid hormone
Genetic polymorphism
Genitalia external ambiguous
Gilbert's syndrome
Gitelman's syndrome
Glomerulonephritis
Glomerulonephritis acute
Glomerulonephritis chronic
Glomerulonephritis membranoproliferative
Glomerulonephritis membranous
Glomerulonephritis minimal lesion
Glomerulonephritis proliferative
Glomerulonephritis rapidly progressive
Glucose transporter type 1 deficiency syndrome
Glucose-6-phosphate dehydrogenase deficiency
Glucose-galactose malabsorption
Glutathione synthetase deficiency
Glycogen storage disease type I
Glycogen storage disease type II
Glycogen storage disease type III  
Glycogen storage disease type IV
Glycogen storage disease type IX
Glycogen storage disease type V
Glycogen storage disease type VI
Glycogen storage disease type VII
Glycogen storage disease type VIII
Glycogen storage disorder
Gnathoschisis
Goitre congenital
Gollop-Wolfgang complex
Gonadal dysgenesis
Granulocyte count decreased
Granulocytes abnormal
Granulocytes maturation arrest
Granulocytopenia
Granulocytopenia neonatal
Greig's syndrome
Grey matter heterotopia
Griscelli syndrome
Guillain-Barre syndrome
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
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209 of 229 
 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        H-ras gene mutation                                                                        
                                                   HER2 gene amplification                                                                    
                                                   HER2 protein overexpression                                                                
                                                   HERG gene mutation                                                                         
                                                   HIV associated nephropathy                                                                 
                                                   Haematotoxicity                                                                            
                                                   Haemochromatosis trait                                                                     
                                                   Haemoglobin C disease                                                                      
                                                   Haemoglobin C trait                                                                        
                                                   Haemoglobin D disease                                                                      
                                                   Haemoglobin D trait                                                                        
                                                   Haemoglobin E disease                                                                      
                                                   Haemoglobin E trait                                                                        
                                                   Haemoglobin E-thalassaemia disease                                                         
                                                   Haemoglobinopathy                                                                          
                                                   Haemophilia                                                                                
                                                   Haemophilia A with anti factor VIII                                                        
                                                   Haemophilia A without inhibitors                                                           
                                                   Haemophilia B with anti factor IX                                                          
                                                   Haemophilia B without inhibitors                                                           
                                                   Haemophilia carrier                                                                        
                                                   Haemorrhagic arteriovenous malformation                                                    
                                                   Hand-foot-genital syndrome                                                                 
                                                   Harlequin foetus                                                                           
                                                   Hartnup disease                                                                            
                                                   Heart disease congenital                                                                   
                                                   Hemihypertrophy                                                                            
                                                   Hemimegalencephaly                                                                         
                                                   Hemivertebra                                                                               
                                                   Hepatic arteriovenous malformation                                                         
                                                   Hepatitis virus-associated nephropathy                                                     
                                                   Hepato-lenticular degeneration                                                             
                                                   Hereditary angioedema with normal C1 esterase                                              
                                                   inhibitor                                                                                  
                                                   Hereditary areflexic dystasia                                                              
                                                   Hereditary ataxia                                                                          
                                                   Hereditary cerebral degeneration                                                           
                                                   Hereditary choroidal dystrophy                                                             
                                                   Hereditary disorder                                                                        
                                                   Hereditary fructose intolerance                                                            
                                                   Hereditary haemochromatosis                                                                
                                                   Hereditary haemolytic anaemia                                                              
                                                   Hereditary haemorrhagic telangiectasia                                                     
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
210 of 229 
 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Hereditary hypophosphataemic rickets                                                       
                                                   Hereditary motor and sensory neuropathy                                                    
                                                   Hereditary motor neurone disease                                                           
                                                   Hereditary neuropathic amyloidosis                                                         
                                                   Hereditary neuropathy with liability to pressure                                           
                                                   palsies                                                                                    
                                                   Hereditary optic atrophy                                                                   
                                                   Hereditary palmoplantar keratoderma                                                        
                                                   Hereditary renal microhaematuria                                                           
                                                   Hereditary retinal dystrophy                                                               
                                                   Hereditary sideroblastic anaemia                                                           
                                                   Hereditary spastic paraplegia                                                              
                                                   Hereditary spherocytosis                                                                   
                                                   Hereditary stomatocytosis                                                                  
                                                   Hermansky-Pudlak syndrome                                                                  
                                                   Hermaphroditism                                                                            
                                                   Hernia congenital                                                                          
                                                   Heterochromia iridis                                                                       
                                                   Heterotaxia                                                                                
                                                   Hexokinase deficiency anaemia                                                              
                                                   High arched palate                                                                         
                                                   Hollow visceral myopathy                                                                   
                                                   Holoprosencephaly                                                                          
                                                   Holt-Oram syndrome                                                                         
                                                   Homocystinaemia                                                                            
                                                   Homocystinuria                                                                             
                                                   Hooded prepuce                                                                             
                                                   Huntington's disease                                                                       
                                                   Hydranencephaly                                                                            
                                                   Hydrocele                                                                                  
                                                   Hydronephrosis                                                                             
                                                   Hydroureter                                                                                
                                                   Hydroxyprolinaemia                                                                         
                                                   Hyper IgD syndrome                                                                         
                                                   Hyper IgE syndrome                                                                         
                                                   Hyper IgM syndrome                                                                         
                                                   Hyperexplexia                                                                              
                                                   Hyperglycinaemia                                                                           
                                                   Hyperlysinaemia                                                                            
                                                   Hypermethioninaemia                                                                        
                                                   Hypermethioniuria                                                                          
                                                   Hypermutation                                                                              
                                                   Hyperphenylalaninaemia                                                                     
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
NN9535-4506 
- 
Version: 
1.0 
Page: 
211 of 229 
 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Hyperpipecolic acidaemia                                                                   
                                                   Hyperprolinaemia                                                                           
                                                   Hypersplenism congenital                                                                   
                                                   Hypertelorism of orbit                                                                     
                                                   Hyperthermia malignant                                                                     
                                                   Hypocalvaria                                                                               
                                                   Hypochondroplasia                                                                          
                                                   Hypodontia                                                                                 
                                                   Hypomelanosis of Ito                                                                       
                                                   Hypophosphatasia                                                                           
                                                   Hypopituitarism foetal                                                                     
                                                   Hypoplastic left heart syndrome                                                            
                                                   Hypoplastic nasal cartilage                                                                
                                                   Hypoplastic right heart syndrome                                                           
                                                   Hypospadias                                                                                
                                                   Hypotelorism of orbit                                                                      
                                                   Hypotonia-cystinuria syndrome                                                              
                                                   Hypoxanthine-guanine phosphoribosyl transferase                                            
                                                   deficiency                                                                                 
                                                   IPEX syndrome                                                                              
                                                   Ichthyosis                                                                                 
                                                   Idiopathic interstitial pneumonia                                                          
                                                   Idiopathic neutropenia                                                                     
                                                   Idiopathic pneumonia syndrome                                                              
                                                   Idiopathic pulmonary fibrosis                                                              
                                                   IgA nephropathy                                                                            
                                                   IgM nephropathy                                                                            
                                                   Ileal atresia                                                                              
                                                   Immune-mediated nephritis                                                                  
                                                   Immune-mediated pancytopenia                                                               
                                                   Immune-mediated pneumonitis                                                                
                                                   Immunodeficiency congenital                                                                
                                                   Immunotactoid glomerulonephritis                                                           
                                                   Imperforate hymen                                                                          
                                                   Imperforate oesophagus                                                                     
                                                   Inborn error in primary bile acid synthesis                                                
                                                   Inborn error of amino acid metabolism                                                      
                                                   Inborn error of bilirubin metabolism                                                       
                                                   Inborn error of lipid metabolism                                                           
                                                   Inborn error of metabolism                                                                 
                                                   Infantile cortical hyperostosis                                                            
                                                   Infantile genetic agranulocytosis                                                          
                                                   Inherited cardiac conduction disorder                                                      
.


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Rare events                                        Iniencephaly                                                                               
                                                   Interferon gamma receptor deficiency                                                       
                                                   Interleukin 28B polymorphism                                                               
                                                   Interruption of aortic arch                                                                
                                                   Interstitial lung disease                                                                  
                                                   Intestinal atresia                                                                         
                                                   Intestinal malrotation                                                                     
                                                   Intestinal neuronal dysplasia                                                              
                                                   Intestinal transposition                                                                   
                                                   Intracranial arterial fenestration                                                         
                                                   Intracranial lipoma                                                                        
                                                   Iris coloboma                                                                              
                                                   Isodicentric chromosome 15 syndrome                                                        
                                                   Isovaleric acidaemia                                                                       
                                                   Janus kinase 2 mutation                                                                    
                                                   Johanson-Blizzard syndrome                                                                 
                                                   Joubert syndrome                                                                           
                                                   Juvenile Paget's disease                                                                   
                                                   K-ras gene mutation                                                                        
                                                   Kabuki make-up syndrome                                                                    
                                                   Kaufman-McKusick syndrome                                                                  
                                                   Kearns-Sayre syndrome                                                                      
                                                   Kenny-Caffey syndrome                                                                      
                                                   Keratitis-ichthyosis-deafness syndrome                                                     
                                                   Keratolysis exfoliativa congenital                                                         
                                                   Keratosis follicular                                                                       
                                                   Kidney duplex                                                                              
                                                   Kidney malformation                                                                        
                                                   Kidney malrotation                                                                         
                                                   Kimmerle's anomaly                                                                         
                                                   Kinematic imbalances due to suboccipital strain                                            
                                                   Kleefstra syndrome                                                                         
                                                   Klinefelter's syndrome                                                                     
                                                   Klippel-Feil syndrome                                                                      
                                                   Klippel-Trenaunay syndrome                                                                 
                                                   Kniest dysplasia                                                                           
                                                   Kommerell's diverticulum                                                                   
                                                   Kosaki overgrowth syndrome                                                                 
                                                   Krabbe's disease                                                                           
                                                   Kyphosis congenital                                                                        
                                                   LDLR mutation                                                                              
                                                   Laband syndrome                                                                            
                                                   Labial tie                                                                                 
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Lacrimal punctum agenesis
Laevocardia
Lafora's myoclonic epilepsy
Lamin A/C gene mutation
Langer-Giedion syndrome
Laron syndrome
Larsen syndrome
Laryngeal cleft
Laryngeal web
Laryngo-onycho-cutaneous syndrome
Laryngocele 
Laryngomalacia
Laurence-Moon-Bardet-Biedl syndrome
Leber's congenital amaurosis
Lecithin-cholesterol acyltransferase deficiency
Left ventricle outflow tract obstruction
Left ventricular false tendon
Left-to-right cardiac shunt
Lens abnormality, congenital
Leptin receptor deficiency
Leukocyte adhesion deficiency type I
Leukodystrophy
Leukopenia
Leukopenia neonatal
Li-Fraumeni syndrome
Lichen spinulosus
Liddle's syndrome
Limb hypoplasia congenital
Limb malformation
Limb reduction defect
Lipid proteinosis
Lipidosis
Lipomeningocele
Lissencephaly
Loeys-Dietz syndrome
Long-chain acyl-coenzyme A dehydrogenase
deficiency
Low set ears
Lowry-Wood syndrome
Lumbarisation
Lung infiltration
Lupus nephritis
Lymphangiectasia intestinal congenital
.


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Rare events                                        Lymphocyte count abnormal                                                                  
                                                   Lymphocyte count decreased                                                                 
                                                   Lymphocyte percentage abnormal                                                             
                                                   Lymphocyte percentage decreased                                                            
                                                   Lymphocytopenia neonatal                                                                   
                                                   Lymphopenia                                                                                
                                                   Lysinuric protein intolerance                                                              
                                                   Lysosomal acid lipase deficiency                                                           
                                                   MELAS syndrome                                                                             
                                                   MLASA syndrome                                                                             
                                                   MYH9-related disease                                                                       
                                                   Macrocephaly                                                                               
                                                   Macrocheilia                                                                               
                                                   Macrocornea                                                                                
                                                   Macrodactyly                                                                               
                                                   Macrogenia                                                                                 
                                                   Macroglossia                                                                               
                                                   Macrognathia                                                                               
                                                   Macrostomia                                                                                
                                                   Macrotia                                                                                   
                                                   Macular dystrophy congenital                                                               
                                                   Majeed's syndrome                                                                          
                                                   Malformation biliary                                                                       
                                                   Malformation venous                                                                        
                                                   Mandibulofacial dysostosis                                                                 
                                                   Mannose-binding lectin deficiency                                                          
                                                   Maple syrup disease                                                                        
                                                   Marcus Gunn syndrome                                                                       
                                                   Marfan's syndrome                                                                          
                                                   Maxillonasal dysplasia                                                                     
                                                   Mayer-Rokitansky-Kuster-Hauser syndrome                                                    
                                                   McLeod neuroacanthocytosis syndrome                                                        
                                                   Medium-chain acyl-coenzyme A dehydrogenase                                                 
                                                   deficiency                                                                                 
                                                   Megakaryocytes decreased                                                                   
                                                   Meier-Gorlin syndrome                                                                      
                                                   Melkersson-Rosenthal syndrome                                                              
                                                   Membranous lipodystrophy                                                                   
                                                   Membranous-like glomerulopathy with masked                                                 
                                                   IgG-kappa deposits                                                                         
                                                   Meningocele                                                                                
                                                   Meningomyelocele                                                                           
                                                   Menkes' syndrome                                                                           
.


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Rare events                                        Mesangioproliferative glomerulonephritis                                                   
                                                   Metabolic myopathy                                                                         
                                                   Metachromatic leukodystrophy                                                               
                                                   Metamyelocyte count decreased                                                              
                                                   Metaphyseal dysplasia                                                                      
                                                   Metatarsus primus varus                                                                    
                                                   Metatropic dysplasia                                                                       
                                                   Methylenetetrahydrofolate reductase deficiency                                             
                                                   Methylenetetrahydrofolate reductase gene mutation                                          
                                                   Methylenetetrahydrofolate reductase polymorphism                                           
                                                   Methylmalonic aciduria                                                                     
                                                   Mevalonate kinase deficiency                                                               
                                                   Mevalonic aciduria                                                                         
                                                   Microcephaly                                                                               
                                                   Microcheilia                                                                               
                                                   Microcolon                                                                                 
                                                   Microcornea                                                                                
                                                   Microencephaly                                                                             
                                                   Microgenia                                                                                 
                                                   Microglossia                                                                               
                                                   Micrognathia                                                                               
                                                   Microorchidism                                                                             
                                                   Micropenis                                                                                 
                                                   Microphthalmos                                                                             
                                                   Microstomia                                                                                
                                                   Microtia                                                                                   
                                                   Microvillous inclusion disease                                                             
                                                   Miller Fisher syndrome                                                                     
                                                   Mitochondrial DNA deletion                                                                 
                                                   Mitochondrial DNA depletion                                                                
                                                   Mitochondrial DNA duplication                                                              
                                                   Mitochondrial DNA mutation                                                                 
                                                   Mitochondrial encephalomyopathy                                                            
                                                   Mitochondrial enzyme deficiency                                                            
                                                   Mitochondrial hepatopathy                                                                  
                                                   Mitochondrial myopathy                                                                     
                                                   Mitochondrial neurogastrointestinal encephalopathy                                         
                                                   Mitral valve atresia                                                                       
                                                   Mitral valve hypoplasia                                                                    
                                                   Mittendorf dot                                                                             
                                                   Mobile caecum syndrome                                                                     
                                                   Moebius II syndrome                                                                        
                                                   Molybdenum cofactor deficiency                                                             
.


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Rare events                                        Monoblast count decreased                                                                  
                                                   Monocyte count abnormal                                                                    
                                                   Monocyte count decreased                                                                   
                                                   Monocyte percentage decreased                                                              
                                                   Monocytopenia                                                                              
                                                   Monolid eyes                                                                               
                                                   Mononuclear cell count decreased                                                           
                                                   Monopodia                                                                                  
                                                   Morgagni-Stewart-Morel syndrome                                                            
                                                   Morning glory syndrome                                                                     
                                                   Morton's syndrome                                                                          
                                                   Mosaicism                                                                                  
                                                   Mount-Reback syndrome                                                                      
                                                   Muckle-Wells syndrome                                                                      
                                                   Mucolipidosis                                                                              
                                                   Mucolipidosis type I                                                                       
                                                   Mucolipidosis type II                                                                      
                                                   Mucolipidosis type III                                                                     
                                                   Mucolipidosis type IV                                                                      
                                                   Mucopolysaccharidosis                                                                      
                                                   Mucopolysaccharidosis I                                                                    
                                                   Mucopolysaccharidosis II                                                                   
                                                   Mucopolysaccharidosis III                                                                  
                                                   Mucopolysaccharidosis IV                                                                   
                                                   Mucopolysaccharidosis IX                                                                   
                                                   Mucopolysaccharidosis V                                                                    
                                                   Mucopolysaccharidosis VI                                                                   
                                                   Mucopolysaccharidosis VII                                                                  
                                                   Multiple carboxylase deficiency                                                            
                                                   Multiple cardiac defects                                                                   
                                                   Multiple congenital abnormalities                                                          
                                                   Multiple epiphyseal dysplasia                                                              
                                                   Multiple gastrointestinal atresias                                                         
                                                   Multiple lentigines syndrome                                                               
                                                   Muscular dystrophy                                                                         
                                                   Mutagenic effect                                                                           
                                                   Myeloblast count decreased                                                                 
                                                   Myeloblast percentage decreased                                                            
                                                   Myelocyte count decreased                                                                  
                                                   Myelocyte percentage decreased                                                             
                                                   Myeloid maturation arrest                                                                  
                                                   Myeloperoxidase deficiency                                                                 
                                                   Myocardial bridging                                                                        
.


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Rare events                                        Myoclonic epilepsy and ragged-red fibres                                                   
                                                   Myotonia congenita                                                                         
                                                   Myotonic dystrophy                                                                         
                                                   N-acetylglutamate synthase deficiency                                                      
                                                   N-ras gene mutation                                                                        
                                                   NAT1 polymorphism                                                                          
                                                   NAT2 polymorphism                                                                          
                                                   NTRK gene fusion overexpression                                                            
                                                   NUT gene mutation                                                                          
                                                   Naevus anaemicus                                                                           
                                                   Naevus flammeus                                                                            
                                                   Naevus spider congenital                                                                   
                                                   Nail aplasia                                                                               
                                                   Nail-patella syndrome                                                                      
                                                   Nasopharyngeal atresia                                                                     
                                                   Necrotising bronchiolitis                                                                  
                                                   Neonatal alloimmune thrombocytopenia                                                       
                                                   Neonatal haemochromatosis                                                                  
                                                   Neonatal lupus erythematosus                                                               
                                                   Nephritic syndrome                                                                         
                                                   Nephritis                                                                                  
                                                   Nephritis haemorrhagic                                                                     
                                                   Nephritis radiation                                                                        
                                                   Nephrotic syndrome                                                                         
                                                   Netherton's syndrome                                                                       
                                                   Neural tube defect                                                                         
                                                   Neuroacanthocytosis                                                                        
                                                   Neurodegeneration with brain iron accumulation                                             
                                                   disorder                                                                                   
                                                   Neuroleptic malignant syndrome                                                             
                                                   Neuronal ceroid lipofuscinosis                                                             
                                                   Neuronal migration disorder                                                                
                                                   Neuropathy, ataxia, retinitis pigmentosa syndrome                                          
                                                   Neutropenia                                                                                
                                                   Neutropenia neonatal                                                                       
                                                   Neutropenic infection                                                                      
                                                   Neutropenic sepsis                                                                         
                                                   Neutrophil Fc gamma RIIIb deficiency                                                       
                                                   Neutrophil count abnormal                                                                  
                                                   Neutrophil count decreased                                                                 
                                                   Neutrophil percentage decreased                                                            
                                                   Newborn persistent pulmonary hypertension                                                  
                                                   Niemann-Pick disease                                                                       
.


NN9535 
Clinical Trial Report 
Date: 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Nievergelt-Pearlman syndrome
Nijmegen breakage syndrome
Non-compaction cardiomyopathy
Noonan syndrome
Norrie's disease
OHVIRA syndrome
Obliterative bronchiolitis
Ocular albinism
Oculoauriculovertebral dysplasia   
Oculocerebrorenal syndrome
Oculodentodigital dysplasia
Oculopharyngeal dystrophy
Oesophageal atresia
Oestrogen receptor gene overexpression
Ogden syndrome
Olfacto genital dysplasia
Olfactory nerve agenesis
Olmsted syndrome
Opitz trigonocephaly syndrome
Opitz-G/BBB syndrome
Optic disc pit
Optic nerve hypoplasia
Oral-facial-digital syndrome type II
Ornithine transcarbamoylase deficiency
Oroticaciduria congenital
Os trigonum
Osteogenesis imperfecta
Osteopathia striata
Osteopetrosis
Osteopoikilosis
Osteoporosis-pseudoglioma syndrome
Otocephaly
Ovarian agenesis
Ovarian hypoplasia
Oxycephaly
PAPSS2 gene mutation
PIK3CA related overgrowth spectrum
PIK3CA-activated mutation
PSTPIP1-associated myeloid-related proteinaemia
inflammatory syndrome
PTEN gene mutation
Pachydermoperiostosis
Pachygyria
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Pachyonychia congenita                                                                     
                                                   Pallister-Killian syndrome                                                                 
                                                   Pancreas divisum                                                                           
                                                   Pancytopenia                                                                               
                                                   Panmyelopathy                                                                              
                                                   Papillon-Lefevre syndrome                                                                  
                                                   Parachute mitral valve                                                                     
                                                   Paranasal sinus aplasia                                                                    
                                                   Paranasal sinus hypoplasia                                                                 
                                                   Parkes-Weber syndrome                                                                      
                                                   Paroxysmal extreme pain disorder                                                           
                                                   Patent ductus arteriosus                                                                   
                                                   Pearson's syndrome                                                                         
                                                   Pectus carinatum                                                                           
                                                   Pectus excavatum                                                                           
                                                   Pelizaeus-Merzbacher disease                                                               
                                                   Pelvi-ureteric obstruction                                                                 
                                                   Pelvic fibrosis                                                                            
                                                   Pelvic kidney                                                                              
                                                   Pendred syndrome                                                                           
                                                   Penile torsion                                                                             
                                                   Penoscrotal fusion                                                                         
                                                   Penoscrotal transposition                                                                  
                                                   Penta X syndrome                                                                           
                                                   Perinephritis                                                                              
                                                   Periodontal congenital anomaly                                                             
                                                   Perry syndrome                                                                             
                                                   Persistent Muellerian duct syndrome                                                        
                                                   Persistent cloaca                                                                          
                                                   Persistent foetal circulation                                                              
                                                   Persistent left superior vena cava                                                         
                                                   Persistent pupillary membrane                                                              
                                                   Persistent urogenital sinus                                                                
                                                   Pfeiffer syndrome                                                                          
                                                   Phalangeal agenesis                                                                        
                                                   Phalangeal hypoplasia                                                                      
                                                   Phelan-McDermid syndrome                                                                   
                                                   Phenylketonuria                                                                            
                                                   Phimosis                                                                                   
                                                   Phytosterolaemia                                                                           
                                                   Pierre Robin syndrome                                                                      
                                                   Pilonidal cyst congenital                                                                  
                                                   Plagiocephaly                                                                              
.


NN9535 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Plasma cell disorder
Plasma cells absent
Plasmablast count decreased
Plasminogen activator inhibitor polymorphism
Plasminogen activator inhibitor type 1 deficiency
Platelet count decreased
Platelet glycoprotein gene mutation
Platelet maturation arrest
Platelet production decreased
Platelet toxicity
Platelet-derived growth factor receptor gene
mutation
Platelet-derived growth factor receptor
overexpression
Platonychia
Platybasia
Platyspondylia
Pneumonitis
Poland's syndrome
Polycystic liver disease
Polydactyly
Polymicrogyria
Polyorchidism
Popliteal pterygium syndrome
Porencephaly
Porokeratosis
Porphyria
Porphyria acute
Porphyria non-acute
Porphyrin metabolism disorder
Porphyrinuria
Portal venous system anomaly
Post infection glomerulonephritis
Post streptococcal glomerulonephritis
Postauricular fistula
Posterior segment of eye anomaly congenital
Potter's syndrome
Prader-Willi syndrome
Preauricular cyst
Preduodenal portal vein
Preternatural anus
Primary cerebellar degeneration
Primary ciliary dyskinesia
.


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Rare events                                        Primary coenzyme Q10 deficiency                                                            
                                                   Primary familial hypomagnesaemia                                                           
                                                   Primary hypercholesterolaemia                                                              
                                                   Primary hyperoxaluria                                                                      
                                                   Primary immunodeficiency syndrome                                                          
                                                   Primary insulin like growth factor-1 deficiency                                            
                                                   Pro-opiomelanocortin deficiency                                                            
                                                   Progeria                                                                                   
                                                   Progesterone receptor gene overexpression                                                  
                                                   Progressive cerebellar degeneration                                                        
                                                   Progressive external ophthalmoplegia                                                       
                                                   Progressive familial intrahepatic cholestasis                                              
                                                   Progressive massive fibrosis                                                               
                                                   Prominent epicanthal folds                                                                 
                                                   Promyelocyte count decreased                                                               
                                                   Protein C deficiency                                                                       
                                                   Protein S deficiency                                                                       
                                                   Proteus syndrome                                                                           
                                                   Protuberant ear                                                                            
                                                   Proximal focal femoral deficiency                                                          
                                                   Pseudocholinesterase deficiency                                                            
                                                   Pseudohermaphroditism                                                                      
                                                   Pseudohermaphroditism female                                                               
                                                   Pseudohermaphroditism male                                                                 
                                                   Pseudohypoaldosteronism                                                                    
                                                   Pseudohypoparathyroidism                                                                   
                                                   Pseudomembranous colitis                                                                   
                                                   Pseudotruncus arteriosus                                                                   
                                                   Pseudoxanthoma elasticum                                                                   
                                                   Pterygium colli                                                                            
                                                   Pulmonary aplasia                                                                          
                                                   Pulmonary arteriovenous fistula                                                            
                                                   Pulmonary artery atresia                                                                   
                                                   Pulmonary artery stenosis congenital                                                       
                                                   Pulmonary fibrosis                                                                         
                                                   Pulmonary hypoplasia                                                                       
                                                   Pulmonary lymphangiectasia                                                                 
                                                   Pulmonary malformation                                                                     
                                                   Pulmonary necrosis                                                                         
                                                   Pulmonary radiation injury                                                                 
                                                   Pulmonary renal syndrome                                                                   
                                                   Pulmonary sequestration                                                                    
                                                   Pulmonary toxicity                                                                         
.


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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Pulmonary valve stenosis congenital                                                        
                                                   Pure white cell aplasia                                                                    
                                                   Pycnodysostosis                                                                            
                                                   Pyloric stenosis                                                                           
                                                   Pyogenic sterile arthritis pyoderma gangrenosum                                            
                                                   and acne syndrome                                                                          
                                                   Pyruvate carboxylase deficiency                                                            
                                                   Pyruvate dehydrogenase complex deficiency                                                  
                                                   Pyruvate kinase deficiency anaemia                                                         
                                                   RET gene mutation                                                                          
                                                   ROS1 gene rearrangement                                                                    
                                                   RPE65 gene mutation                                                                        
                                                   Radiation alveolitis                                                                       
                                                   Radiation fibrosis - lung                                                                  
                                                   Radiation leukopenia                                                                       
                                                   Radiation pneumonitis                                                                      
                                                   Rapid-onset dystonia-parkinsonism                                                          
                                                   Rathke's cleft cyst                                                                        
                                                   Rectal atresia                                                                             
                                                   Red blood cell enzymes abnormal                                                            
                                                   Refsum's disease                                                                           
                                                   Renal aplasia                                                                              
                                                   Renal arteriovenous malformation                                                           
                                                   Renal dysplasia                                                                            
                                                   Renal fusion anomaly                                                                       
                                                   Renal hypoplasia                                                                           
                                                   Renal malposition                                                                          
                                                   Renal vessel congenital anomaly                                                            
                                                   Reproductive tract hypoplasia, male                                                        
                                                   Respiratory tract malformation                                                             
                                                   Retinal anomaly congenital                                                                 
                                                   Retinal arteriovenous malformation                                                         
                                                   Retinal coloboma                                                                           
                                                   Retinitis pigmentosa                                                                       
                                                   Retinopathy congenital                                                                     
                                                   Retinoschisis congenital                                                                   
                                                   Retroperitonitis                                                                           
                                                   Rett syndrome                                                                              
                                                   Rhesus haemolytic disease of newborn                                                       
                                                   Rib hypoplasia                                                                             
                                                   Rib synostosis                                                                             
                                                   Right aortic arch                                                                          
                                                   Right ventricular false tendon                                                             
.


NN9535 
Clinical Trial Report 
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04 December 2020 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Rare events
Right-to-left cardiac shunt
Riley-Day syndrome
Ring chromosome
Rippling muscle disease
Rotor's syndrome
Rubinstein-Taybi syndrome
SADDAN syndrome
SATB2-associated syndrome
Sacral hypoplasia
Sacralisation
Saposin C deficiency
Sarcoglycanopathy
Sarcosinaemia
Scaphocephaly
Schimke immunoosseous dysplasia
Schinzel-Giedion syndrome
Schizencephaly
Schmid Fraccaro syndrome
Schwartz Jampel syndrome
Scimitar syndrome
Sclerotylosis
Sensory neuropathy hereditary
Septate hymen
Septo-optic dysplasia
Septum pellucidum agenesis
Serotonin syndrome
Sertoli-cell-only syndrome
Severe myoclonic epilepsy of infancy
Severe primary insulin like growth factor-1
deficiency
Sex chromosome abnormality
Shawl scrotum
Shone complex
Short stature homeobox gene mutation 
Short-chain acyl-coenzyme A dehydrogenase
deficiency
Shprintzen-Goldberg syndrome
Shwachman-Diamond syndrome
Sickle cell anaemia
Sickle cell disease
Sickle cell trait
Silver-Russell syndrome
Single atrium
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
Final 
Novo Nordisk 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Single umbilical artery                                                                    
                                                   Sirenomelia                                                                                
                                                   Sjogren-Larsson syndrome                                                                   
                                                   Skeletal dysplasia                                                                         
                                                   Skin hypoplasia                                                                            
                                                   Skin malformation                                                                          
                                                   Skull malformation                                                                         
                                                   Small airways disease                                                                      
                                                   Smith-Lemli-Opitz syndrome                                                                 
                                                   Smith-Magenis syndrome                                                                     
                                                   Sotos' syndrome                                                                            
                                                   Special senses congenital anomaly                                                          
                                                   Spherophakia                                                                               
                                                   Spina bifida                                                                               
                                                   Spina bifida cystica                                                                       
                                                   Spina bifida occulta                                                                       
                                                   Spinal muscular atrophy                                                                    
                                                   Spine malformation                                                                         
                                                   Spleen malformation                                                                        
                                                   Spondyloepiphyseal dysplasia                                                               
                                                   Stahl's ear                                                                                
                                                   Stargardt's disease                                                                        
                                                   Stickler's syndrome                                                                        
                                                   Sticky platelet syndrome                                                                   
                                                   Strabismus congenital                                                                      
                                                   Straddling tricuspid valve                                                                 
                                                   Sturge-Weber syndrome                                                                      
                                                   Subacute inflammatory demyelinating polyneuropathy                                         
                                                   Sucrase-isomaltase deficiency                                                              
                                                   Supernumerary nipple                                                                       
                                                   Supernumerary vertebra                                                                     
                                                   Syndactyly                                                                                 
                                                   Synostosis                                                                                 
                                                   Syringomyelia                                                                              
                                                   Systemic right ventricle                                                                   
                                                   T-lymphocyte count abnormal                                                                
                                                   T-lymphocyte count decreased                                                               
                                                   TORCH infection                                                                            
                                                   TRPV4 gene mutation                                                                        
                                                   Talipes                                                                                    
                                                   Tangier disease                                                                            
                                                   Telangiectasia congenital                                                                  
                                                   Teratogenicity                                                                             
.


NN9535 
Clinical Trial Report 
Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
- 
Version: 
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Pre-defined MedDRA search - list of preferred terms 
  
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Testicular dysplasia                                                                       
                                                   Testotoxicosis                                                                             
                                                   Tetrahydrobiopterin deficiency                                                             
                                                   Thalassaemia                                                                               
                                                   Thalassaemia alpha                                                                         
                                                   Thalassaemia beta                                                                          
                                                   Thalassaemia minor                                                                         
                                                   Thalassaemia sickle cell                                                                   
                                                   Thalidomide embryopathy                                                                    
                                                   Thanatophoric dwarfism                                                                     
                                                   Thiopurine methyltransferase polymorphism                                                  
                                                   Thrombocytopenia                                                                           
                                                   Thrombocytopenia-absent radius syndrome                                                    
                                                   Thymus hypoplasia                                                                          
                                                   Thyroglossal fistula                                                                       
                                                   Thyroid hemiagenesis                                                                       
                                                   Thyroid malformation                                                                       
                                                   Tibial agenesis                                                                            
                                                   Tibial torsion                                                                             
                                                   Tilted disc syndrome                                                                       
                                                   Timothy syndrome                                                                           
                                                   Tooth discolouration congenital                                                            
                                                   Tooth hypoplasia                                                                           
                                                   Tooth malformation hereditary                                                              
                                                   Tourette's disorder                                                                        
                                                   Tracheal atresia                                                                           
                                                   Tracheal web                                                                               
                                                   Tracheo-oesophageal fistula                                                                
                                                   Tracheobronchomegaly                                                                       
                                                   Transcobalamin deficiency                                                                  
                                                   Transfusion-related acute lung injury                                                      
                                                   Transgenerational epigenetic inheritance                                                   
                                                   Transitional vertebrae                                                                     
                                                   Transmembrane receptor tyrosine kinase                                                     
                                                   overexpression                                                                             
                                                   Transposition of the great vessels                                                         
                                                   Trichorhinophalangeal syndrome                                                             
                                                   Trifunctional protein deficiency                                                           
                                                   Trimethylaminuria                                                                          
                                                   Triple A syndrome                                                                          
                                                   Trisomy 11                                                                                 
                                                   Trisomy 13                                                                                 
                                                   Trisomy 14                                                                                 
.


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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
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Version: 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Trisomy 15                                                                                 
                                                   Trisomy 16                                                                                 
                                                   Trisomy 17                                                                                 
                                                   Trisomy 18                                                                                 
                                                   Trisomy 21                                                                                 
                                                   Trisomy 22                                                                                 
                                                   Trisomy 4p                                                                                 
                                                   Trisomy 8                                                                                  
                                                   Trisomy 9                                                                                  
                                                   Truncus arteriosus persistent                                                              
                                                   Tubulointerstitial nephritis                                                               
                                                   Tubulointerstitial nephritis and uveitis syndrome                                          
                                                   Tumour necrosis factor receptor-associated                                                 
                                                   periodic syndrome                                                                          
                                                   Turner's syndrome                                                                          
                                                   Twin reversed arterial perfusion sequence                                                  
                                                   malformation                                                                               
                                                   Tympanomeningeal fissure                                                                   
                                                   Type I hyperlipidaemia                                                                     
                                                   Type II hyperlipidaemia                                                                    
                                                   Type III hyperlipidaemia                                                                   
                                                   Type IIa hyperlipidaemia                                                                   
                                                   Type IIb hyperlipidaemia                                                                   
                                                   Type IV hyperlipidaemia                                                                    
                                                   Type V hyperlipidaemia                                                                     
                                                   Tyrosinaemia                                                                               
                                                   Tyrosine kinase mutation                                                                   
                                                   UGT1A1 gene mutation                                                                       
                                                   UGT1A1 gene polymorphism                                                                   
                                                   Uhl's anomaly                                                                              
                                                   Umbilical artery hypoplasia                                                                
                                                   Umbilical malformation                                                                     
                                                   Unicuspid aortic valve                                                                     
                                                   Univentricular heart                                                                       
                                                   Urachal abnormality                                                                        
                                                   Urea cycle disorder                                                                        
                                                   Ureteric atresia                                                                           
                                                   Ureteric compression                                                                       
                                                   Ureteric dilatation                                                                        
                                                   Ureteric obstruction                                                                       
                                                   Ureteric stenosis                                                                          
                                                   Urethral atresia                                                                           
                                                   Urethral valves                                                                            
.


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Date: 
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Status: 
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Novo Nordisk 
NN9535-4506 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Urinary tract malformation                                                                 
                                                   Urinary tract obstruction                                                                  
                                                   Usher's syndrome                                                                           
                                                   Uterine aplasia                                                                            
                                                   Uterine cervix canal atresia                                                               
                                                   Uterine cervix hypoplasia                                                                  
                                                   Uterine hypoplasia                                                                         
                                                   Uvula aplasia                                                                              
                                                   VACTERL syndrome                                                                           
                                                   VKORC1 gene polymorphism                                                                   
                                                   Vaginal atresia                                                                            
                                                   Vaginal hypoplasia                                                                         
                                                   Vaginal septum                                                                             
                                                   Vascular endothelial growth factor overexpression                                          
                                                   Vascular malformation                                                                      
                                                   Velo-cardio-facial syndrome                                                                
                                                   Venolymphatic malformation                                                                 
                                                   Ventricular hypoplasia                                                                     
                                                   Ventricular septal defect                                                                  
                                                   Vertebral artery hypoplasia                                                                
                                                   Vertical talus                                                                             
                                                   Very long-chain acyl-coenzyme A dehydrogenase                                              
                                                   deficiency                                                                                 
                                                   Vestibulocerebellar syndrome                                                               
                                                   Virilism foetal                                                                            
                                                   Vitello-intestinal duct remnant                                                            
                                                   Von Hippel-Lindau disease                                                                  
                                                   Von Willebrand's disease                                                                   
                                                   Von Willebrand's disease gene carrier                                                      
                                                   Waardenburg syndrome                                                                       
                                                   Wagner's disease                                                                           
                                                   Weaver syndrome                                                                            
                                                   Weill-Marchesani syndrome                                                                  
                                                   Welander distal myopathy                                                                   
                                                   Werner's syndrome                                                                          
                                                   White blood cell analysis abnormal                                                         
                                                   White blood cell count abnormal                                                            
                                                   White blood cell count decreased                                                           
                                                   White blood cell disorder                                                                  
                                                   Wildervanck syndrome                                                                       
                                                   Williams syndrome                                                                          
                                                   Winchester syndrome                                                                        
                                                   Wiskott-Aldrich syndrome                                                                   
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
NN9535-4506 
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Version: 
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Pre-defined MedDRA search                          Preferred term                                                                             
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
                                                                                                                                              
Rare events                                        Wolf-Hirschhorn syndrome                                                                   
                                                   Wolfram syndrome                                                                           
                                                   Woodhouse-Sakati syndrome                                                                  
                                                   Wyburn Mason's syndrome                                                                    
                                                   X-linked chromosomal disorder                                                              
                                                   X-linked intellectual disability, Siderius type                                            
                                                   XXX syndrome                                                                               
                                                   XXXY syndrome                                                                              
                                                   XXYY syndrome                                                                              
                                                   XYY syndrome                                                                               
                                                   Xeroderma pigmentosum                                                                      
                                                   Y-linked chromosomal disorder                                                              
                                                   Young's syndrome                                                                           
                                                   Zhu-Tokita-Takenouchi-Kim syndrome                                                         
                                                   Zika virus associated Guillain Barre syndrome                                              
                                                   Zika virus associated birth defect                                                         
                                                   Zika virus associated microencephaly                                                       
                                                   Zika virus associated ocular birth defect                                                  
                                                                                                                                              
Suspected transmission of an infectious agent      Air-borne transmission                                                                     
                                                   Arthropod-borne disease                                                                    
                                                   Bacterial disease carrier                                                                  
                                                   Community acquired infection                                                               
                                                   Diphtheria carrier                                                                         
                                                   Direct infection transmission                                                              
                                                   Faecal-oral transmission of infection                                                      
                                                   Fungal disease carrier                                                                     
                                                   HIV carrier                                                                                
                                                   HTLV-1 carrier                                                                             
                                                   Human immunodeficiency virus transmission                                                  
                                                   Iatrogenic infection                                                                       
                                                   Indirect infection transmission                                                            
                                                   Infection transmission via personal contact                                                
                                                   Infection via vaccinee                                                                     
                                                   Infectious disease carrier                                                                 
                                                   Mycobacterial disease carrier                                                              
                                                   Nosocomial infection                                                                       
                                                   Primary transmission                                                                       
                                                   SARS-CoV-2 carrier                                                                         
                                                   Secondary transmission                                                                     
                                                   Sexual transmission of infection                                                           
                                                   Sexually transmitted disease                                                               
                                                   Sexually transmitted disease carrier                                                       
.


NN9535 
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Date: 
04 December 2020 
Status: 
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Novo Nordisk 
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Version: 
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————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Pre-defined MedDRA search                          Preferred term
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
Suspected transmission of an infectious agent
Suspected transmission of an infectious agent via
product
Transmission of an infectious agent via product
Transmission of an infectious agent via transplant
Typhoid carrier
Vaccine bacteria shedding
Vaccine virus shedding
Vector-borne transmission of infection  
Vertical infection transmission
Viral disease carrier
Viral hepatitis carrier
————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— 
MeDRA version 23.0
nn9535/nn9535-4506/ctr_20201204_er 
04DEC2020:14:40:12 - lmeddrapt.sas/lmeddrapt.txt 
.

Prot_000.pdf: 
Cover Page for Protocol 
Sponsor name: 
Novo Nordisk A/S 
NCT number 
NCT03989232 
Sponsor trial ID: 
NN9535-4506 
Official title of study: 
Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly 
Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects 
With Type 2 Diabetes 
Document date*: 
'HFHPEHU 2020 
*Document date refers to the date on which the document was most recently updated.
Note: The date in the header from Page 2 is the date of compilation of the documents and not of an update to content.


Link
Link
Link
Link
List of contents
Protocol  Y...........................................................................
Attachment I and II............................................................................................................................
Protocol amendment 1 - CZ ..............................................................................................................
Protocol Amendment  2 - Global.......................................................................................................
CONFIDENTIAL
Date:
Novo Nordisk
Version:
Status:
Once-weekly Semaglutide
Trial ID: NN9535-4506
Clinical Trial Report
Appendix 16.1.1
08 December 2020
1.0
Final
16.1.1 Protocol and protocol amendments
CONFIDENTIAL
 
 
 
 
 
Redacted protocol 
Includes redaction of personal identifiable information only. 
 
 
 
. 
 
 


Protocol
CONFIDENTIAL
Date:
15 June 2020
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Trial ID: NN9535-4506
Version:
4.0
Status:
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Page:
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Protocol
Protocol title: Efficacy and safety of semaglutide 2.0 mg s.c. once-weekly compared to 
semaglutide 1.0 mg s.c. once-weekly in subjects with type 2 diabetes
Substance : Semaglutide
Universal Trial Number: U1111-1224-5162
EUdraCT Number: 2018-004529-96
Trial phase: 3b
In the following, Novo Nordisk A/S and its affiliates will be stated as “Novo Nordisk”.
This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.
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CONFIDENTIAL
This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.


Protocol
CONFIDENTIAL
Date:
15 June 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
4.0
Status:
Final
Page:
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Protocol amendment summary of changes table
DOCUMENT HISTORY
Document version
Date
Applicable in country (-ies) and/or 
sites
Protocol version 4.0
15 June 2020
All
Protocol version 3.0
05 March 2020
All
Protocol version 2.0
05 July 2019
All
Original protocol version 1.0
21 March 2019
All
Protocol version 4 (15 June 2020)
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union1.
Overall rationale for preparing protocol, version 4:
Primary statistical analysis for the treatment policy estimand has been revised.
Section # and name
Description of change
Brief Rationale
10.3.1 Analyses 
addressing the treatment 
policy estimand
Primary analysis
Revision of the primary analysis for the 
treatment policy estimand.
To revise the imputation method for 
missing data.
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Protocol
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Date:
15 June 2020
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Trial ID: NN9535-4506
Version:
4.0
Status:
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Page:
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Table of Contents
Page
Protocol amendment summary of changes table...........................................................................................2 
Table of Contents..............................................................................................................................................3 
1 
Synopsis......................................................................................................................................................6 
2 
Flowchart .................................................................................................................................................10 
3 
Introduction.............................................................................................................................................17 
3.1 
Trial rationale...............................................................................................................................17 
3.2 
Background..................................................................................................................................17 
3.3 
Benefit-risk assessment................................................................................................................18 
3.3.1 
Risks related to semaglutide ......................................................................................18 
3.3.2 
Benefits......................................................................................................................21 
3.3.3 
Risk-benefit conclusion .............................................................................................22 
4 
Objectives and endpoints........................................................................................................................23 
4.1 
Objectives ....................................................................................................................................23 
4.1.1 
Primary objective.......................................................................................................23 
4.1.2 
Secondary objective...................................................................................................23 
4.2 
Estimands.....................................................................................................................................23 
4.3 
Endpoints .....................................................................................................................................24 
4.3.1 
Primary endpoint........................................................................................................24 
4.3.2 
Secondary endpoints..................................................................................................24 
4.3.2.1 
Confirmatory secondary endpoint.......................................................24 
4.3.2.2 
Supportive secondary endpoints..........................................................24 
5 
Trial design ..............................................................................................................................................25 
5.1 
Overall design..............................................................................................................................25 
5.2 
Subject and trial completion ........................................................................................................26 
5.3 
End of trial definition...................................................................................................................27 
5.4 
Scientific rationale for trial design...............................................................................................27 
5.5 
Justification for dose....................................................................................................................27 
6 
Trial population.......................................................................................................................................29 
6.1 
Inclusion criteria ..........................................................................................................................29 
6.2 
Exclusion criteria.........................................................................................................................29 
6.3 
Lifestyle restrictions ....................................................................................................................30 
6.3.1 
Meals and dietary restrictions....................................................................................30 
6.4 
Screen failures..............................................................................................................................30 
7 
Treatments...............................................................................................................................................32 
7.1 
Treatments administered..............................................................................................................32 
7.1.1 
Medical devices .........................................................................................................34 
7.2 
Dose modification........................................................................................................................35 
7.3 
Method of treatment assignment..................................................................................................35 
7.4 
Blinding .......................................................................................................................................35 
7.5 
Preparation/Handling/Storage/Accountability.............................................................................36 
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Trial ID: NN9535-4506
Version:
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Status:
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7.6 
Treatment compliance..................................................................................................................36 
7.7 
Concomitant medication..............................................................................................................37 
7.7.1 
Rescue medication.....................................................................................................38 
7.8 
Treatment after the end of the trial ..............................................................................................38 
8 
Discontinuation/Withdrawal criteria ....................................................................................................39 
8.1 
Discontinuation of trial treatment ................................................................................................39 
8.1.1 
Temporary discontinuation of trial treatment ............................................................40 
8.1.2 
Rescue criteria............................................................................................................40 
8.2 
Withdrawal from the trial.............................................................................................................41 
8.2.1 
Replacement of subjects ............................................................................................41 
8.3 
Lost to follow-up .........................................................................................................................41 
9 
Trial assessments and procedures .........................................................................................................42 
9.1 
Efficacy assessments....................................................................................................................42 
9.1.1 
Clinical efficacy laboratory assessments ...................................................................43 
9.1.2 
Body measurements...................................................................................................43 
9.2 
Adverse events.............................................................................................................................43 
9.2.1 
Time period and frequency for collecting AE and SAE information ........................43 
9.2.2 
Method of detecting AEs and SAEs ..........................................................................45 
9.2.3 
Follow-up on AEs and SAEs.....................................................................................45 
9.2.4 
Regulatory reporting requirements for SAEs.............................................................45 
9.2.5 
Cardiovascular and death events................................................................................46 
9.2.6 
Disease-related events and/or disease-related outcomes not qualifying as an AE 
or SAE........................................................................................................................46 
9.2.7 
Pregnancies and associated adverse events................................................................47 
9.2.8 
Medical device incidents (including malfunctions)...................................................47 
9.2.9 
Technical complaints.................................................................................................47 
9.3 
Treatment of overdose .................................................................................................................48 
9.4 
Safety assessments.......................................................................................................................48 
9.4.1 
Physical examinations................................................................................................49 
9.4.2 
Vital signs ..................................................................................................................49 
9.4.3 
Eye examination ........................................................................................................49 
9.4.4 
Clinical safety laboratory assessments.......................................................................50 
9.5 
Pharmacokinetics.........................................................................................................................50 
9.6 
Pharmacodynamics ......................................................................................................................51 
9.7 
Genetics .......................................................................................................................................51 
9.8 
Biomarkers...................................................................................................................................51 
9.9 
Severe hypersensitivity................................................................................................................51 
10 Statistical considerations ........................................................................................................................52 
10.1 
Sample size determination...........................................................................................................52 
10.2 
Definition of analysis sets............................................................................................................53 
10.3 
Statistical analyses.......................................................................................................................54 
10.3.1 
Primary endpoint........................................................................................................55 
10.3.2 
Secondary endpoints..................................................................................................57 
10.3.2.1 
Confirmatory secondary endpoint.......................................................57 
10.3.2.2 
Supportive secondary endpoints..........................................................59 
10.3.3 
Other analyses............................................................................................................60 
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Trial ID: NN9535-4506
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Status:
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10.4 
Pharmacokinetic and/or pharmacodynamic modelling................................................................61 
10.5 
Partial database lock ....................................................................................................................61 
11 References................................................................................................................................................62 
12 Appendices...............................................................................................................................................65 
Appendix 1 
Abbreviations and Trademarks ..........................................................................................65 
Appendix 2 
Clinical laboratory tests .......................................................................................................68 
Appendix 3 
Trial governance considerations .........................................................................................70 
Appendix 4 
Adverse events: definitions and procedures for recording, evaluation, follow-up, 
and reporting...........................................................................................................................................79 
Appendix 5 
Contraceptive guidance and collection of pregnancy information...................................85 
Appendix 6 
Technical complaints: Definition and procedures for recording, evaluation, follow-
up and reporting......................................................................................................................................88 
Appendix 7 
Hypoglycaemic episodes.......................................................................................................90 
Appendix 8 
NN9535-4191 Clinical Trial Report Synopsis ....................................................................95 
Appendix 9 
Country-specific requirements..........................................................................................113 
Appendix 10 Protocol amendment history..............................................................................................114 
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1
Synopsis
Rationale:
Glucagon–like peptide-1 receptor agonists (GLP-1 RAs) are recommended for the treatment of 
patients with type 2 diabetes (T2D) who cannot reach their target HbA1c and need to lose weight or 
minimise weight gain. It has been consistently demonstrated that weight loss in patients with T2D 
has a beneficial impact on glycaemic control.
Currently, there are two doses of semaglutide available for treatment of subjects with T2D (0.5 mg 
and 1.0 mg). Although these are effective, results across the phase 3a trials in the clinical 
development program showed that ~20−30% of patients treated with semaglutide 1.0 mg did not 
achieve the treatment target of HbA1c of <7%.
Dose-dependent effects of semaglutide at doses exceeding the currently maximum approved dose 
for the treatment of T2D (1.0 mg once-weekly), have been demonstrated in relation to glycaemic 
control and body weight.
The present trial has been designed to investigate the effects of semaglutide 2.0 mg on glycaemic 
control, weight loss and safety in subjects with T2D.
Objectives and endpoints
Primary Objective
To establish the superior effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c.
1.0 mg once-weekly on glycaemic control in subjects with T2D, on a background of metformin 
with or without sulphonylurea (SU) treatment. 
Secondary Objective
To compare the effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c. 1.0 mg once-
weekly in subjects with T2D on a background of metformin with or without SU treatment, on:
x
Body weight
x
Vital signs
x
Hypoglycaemia
x
General safety and tolerability
Hypothetical estimand for the primary objective
The hypothetical estimand for the primary objective will be estimated as the absolute treatment 
difference in mean change from baseline to week 40 in HbA1c (%-point) of semaglutide 2.0 mg 
versus semaglutide 1.0 mg, both as an add-on to metformin with or without SU, in all randomised 
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Date:
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Trial ID: NN9535-4506
Version:
4.0
Status:
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subjects with T2D, regardless of change in treatment dose and had they not discontinued treatment 
due to adverse events (AEs) or initiated any rescue medication (anti-diabetic medications).
Hypothetical estimand for the secondary objective regarding body weight
This estimand will be similar to the hypothetical estimand for the primary objective, however, with 
“HbA1c (%-point)” replaced by “body weight (kg)”.
Treatment policy estimand for the primary objective
The treatment policy estimand for the primary objective will be estimated as the absolute treatment 
difference in mean change from baseline to week 40 in HbA1c (%-point) of semaglutide 2.0 mg 
versus semaglutide 1.0 mg, both as an add-on to metformin with or without SU, in all randomised 
subjects with T2D, regardless of change in treatment dose, discontinuation of treatment due to AEs 
and initiation of rescue medication (anti-diabetic medications).
Treatment policy estimand for the secondary objective regarding body weight
This estimand will be similar to the treatment policy estimand for the primary objective, however, 
with “HbA1c (%-point)” replaced by “body weight (kg)”.
The hypothetical estimand will be considered the primary estimand except in the US, where FDA 
specifically has requested the treatment policy estimand to be the primary.
Primary Endpoint
x
Change from baseline (week 0) to week 40 in HbA1c (%-point)
Confirmatory Secondary Endpoint
x
Change from baseline (week 0) to week 40 in body weight (kg)
Supportive Secondary Endpoints
Change from baseline (week 0) to week 40 in:
x
Fasting plasma glucose (FPG) (mmol/l)
x
Body mass index (BMI) (kg/m2)
x
Waist circumference (cm)
x
HbA1c < 7% at week 40 (yes/no)
x
HbA1c ≤ 6.5% at week 40 (yes/no)
x
Weight loss ≥ 5% at week 40 (yes/no)
x
Weight loss ≥ 10% at week 40 (yes/no)
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Protocol
CONFIDENTIAL
Date:
15 June 2020
Novo Nordisk
Trial ID: NN9535-4506
Version:
4.0
Status:
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Supportive Secondary Safety Endpoints
x
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic 
episodes from first dose to week 40
x
Change from baseline (week 0) to week 40 in pulse rate (bpm)
Overall design:
This is a 40-week, randomised, double blind, active comparator, two-armed, multi-centre, 
multinational clinical trial comparing semaglutide s.c. 2.0 mg once-weekly with semaglutide 
s.c.1.0 mg once-weekly in subjects with T2D, on a background of metformin with or without SU 
treatment.
Key Inclusion Criteria
x
Male or female, age ≥18 years at the time of signing informed consent
x
Diagnosed with T2D ≥180 days prior to the day of screening
x
HbA1c of 8-10% (64−86 mmol/mol) (both inclusive)
x
Stable daily dose(s) for 90 days prior to the day of screening of:
x
Any metformin formulations (≥1500 mg or maximum tolerated or effective dose) alone or 
in combination with sulfonylureas (SU) (≥half of the maximum approved dose according to 
local label or maximum tolerated or effective dose)
Key Exclusion Criteria
x
Treatment with any medication for the indication of diabetes or obesity other than stated in the 
inclusion criteria within the past 90 days prior to the day of screening. However, short term 
insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior 
insulin treatment for gestational diabetes
x
Renal impairment measured as estimated glomerular filtration rate (eGFR) value of 
<30 mL/min/1.73 m2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-
EPI) creatinine equation as defined by KDIGO 2012 classification
x
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 
examination performed within the past 90 days prior to screening or in the period between 
screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a 
digital fundus photography camera specified for non-dilated examination
Number of subjects:
Approximately 1377 subjects will be screened to achieve 964 randomised subjects. Number of 
subjects expected to complete the trial will be 867. Subjects will be followed for the planned 
duration of the trial.
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Treatment groups and duration:
The total trial duration for the individual subject will be approximately 49 weeks. The trial includes 
a screening period of approximately 2 weeks followed by randomisation. Eligible subjects fulfilling 
all eligibility criteria at visit 2 (V2) will be randomised in a 1:1 manner to receive either:
x
Semaglutide s.c. 2.0 mg once-weekly
x
Semaglutide s.c. 1.0 mg once-weekly
Randomisation will be stratified based on country (Japan/other).
Dose escalation to the target maintenance doses of semaglutide 1.0 mg or 2.0 mg once-weekly 
should take place during the first 12 weeks after randomisation.
The following trial products will be supplied by Novo Nordisk A/S for the duration of the trial:
Trial products
x
Semaglutide 1.34 mg/mL, solution for 1.5 mL pre-filled PDS290 pen injector. One pre-filled
pen contains 2.0 mg of semaglutide
x
Semaglutide placebo, solution for injection, 1.5 mL pre-filled PDS290 pen injector
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2
Flowchart
Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
SUBJECT RELATED 
INFO/ASSESSMENTS
Informed consent
Appendix 
3
X
In/exclusion criteria
6.1
6.2
X
X
Randomisation
X
Discontinuation criteria
8.1
X
X
X
X
X
X
X
Concomitant illness
9.4
X
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Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
Concomitant medication
7.7
X
X
X
X
X
X
X
X
X
X
X
X
X
Demographya
X
Diagnosis of diabetes
X
Diabetes history and 
diabetes complications
X
Medical history
9.4
X
Tobacco usec
X
Childbearing potential
Appendix 
5
X
EFFICACY
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Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
Body weight
9.1.2
X
X
X
X
X
X
X
X
X
X
Height 
9.1.2
X
Waist circumference
9.1.2
X
X
X
X
Systolic blood pressure
9.4.2
X
X
X
X
X
X
X
X
Diastolic blood pressure
9.4.2
X
X
X
X
X
X
X
X
FPG
Appendix 
2
X
X
X
X
X
HbA1c
Appendix 
2
X
X
X
X
X
X
X
X
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Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
Semaglutide plasma 
concentration
9.5
X
X
X
X
X
SAFETY
Hypoglycaemic episodes
9.2.6
Appendix7
X
X
X
X
X
X
X
X
X
X
X
X
Eye examination
9.4.3
X
X
X
Physical examination
9.4.1
X
X
X
Pulse
9.4.2
X
X
X
X
X
X
X
X
Biochemistry
Appendix 
2
X
X
X
X
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Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
Creatinine (including 
eGFR) 
Appendix 
2
X
X
X
X
Haematology
Appendix 
2
X
X
X
X
Pregnancy test
Appendix 
2
Appendix 
5
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse events
9.2
Appendix 
4
X
X
X
X
X
X
X
X
X
X
X
X
Calcitonin
Appendix 
2
X
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Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
TRIAL MATERIAL
Dispensing visit
X
X
X
X
X
X
Drug accountability
7.5
X
X
X
X
X
X
X
X
IWRS session
7.3 7.4
X
X
X
X
X
X
X
X
X
REMINDERS
End of treatment
X
X
End of trial
X
Attend visit fasting
6.3.1
X
X
X
X
X
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Trial Periods
Protocol section
Screening
Randomisation
Treatment
End of treatmentb
Follow upb
Treatment 
discontinuation
End of 
treatmentb
Follow upb
Site visit (V)/
phone contact (P)
V1
V2
V3
V4
V5
V6
V7
V8
P9
V10
P11
V10A
P11A
Timing of visit (weeks)
-2
0
4
8
12
16
20
28
34
40
End of 
treatment 
+ 7 weeks
End of 
treatment 
+ 7 weeks
Visit window (days)
±7
±7
±7
±7
±7
±7
±14
±14
±7
+7
Directions for use (DFU)
X
Training in trial product 
and pen handling
7.1.1
X
X
X
Handout ID card
X
Handout and instruct in 
diary
9.2.6
X
Handout and instruct in 
BG meter
7.1 9.2.6
X
a Demography consists of date of birth, sex, ethnicity and race (according to local regulation).
b Please refer to Section 8 for details on discontinuation and withdrawal.
c Smoking is defined as smoking at least one cigarette or equivalent daily
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3
Introduction
3.1
Trial rationale
Glucagon–like peptide-1 receptor agonists (GLP-1 RAs) are recommended for the treatment of 
patients with T2D who cannot reach their target HbA1c and need to lose weight or minimise weight 
gain2. It has been consistently demonstrated that weight loss in patients with T2D has a beneficial 
impact on glycaemic control3, 4.
Currently, there are two doses of semaglutide available for treatment of subjects with T2D (0.5 mg 
and 1 mg). Although these are effective, results across the phase 3a trials5-9 (excluding the 
cardiovascular outcomes trial10) in the clinical development program showed that ~20−30% of 
patients treated with semaglutide 1 mg did not achieve the treatment target of HbA1c of <7%.
Dose-dependent effects of semaglutide at doses exceeding the currently maximum approved dose 
for the treatment of T2D (1 mg once-weekly), have been demonstrated in relation to glycaemic 
control and body weight11, 12.
The present trial has been designed to investigate the effects of semaglutide 2.0 mg on glycaemic 
control, weight loss and safety in subjects with T2D.
3.2
Background
Semaglutide s.c. 0.5 mg and 1 mg once-weekly (Ozempic®) is indicated as an adjunct to diet and
exercise to improve glycaemic control in adults with T2D13, 14. The currently approved indication 
was based on a comprehensive global phase 3a clinical development programme for semaglutide 
s.c. once-weekly (the SUSTAIN programme). The present trial will investigate a 3rd maintenance 
dose of semaglutide s.c. 2.0 mg once-weekly, for additional glycaemic control in subjects with 
T2D.
In the SUSTAIN programme, semaglutide provided superior long-term glycaemic control in 
addition to clinically relevant reductions in body weight as compared to commonly used marketed 
products across the spectrum of patients with T2D, ranging from treatment-naïve to insulin-treated. 
The safety profile of semaglutide is well-documented based on data from the non-clinical and 
clinical development programmes, and is consistent with the safety profile of other drugs within the 
GLP-1 RA drug class13, 14.
Two recent dose-finding trials have investigated the efficacy and tolerability of semaglutide s.c. at
doses higher than previously studied; both for the use in T2D11 and in weight management12.
For the dose-finding trial for once-daily semaglutide in T2D, semaglutide at doses up to 0.3 mg 
once-daily (equivalent to 2.1 mg once-weekly and thereby exceeding the maximum approved dose 
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of 1 mg once-weekly) were investigated. In this trial, 65 and 63 patients were exposed to doses 
equivalent to 1.4 mg and 2.1mg, respectively. In subjects with T2D and overweight or obesity, 
once-daily semaglutide (in doses of 0.05, 0.1, 0.2, or 0.3 mg/day, corresponding to doses of 0.35 to 
2.1 mg/week), demonstrated dose-dependent changes in HbA1c from baseline to week 26 ranging 
from -1.05%-points with semaglutide 0.05 mg to -1.88%-points with semaglutide 0.30 mg. In 
addition, semaglutide showed dose-dependent changes from baseline to week 26 in body weight, 
ranging from -2.76 kg with semaglutide 0.05 mg to -8.23 kg with semaglutide 0.30 mg11. The rate 
of AEs increased with increasing semaglutide dose, however, no marked differences across the 
semaglutide groups were observed in the proportion of subjects with AEs leading to premature 
treatment discontinuation. The majority of AEs were gastrointestinal (GI) AEs, and for these, a 
dose-dependency was seen, with an increasing proportion of subjects reporting GI AEs at increasing 
dose of semaglutide. GI adverse events were typically mild to moderate and no dose-dependency 
was observed in relation to GI AEs leading to premature treatment discontinuation with few of 
these events across the semaglutide groups. In conclusion, the safety profile of the doses equivalent 
to above 1 mg of semaglutide was generally well tolerated in subjects with T2D during 26 weeks of 
treatment and no unanticipated safety concerns were identified. For further details on efficacy and 
safety of semaglutide s.c. once-daily please refer to Appendix 8.
In a 52-week dose-finding trial for semaglutide s.c. in overweight or obese subjects without 
diabetes, treatment with once-daily semaglutide in doses up to 0.4 mg (equivalent to a weekly sum 
of 2.8 mg/week) resulted in a clear and dose-dependent weight loss, with the semaglutide s.c. 
0.4 mg once-daily dose providing a 13.8% reduction in body weight from baseline to week 52, 
while displaying an acceptable tolerability profile12. All semaglutide doses were generally well 
tolerated, with no new safety concerns. The most common adverse events were dose-related 
gastrointestinal symptoms, primarily nausea, as seen previously with GLP-1 receptor agonists. A
semaglutide s.c. dose of 2.4 mg once-weekly is currently being investigated as the target 
maintenance dose for semaglutide s.c. in weight management in a large phase 3a development 
programme.
A comprehensive review of results from the non-clinical and clinical studies of semaglutide can be 
found in the current edition of the investigator’s brochure (IB) and any updates hereof15.
3.3
Benefit-risk assessment
3.3.1
Risks related to semaglutide
The sections below describe identified and potential risks associated with semaglutide treatment. 
For further details of the risks, please refer to the current version of the IB or any updates hereof15.
The identified/potential risks are based on findings in non-clinical studies and clinical trials with 
semaglutide as well as other GLP-1 RAs. For each of these risks, mitigating actions have been 
implemented to minimise the risks for subjects enrolled in this trial.
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Identified risks
Gastrointestinal disorders
Consistent with findings with other GLP-1 RAs, the most frequently reported 
adverse events (AE) in clinical trials with semaglutide were gastrointestinal 
AEs. A dose dependency has been observed for most of the gastrointestinal 
disorders. A low starting dose and dose escalation steps will be implemented 
in the trial to mitigate the risk of gastrointestinal AEs.
In patients treated with GLP-1 RAs, nausea, vomiting and diarrhoea may lead 
to significant dehydration. This should be considered when treating patients 
with impaired renal function as it may cause a deterioration of renal function. 
Patients with GI AEs are recommended to drink plenty of fluids to avoid 
volume depletion.
Hypoglycaemia
There is a low risk of hypoglycaemic episodes when semaglutide is used as 
monotherapy. Subjects treated with semaglutide in combination with  SU or 
insulin have an increased risk of hypoglycaemia. The risk of hypoglycaemia 
can be lowered by reducing the dose of SU when initiating treatment with 
semaglutide (or insulin if subjects have been allowed to use insulin as rescue 
therapy).
Cholelithiasis 
In the semaglutide s.c. T2D clinical development programme (NN9535), 
events of cholelithiasis were reported more frequently with semaglutide s.c. 
than with comparators. Few events were serious and there was no clear 
correlation between events of cholelithiasis and weight loss. Events of 
cholelithiasis did not lead to an increased risk of complications such as 
cholecystitis or pancreatitis. 
Diabetic retinopathy 
complications
The cardiovascular outcome trial in the semaglutide T2D development 
programme showed an increased risk of events related to diabetic retinopathy 
complications in subjects treated with semaglutide compared to placebo, 
albeit the proportion of subjects with an event of diabetic retinopathy 
complications was low. The imbalance was driven by subjects with a history 
of diabetic retinopathy at baseline and subjects who were treated with insulin. 
Rapid improvement in glucose control has been associated with a temporary 
worsening of diabetic retinopathy. Long-term glycaemic control decreases the 
risk of diabetic retinopathy. Patients with a history of diabetic retinopathy 
should be monitored for worsening and treated according to clinical 
guidelines. 
As a precaution, subjects with a history of uncontrolled and potentially 
unstable diabetic retinopathy or maculopathy will be excluded from the trial, 
and fundus photography or slit-lamp biomicroscopy examination with 
pharmacologically dilated pupils will be performed according to flowchart.
Other risks
Patients treated with semaglutide may also experience decreased appetite, 
dizziness, dysgeusia, fatigue, increased heart rate, increased lipase and 
amylase, injection site reactions and weight decrease.
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In a phase 2 trial in doses of up 0.4mg/day in non-diabetic patients with 
obesity, early satiety, insomnia, dry mouth, and alopecia were also reported 
more with semaglutide.
Potential risks
Allergic reactions
As is the case with all protein-based pharmaceuticals, subjects treated with 
semaglutide are at risk of developing immunogenic and allergic reactions. As a
precaution, subjects with known or suspected hypersensitivity to semaglutide or 
related products will not be enrolled in this trial.
Acute pancreatitis
Acute pancreatitis has been observed with the use of GLP-1 RAs. Patients should 
be informed of the characteristic symptoms of acute pancreatitis and if 
pancreatitis is suspected, semaglutide should be discontinued. If confirmed, 
semaglutide should not be restarted.
Malignant neoplasms
There is no indication of a causal relationship between semaglutide and 
malignant neoplasm based on the available data. However, it is not possible to 
draw any firm conclusions due to very low numbers. As a precaution, subjects 
with a history of malignant neoplasms within the past 5 years prior to screening 
will be excluded from the trial.
Pancreatic cancer
Patients with T2D have an increased risk of certain types of cancer such as 
pancreatic cancer. There is currently no support from non-clinical studies, 
clinical trials or post-marketing data that GLP-1 RA-based therapies increase the 
risk of pancreatic cancer, but pancreatic cancer has been classified as a potential 
class risk of GLP-1 RAs by European Medicines Agency. As a precaution, 
subjects with a history of malignant neoplasms within the past 5 years prior to
screening will be excluded from the trial.
Medullary thyroid 
cancer
Expected proliferative thyroid C-cell changes were seen in the mouse and rat 
carcinogenicity studies after daily exposure to semaglutide for 2 years. No 
hyperplasia was observed in monkeys after 52 weeks exposure up to 13-fold 
above the clinical plasma exposure at 2.4 mg/week. In clinical trials with 
semaglutide, there have been no clinically relevant changes in calcitonin levels. 
The C-cell changes in rodents are mediated by the GLP-1 receptor, which is not 
expressed in the normal human thyroid. Accordingly, the risk of GLP-1 receptor-
mediated C-cell changes in humans is considered to be low. However, as a 
precaution an exclusion criterion related to medical history of multiple endocrine
neoplasia type2 (MEN 2) or medullary thyroid cancer (MTC) and elevated 
plasma levels of calcitonin (biomarker for MTC) have been implemented in the 
trial.
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Other safety considerations
Drug interactions
Semaglutide delays gastric emptying and has the potential to impact the rate of 
absorption of concomitantly administered oral medicinal products. The potential 
effect of semaglutide on the absorption of co-administered oral medications was 
studied in trials at semaglutide 1 mg/week steady state exposure. No clinically 
relevant drug-drug interactions with semaglutide were observed based on the 
evaluated medications.
Semaglutide did not change the overall pharmacodynamics of warfarin as 
measured by the international normalised ratio (INR). However, upon initiation of 
semaglutide treatment in patients on warfarin and/or coumarin derivatives, 
frequent monitoring of INR is recommended.
Pregnancy, lactation 
and fertility
Studies in animals have shown reproductive toxicity. There are limited data from 
the use of semaglutide in pregnant women. Therefore, semaglutide should not be 
used during pregnancy. If a patient wishes to become pregnant, or pregnancy 
occurs, semaglutide should be discontinued. Semaglutide should be discontinued at 
least 7 weeks before a planned pregnancy due to the long half-life. 
In lactating rats, semaglutide was excreted in milk. As a risk to a breast-fed child 
cannot be excluded, semaglutide should not be used during breast-feeding.
The effect of semaglutide on fertility in humans is unknown. Semaglutide did not 
affect male fertility in rats. In female rats, an increase in oestrous length and a 
small reduction in number of ovulations were observed at doses associated with 
maternal body weight loss.
3.3.2
Benefits
Semaglutide s.c. once-weekly in doses of 0.5 mg and 1 mg has demonstrated clinically relevant and 
dose-dependent improvements in glycaemic control and body weight in subjects with T2D. Also, 
the reduction in HbA1c was consistently greater with higher baseline HbA1c16. Further dose-
dependent reductions in HbA1c and body weight have been observed in phase 2 trials with 
semaglutide doses exceeding 1 mg/week, both for the use in T2D11 and in weight management12.
Consequently, it is expected that semaglutide 2.0 mg will provide equal or better glycaemic and 
body weight control as compared to semaglutide 1.0 mg in subjects with T2D. All subjects will 
therefore be treated with a more efficacious regimen compared to the treatment they receive at trial 
entry.
In addition, it is expected that all subjects will benefit from participation through close contact with 
the trial site with close monitoring and treatment of T2D and a careful medical examination, all of 
which will most likely result in an intensified management of their diabetes.
Investigators will ensure that subjects are treated according to recommended standard-of-care for 
T2D management. Safety and efficacy will be monitored regularly, and acceptable glycaemic 
control will be reinforced at all times during the trial.
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All subjects in this trial will receive trial product and auxiliary supplies free of charge.
3.3.3
Risk-benefit conclusion
Necessary precautions have been implemented in the design and planned conduct of the trial in 
order to minimise the risks and inconveniences of participation in the trial. The safety profile for 
semaglutide generated from the clinical and non-clinical development programme has not revealed 
any safety issues that would prohibit administration of semaglutide 2.0 mg once-weekly. The results 
of the two phase 2 trials indicate that semaglutide provides dose-dependent reductions in HbA1c and 
weight11, 12.
It is therefore concluded that the potential benefits from the trial will outweigh the potential risks 
for the subjects. More detailed information about the known and expected benefits and risks and 
reasonably expected adverse events (AEs) of semaglutide s.c. may be found in the Investigator’s 
Brochure (IB) and any updates hereof15, and in Appendix 8.
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4
Objectives and endpoints
4.1
Objectives
4.1.1
Primary objective
To establish the superior effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c.
1.0 mg once-weekly on glycaemic control in subjects with T2D, on a background of metformin 
with or without SU treatment.
4.1.2
Secondary objective
To compare the effect of semaglutide s.c. 2.0 mg once-weekly versus semaglutide s.c. 1.0 mg once-
weekly in subjects with T2D, on a background of metformin with or without SU treatment, on:
x
Body weight
x
Vital signs
x
Hypoglycaemia
x
General safety and tolerability
4.2
Estimands
Hypothetical estimand for the primary objective
The hypothetical estimand for the primary objective will be estimated as the absolute treatment 
difference in mean change from baseline to week 40 in HbA1c (%-point) of semaglutide 2.0 mg 
versus semaglutide 1.0 mg, both as an add-on to metformin with or without SU, in all randomised 
subjects with T2D, regardless of change in treatment dose and had they not discontinued treatment 
due to AEs or initiated any rescue medication (anti-diabetic medications).
Hypothetical estimand for the secondary objective regarding body weight
This estimand will be similar to the hypothetical estimand for the primary objective, however, with 
“HbA1c (%-point)” replaced by “body weight (kg)”.
Treatment policy estimand for the primary objective
The treatment policy estimand for the primary objective will be estimated as the absolute treatment 
difference in mean change from baseline to week 40 in HbA1c (%-point) of semaglutide 2.0 mg 
versus semaglutide 1.0 mg, both as an add-on to metformin with or without SU, in all randomised 
subjects with T2D, regardless of change in treatment dose, discontinuation of treatment due to AEs 
and initiation of rescue medication (anti-diabetic medications).
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Treatment policy estimand for the secondary objective regarding body weight
This estimand will be similar to the treatment policy estimand for the primary objective, however, 
with “HbA1c (%-point)” replaced by “body weight (kg)”.
The hypothetical estimand will be considered the primary estimand except in the US, where FDA 
specifically has requested the treatment policy estimand to be the primary.
4.3
Endpoints
4.3.1
Primary endpoint
x
Change from baseline (week 0) to week 40 in HbA1c (%-point)
4.3.2
Secondary endpoints
4.3.2.1
Confirmatory secondary endpoint
x
Change from baseline (week 0) to week 40 in body weight (kg)
4.3.2.2
Supportive secondary endpoints
Supportive secondary effect endpoints
Change from baseline (week 0) to week 40 in:
x
Fasting plasma glucose (FPG) (mmol/l)
x
Body mass index (BMI) (kg/m2)
x
Waist circumference (cm)
x
HbA1c < 7% at week 40 (yes/no)
x
HbA1c ≤ 6.5% at week 40 (yes/no)
x
Weight loss ≥ 5% at week 40 (yes/no)
x
Weight loss ≥ 10% at week 40 (yes/no)
Supportive secondary safety endpoints
x
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic 
episodes from first dose to week 40
x
Change from baseline (week 0) to week 40 in pulse rate (bpm)
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5
Trial design
5.1
Overall design
x
This is a 40-week, randomised, double-blind, active comparator, two-armed, multi-centre,
multinational clinical trial.
x
Subjects will be randomised in a 1:1 manner to receive either:
x
Semaglutide s.c. 2.0 mg once-weekly
x
Semaglutide s.c. 1.0 mg once-weekly
x
Randomisation will be stratified based on country (Japan/other).
x
There is a 2-week screening period followed by a randomisation visit and a 40-week treatment
period. The treatment period is divided into a dose escalation period of 12 weeks and a
maintenance period of 28 weeks. After the end of treatment visit (V10), all subjects will enter a
follow-up period of 7 weeks, ended by a follow up phone contact, which corresponds to the end
of trial (P11). Total trial duration for the individual subject will be approximately 49 weeks.
x
The trial population will consist of subjects with T2D using metformin with or without SU, with
an HbA1c of 8-10% (both inclusive)
A schematic illustration of the trial design is provided in Figure 5-1.
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Figure 5-1
A schematic diagram of the trial design, with the duration of the trial periods.
As outlined in the figure, all subjects in the trial will receive one injection per 
week during a 12-week dose escalation period, until the target dose for 
semaglutide 2.0 mg is reached. Starting week 13 to end of treatment, all subjects 
in the trial will receive two injections using two pens per week to ensure 
blinding of the target maintenance dose of semaglutide 2.0 mg (Table 7-2)
5.2
Subject and trial completion
Approximately 1377 subjects will be screened in order to achieve 964 subjects to be randomly 
assigned to trial product. The number of subjects expected to complete the trial will be 867 subjects 
(see Section 10.1 for further details on the sample size considerations). Subjects will be followed 
for the planned duration of the trial.
Trial period completion for a subject:
Trial period completion is defined as when the randomised subject has completed the final 
scheduled visit ‘end of trial’ according to the flowchart in Section 2).
'Date of trial completion' is the date the subject completed the final scheduled visit, as mentioned 
above.
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Treatment period completion for a subject: 
Treatment period completion is defined as when the randomised subject has received the required 
treatment and attended the 'end of treatment' visit according to the flowchart in Section 2.
5.3
End of trial definition
The end of the trial is defined as the date of the last visit of the last subject in the trial.
5.4
Scientific rationale for trial design
The treatment duration of the trial is 40 weeks, with an additional 7 weeks of follow-up. A follow 
up phone contact, that will take place 7 weeks after the end of treatment, is included to account for 
the exposure and long half-life of semaglutide. A 40-week treatment duration (including 28 weeks 
on target doses) will provide robust data for the evaluation of efficacy and safety parameters.
A randomised, double blind, active comparator, two armed, multicentre, multinational trial design is 
chosen to minimise bias in the assessment of the effect and safety of semaglutide 2.0 mg and 
semaglutide 1.0 mg.
The trial includes a screening visit to assess the subject’s eligibility. After randomisation visit, visits 
are scheduled every 4 weeks to support the subject during dose escalation. To mimic usual clinic 
practice, from week 20, a visit is planned at week 28, a phone contact at week 34 and the end of 
treatment visit at week 40. A follow-up visit (‘end of trial’) for safety assessments is scheduled 7 
weeks after end of treatment to account for the exposure and the long half-life of semaglutide.
The trial population will consist of subjects with T2D treated with stable doses of metformin only or 
metformin in combination with sulphonylurea, in need of the treatment intensification. Subjects 
with an HbA1c of 8-10% are included as they are anticipated to particularly benefit from advancing 
to a higher dose of semaglutide. Further, this population represents a clinically relevant population,
as it is likely to benefit both from the better glycaemic control, as well as from the anticipated body 
weight loss.
5.5
Justification for dose
Results from the phase 2 dose-finding trial (NN9536-4191) showed that the semaglutide 0.3 mg 
once-daily dose was the most effective in terms of both glycaemic control and weight management, 
while displaying an acceptable tolerability profile (refer to Appendix 8). The daily dose of 0.3mg 
corresponds to a weekly dose of 2.1mg.
A target dose of 2.0 mg has been selected for this trial and as an intended 3rd maintenance dose of 
semaglutide s.c. once-weekly for glycaemic control in T2D, in addition to 0.5 mg and 1.0 mg. A 
single, intuitive dose escalation step is implemented to ensure simplicity when progressing the dose 
from 1.0 mg to 2.0 mg in clinical practice.
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Subjects will therefore be initiated at a once-weekly dose of 0.25 mg and follow a fixed-dose 
escalation regimen, with dose increases every 4 weeks (to doses of 0.5, 1.0 and 2.0 mg/week), until 
the target maintenance dose of 2.0 mg is reached after 12 weeks.
Semaglutide s.c. 2.0 mg once-weekly will provide a simpler treatment intensification regimen as 
compared to advancing treatment with additional anti-hyperglycaemic agents or combination 
injectable therapy in order to reach glycaemic targets. The added benefit of significant weight loss 
observed with higher dose would also allow clinicians to further individualise the treatment to meet 
the needs of the subject with T2D.
A treatment arm with semaglutide 1.0 mg once-weekly is included to be able to compare the effect 
on glycaemic control, body weight and safety between the two semaglutide doses (1.0 and 2.0 mg).
Please refer to Section 7.1 for more details on treatment doses.
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6
Trial population
Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as 
protocol waivers or exemptions, is not permitted.
6.1
Inclusion criteria
Subjects are eligible to be included in the trial only if all the following criteria apply:
1. Informed consent obtained before any trial-related activities. Trial-related activities are any 
procedures that are carried out as part of the trial, including activities to determine suitability for 
the trial.
2. Male or female, age ≥18 years at the time of signing informed consent. 
3. Diagnosed with type 2 diabetes mellitus ≥ 180 days prior to the day of screening.
4. HbA1c of 8-10% (64−86 mmol/mol) (both inclusive)
5. Stable daily dose(s) for 90 days prior to the day of screening of: any metformin formulations 
(≥1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas 
(SU) (≥half of the maximum approved dose according to local label or maximum tolerated or 
effective dose).
Japan: For country specific requirements, refer to Appendix 9.
6.2
Exclusion criteria 
Subjects are excluded from the trial if any of the following criteria apply:
Diabetes related
1. Treatment with any medication for the indication of diabetes or obesity other than stated in the 
inclusion criteria within the past 90 days prior to the day of screening. However, short term 
insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior 
insulin treatment for gestational diabetes
2. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) 
known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or 
corticosteroids)
3. Renal impairment measured as estimated glomerular filtration rate (eGFR) value of
<30 mL/min/1.73 m2 according to CKD-EPI creatinine equation as defined by KDIGO 2012 
classification17
4. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 
examination performed within the past 90 days prior to screening or in the period between 
screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a 
digital fundus photography camera specified for non-dilated examination
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General safety
5. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary 
thyroid carcinoma
6. Calcitonin ≥ 100 ng/L as measured by the central laboratory at screening
7. Presence or history of pancreatitis (acute or chronic)
8. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic 
attack within 180 days prior to the day of screening
9. Presently classified as being in New York Heart Association (NYHA) Class IV
10. Planned coronary, carotid or peripheral artery revascularisation
11. Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal 
and squamous cell skin cancer and any carcinoma in-situ is allowed
12. Known or suspected hypersensitivity to trial product(s) or related products 
13. Previous participation in this trial. Participation is defined as signed informed consent 
14. Receipt of any investigational medicinal product within 30 days before screening
15. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing 
potential and not using a highly effective contraceptive method
16.Any disorder, unwillingness or inability, which in the investigator’s opinion, might jeopardise 
the subject’s safety or compliance with the protocol 
6.3
Lifestyle restrictions
To ensure alignment in regard to performance of assessments across subjects and trial sites, the 
below restrictions apply.
6.3.1
Meals and dietary restrictions
x
Subjects must attend the visits fasting according to the flowchart.
x
Fasting is defined as at least 6 hours prior to the visit without food or liquids, except for water. 
Trial product and any medication which should be taken with or after a meal should be withheld 
on the day of the visit until blood samples have been obtained.
x
If the subject is not fasting as required, the subject should be called in for a new visit within the 
visit window to have the fasting procedures done.
6.4
Screen failures
Screen failures are defined as subjects who consent to participate in the clinical trial but are not 
eligible for participation according to in/exclusion criteria. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure subjects to meet 
requirements from regulatory authorities. Minimal information includes date of inform consent, 
demography, date of visit, screen failure details, eligibility criteria, and any SAE. A screen failure 
session must be made in the Interactive Web Response System (IWRS).
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Individuals who do not meet the criteria for participation in this trial may not be rescreened. Re-
sampling is not allowed if the subject has failed one of the inclusion criteria or fulfilled one of the 
exclusion criteria related to laboratory parameters. However, in case of technical issues (e.g. 
haemolysed or lost), re-sampling is allowed for the affected parameters.
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7
Treatments
7.1
Treatments administered
The investigational medicinal products (trial products) provided by Novo Nordisk are listed in 
Table 7-1. Trial product must only be used, if it appears clear and colourless.
Table 7-1
Trial products provided by Novo Nordisk A/S
Trial product name:
semaglutide 1.34 mg/mL
semaglutide placebo
Dosage form:
Solution for injection
Solution for injection
Route of administration:
Subcutaneous
Subcutaneous
Dosing instructions:
Once-weekly
Once-weekly
Packaging
1.5 mL pre-filled PDS290 
pen-injector
1.5 mL pre-filled PDS290 
pen-injector
Dose escalation
All subjects are to reach the target maintenance dose of semaglutide 1.0 mg or 2.0 mg once-weekly.
Dose escalation to the target maintenance doses of semaglutide 1.0 mg or 2.0 mg once-weekly 
should take place during the first 12 weeks after randomisation. From V5 (week 12) the treatment 
will include 2 injections using 2 pens as described in Figure 5-1 and Table 7-2.
If a subject does not tolerate the designated target dose, the subject may stay at a lower dose level. 
This should only be allowed if the subject would otherwise discontinue trial product completely and 
if considered safe to continue trial product at a lower dose, as per the investigator’s discretion. The 
subject should make at least one attempt to re-escalate to the designated target dose, as per the 
investigator’s discretion.
It is recommended that the investigator consults Novo Nordisk in case of persistent deviations from 
the planned escalation regimen.
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Table 7-2
Dose escalation and maintenance
Trial periods
Screening 
Treatment 
period 1
Treatment 
period 2
Treatment 
period 3
Treatment 
period 4
Follow-up
Alias for trial period
Screening
Dose 
escalation
Dose 
escalation
Dose 
escalation
Maintenance
Follow-up
Visits in each period
V1
V2
V3
V4
V5-V10
P11
Duration of each period
2 weeks
4 weeks
4 weeks
4 weeks
28 weeks
Treatment arm
semaglutide s.c. 1.0 mg
Screening
semaglutide 
0.25 mg
semaglutide 
0.5 mg
semaglutide 
1.0 mg
semaglutide 
1.0 mg and 
semaglutide 
placebo 1.0 mg
Follow-up
semaglutide s.c. 2.0 mg
Screening
semaglutide 
0.25 mg
semaglutide 
0.5 mg
semaglutide 
1.0 mg
semaglutide 
1.0 mg and 
semaglutide 
1.0 mg
Follow-up
All subjects on background medication of metformin with or without sulphonylurea treatment.
Please refer to Figure 5-1 for more information.
Instructions for the subject
Subjects will be instructed to inject the trial product(s) subcutaneously once weekly in the abdomen, 
thigh, or upper arm. The injection site can be changed without dose adjustment.Subjects must be 
trained in handling the pen-injectors when dispensed the first time and training must be repeated 
during the trial as indicated per flowchart Section 2.The investigator may choose to observe the 
subject when administering the first dose.
The investigator must document that directions for use (DFU) are given to the subject orally and in 
writing at the first dispensing visit and again during the trial, if the investigator finds it relevant. The 
injection can be administered at any time of the day irrespective of meals, but on the same day of 
the week. The day of weekly administration can be changed if necessary if the time between two 
doses is at least 2 days (>48 hours) or in accordance with the local label. After selecting a new 
dosing day, once weekly dosing should be continued.
The investigator should give the dose reminder card at each dispensing visit. At V5 the investigator 
should also give the pen differentiation guide to the subject.
Missed doses
If a semaglutide dose is missed, it should be administered as soon as noticed, provided the time to 
the next scheduled dose is at least 2 days (48 hours). If a dose is missed and the next scheduled dose 
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is less than 2 days (48 hours) away, the subject should not administer the missed dose. A missed 
dose should not affect the scheduled dosing day of the week.
If ≥ 2 consecutive doses of trial product are missed, the subject should be encouraged to re-
commence the treatment if considered safe as per the investigator’s discretion and if the subject 
does not meet any of the discontinuation criteria (Section 8.1). The trial product should be 
continued as early as the situation allows. The missed doses should not affect the scheduled dosing 
day of the week. The start dose for re-initiation of trial product is at the investigator’s discretion. In 
case of questions related to re-initiation of trial product, the investigator should consult Novo 
Nordisk global medical experts. If doses are missed blood glucose should be more closely 
monitored if judged necessary by the investigator.
Auxiliary supplies
The following auxiliary supplies will be provided by Novo Nordisk:
x
Needles for the pre-filled PDS290 pen-injectors
x
Directions for use (DFU) for the pre-filled PDS290 pen-injector
x
Blood glucose (BG) meter and related auxiliaries
Subjects will be instructed in how to use the BG-meter and the instructions will be repeated during 
the trial as needed.
Only needles provided by Novo Nordisk must be used for administration of trial product. The 
subject should be advised to discard the injection needle after each injection and store the pen 
without an injection needle attached. Needles to be used with the trial product should be provided 
throughout the trial as needed.
7.1.1
Medical devices
Information about the PDS290 pre-filled pen-injector for semaglutide 1.34 mg/mL may be found in 
the IB and any updates hereof.
Information about the use of the PDS290 pre-filled pen-injector for semaglutide 1.34 mg/mL and 
semaglutide placebo can be found in the DFU.
Training for the pre-filled PDS290 pen-injector
When training the subjects, the following should be emphasised:
x
Always use a new needle for each injection as this will prevent contamination and ensure 
correct dose.
x
Remember to prime the pen-injector the first time it is used to ensure product flow.
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x
Check the dose counter to see that the correct dose has been dialled.
x
The needle should be kept in the skin while counting slowly to 6 after the dose counter has 
returned to zero after injection. If the needle is removed too early then the full dose may not 
have been delivered.
x
In-use conditions of the pen-injector including in-use time and storage (see Section 7.5).
7.2
Dose modification
Not applicable for this trial. Please refer to Section 7.1 for description of missed dose(s).
7.3
Method of treatment assignment
All subjects will be centrally randomised using an IWRS and assigned to the next available 
treatment according to randomisation schedule. Trial product will be dispensed/allocated at the trial 
visits summarised in the flowchart.
At screening, each subject will be assigned a unique 6-digit subject number which will remain the 
same throughout the trial. Each site is assigned a 3-digit number and all subject numbers will start 
with the site number.
7.4
Blinding
The first 12 weeks during escalation all the trial products are packed open-label. From week 13 the 
subject will receive trial product which is packed open-label as well as trial product which is packed 
blinded containing either semaglutide 1.34 mg/mL or semaglutide placebo. The active drug and 
placebo drug are visually identical.
The IWRS is used for blind-breaking instructions. The blind may be broken in a medical emergency 
if knowing the actual treatment would influence the treatment of the subject. Novo Nordisk will be 
notified immediately after breaking the blind. The date when and reason why the blind was broken 
must be recorded in the source documentation.
Whenever the blind is broken, the person breaking the blind must print the “code break 
confirmation” notification generated by the IWRS, record the reason and sign and date the 
document.
When the blind is broken, the treatment allocation will be accessible to the investigator and the 
Novo Nordisk Global Safety department. If IWRS is not accessible at the time of blind break, the 
IWRS helpdesk should be contacted. Contact details are listed in Attachment I.
If the blind has been broken by investigator, the subject must discontinue treatment with trial 
product and a treatment discontinuation session must be completed in IWRS.
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7.5
Preparation/Handling/Storage/Accountability
Only subjects enrolled in the trial may receive trial product and only authorised site staff may 
supply or administer trial product. Each trial site will be supplied with sufficient trial products for 
the trial on an on-going basis controlled by the IWRS. Trial product will be distributed to the trial 
sites according to screening and randomisation.
The investigator must confirm that appropriate temperature conditions have been maintained during 
transit for all trial products received and any discrepancies are reported and resolved before use of 
the trial products.
All trial products must be stored in a secure, controlled, and monitored (manual or automated) area 
in accordance with the labelled storage conditions with access limited to the investigator and 
authorised site staff. For the storage and in-use conditions see the trial materials manual (TMM) and 
the labels of trial product. The investigator must inform Novo Nordisk immediately if any trial 
product has been stored outside specified conditions. Additional details regarding handling of 
temperature deviations can be found in the TMM. Trial product that has been stored improperly 
must not be dispensed to any subject before it has been evaluated and approved for further use by 
Novo Nordisk.
Subjects must return all used, partly used and unused trial products as instructed by the investigator. 
The investigator is responsible for drug accountability and record maintenance (i.e. receipt, 
accountability and final disposition records). Drug accountability must be performed in the IWRS 
by registering pen-injectors as returned either as used/partly used, unused or as lost.
Destruction of trial products can be performed on an ongoing basis and will be done according to 
local procedures after accountability is finalised by the site and reconciled by the monitor. 
Destruction of trial products must be documented in the IWRS.
All returned, expired or damaged trial products (for technical complaint samples see Appendix 6) 
must be stored separately from non-allocated trial products. No temperature monitoring is required. 
Non-allocated trial products including expired or damaged products must be accounted as unused, 
at the latest at closure of the trial site.
Japan: For country specific requirements, refer to Appendix 9
7.6
Treatment compliance
Throughout the trial, the investigator will remind the subjects to follow the trial procedures and 
requirements to ensure subject compliance. If a subject is found to be non-compliant the 
investigator will remind the subject of the importance of following the instructions given including 
taking the trial products as prescribed.
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Treatment compliance of trial product will be assessed by asking subject about changes in the dose 
taken or missed doses, and by monitoring of drug accountability. Information about compliance 
should be described in the subject’s source documents.
7.7
Concomitant medication
Any medication (including over-the-counter or prescription medicines) other than the trial product 
that the subject is receiving at the time of the first visit or receives during the trial must be recorded 
along with:
x
Trade name or generic name
x
Indication
x
Dates of administration including start and stop dates
x
Dose (only to be recorded for anti-hyperglycaemic medication)
After signing the informed consent, subjects must continue their anti-diabetic background 
medication (metformin with or without SU) throughout the entire trial. 
To mitigate SU-induced hypoglycaemia, subjects treated with SU should, at the discretion of the 
investigator, reduce the SU dose at randomisation by approximately 50%.
Apart from the initial dose reduction of SU, background medication dose should remain at the same 
dose level and with the same frequency during the entire treatment period unless glycaemic rescue 
treatment is needed (as described in Section 8.1.2) or safety concern related to the use of 
background medications arises.
In addition, all background medication(s):
x
is considered to be non-investigational medicinal product.
x
will not be provided by Novo Nordisk A/S, except if required by local regulations and not in 
contradiction to local regulations.
x
should be used in accordance with standard of care and current approved label in the individual 
country.
x
should not exceed the maximum approved dose in the individual country.
Investigators can switch OAD treatment within the same drug class, e.g. in case specific drugs 
become unavailable. 
Any change in concomitant medication, including switch of OAD treatment within the same drug 
class, must be recorded at each visit. If a change is due to an AE, then this must be reported 
according to Section 9.2.
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7.7.1
Rescue medication 
Glycaemic rescue medication, i.e. intensification of background OAD treatment and/or initiation of 
new anti-hyperglycaemic treatment, should be implemented at the discretion of the investigator in 
case of persistent hyperglycaemia. Please see Section 8.1.2.
Rescue medication should be selected according to ADA/EASD guideline2 (excluding GLP-1 RAs, 
dipeptidyl peptidase-4 (DPP-4) inhibitors and amylin analogues). 
Subjects that are started on rescue medication should continue to follow the protocol-specified visit 
schedule and stay on randomised treatment unless the investigator judge that it jeopardises subject’s 
safety.
Rescue medication should be documented in medical records and reported on the concomitant 
medication form in the case report form (CRF).
Rescue medication will not be supplied by Novo Nordisk but reimbursed as long as subject is 
participating in the trial, if required according to local regulations (Appendix 9).
7.8
Treatment after the end of the trial
When discontinuing trial product at the ‘end-of-treatment visit’, the subject should be transferred to 
a suitable marketed product at the discretion of the investigator. Considering the long half-life of 
semaglutide and to avoid over-exposure to GLP-1 RAs and interference with safety data collection, 
initiating GLP-1RA or DPP-4i should be avoided between the ‘end-of-treatment’ visit and the 
follow up visit.
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8
Discontinuation/Withdrawal criteria
The subject may be discontinued at any time during the trial at the discretion of the investigator for 
safety, behavioural, compliance or administrative reasons.
Efforts must be made to have the subjects, who discontinue trial product, to continue in the trial.
Subjects must be educated about the continued scientific importance of their data, even if they 
discontinue trial product. Only subjects who withdraw informed consent will be considered as 
withdrawn from the trial.
8.1
Discontinuation of trial treatment
Discontinuation of trial treatment can be decided by either the investigator or the subject.
Subjects who discontinue trial product should continue with the scheduled visits and assessments to 
ensure continued counselling and data collection.
The subject must be discontinued from trial product, if the following applies:
17. Safety concern as judged by the investigator
18. Confirmation of acute pancreatitis
19. Pregnancy
20. Intention of becoming pregnant
21. Simultaneous participation in another clinical trial of an approved or non-approved 
investigational medicinal product
As soon as possible after the decision to discontinue trial product, the subject should attend the 
treatment discontinuation visit (V10A), followed by the treatment discontinuation follow-up visit 
(P11A) 7 weeks after treatment discontinuation. See the flowchart (Section 2) for data to be 
collected at the time of treatment discontinuation and follow-up and for any further evaluations that 
need to be completed.
The subjects should continue with the remaining scheduled visits and assessments until the time of 
the originally scheduled ‘end of treatment’ visit (V10) and “end of trial” visit (phone contact P11).
All efforts should be made to have the subject attend at least the ‘end of treatment’ clinic visit 
containing the final data collection of primary and confirmatory secondary efficacy endpoints, and 
the “end of trial” visit. If the subject does not wish to attend the scheduled clinic visits efforts 
should be made to have the remaining visits converted to phone contacts. 
The investigator should discuss with the subject about the continued scientific importance of their 
data even if they discontinue trial product. If a subject is unwilling to attend any of the visits, 
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information about the attempts to follow up with the subject must be documented in the subject’s 
medical record.
The primary reason for discontinuation of trial product must be specified in the end-of-treatment 
form in the case report form (CRF), and final drug accountability must be performed. A treatment 
discontinuation session must be made in the IWRS.
8.1.1
Temporary discontinuation of trial treatment
In case of suspicion of acute pancreatitis, the trial product should promptly be interrupted (treatment 
discontinuation session should not be made in IWRS before diagnosis of acute pancreatitis is 
confirmed). Appropriate actions should be initiated, including local measurement of amylase and 
lipase (see Appendix 4 for reporting).
If acute pancreatitis is confirmed, trial product should not be restarted, and a treatment 
discontinuation session should be made in IWRS. If the Atlanta criteria18 are not fulfilled and thus, 
the suspicion of acute pancreatitis is not confirmed, trial product may be resumed.
If a subject has discontinued trial product due to temporary safety concern not related to trial 
product and is allowed to resume, the subject should follow the guide for missed doses 
(Section 7.1). Similarly, a subject who discontinues trial product on their own initiative should be 
encouraged to resume the trial product (Section 7.1).
8.1.2
Rescue criteria
Subjects with persistent and unacceptable hyperglycaemia should be offered treatment 
intensification. To allow time for dose escalation to maximum dose and to observe the expected 
effect of treatment on glycaemic parameters, rescue criteria will be applied at week 16 and onwards.
If any of the HbA1c values exceeds the limit outlined below and no intercurrent cause of the 
hyperglycaemia can be identified, a confirmatory HbA1c in the central laboratory should be 
obtained within 30 days.
If the confirmatory HbA1c exceeds the value described below then the subject should be offered 
treatment intensification (rescue medication) at the discretion of the investigator and in accordance 
with the ADA/EASD guidelines2 (excluding GLP-1RAs, DPP-4 inhibitors and amylin analogues).
Rescue medication should be offered from week 16 to week 40 to:
x
subjects with persistent poor glycaemic control, as expressed by a stable HbA1c value above 
8.5% (69 mmol/mol) that is confirmed within 30 days by the central laboratory and 
considered unacceptably high according to investigator’s assessment.
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Refer to Section 7.7.1 for description of rescue medication.
8.2
Withdrawal from the trial
A subject may withdraw consent at any time at his/her own request.
If a subject withdraws consent, the investigator must ask the subject if he/she is willing, as soon as 
possible, to have assessment performed according to visit 10A. See the flowchart (Section 2) for 
data to be collected.
Final drug accountability must be performed even if the subject is not able to come to the trial site. 
A treatment discontinuation session must be made in the IWRS.
If a subject withdraws from the trial, he/she may request destruction of any samples taken and not 
tested, and the investigator must document this in the medical record.
If the subject withdraws consent, Novo Nordisk may retain and continue to use any data collected 
before such a withdrawal of consent.
Although a subject is not obliged to give his/her reason(s) for withdrawing, the investigator must 
make a reasonable effort to ascertain the reason(s), while fully respecting the subject's rights. Where 
the reasons are obtained, the primary reason for withdrawal must be specified in the end of trial 
form in the CRF.
8.2.1
Replacement of subjects
Subjects who discontinue trial product or withdraw from trial will not be replaced.
8.3
Lost to follow-up
A subject will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the trial site.
The following actions must be taken if a subject fails to return to the trial site for a required visit:
x
The site must attempt to contact the subject and reschedule the missed visit as soon as possible 
and counsel the subject on the importance of maintaining the assigned visit schedule and 
ascertain whether the subject wishes to and/or should continue in the trial.
x
Before a subject is deemed lost to follow-up, the investigator must make every effort to regain 
contact with the subject (where possible, at least three telephone calls and, if necessary, a 
certified letter to the subject's last known mailing address or local equivalent methods). These 
contact attempts should be documented in the subject's source document.
x
Should the subject continue to be unreachable, he/she will be considered to have withdrawn 
from the trial with a primary reason of lost to 'follow-up'.
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9
Trial assessments and procedures
x
Trial procedures and their timing are summarised in the flowchart.
x
Informed consent must be obtained before any trial related activity, see Appendix 3.
x
All screening evaluations must be completed and reviewed to confirm that potential subjects 
meet all eligibility criteria.
x
The investigator will maintain a screening log to record details of all subjects screened and to 
confirm eligibility or record reason for screen failure, as applicable.
x
At screening, subjects will be provided with a card stating that they are participating in a trial 
and giving contact details of relevant trial site staff.
x
Adherence to the trial design requirements, including those specified in the flowchart, is 
essential and required for trial conduct.
x
A subject who does not fulfil the eligibility criteria must not be randomised. If a subject is 
randomised in violation of inclusion and exclusion criteria, this will be handled as an important 
protocol deviation, and the IEC/IRB and regulatory authorities must be notified according to 
local requirements.
x
The investigator must ensure they keep regular contact with each subject throughout the entire 
trial, and always have updated contact information. Even if a visit is missed and it is not 
possible to reschedule, every effort to have all subjects followed for the primary endpoint and
AEs must be made.
x
It is the responsibility of the investigator to schedule the visits and contacts as per the protocol 
flowchart (Section 2) and to ensure they take place.
x
Assessments should be carried out according to the clinic’s standard of practice unless 
otherwise specified in the current section. Efforts should be made to limit the bias between 
assessments.
x
Review of completed hypoglycaemic episode diaries must be documented either on the 
documents or in the subject's source documents. If clarification of entries or discrepancies in the 
diary is needed, the subject must be questioned and a conclusion made in the subject's source 
documents. Care must be taken not to bias the subject.
x
Review of laboratory reports must be documented either on the documents or in the subject's 
source documents.
x
Repeat samples may be taken for technical issues and unscheduled samples or assessments may 
be taken for safety reasons. Refer to Appendix 2 for further details on laboratory samples.
US and Canada: For country specific requirements, refer to Appendix 9
9.1
Efficacy assessments 
Planned time points for all efficacy assessments are provided in the flowchart.
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9.1.1
Clinical efficacy laboratory assessments
All protocol-required laboratory assessments, as defined in Appendix 2, must be conducted in 
accordance with the flowchart and the laboratory manual.
9.1.2
Body measurements
Body measurements (height, weight, waist circumference) will be measured and recorded as 
specified in the flowchart.
Height is measured without shoes in centimetres or inches and recorded to nearest ½cm or ¼inch.
Body weight should be measured without shoes and only wearing light clothing and recorded in the 
eCRF in kilogram or pound [kg/lb], with a precision of 1/10 unit, (e.g. 45.2 kg / 137.2 lb). BMI will 
be calculated in the eCRF.
The waist circumference is defined as the minimal abdominal circumference located midway 
between the lower rib margin and the iliac crest and will be measured using a non-stretchable 
measuring tape. The measurement of waist circumference should be performed and recorded in the 
eCRF to the nearest ½ cm or ¼inch. The waist circumference should be measured in a standing 
position with an empty bladder and wearing light clothing with accessible waist. The subject should 
be standing with arms down their side and feet together. The tape should touch the skin but not 
compress soft tissue. The subject should be asked to breathe normally, and the measurement should 
be taken when the subject is breathing out gently.
9.2
Adverse events
The definitions of AEs and SAEs can be found in Appendix 4.
The investigator is responsible for detecting, documenting, recording and following up on events 
that meet the definition of an AE or SAE.
9.2.1
Time period and frequency for collecting AE and SAE information
All AEs will be collected from the first trial-related activity after obtaining informed consent and 
until the follow up phone contact, at the time points specified in the flowchart.
All SAEs will be recorded and reported to Novo Nordisk or designee within 24 hours, as indicated 
in Appendix 4. The investigator must submit any updated SAE data to Novo Nordisk within 24 
hours of it being available.
Investigators are not obligated to actively seek for AE or SAE in former trial subjects. However, if 
the investigator learns of any SAE, including a death, at any time after a subject has been 
discontinued from/completed the trial, and the investigator considers the event to be 
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possibly/probably related to the investigational trial product or trial participation, the investigator 
must promptly notify Novo Nordisk.
The method of recording, evaluating and assessing causality of AE and SAE and the procedures for 
completing and transmitting SAE reports are provided in Appendix 4.
Timelines for reporting of AEs are listed in Figure 9-1.
Some AEs require additional data collection via a specific event form. This includes medication 
errors observed during the trial. The relevant specific events are listed in Table 9-1 and the 
reporting timelines in Figure 9-1.
AE identified
AE form ≤  24 hours
SIF ≤ 5 calendar days
Sign off ≤ 7 calendar days
Is the AE serious or 
non-serious?
AE form
Is the AE listed as 
requiring a Specific Event 
Form to be completed?
Non-serious
Serious
No additional action
No
Specific event form
For SAE:
 ≤ 14 calendar days
Yes
Timelines are from the awareness of an AE.
Queries and follow-up requests to be resolved ≤ 14 calendar days.
AE: Adverse Events, SAE: Serious Adverse Events, SIF: Safety Information Form
Figure 9-1
Decision tree for determining the event type and the respective forms to 
complete with associated timelines
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Table 9-1
AEs requiring additional data collection (via specific event form)
Event type
Acute gallbladder disease
Acute pancreatitis
Acute renal failure
Diabetic retinopathy
Hepatic event
Malignant neoplasms
Medication error
9.2.2
Method of detecting AEs and SAEs
Care should be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and non-
leading verbal questioning of the subject is the preferred method to inquire about events.
9.2.3
Follow-up on AEs and SAEs
After the initial AE/SAE report, the investigator is required to proactively follow each subject at 
subsequent visits/contacts. All SAEs, will be followed until resolution, stabilisation, or if the event 
is otherwise explained (e.g. chronic condition) or the subject is lost to follow-up (as defined in
Section 8.3). Further information on follow-up procedures is given in Appendix 4.
9.2.4
Regulatory reporting requirements for SAEs
Prompt notification by the investigator to Novo Nordisk of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects and the safety of a trial 
product under clinical investigation are met.
Novo Nordisk has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a trial product under clinical investigation. Novo Nordisk 
will comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory requirements 
and Novo Nordisk policy and forwarded to investigators as necessary.
An investigator who receives an investigator safety report describing a SAE or other specific safety 
information (e.g. summary or listing of SAEs), from Novo Nordisk will review and then file it 
along with the investigator's brochure and will notify the IRB/IEC, if appropriate according to local 
requirements.
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9.2.5
Cardiovascular and death events
Cardiovascular and death events will be handled and reported according to AE/SAEs description in 
Section 9.2.1.
9.2.6
Disease-related events and/or disease-related outcomes not qualifying as an AE or 
SAE
The following Disease-Related Events (DREs) are common in subjects with T2D and can be 
serious/life threatening:
x
Hypoglycaemic episodes
Definitions, classification and reporting requirements are described in Appendix 7.
Hypoglycaemia
Non-serious hypoglycaemia must be reported on a hypoglycaemic episode form.
If the hypoglycaemic episode fulfils the criteria for an SAE then in addition to the above, an AE 
form and a safety information form must also be filled in. One AE form and safety information 
form can cover several hypoglycaemic episode forms, if the subject has not recovered between the 
episodes.
BG meter and hypoglycaemic episode diary
Subjects will be provided with a blood glucose (BG) meter including auxiliaries as well as 
instructions for use. The subjects will be instructed in how to use the device and the instruction will
be repeated at regular intervals as indicated in the flowchart.
The BG meters use test strips calibrated to plasma values. Therefore, all measurements performed 
with capillary blood are automatically calibrated to plasma equivalent glucose values, which will be 
shown on the display.
The BG meter provided by Novo Nordisk should be used for the measurements required in the 
protocol as described in Appendix 7.
Subjects will also be provided with a hypoglycaemic episode diary. When subject experiences a 
hypoglycaemic episode, subject should use the BG meter and record the general information in 
relation to the hypoglycaemia in a diary as described in Appendix 7.
Relevant data from the diary must be transcribed into the CRF, as specified in Appendix 7, during 
or following the contact. If obtained via phone and a discrepancy is later detected, the values in the 
CRF must be corrected.
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Occasional review by the investigator of the BG meter values stored in the memory of the BG meter 
and correct reporting of these in the diary is advised in order to ensure adequacy of the data reported 
in the trial database.
9.2.7
Pregnancies and associated adverse events
Details of pregnancies in female subjects will be collected after the first-trial-related activity after 
obtaining informed consent and until the follow up phone contact (7 weeks after the end of 
treatment).
If a pregnancy is reported in female subjects, the investigator should inform Novo Nordisk within 
14 calendar days of learning of the pregnancy and should follow the procedures outlined in 
Figure 9-2 and Appendix 5.
Pregnancy outcome should be documented in the subject's medical record. Abnormal pregnancy 
outcome (e.g. spontaneous abortion, foetal death, stillbirth, congenital anomalies and ectopic 
pregnancy) is considered an SAE.
Maternal form 1b 
≤ 14 calendar days after birth
Maternal form 1a
≤ 14 calendar days
After birth/
termination 
of pregnancy
No additional 
action
Normal outcome 
Maternal form 2 ≤ 14 calendar days
Paternal form*1 ≤ 14 calendar days
Abnormal outcome 
Pregnancy 
verified
*1 Further information collected on Paternal form for male partners of 
female subjects requires signing of specific informed consent.
AE/SAEs in connection with the pregnancy and in the foetus/newborn 
should follow the timelines in Figure 9.1.
Prior to 
birth or 
pregnancy 
termination 
For female subjects
Figure 9-2
Decision tree for determining the forms to complete with associated timelines 
for pregnancy.
9.2.8
Medical device incidents (including malfunctions)
Section not applicable for this trial. Refer to technical complaints in Section 9.2.9.
9.2.9
Technical complaints
The investigator must assess whether a technical complaint is related to an AE.
The definitions and reporting process for technical complaints can be found in Appendix 6.
Timelines for reporting technical complaints are listed in Figure 9-3.
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Technical complaint form: ≤ 24 hours 
AE form: ≤ 24 hours 
SIF: ≤ 5 calendar days
Is it related 
to an SAE?
Technical complaint 
identified
Is it related 
to an AE?
Yes
No
Technical complaint form
≤ 5 calendar days
Technical complaint form: 
≤ 5 calendar days
AE form: ≤ 5 calendar days
No
Yes
AE: Adverse Event, SAE: Serious Adverse Event,  SIF: Safety Information Form
Figure 9-3
Decision tree for determining the forms to complete with associated timelines 
for technical complaints.
9.3
Treatment of overdose
Overdoses of up to 4.0 mg in a single dose and up to 4.0 mg in a week have been reported in 
clinical trials. The most commonly reported AE was nausea. All subjects recovered without 
complications.
There is no specific antidote for overdose with semaglutide. In the event of an overdose, appropriate 
supportive treatment should be initiated according to subject’s clinical signs and symptoms.
Accidental overdose must be reported as a medication error. Refer to Section 9.2.1 for further 
details.
In the event of an overdose, the investigator should closely monitor the subject for overdose-related 
AE/SAE and laboratory abnormalities. A prolonged period of observation and treatment may be 
necessary, taking into account the long half-life of semaglutide of approximately one week.
Decisions regarding dose interruptions or modifications will be made by the investigator based on 
the clinical evaluation of the subject.
For more information on overdose, also consult the current version of the investigator's brochure 
and any updates hereof15.
9.4
Safety assessments 
Planned time points for all safety assessments are provided in the flowchart.
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A concomitant illness is any illness that is present at the start of the trial (i.e. at the first visit) or 
found as a result of a screening procedure or other trial procedures performed before exposure to 
trial product.
Medical history is a medical event that the subject has experienced in the past. Only relevant and
significant medical history as judged by the investigator should be recorded in the eCRF at the 
screening visit. Findings of specific medical history should de described in designated forms.
In case of an abnormal and clinically significant finding, the investigator must record the finding on 
the Medical History/Concomitant Illness form if it is present at screening. Any new finding 
fulfilling the AE definition (see Appendix4) during the trial and any clinically significant worsening 
from baseline must be reported as an AE (see Section 9.2).
9.4.1
Physical examinations
x
A physical examination must be performed and include the following:
General appearance, skin, thyroid gland, respiratory system, cardiovascular system, 
gastrointestinal system including mouth, central and peripheral nervous system, and lymph node 
palpation
x
Investigators should pay special attention to clinical signs related to previous serious illnesses.
9.4.2
Vital signs
x
Pulse rate as well as diastolic and systolic blood pressure will be assessed.
x
Blood pressure at randomisation will consist of 3 diastolic and systolic blood pressure 
measurements with intervals of at least 1 minute.
x
Pulse rate at randomisation will also consist of 3 measurements.
x
At randomisation, all blood pressure and pulse readings must be entered in the eCRF and the 
average of the 3 blood pressure and the average of the 3 pulse readings will be calculated in the 
eCRF. At the subsequent visits, the blood pressure and pulse should only be measured once.
x
Blood pressure (diastolic and systolic) and pulse measurements should be preceded by at least 5 
minutes of rest for the subject in a quiet setting without distractions (e.g. television, cell 
phones).
x
Blood pressure and pulse measurements will be assessed in a sitting position with a completely 
automated device. Manual techniques will be used only if an automated device is not available.
9.4.3
Eye examination
Subjects with uncontrolled and potentially unstable diabetic retinopathy or maculopathy are not
eligible, as this indicates retinopathy that has recently progressed to a level that requires 
intervention or is approaching intervention but has yet to be brought under control.
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Results of an eye examination performed by an ophthalmologist or another suitably qualified 
healthcare provider must be available and evaluated by the investigator before randomisation to
assess eligibility. The eye examination should be performed as a fundus photography (e.g. 2-field
60 degree or better, colour or red-free) or by slit-lamp biomicroscopy examination (e.g. using a pre-
corneal or corneal contact lens examination). Pharmacological pupil-dilation is a requirement unless 
using a fundus photography camera specified for non-dilated examination.
If the subject had such an eye examination performed within 90 days prior to screening, the 
investigator may base his/her evaluation upon the results of that examination. The examination must
be repeated before randomisation if the subject has experienced worsening of visual function since
the last examination. If the applicable eye examination was performed before the subject signed the
informed consent form, it must be documented that the reason for performing the examination was
not related to this trial.
After randomisation an eye examination performed according to the above must be performed as 
per the flowchart in Section 2. Results must be available at V10 (end of treatment visit). An eye 
examination performed within 3 weeks prior to V10 is acceptable, provided no clinical symptoms 
suggestive of eye disease have occurred in the meantime.
The investigator should indicate the outcome of each eye examination. Relevant findings prior to 
randomisation must be recorded as concomitant illness/medical history, while relevant findings 
occurring after randomisation should be reported as an AE, if applicable according to Section 9.2.
9.4.4
Clinical safety laboratory assessments
All protocol-required laboratory assessments, as defined in Appendix 2, must be conducted in 
accordance with the laboratory manual and the flowchart in 2.
9.5
Pharmacokinetics
x
Single blood samples for measuring plasma concentration of semaglutide will be drawn on 
visits specified in the flowchart.
x
Subject must be instructed to withhold their trial product dose in the morning of the clinic visit 
until blood sampling has been performed.
x
The exact timing of obtaining the pharmacokinetic (PK) sample must be recorded on the 
laboratory form.
x
The purpose of measuring plasma semaglutide levels is to conduct exposure-response, to 
evaluate the dose response and the adherence to the treatment.
x
Blood samples for PK assessments must be collected, handled and shipped according to the 
description in the laboratory manual supplied by the central laboratory. The bioanalysis of 
semaglutide PK will be performed by a special laboratory. Semaglutide PK samples will be 
stored at the special laboratory responsible for PK until final Clinical Trial Report (CTR) in case 
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Novo Nordisk requests further analysis of the PK samples. Details of the bioanalysis will be 
outlined in a bioanalytical study plan issued by the special laboratory.
9.6
Pharmacodynamics
Not applicable for this trial.
9.7
Genetics
Not applicable for this trial.
9.8
Biomarkers
Not applicable for this trial.
9.9
Severe hypersensitivity
In the event of a severe immediate hypersensitivity reaction to trial product, blood sampling for 
assessment of anti-semaglutide IgE and binding antibodies should be conducted after 1–2 weeks 
and 7 weeks of trial product wash-out (i.e. after the subject had the last dose of the trial product). In 
these cases, it is also recommended to test for tryptase (total and/or mature tryptase) within 3 hours 
of the hypersensitivity reaction. In case a tryptase sample was collected within 3 hours of the event 
of hypersensitivity reaction, a baseline tryptase sample should be taken at the same time points as 
the IgE sample is obtained (after 1-2 weeks of drug wash-out). Tryptase concentrations (if 
measured) as well as results of anti-semaglutide antibody and IgE isotype anti-semaglutide 
antibodies will be collected by Novo Nordisk and the results will be reported in the CTR.
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10 Statistical considerations 
10.1
Sample size determination 
The primary endpoint is change from baseline (week 0) to week 40 in HbA1c (%-point) and the 
confirmatory secondary endpoint is change from baseline (week 0) to week 40 in body weight (kg). 
Both endpoints will be tested for superiority. The type-I error rate will be controlled in the strong 
sense across the primary and the confirmatory secondary hypotheses, separately for each estimand, 
at an overall alpha level (two-sided) of 0.05. Multiplicity control and criteria for confirming the 
hypotheses is described in Section 10.3 below.
The sample size calculation is performed to ensure sufficient power for confirming superiority of 
semaglutide 2.0 mg vs. semaglutide 1.0 mg on change from baseline to week 40 in HbA1c (%-point) 
based on each estimand separately.
Primary endpoint
An on-treatment HbA1c treatment effect of −0.26%-point was predicted based on exposure-response 
modelling.
To accommodate the treatment policy estimand, the on-treatment effect is adjusted by 15% based 
on results from the SUSTAIN phase 3a programme, where a lower effect was observed for the
treatment policy estimand as compared to the on-treatment effect. With the adjusted HbA1c
treatment effect of −0.22%-point and a standard deviation of 1.1%-point, 964 subjects will be 
randomised in order to obtain 87% power for confirming superiority for the primary endpoint based 
on the treatment policy estimand and at least 87% power for confirming superiority for the primary 
endpoint based on the hypothetical estimand. This is based on a 1:1 randomisation, a two-sided
significance level of 0.05, and a t-test. The assumed standard deviation is based on the SUSTAIN 
programme.
Confirmatory secondary endpoint
With 964 subjects randomised to ensure sufficient power (87%) for confirming superiority for the 
primary endpoint based on the treatment policy estimand, a marginal power of 90% for confirming 
that semaglutide 2.0 mg is superior to semaglutide 1.0 mg on change from baseline to week 40 in 
body weight (based on each estimand) is obtained if the true treatment difference is as low as 
- 0.84 kg. This is based on a 1:1 randomisation, a two-sided significance level of 0.05, a t-test, and a 
standard deviation of 4.0 kg. The assumed standard deviation is based on the SUSTAIN 
programme.
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Sensitivity analyses for the sample size calculation
The sensitivity of power for confirming superiority for the primary endpoint based on the treatment 
policy estimand for a fixed sample size of 964 subjects is presented in Table 10-1.
Table 10-1
Power for different scenarios
Scenario
On-treatment 
effect 
Adjusted for the 
treatment policy 
estimand 
Adjusted 
treatment effect
Randomised 
subjects
Power
Scenario 1
-0.25 %-point
15 %
-0.21
964
84 %
Scenario 2
-0.25 %-point
20 %
-0.20
964
81 %
Scenario 3
-0.27 %-point
15 %
-0.23
964
90 %
Scenario 4
-0.27 %-point
20 %
-0.22
964
87%
Scenario 5
-0.29 %-point
15 %
-0.25
964
94 %
Scenario 6
-0.29 %-point
20 %
-0.23
964
90 %
10.2
Definition of analysis sets
Data selection for statistical analyses will be a two-step process, first selecting subjects based on the 
analysis population and subsequently events/data for those subjects based on the observation period. 
Full analysis set (FAS): All randomised subjects. Subjects will be analysed according to the 
treatment to which they were assigned at randomisation.
Safety analysis set (SAS): All subjects exposed to at least one dose of trial product. Subjects will be 
analysed according to the trial product received for the majority of the period they were 
on treatment.
‘In-trial’ observation period: This observation period is defined as the period from the date of 
randomisation to the first of the following dates, both inclusive:
x
Date of the end-of-treatment visit (V10)
x
Date of death
x
Date when subject withdrew informed consent
x
Date of last contact for subjects lost to follow-up
‘On-treatment’ observation period: This observation period is a sub-set of the ‘in-trial’ observation 
period and represents the time period where subjects are considered exposed to trial product. The 
observation period starts at the date of first dose of trial product and ends at an endpoint-specific 
end-date. For adverse events including hypoglycaemic events, the observation period ends at the
first date of any of the following:
x
The follow-up visit (P11)
x
The treatment discontinuation follow-up visit (P11A)
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x
The date of last dose of trial product +49 days
x
The end-date for the ‘in-trial’ observation period
The follow-up visit is scheduled to take place 7 weeks after the last date on trial product, i.e., 49 
days.
For efficacy and other safety assessments (laboratory assessments, body measurements, and vital 
signs) the ‘on-treatment’ observation period ends at the last date on trial product with a visit 
window of +14 days. Hence, for these assessments, the ‘on-treatment’ observation period reflects 
the period in which subjects are treated.
‘On-treatment without rescue medication’ observation period: This observation period is a sub-set 
of the ‘on-treatment’ observation period and represents the time period where subjects are 
considered treated with trial product but have not initiated any rescue medications. The observation 
period starts at the date of first dose of trial product and ends at the first date of any of the 
following:
x
Initiation of rescue medication
x
The date of last dose of trial product +14 days
Data points collected outside an observation period will be treated as missing in the analysis. 
Baseline data will always be included in an observation period.
Before data are locked for statistical analysis, a review of all data will take place. In general 
subjects should not be excluded from an analysis set and observations should not be excluded from
an observation period, if they fulfil the criteria. If subjects or observations are excluded, the reasons 
for their exclusion must be documented before database lock and described in the clinical trial 
report. Any decision to exclude either a subject or single observation from the statistical analysis is 
the joint responsibility of the members of the Novo Nordisk study group.
10.3
Statistical analyses
If necessary, a statistical analysis plan (SAP) may be written in addition to the protocol, including a 
more technical and detailed elaboration of the statistical analyses. The SAP will be finalised before 
the partial database lock.
General considerations
The comparison presented from a statistical analysis will be semaglutide 2.0 mg versus 
semaglutide 1.0 mg and results will be presented by the estimated treatment contrast with associated 
two-sided 95% confidence intervals and p-values corresponding to two-sided tests of no difference 
if not otherwise specified.
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Data from all sites will be analysed and reported together. 
If no statistical analysis is specified, data will be presented using relevant summary statistics. 
Accordingly, adverse events will be summarised descriptively. Data collected before randomisation 
(V2) will only be summarised descriptively.
Multiplicity control and criteria for confirming hypotheses
The statistical testing strategy will be performed for the primary analysis of each of the two 
estimands separately. In order to preserve the overall type-I error in the strong sense at a 5% 
significance level (two-sided), the conclusion of superiority of semaglutide 2.0 mg versus 
semaglutide 1.0 mg will be evaluated hierarchically according to the sequence below. The treatment 
difference is defined as μ = (semaglutide 2.0 mg minus semaglutide 1.0 mg).
1. Superiority of semaglutide 2.0 mg versus semaglutide 1.0 mg on change from baseline to 
week 40 in HbA1c
x
H0: μ ≥ 0.0 %-point against Ha: μ < 0.0 %-point
2. Superiority of semaglutide 2.0 mg vs. semaglutide 1.0 mg on change from baseline to week 
40 in body weight
x
H0: μ ≥ 0.0 kg against Ha: μ < 0.0 kg
10.3.1
Primary endpoint
The primary endpoint is change from baseline (week 0) to week 40 in HbA1c (%-point).
Analyses addressing the hypothetical estimand
Primary analysis
The hypothetical estimand will be estimated based on FAS using post-baseline data collected up to 
and including week 40 from the ‘on-treatment without rescue medication’ observation period. 
Imputation of missing data will be handled by multiple imputation (MI) assuming that missing data 
are missing at random (MAR). The imputation will be performed separately within each treatment 
group defined by randomised treatment. First, intermittent missing values are imputed using a 
Markov Chain Monte Carlo (MCMC) method, to obtain a monotone missing data pattern, 
generating 500 complete data sets. Secondly, a sequential conditional linear regression approach for 
imputing monotone missing values will be implemented starting with the first visit after baseline 
and sequentially continuing to the last planned visit at week 40. The model used for imputation will 
include the baseline and post-baseline HbA1c values observed prior to the visit in question as 
covariates. 
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The 500 complete datasets will be analysed using an analysis of covariance (ANCOVA) with 
treatment and stratification as fixed factors and the baseline HbA1c as covariate. Rubin’s rule19 will 
be applied to obtain inference.
Tipping point sensitivity analysis
For the tipping point sensitivity analysis, the primary analysis will be repeated, however, prior to 
analysis subjects from the semaglutide 2.0 mg group with missing observations at week 40 will be 
given a penalty, i.e., it is assumed that subjects with missing observations who are randomised to 
semaglutide 2.0 mg will receive a treatment that is less beneficial than subjects with observed 
values who are randomised to semaglutide 2.0 mg. The addition of the penalty values and 
subsequent analysis steps should be repeated with increasing penalty values until a significant result 
in the corresponding superiority analysis is no longer significant. This analysis will only be 
performed if superiority is confirmed based on the primary analysis.
Analyses addressing the treatment policy estimand
Primary analysis
The treatment policy estimand will be estimated based on the FAS using week 40 data from the ‘in-
trial’ observation period.
Imputation of missing data will be handled by MI assuming that missing data are missing at 
random. The imputation will be performed by imputing missing week 40 data separately within 
groups defined by randomised treatment and treatment status at week 40 (retrieved drop-out), in 
total, four groups as follows; (i) semaglutide 1.0 mg and on-treatment at week 40, (ii) semaglutide 
1.0 mg and off-treatment at week 40, (iii) semaglutide 2.0 mg and on-treatment at week 40, (iv) 
semaglutide 2.0 mg and off-treatment at week 40.
For each of the four groups an ANCOVA with baseline HbA1c as covariate will be fitted to 
observed values of the change from baseline in HbA1c at week 40. The estimated parameters for 
location and dispersion will then be used to impute 500 values for each subject with missing week 
40 data based on only baseline HbA1c. 
The 500 complete datasets will be analysed using an analysis of covariance (ANCOVA) with 
treatment and stratification as fixed factors and the baseline HbA1c as covariate. Rubin’s rule[ref 
19] will be applied to obtain inference.
Tipping point sensitivity analysis
The tipping point analysis will be performed in the same manner as for the tipping point sensitivity 
analysis addressing the hypothetical estimand, however, with the primary analysis addressing the 
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treatment policy estimand as foundation. This analysis will only be performed if superiority is 
confirmed based on the primary analysis.
10.3.2
Secondary endpoints
10.3.2.1
Confirmatory secondary endpoint
The confirmatory secondary endpoint is change from baseline (week 0) to week 40 in body weight 
(kg).
Analyses addressing the hypothetical estimand
Similar analyses as for the primary endpoint including body weight values instead of HbA1c values 
will be performed.
Analyses addressing the treatment policy estimand
Similar analyses as for the primary endpoint including body weight values instead of HbA1c values 
will be performed.
Overview of statistical analyses and intercurrent events
An overview of all analyses addressing the two estimands for the confirmatory endpoints is 
provided in Table 10-2.
Table 10-2
Statistical analyses of the confirmatory endpoints
Endpoint
Estimand
Analysis 
set
Observation 
period
Statistical 
model
Imputation approach
Sensitivity 
analysis
Primary endpoint
Change in 
HbA1c (%-point)
Hypothetical
FAS
On-
treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Tipping 
point 
analysis
Treatment 
policy
FAS
In-trial
ANCOVA
MAR within group 
defined by randomised 
treatment and treatment 
status at week 40
Tipping 
point 
analysis
Confirmatory secondary endpoint
Change in body 
weight (kg)
Hypothetical
FAS
On-
treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Tipping 
point 
analysis
Treatment 
policy
FAS
In-trial
ANCOVA
MAR within group 
defined by randomised 
treatment and treatment 
status at week 40
Tipping 
point 
analysis
Abbreviations: ANCOVA; Analysis of Covariance; FAS: Full Analysis Set; MAR: Missing At Random.
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The following Table 10-3 describes how anticipated intercurrent events during the trial are handled 
for confirmatory endpoints. The different intercurrent events will be handled in the same manner for 
both confirmatory endpoints.
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Table 10-3
Statistical handling of intercurrent events for the primary analyses of the 
confirmatory endpoints
Intercurrent event
Handling
Hypothetical estimand
Treatment policy estimand
Strategy
Data
Strategy
Data
x Change in dose 
during and after the 
dose escalation 
period
Treatment 
policy
Assessments will be 
performed and collected 
at scheduled visits after 
the intercurrent event and 
used in the analysis
Treatment 
policy
Assessments will be 
performed and collected 
at scheduled visits after 
the intercurrent event and 
used in the analysis
x Treatment 
discontinuation due 
to AEs
x Initiation of rescue 
(anti-diabetic) 
medication
Hypothetical
Assessments for 
scheduled visits after the 
time of the intercurrent 
event are considered 
missing and will be 
imputed assuming MAR 
as described in the 
analysis
Treatment 
policy
Assessments will be 
performed and collected 
at scheduled visits after 
the intercurrent event and 
used in the analysis
10.3.2.2
Supportive secondary endpoints
The supportive secondary endpoints are listed in Section 4.3.2.2. All analyses of these endpoints 
will be addressing a hypothetical estimand similar to the hypothetical estimand for the primary 
objective and based on the FAS using data from the ‘on-treatment without rescue medication’ 
observation period unless otherwise stated.
Continuous endpoints 
The continuous endpoints will be analysed using a similar model approach as for the primary 
analysis of the primary endpoint with the associated baseline value as covariate instead of HbA1c for 
their respective analyses. The analysis of change from baseline to week 40 in pulse rate will be 
based on SAS using data from the ‘on-treatment’ observation period.
Responder endpoints
To account for missing data, the binary endpoints will be derived from the 500 imputed datasets 
from the associated primary analysis addressing the hypothetical estimand. Each of the complete 
data sets will be analysed using a logistic regression (LR) model with treatment and stratification as 
fixed effects and associated baseline response as covariate. Estimated odds ratios will be 
log-transformed and inference will be drawn using Rubin’s rule19. The results will be back-
transformed and described by the odds ratio between treatments and the associated 95% CI and p-
value for no treatment difference.
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Other endpoints
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic 
episodes at week 40 will be analysed using a negative binomial regression (NBR) model with a 
log-link function and the logarithm of the time period covered by the subject’s ‘on-treatment’ 
observation period as offset. The model will include treatment and stratification as fixed factors and 
baseline HbA1c as a covariate. This analysis will be based on the SAS using the ‘on-treatment’ 
observation period. The results will be described by the rate ratio between treatments and the 
associated 95% CI and p-value for no treatment difference.
Overview of statistical analyses
An overview of all analyses of the supportive secondary endpoints is provided in Table 10-4.
Table 10-4
Statistical analyses of the supportive secondary endpoints
Endpoint
Estimand
Analysis 
set
Observation 
period
Statistical 
model
Imputation approach
Supportive secondary endpoints (effect related)
Change in FPG 
(mmol/)
Hypothetical
FAS
On-treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Change in BMI 
(kg/m2)
Hypothetical
FAS
On-treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
Change in waist 
circumference (cm)
Hypothetical
FAS
On-treatment 
w/o rescue
ANCOVA
MAR within randomised 
treatment group
HbA1c < 7% (yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
HbA1c ≤ 6.5% 
(yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
Weight loss ≥ 5% 
(yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
Weight loss ≥ 10% 
(yes/no)
Hypothetical
FAS
On-treatment 
w/o rescue
LR
MAR within randomised 
treatment group
Supportive secondary endpoints (safety related)
Change in pulse 
(bpm)
-
SAS
On-treatment 
ANCOVA
MAR within randomised 
treatment group
Number of 
hypoglycaemic 
episodes
-
SAS
On-treatment 
NBR
-
Abbreviations: ANCOVA; Analysis of Covariance; FAS: Full Analysis Set; LR: Logistic Regression; MAR: Missing 
At Random; NBR: Negative Binomial Regression; SAS: Safety Analysis Set
10.3.3
Other analyses
The binary assessment indicating whether a subject has had no treatment emergent severe or blood 
glucose confirmed symptomatic hypoglycaemic episodes at week 40 or at least one will be analysed 
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using a logistic regression model. The model will include treatment and stratification as fixed 
effects and baseline HbA1c as covariate, and the analysis will be based on SAS using data from the 
‘on-treatment’ observation period. The results will be described by the odds ratio between 
treatments and the associated 95% confidence interval and p-value for no treatment difference.
10.4
Pharmacokinetic and/or pharmacodynamic modelling
Population PK modelling and exposure-response analyses may be included to support dose 
selection and to explore the benefits of high versus lower doses of semaglutide in subjects with 
T2D. 
The modelling will include data from all randomised subjects that were exposed to semaglutide in 
this trial and might be performed as a meta-analysis including data from historical trials. Actual 
dose and date of administration of last dose before PK sampling will be registered in the CRF and 
used in the analysis, together with actual time point for PK sampling. The analysis will be further 
specified in a modelling analysis plan that is to be prepared before database lock. 
The modelling analyses will be performed by Quantitative Clinical Pharmacology at Novo Nordisk 
A/S and will be reported separately from the CTR. 
10.5
Partial database lock
A partial database lock will be performed at the end of the treatment period for all subjects, i.e. after 
the date of the last patient last treatment (LPLT) visit. The database will be updated after the partial 
database lock to include remaining PK data and any additional safety information. The full database 
lock will be performed after the date of the last patient last visit (LPLV).
Novo Nordisk will become unblinded at the time of the partial database lock, whereas subjects and 
investigators will remain blinded until after last patient last visit (LPLV). The analysis of the 
primary endpoint and all other efficacy endpoints will be performed based on the data from the 
partial database lock. Analysis of safety and PK data will be performed after the full database lock. 
This approach is implemented to allow earlier availability of semaglutide 2 mg to the patient 
population expected to benefit from a higher dose and to support further development activities with 
semaglutide s.c. A detailed plan for data handling and operational aspects of the partial database 
lock and the database update will be finalised before the partial database lock.
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11 References
1.
The European Parliament and the Council of the European Council. Directive 2001/20/EC 
of the European Parliament and of the Council of 4 April 2001 on the approximation of the 
laws, regulations and administrative provisions of the Member States relating to the 
implementation of good clinical practice in the conduct of clinical trials on medicinal 
products for human use, article 11. Official Journal of the European Communities. 01 May
2001.
2.
Davies M, D’Alessio D, Fradkin J, Kernan W, Mathieu C, Mingrone G, et al. Management 
of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes 
Association (ADA) and the European Association for the Study of Diabetes (EASD). 
Diabetes Care. 2018;41(12):2669-701.
3.
Pi-Sunyer FX. Weight loss in type 2 diabetic patients. Diabetes Care. 2005;28(6):1526-7.
4.
Look AHEAD Research Group, Wing RR. Long-term effects of a lifestyle intervention on 
weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year 
results of the Look AHEAD trial. Arch Intern Med. 2010;170(17):1566-75.
5.
Sorli C, Harashima SI, Tsoukas GM, Unger J, Karsbøl JD, Hansen T, et al. Efficacy and 
safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 
diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, 
multinational, multicentre phase 3a trial. Lancet Diabetes Endocrinol. 2017;5(4):251-60.
6.
Ahrén B, Masmiquel L, Kumar H, Sargin M, Karsbøl JD, Jacobsen SH, et al. Efficacy and 
safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, 
thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, 
double-blind, phase 3a, randomised trial. Lancet Diabetes Endocrinol. 2017;5(5):341-54.
7.
Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, et al. Efficacy and 
Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 
Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes 
Care. 2018;41(2):258-66.
8.
Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, et al. Semaglutide 
Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. 
J Clin Endocrinol Metab. 2018;103(6):2291-301.
9.
Aroda VR, Bain SC, Cariou B, Piletič M, Rose L, Axelsen M, et al. Efficacy and safety of 
once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or 
without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a 
randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet 
Diabetes Endocrinol. 2017;5(5):355-66.
10.
Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jódar E, Leiter LA, et al. Semaglutide and 
Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 
2016;375(19):1834-44.
11.
Lingvay I, Desouza CV, Lalic KS, Rose L, Hansen T, Zacho J, et al. A 26-Week 
Randomized Controlled Trial of Semaglutide Once Daily Versus Liraglutide and Placebo in 
Patients With Type 2 Diabetes Suboptimally Controlled on Diet and Exercise With or 
Without Metformin. Diabetes Care. 2018;41(9):1926-37.
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12.
O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, et al. 
Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in 
patients with obesity: a randomised, double-blind, placebo and active controlled, dose-
ranging, phase 2 trial. Lancet. 2018;392(10148):637-49.
13.
Novo Nordisk A/S. Ozempic® (semaglutide), EU Summary of Product Characteristics 
(SmPC). 2018.
14.
Novo Nordisk A/S. Ozempic ® (semaglutide), US Prescribing Information (PI). Dec 2017.
15.
Novo Nordisk A/S. Investigator's Brochure, semaglutide s.c. (Ozempic®), project NN9535 
(edition 14), or any updates hereof. 31 Jul 2018.
16.
Aroda V, Ahmann A, Cariou B, Chow F, Davies M, J´odar E, et al. Comparative efficacy, 
safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the 
treatment of type 2 diabetes: Insights from the SUSTAIN 1–7 trials. Diabetes & 
Metabolism. 2018.
17.
Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 
Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. 
Kidney Int Suppl. 2013;3(1):1-150.
18.
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, et al. Classification 
of acute pancreatitis-2012: revision of the Atlanta classification and definitions by 
international consensus. Gut. 2013;62(1):102-11.
19.
Little RJA, Rubin DB. Statistical analysis with missing data. New York: Wiley. 1987. xiv, 
278 p. p.
20.
World Medical Association. WMA Declaration of Helsinki - Ethical Principles for Medical 
Research Involving Human Subjects. Last amended by the 64th WMA General Assembly, 
Fortaleza, Brazil. October 2013.
21.
ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R2), Step 4 
version. 09 Nov 2016.
22.
International Committee of Medical Journal Editors. Recommendations for the Conduct,
Reporting, Editing, and Publication of Scholarly Work in Medical Journals. December 
update 2017.
23.
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial 
registration: a statement from the International Committee of Medical Journal Editors. N 
Engl J Med. 2004;351(12):1250-1.
24.
U.S. Department of Health and Human Services, Food and Drug Administration. Food and 
Drug Administration Amendments Act of 2007 as amended by the Final Rule "Clinical 
Trials Registration and Results Information Submission". 21 September 2016.
25.
The European Parliament and the Council of the European Council. Regulation (EC) No 
726/2004 of the European Parliament and of the Council of 31 March 2004 laying down 
Community procedures for the authorisation and supervision of medicinal products for 
human and veterinary use and establishing a European Medicines Agency, article 57. 30 
April 2004.
26.
Schwartz NS, Clutter WE, Shah SD, Cryer PE. Glycemic thresholds for activation of 
glucose counterregulatory systems are higher than the threshold for symptoms. J Clin Invest. 
1987;79(3):777-81.
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27.
Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, et al. Hypoglycemia 
and diabetes: a report of a workgroup of the American Diabetes Association and the 
Endocrine Society. Diabetes Care. 2013;36(5):1384-95.
28.
U.S. Department of Health and Human Services, Food and Drug Administration. Guidance 
for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to 
Support Labeling Claims. Avaliable from: 
http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf. 2009.
29.
Stull DE, Leidy NK, Parasuraman B, Chassany O. Optimal recall periods for patient-
reported outcomes: challenges and potential solutions. Curr Med Res Opin. 2009;25(4):929-
42.
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12 Appendices
Appendix 1
Abbreviations and Trademarks
AACE
American Association of Clinical Endocrinologists
ADA
American Diabetes Association
AE
adverse event
ALT
alanine aminotransferase
ANCOVA 
analysis of covariance
AST
aspartate aminotransferase
BG
blood glucose
BMI 
body mass index 
BUN
blood urea nitrogen 
CFR
Code of Federal Regulations 
CI 
confidence interval
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
CRF
case report form
CTR
clinical trial report
CV
cardiovascular
DBP
diastolic blood pressure 
DMC
data monitoring committee
DFU
directions for use 
DPP-4i 
dipeptidyl peptidase-4 inhibitor
DRE
disease related event
DUN
dispensing unit number
EAC
event adjudication committee
EASD
European Association for the Study of Diabetes
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ECG
electrocardiogram
eGFR
estimated glomerular filtration rate
ETD
estimated treatment differences 
FAS
full analysis set
FDA
U.S. Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act
FPG
fasting plasma glucose
FSH
follicle-stimulating hormone 
GCP
Good Clinical Practice
GI 
gastrointestinal
GIAE
gastrointestinal adverse event
GLP-1 RA 
glucagon-like peptide-1 receptor agonist
HbA1c
glycated haemoglobin
hCG
human chorionic gonadotropin 
HRT
hormone replacement therapy
IB
investigator’s brochure
ICH
International Council for Harmonisation
IEC
independent ethics committee
INR
international normalised ratio 
IRB
institutional review board
IUD
intrauterine device
IUS
intrauterine hormone-releasing system 
IWRS
interactive web response system
KDIGO
Kidney disease improving global outcomes
LOCF
last available observation carried forward 
LR
logistic regression 
LSFT
last subject first treatment 
MAR
missing at random
MCMC
Markov Chain Monte Carlo 
MEdDRA
medical dictionary for regulatory activities
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MEN2
multiple endocrine neoplasia type 2 
MI
multiple imputation
MMRM
mixed model for repeated measurement
MTC
medullary thyroid cancer 
NBR
negative binomial regression 
NYHA
New York Heart Association
OD
once daily
PCD
primary completion date
PG
plasma glucose
PK 
pharmacokinetic
PMM
pattern mixture model 
PP
per protocol
PT
preferred terms 
PYE
patient-years of exposure 
SBP 
systolic blood pressure 
SAE
serious adverse event
SAP
statistical analysis plan
SMQ
standardised MedDRA queries 
SMPG
self-measured plasma glucose
SOC
system organ class 
SUSAR
suspected unexpected serious adverse reaction
T2D
type 2 diabetes
TEAE
treatment-emergent adverse event
TMM
trial materials manual
ULN
upper limit of normal
WOCBP
woman of child bearing potential
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Appendix 2
Clinical laboratory tests
x
The tests detailed in Table 12-1 and Table 12-2 will be performed by the central laboratory.
x
Additional tests may be performed at any time during the trial as determined necessary by the
investigator or required by local regulations. Only laboratory samples specified in the protocol 
should be sent to the central laboratory for analysis; if additional laboratory sampling is needed, 
e.g. to follow up on AEs, this must be done at a local laboratory.
x
The laboratory equipment may provide analyses not requested in the protocol but produced 
automatically in connection with the requested analyses according to specifications in the
laboratory standard operating procedures. 
x
The investigator must review all laboratory results for concomitant illnesses and AEs.
x
Laboratory samples will be destroyed no later than at finalisation of the clinical trial report.
Table 12-1
Protocol-required efficacy laboratory assessments
Laboratory assessments
Parameters
Glucose metabolism 
x Fasting plasma glucose1
x HbA1c
NOTES:
1A FPG result ≤3.9 mmol/L (70 mg/dL) in relation to planned fasting visits should not be reported as a 
hypoglycaemic episode.
Table 12-2
Protocol-required safety laboratory assessments
Laboratory assessments
Parameters
Haematology
x Basophils
x Eosinophils
x Erythrocytes
x Haematocrit
x Haemoglobin
x Leucocytes
x Lymphocytes
x Monocytes
x Neutrophils
x Thrombocytes
Biochemistry1
x Alanine Aminotransferase (ALT)
x Alkaline phosphatase
x Amylase
x Aspartate Aminotransferase (AST)
x Creatinine
x Lipase
x Potassium
x Sodium
x Total Bilirubin
x Urea
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Hormones
x Calcitonin (only for screening purposes)
Pregnancy Testing
x Urine human chorionic gonadotropin (hCG) pregnancy test (as needed for women of 
childbearing potential)2
Other tests
x eGFR calculated by the central laboratory based on the creatinine value using the 
CKD-EPI equation
Notes:
1Details of required actions and follow-up assessments for increased liver parameters including any discontinuation 
criteria are given in Appendix 4 (Hy’s Law) and Section 8.1.
2Local urine testing will be standard unless serum testing is required by local regulation or IRB/IEC.
All trial-required laboratory assessments will be performed by a central laboratory, with the 
exception of:
x
urine pregnancy testing, which will be performed locally
x
semaglutide plasma concentrations, which will be performed at a specialised laboratory and
x
anti-semaglutide IgE and binding antibodies (in the event of a severe immediate hypersensitivity 
reaction to trial product), which will be performed at a specialised laboratory 
Laboratory/analyte results that could unblind the trial will not be reported to the trial sites until the 
trial has been unblinded.
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Appendix 3
Trial governance considerations
1) Regulatory and ethical considerations
x
This trial will be conducted in accordance with the protocol and with the following:
x
Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki20 and applicable ICH Good Clinical Practice (GCP) Guideline21
x
Applicable laws and regulations
x
The protocol, informed consent form, investigator’s brochure (as applicable) and other relevant 
documents (e.g. advertisements), must be submitted to an IRB/IEC and reviewed and approved 
by the IRB/IEC before the trial is initiated.
x
Regulatory authorities will receive the clinical trial application, protocol amendments, reports 
on SAEs, and the clinical trial report according to national requirements.
x
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the trial design, except for changes necessary to eliminate an immediate safety 
hazard to trial subjects.
x
Before a trial site is allowed to start screening subjects, written notification from Novo Nordisk 
must be received.
x
The investigator will be responsible for:
x
providing written summaries of the status of the trial annually or more frequently in 
accordance with the requirements, policies, and procedures established by the IRB/IEC 
and/or regulatory authorities
x
notifying the IRB/IEC of SAEs or other significant safety findings as required by IRB/IEC 
procedures
x
providing oversight of the conduct of the trial at the site and adherence to requirements of 
ICH guidelines, the IRB/IEC, and all other applicable local regulations ensuring submission 
of the clinical trial report (CTR) synopsis to the IRB/IEC.
Japan: For country specific requirements, refer to Apppendix 9
2) Financial disclosure
Investigators and sub-investigators will provide Novo Nordisk with sufficient, accurate financial 
information as requested to allow Novo Nordisk to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the trial and one 
year after completion of the trial.
For US trial sites: verification under disclosures per Code of Federal Regulations (CFR) of 
Financial Conflict of Interest.
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3) Informed consent process
x
The investigator or his/her representative will explain the nature of the trial to the subject and 
answer all questions regarding the trial.
x
The investigator must ensure the subject ample time to come to a decision whether or not to 
participate in the trial. 
x
Subjects must be informed that their participation is voluntary.
x
Subjects will be required to sign and date a statement of informed consent that meets the 
requirements of local regulations, ICH guidelines21, Declaration of Helsinki20 and the IRB/IEC 
or trial site.
x
The medical record must include a statement that written informed consent was obtained before 
any trial related activity and the date when the written consent was obtained. The authorised 
person obtaining the informed consent must also sign and date the informed consent form before 
any trial related activity.
x
The responsibility of seeking informed consent must remain with the investigator, but the 
investigator may delegate the task of informing to a medically qualified person, in accordance 
with local requirements.
x
Subjects must be re-consented to the most current version of the informed consent form(s) 
during their participation in the trial.
x
A copy of the informed consent form(s) must be provided to the subject.
4) Information to subjects during trial
The site will be offered a communication package for the subject during the conduct of the trial. 
The package content is issued by Novo Nordisk. The communication package will contain written 
information intended for distribution to the subjects. The written information will be translated and 
adjusted to local requirements and distributed to the subject at the discretion of the investigator. The 
subject may receive a “welcome to the trial letter” and a “thank you for your participation letter” 
after completion of the trial. Further the subject may receive other written information during the 
trial.
All written information to subjects must be sent to IRB/IEC for approval/favourable opinion and to 
regulatory authorities for approval or notification according to local regulations.
5) Data protection
x
Subjects will be assigned a 6-digit unique identifier, a subject number. Any subject records or
datasets that are transferred to Novo Nordisk will contain the identifier only; subject names or 
any information which would make the subject identifiable will not be transferred.
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x
The subject and any biological material obtained from the subject will be identified by subject 
number, visit number and trial ID. Appropriate measures such as encryption or leaving out 
certain identifiers will be enforced to protect the identity of subjects as required by local, 
regional and national requirements. 
x
The subject must be informed that his/her personal trial related data will be used by Novo 
Nordisk in accordance with local data protection law. The disclosure of the data must also be 
explained to the subject. 
x
The subject must be informed that his/her medical records may be examined by auditors or 
other authorised personnel appointed by Novo Nordisk, by appropriate IRB/IEC members, and 
by inspectors from regulatory authorities.
6) Committee structure
Novo Nordisk safety committee
Novo Nordisk will constitute an internal semaglutide s.c. safety committee to perform ongoing 
safety surveillance. The semaglutide s.c. safety committee may recommend unblinding of any data 
for further analysis, and in this case an independent ad hoc group will be established in order to 
maintain the blinding of the trial personnel.
7) Publication policy
The information obtained during the conduct of this trial is considered confidential and may be used 
by or on behalf of Novo Nordisk for regulatory purposes as well as for the general development of 
the trial product. All information supplied by Novo Nordisk in connection with this trial shall 
remain the sole property of Novo Nordisk and is to be considered confidential information.
No confidential information shall be disclosed to others without prior written consent from Novo 
Nordisk. Such information shall not be used except in the performance of this trial.
The information obtained during this trial may be made available to other investigators who are 
conducting other clinical trials with the trial product, if deemed necessary by Novo Nordisk. 
Provided that certain conditions are fulfilled, Novo Nordisk may grant access to information 
obtained during this trial to researchers who require access for research projects studying the same 
disease and/or trial product studied in this trial.
Novo Nordisk may publish on its clinical trials website a redacted clinical trial report for this trial.
One (or two) investigator (s) will be appointed by Novo Nordisk to review and sign the clinical trial 
report (signatory investigator) on behalf of all participating investigators. The signatory 
investigator(s) will be appointed based upon the criteria defined by the International Committee of 
Medical Journal Editors for research publications.22
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Communication of results
Novo Nordisk commits to communicate and disclose results of trials regardless of outcome. 
Disclosure includes publication of a manuscript in a peer-reviewed scientific journal, abstract 
submission with a poster or oral presentation at a scientific meeting or disclosure by other means. 
The results of this trial will be subject to public disclosure on external web sites according to 
international and national regulations. Novo Nordisk reserves the right to defer the release of data 
until specified milestones are reached, for example when the clinical trial report is available. This 
includes the right not to release the results of interim analyses, because the release of such 
information may influence the results of the entire trial.
At the end of the trial, one or more scientific publications may be prepared collaboratively by the 
investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or 
communication for up to 60 days to protect intellectual property.
In all cases the trial results will be reported in an objective, accurate, balanced and complete 
manner, with a discussion of the strengths and limitations. In the event of any disagreement on the 
content of any publication, both the investigators’ and Novo Nordisk opinions will be fairly and
sufficiently represented in the publication.
Authorship
Novo Nordisk will work with one or more investigator(s) and other experts who have contributed to 
the trial concept or design, acquisition, analysis or interpretation of data to report the results in one 
or more publications.
Authorship of publications should be in accordance with the Recommendations for the Conduct, 
Reporting, Editing and Publication of Scholarly Work in Medical Journals by the International 
Committee of Medical Journal Editors22.
All authors will be provided with the relevant statistical tables, figures, and reports needed to 
evaluate the planned publication. 
Where required by the journal, the investigator from each trial site will be named in an 
acknowledgement or in the supplementary material, as specified by the journal. 
Site-specific publication(s) by investigator(s)
For a multicentre clinical trial, analyses based on single-site data usually have significant statistical 
limitations and frequently do not provide meaningful information for healthcare professionals or
subjects, and therefore may not be supported by Novo Nordisk. Thus, Novo Nordisk may deny a 
request or ask for deferment of the publication of individual site results until the primary manuscript 
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is accepted for publication. In line with Good Publication Practice, such individual reports should
not precede the primary manuscript and should always reference the primary manuscript of the trial.
Investigator access to data and review of results
As owner of the trial database, Novo Nordisk has the discretion to determine who will have access 
to the database.
Individual investigators will have their own research subjects' data and will be provided with the 
randomisation code after results are available.
8) Dissemination of clinical trial data
Information of the trial will be disclosed at clinicaltrials.gov and novonordisk-trials.com. It will also 
be disclosed according to other applicable requirements such as those of the International 
Committee of Medical Journal Editors (ICMJE)23, the Food and Drug Administration Amendments
Act (FDAAA)24, European Commission Requirements1, 25 and other relevant recommendations or 
regulations. If a subject requests to be included in the trial via the Novo Nordisk e-mail contact at 
these web sites, Novo Nordisk may disclose the investigator’s contact details to the subject. As a 
result of increasing requirements for transparency, some countries require public disclosure of 
investigator names and their affiliations.
The Primary Completion Date (PCD) is the last assessment of the primary endpoint and is for this 
trial Last Subject First Treatment (LSFT) + 40 weeks corresponding to V10 (end of treatment visit). 
If the last subject is withdrawn early, the PCD is considered the date when the last subject would 
have completed V10. The PCD determines the deadline for results disclosure at clinicaltrials.gov 
according to FDAAA.
9) Data quality assurance
Case Report Forms (CRFs)
x
Novo Nordisk or designee is responsible for the data management of this trial including quality 
checking of the data.
x
All subject data relating to the trial will be recorded on electronic CRFs unless transmitted 
electronically to Novo Nordisk or designee (e.g. laboratory data). The investigator is responsible 
for verifying that data entries are accurate and correct by physically or electronically signing the 
CRF.
The following will be provided as paper CRFs:
x
Pregnancy forms
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The following will be provided as paper CRFs to be used when access to the CRF is revoked or the 
CRF is temporarily unavailable:
x
AE forms 
x
Safety information forms 
x
Technical complaint forms (also to be used to report complaints that are not subject related, 
e.g. discovered at trial site before allocation)
x
Corrections to the CRF data may be made by the investigator or the investigator’s delegated 
staff. An audit trail will be maintained in the CRF application containing as a minimum: the old 
and the new data, identification of the person entering the data, date and time of the entry and 
reason for the correction. If corrections are made by the investigator’s delegated staff after the 
date when the investigator signed the CRF, the CRF must be signed and dated again by the 
investigator.
x
The investigator must ensure that data is recorded in the CRF as soon as possible, preferably 
within 5 working days after the visit. Once data has been entered, it will be available to Novo 
Nordisk for data verification and validation purposes.
Monitoring
x
The investigator must permit trial-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents (original documents, 
data and records). Direct access includes permission to examine, analyse, verify and reproduce 
any record(s) and report(s) that are important to the evaluation of the trial. If the electronic 
medical record does not have a visible audit trail, the investigator must provide the monitor with 
signed and dated printouts. In addition, the relevant trial site staff should be available for 
discussions at monitoring visits and between monitoring visits (e.g. by telephone).
x
Trial monitors will perform ongoing source data verification to confirm that data entered into 
the CRF by authorised site personnel are accurate, complete and verifiable from source 
documents; that the safety and rights of subjects are being protected, to monitor drug 
accountability and collect completed paper CRF pages, if applicable, and that the trial is being 
conducted in accordance with the currently approved protocol and any other trial agreements, 
ICH GCP, and all applicable regulatory requirements.
x
Monitoring will be conducted using a risk-based approach including risk assessment, 
monitoring plans, centralised monitoring (remote assessment of data by Novo Nordisk) and 
visits to trial sites.
x
Monitors will review the subject’s medical records and other source data to ensure consistency 
and/or identify omissions compared to the CRF.
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Protocol compliance
Deviations from the protocol should be avoided. If deviations do occur, the investigator must 
inform the monitor and the implications of the deviation must be reviewed and discussed.
Deviations must be documented and explained in a protocol deviation by stating the reason, date, 
and the action(s) taken. Some deviations, for which corrections are not possible, can be 
acknowledged and confirmed via edit checks in the CRF or via listings from the trial database.
10) Source documents
x
All data entered in the CRF must be verifiable in source documentation other than the CRF.
x
If source data is entered directly in a paper CRF, each data entry or clear series of data entries 
must be signed and dated separately by the trial staff making the entry.
x
The original of the completed diaries must not be removed from the trial site, unless they form 
part of the CRF and a copy is kept at the site.
x
Source documents provide evidence for the existence of the subject and substantiate the 
integrity of the data collected. Source documents are filed at the trial site.
x
Data reported on the paper CRF or entered in the electronic CRF that are transcribed from 
source documents must be consistent with the source documents or the discrepancies must be 
explained. The investigator may need to request previous medical records or transfer records. 
Also, current medical records must be available.
x
It must be possible to verify subject’s medical history in source documents such as subject’s 
medical record.
x
The investigator must document any attempt to obtain external medical information by noting 
the date(s) when information was requested and who was contacted.
x
Definition of what constitutes source data can be found in a source document agreement at each 
trial site. There will only be one source document defined at any time for any data element.
11) Retention of clinical trial documentation
x
Records and documents, including signed informed consent forms, pertaining to the conduct of 
this trial must be retained by the investigator for 15 years after end of trial unless local 
regulations or institutional policies require a longer retention period. No records may be 
destroyed during the retention period without the written approval of Novo Nordisk. No records
may be transferred to another location or party without written notification to Novo Nordisk.
x
The investigator must be able to access his/her trial documents without involving Novo Nordisk 
in any way. If applicable, electronic CRF and other subject data will be provided in an 
electronic readable format to the investigator before access is revoked to the systems and/or 
electronic devices supplied by Novo Nordisk. Site-specific CRFs and other subject data (in an 
electronic readable format or as paper copies or prints) must be retained by the trial site. If the 
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provided electronic data (e.g. the CD-ROM) is not readable during the entire storage period, the 
investigator can request a new copy. A copy of all data will be stored by Novo Nordisk.
x
Subject’s medical records must be kept for the maximum period permitted by the hospital, 
institution or private practice
12) Trial and site closure
Novo Nordisk reserves the right to close the trial site or terminate the trial at any time for any 
reason at the sole discretion of Novo Nordisk. If the trial is suspended or terminated, the 
investigator must inform the subjects promptly and ensure appropriate therapy and follow-up. The 
investigator and/or Novo Nordisk must also promptly inform the regulatory authorities and 
IRBs/IECs and provide a detailed written explanation.
Trial sites will be closed upon trial completion. A trial site is considered closed when all required 
documents and trial supplies have been collected and a trial site closure visit has been performed.
The investigator may initiate trial site closure at any time, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a trial site by Novo Nordisk or investigator may include but are not 
limited to:
x
failure of the investigator to comply with the protocol, the requirements of the IRB/IEC or local 
health authorities, Novo Nordisk procedures or GCP guidelines
x
inadequate recruitment of subjects by the investigator
x
discontinuation of further trial product development.
13) Responsibilities
The investigator is accountable for the conduct of the trial at his/her site and must ensure adequate 
supervision of the conduct of the trial at the trial site. If any tasks are delegated, the investigator 
must maintain a log of appropriately qualified persons to whom he/she has delegated specified trial-
related duties. The investigator must ensure that there is adequate and documented training for all 
staff participating in the conduct of the trial. It is the investigator’s responsibility to supervise the 
conduct of the trial and to protect the rights, safety, and well-being of the subjects. 
A qualified physician, who is an investigator or a sub-investigator for the trial, must be responsible 
for all trial-related medical decisions. 
The investigator is responsible for filing essential documents (i.e. those documents which 
individually and collectively permit evaluation of the conduct of a trial and the quality of the data 
produced) in the investigator trial master file. The documents, including the subject identification 
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code list must be kept in a secure locked facility so that no unauthorised persons can get access to 
the data.
The investigator will take all necessary technical and organisational safety measures to prevent 
accidental or wrongful destruction, loss or deterioration of data. The investigator will prevent any 
unauthorised access to data or any other processing of data against applicable law. The investigator 
must be able to provide the necessary information or otherwise demonstrate to Novo Nordisk that 
such technical and organisational safety measures have been taken.
During any period of unavailability, the investigator must delegate responsibility for medical care of 
subjects to a specific qualified physician who will be readily available to subjects during that time.
If the investigator is no longer able to fulfil the role as investigator (e.g. if he/she moves or retires) a 
new investigator will be appointed in consultation with Novo Nordisk.
The investigator and other site personnel must have sufficient English skills according to their 
assigned task(s).
14) Indemnity statement 
Novo Nordisk carries product liability for its products, and liability as assumed under the special 
laws, acts and/or guidelines for conducting clinical trials in any country, unless others have shown 
negligence.
Novo Nordisk assumes no liability in the event of negligence or any other liability of the sites or 
investigators conducting the trial or by persons for whom the said site or investigator are 
responsible.
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Appendix 4 Adverse events: definitions and procedures for 
recording, evaluation, follow-up, and reporting
AE definition
x An AE is any untoward medical occurrence in a clinical trial subject that is temporally associated with the use of a 
medicinal product, whether or not considered related to the medicinal product.
x An AE can be any unfavourable and unintended sign, including an abnormal laboratory finding, symptom or 
disease (new or exacerbated) temporally associated with the use of a medicinal product.
Events meeting the AE definition
x Any abnormal laboratory test results or safety assessments, including those that worsen from baseline, considered 
clinically significant in the medical and scientific judgment of the investigator.
x A clinical abnormal laboratory finding which is clinically significant, i.e. an abnormality that suggests a disease 
and/or organ toxicity and is of a severity that requires active management. Active management includes active 
treatment or further investigations, for example change of medicine dose or more frequent follow-up due to the 
abnormality.
x Abuse: Persistent or sporadic, intentional excessive use of a medicinal product, which is accompanied by harmful 
physical or psychological effects (e.g. overdose with the intention to cause harm)
x Misuse: Situations where the medicinal product is intentionally and inappropriately used not in accordance with 
the protocol or the terms of the marketing authorisation.
x Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or 
intensity of the condition.
x Signs, symptoms or the clinical sequelae of a suspected drug-drug interaction.
x Signs, symptoms or the clinical sequelae of a suspected overdose of trial product regardless of intent.
x • A “lack of efficacy” or “failure of expected pharmacological action” per se will not be reported as an AE or 
SAE. Such instances will be captured in the efficacy assessments. However, the signs, symptoms and/or clinical 
sequelae resulting from lack of efficacy will be reported as AE or SAE if they fulfil the definition. 
Events NOT meeting the AE definition 
x Pre-existing conditions, anticipated day-to-day fluctuations of pre-existing conditions, including those identified 
during screening or other trial procedures performed before exposure to trial product. 
Note: pre-existing conditions should be recorded as medical history/concomitant illness.
x Pre-planned procedures, unless the condition for which the procedure was planned has worsened from the first 
trial related activity after the subject has signed the informed consent.
Definition of an SAE
An SAE is an AE that fulfils at least one of the following criteria:
x Results in death
x Is life-threatening
The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death 
at the time of the event. It does not refer to an event which hypothetically might have caused death, if it were more 
severe.
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x Requires inpatient hospitalisation or prolongation of existing hospitalisation
x Hospitalisation signifies that the subject has been detained at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or outpatient setting. 
Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils 
any other serious criteria, the event is serious. When in doubt as to whether “hospitalisation” occurred or was 
necessary, the AE should be considered serious.
x Hospitalisation for elective treatment of a pre-existing condition that did not worsen from baseline is not 
considered an AE.
Note:

Hospitalisations for administrative, trial related and social purposes do not constitute AEs and should 
therefore not be reported as AEs or SAEs.

Hospital admissions for surgical procedures, planned before trial inclusion, are not considered AEs or SAEs.
x Results in persistent or significant disability/incapacity
x The term disability means a substantial disruption of a person’s ability to conduct normal life functions.
x This definition is not intended to include experience of relatively minor medical significance such as 
uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle), 
which may interfere with or prevent everyday life functions but do not constitute a substantial disruption.
x Is a congenital anomaly/birth defect
x Important medical event:
x Medical or scientific judgment should be exercised in deciding whether SAE reporting is appropriate in other 
situations. This includes important medical events that may not be immediately life-threatening or result in 
death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to 
prevent one of the other outcomes listed in the above definition. These events should usually be considered 
serious and reported as SAEs using the important medical event criterion.
x The following adverse events must always be reported as SAEs using the important medical event criterion, if 
no other seriousness criteria are applicable:

suspicion of transmission of infectious agents via the trial product. 

risk of liver injury defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x 
UNL and total bilirubin >2 x UNL, where no alternative aetiology exists (Hy's law).
Description of AEs requiring additional data collection (via specific event form)
AEs requiring additional data collection
AEs requiring additional data collection are AEs where the additional data will benefit the evaluation of the safety of 
the trial product (Table 9-1). The selection of these events is based on the non-clinical and clinical data with 
semaglutide, knowledge from the GLP-1 RA drug class as well as regulatory requirements.
Event type
Description
Medication error: 
A medication error is an unintended failure in the trial drug treatment 
process that leads to, or has the potential to lead to, harm to the subject 
such as:
x
Administration of wrong drug or use of wrong device.
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Note: Use of wrong dispensing unit number (DUN) is not 
considered a medication error unless it results in an 
administration of wrong drug. 
x
Wrong route of administration, such as intramuscular instead of 
subcutaneous. 
x
Accidental administration of higher dose than intended during 
dose escalation or maintenance. However, the administered dose 
must deviate from the intended dose to an extent where clinical 
consequences for the trial subject were likely to happen as judged 
by the investigator, although they did not necessarily occur.
Acute pancreatitis
The diagnosis of acute pancreatitis requires two of the following three 
features:
(1) abdominal pain consistent with acute pancreatitis (acute onset of a 
persistent, severe, epigastric pain often radiating to the back)
(2) serum lipase activity (and/or amylase activity) at least three times 
greater than the upper limit of normal
(3) characteristic findings of acute pancreatitis on imaging
Acute gallbladder disease
Events of symptomatic acute gallbladder disease (including gallstones and 
cholecystitis)
Malignant neoplasm
Confirmed malignant neoplasm by histopathology or other substantial 
clinical evidence
Hepatic event
Hepatic event defined as:
– Disorders of the liver including cholestatic conditions and liver related 
signs and symptoms
– ALT or AST > 3x UNL and total bilirubin > 2x UNL*
– ALT or AST > 3x UNL with the appearance of fatigue, nausea, 
vomiting, right upper quadrant pain or tenderness, fever, rash, and/or 
eosinophilia (>5%)
*Please note that in case of a hepatic event defined as ALT or AST > 3x 
UNL and total bilirubin > 2x UNL, where no alternative aetiology exists 
(Hy's law), this must be reported as an SAE using the important medical 
event criterion if no other seriousness criteria are applicable.
Acute renal failure
Events of an abrupt or rapid decline in renal filtration function. This 
condition is usually marked by a rise in serum creatinine concentration or 
by azotemia (a rise in blood urea nitrogen [BUN] concentration)
Diabetic retinopathy
New onset or worsening of diabetic retinopathy
AE and SAE recording
x The investigator will record all relevant AE/SAE information in the CRF.
x The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or other clinical 
information. In such cases, the diagnosis (not the individual signs/symptoms) will be documented as the AE/SAE.
x When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation (e.g. hospital 
progress notes, laboratory and diagnostics reports) related to the event.
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x There may be instances when copies of source documents (e.g. medical records) for certain cases are requested by 
Novo Nordisk. In such cases, all subject identifiers, with the exception of the subject number, will be redacted on 
the copies of the source documents before submission to Novo Nordisk.
x For all non-serious AEs the applicable forms should be signed when the event is resolved or at the end of the trial 
at the latest. For sign-off of SAE related forms refer to “SAE reporting via paper CRF” later in this section.
x Novo Nordisk products used as concomitant medication if an AE is considered to have a causal relationship with a 
Novo Nordisk marketed product used as concomitant medication in the trial, it is important that the suspected 
relationship is reported to Novo Nordisk, e.g. in the alternative aetiology section on the safety information form. 
Novo Nordisk may need to report this adverse event to relevant regulatory authorities.
Assessment of severity
The investigator will assess intensity for each event reported during the trial and assign it to one of the following 
categories: 
x Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with 
everyday activities.
x Moderate: An event that causes sufficient discomfort and interferes with normal everyday activities.
x Severe: An event that prevents normal everyday activities. 
Note: Severe is a category used for rating the intensity of an event; and both an AE and SAE can be assessed as 
severe. An event is defined as ‘serious’ when it meets at least one of the outcomes described in the definition of an 
SAE and not when it is rated as severe.
Assessment of causality
The investigator is obligated to assess the relationship between trial product and the occurrence of each AE/SAE.
Relationship between an AE/SAE and the relevant trial product(s) should be assessed as: 
x Probable - Good reason and sufficient documentation to assume a causal relationship.
x Possible - A causal relationship is conceivable and cannot be dismissed.
x Unlikely - The event is most likely related to aetiology other than the trial product.
Alternative aetiology, such as underlying disease(s), concomitant medication, and other risk factors, as well as the 
temporal relationship of the event to trial product administration will be considered and investigated.
The investigator should use the investigator’s brochure for the assessment. For each AE/SAE, the investigator must 
document in the medical records that he/she has reviewed the AE/SAE and has provided an assessment of causality.
There may be situations in which an SAE has occurred, and the investigator has minimal information to include in 
the initial report. However, it is important that the investigator always makes an assessment of causality for 
every event before the initial transmission of the SAE data.
The investigator may change his/her opinion of causality in light of follow-up information and send a follow-up 
report with the updated causality assessment.
The causality assessment is one of the criteria used when determining regulatory reporting requirements.
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Final outcome
The investigator will select the most appropriate outcome:
x Recovered/resolved: The subject has fully recovered, or by medical or surgical treatment the condition has 
returned to the level observed at the first trial-related activity after the subject signed the informed consent.
x Recovering/resolving: The condition is improving, and the subject is expected to recover from the event. This 
term is only applicable if the subject has completed the trial or has died from another AE.
x Recovered/resolved with sequelae: The subject has recovered from the condition, but with lasting effect due to a 
disease, injury, treatment or procedure. If a sequela meets an SAE criterion, the AE must be reported as an SAE.
x Not recovered/not resolved: The condition of the subject has not improved, and the symptoms are unchanged, or 
the outcome is not known.
x Fatal: This term is only applicable if the subject died from a condition related to the reported AE. Outcomes of 
other reported AEs in a subject before he/she died should be assessed as “recovered/resolved”, 
“recovering/resolving”, “recovered/resolved with sequelae” or “not recovered/not resolved”. An AE with a fatal 
outcome must be reported as an SAE.
x Unknown: This term is only applicable if the subject is lost to follow-up.
Follow-up of AE and SAE
The investigator is obligated to perform or arrange for the conduct of supplemental measurements and/or evaluations 
as medically indicated or as requested by Novo Nordisk to elucidate the nature and/or causality of the AE or SAE as 
fully as possible (e.g. severe hypersensitivity reactions). This may include additional laboratory tests (e.g. skin prick 
test) or investigations, histopathological examinations, or consultation with other health care professionals.
If a subject dies during participation in the trial or during a recognised follow-up period, the investigator should 
provide Novo Nordisk with a copy of autopsy report including histopathology.
New or updated information will be recorded in the CRF.
SAE reporting via electronic CRF
x Relevant forms (AE and safety information form) must be completed in the CRF. 
x For reporting and sign-off timelines, see box below. 
x If the CRF is unavailable for more than 24 hours, then the site will use the paper AE form and if the CRF is 
unavailable for more than 5 calendar days then the site will use the paper safety information form (see box below).
x The site will enter the SAE data into the CRF as soon as it becomes available, see 9.2.1.
x After the trial is completed at a given site, the CRF will be decommissioned to prevent
the entry of new data or changes to existing data. If a site receives a report of a new
SAE from a subject or receives updated data on a previously reported SAE after CRF
decommission, then the site can report this information on a paper AE and safety
information form (see box below) or to Novo Nordisk by telephone.
SAE reporting via paper CRF
x Relevant CRF forms (AE and safety information form) must be forwarded to Novo Nordisk either by fax, e-mail 
(in an encrypted manner) or courier.
x Initial notification via telephone is acceptable, although it does not replace the need for the investigator to 
complete the AE and safety information forms within the designated reporting time frames (as illustrated in 
Figure 9-1):
x AE form within 24 hours.
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x Safety information form within 5 calendar days. 
x Both forms must be signed within 7 calendar days.
Contact details for SAE reporting can be found in the investigator trial master file.
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Appendix 5
Contraceptive guidance and collection of pregnancy 
information
It must be recorded in the CRF whether female subjects are of childbearing potential. 
Definitions
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. 
Women in the following categories are not considered WOCBP
22. Premenarcheal 
23. Premenopausal female with one of the following:
x
Documented hysterectomy
x
Documented bilateral salpingectomy
x
Documented bilateral oophorectomy
Note: Documentation can come from the site personnel’s review of subject’s medical records, 
medical examination or medical history interview.
24. Postmenopausal female
x
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high Follicle Stimulating Hormone (FSH) level in the postmenopausal 
range may be used to confirm a postmenopausal state in women not using hormonal 
contraception or Hormonal Replacement Therapy (HRT). However, in the absence of 12 
months of amenorrhea, a single Follicle-Stimulating Hormone (FSH measurement is 
insufficient. 
x
Females on HRT and whose menopausal status is in doubt will be required to use one of the 
non-hormonal highly effective contraception methods if they wish to continue their HRT 
during the trial. Otherwise, they must discontinue HRT to allow confirmation of 
postmenopausal status before trial enrolment.
Contraception guidance
Male subjects 
No contraception measures are required for male subjects as the risk of teratogenicity/fetotoxicity 
caused by transfer of semaglutide in seminal fluid is unlikely. 
Female subjects
Female subjects of childbearing potential are eligible to participate if they agree to use methods of 
contraception consistently and correctly as described in table(s) below:
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Table 12-3
Highly effective contraceptive methods
Highly effective contraceptive methods that are user dependent a and b
Failure rate of <1% per year when used consistently and correctly.
Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 
x oral 
x intravaginal 
x transdermal 
Progestogen only hormonal contraception associated with inhibition of ovulation
x oral 
x injectable 
Highly effective methods that are user independent b
Implantable progestogen only hormonal contraception associated with inhibition of ovulation 
x Intrauterine Device (IUD)
x Intrauterine hormone-releasing System (IUS)
x Bilateral tubal occlusion
Vasectomised partner 
A vasectomised partner is a highly effective contraception method provided that the partner is the sole male sexual 
partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used.
Sexual abstinenceb
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse 
during the entire period of risk associated with the trial product. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject.
Notes: 
aTypical use failure rates may differ from those when used consistently and correctly. Use should be consistent with 
local regulations regarding the use of contraceptive methods for subjects participating in clinical trials. 
bContraception should be utilised during the treatment period and for at least 7 weeks after the last dose of trial product.
In certain cases, it is accepted to use double barrier methods (a condom combined with an occlusive 
cap (e.g. diaphragm) with/without the use of spermicide). This should only be allowed in females 
with:
1) known intolerance to the highly effective methods mentioned in Table 12-3 or where the use 
of any of the listed highly effective contraceptive measures are contraindicated in the 
individual subject, and/or
2) if the risk of initiating treatment with a specific highly effective method outweighs the 
benefit for the female.
Justification for accepting double barrier method should be at the discretion of the investigator 
taking into consideration his/her knowledge about the female’s medical history, concomitant illness, 
concomitant medication and observed AEs. The justification must be stated in the medical records.
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Pregnancy testing
x
WOCBP should only be included after a negative highly sensitive urine pregnancy test.
x
Additional urine pregnancy testing should be performed at every site visit (every 4-8 weeks)
during the treatment period, at the end of treatment and after the 7 weeks follow-up period after 
the end of treatment, according to the flow chart.
x
Pregnancy testing should be performed whenever a menstrual cycle is missed or when 
pregnancy is otherwise suspected.
x
All subjects will be provided with a pregnancy test prior to the phone visits to perform them 
prior to the phone call, not only if pregnancy is suspected. 
Collection of pregnancy information 
Female subjects who become pregnant 
x
Investigator will collect pregnancy information on any female subject, who becomes pregnant 
while participating in this trial.
x
Information will be recorded on the appropriate form and submitted to Novo Nordisk within 14 
calendar days of learning of a subject's pregnancy.
x
Subject will be followed to determine the outcome of the pregnancy. The investigator will 
collect follow-up information on subject and neonate, which will be forwarded to Novo 
Nordisk. Generally, follow-up will not be required for longer than 1 month beyond the delivery 
date.
x
Any termination of pregnancy will be reported, regardless of foetal status (presence or absence 
of anomalies) or indication for procedure.
x
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy will be reported as an AE or SAE. 
x
A spontaneous abortion is always considered to be an SAE and will be reported as such.
x
Any SAE occurring as a result of a post-trial pregnancy which is considered possibly/probably 
related to the trial product by the investigator will be reported to Novo Nordisk as described in 
Appendix 4. While the investigator is not obligated to actively seek this information in former 
subjects, he or she may learn of an SAE through spontaneous reporting.
Any female subject who becomes pregnant while participating in the trial will discontinue trial 
product.
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Appendix 6 Technical complaints: Definition and procedures for 
recording, evaluation, follow-up and reporting
Technical complaint definition
x A technical complaint is any written, electronic or oral communication that alleges product (medicine or device)
defects. The technical complaint may be associated with an AE but does not concern the AE itself.
Examples of technical complaints:
x
Problems with the physical or chemical appearance of trial products (e.g. discoloration, particles
or contamination).
x
Problems with packaging material including labelling.
x
Problems related to medical devices (e.g. to the injection mechanism, dose setting mechanism,
push button or interface between the pen-injector and the needle).
Time period for detecting technical complaints 
All technical complaints, which occur from the time of receipt of the product at trial site until the time of the last 
usage of the product, must be collected for products predefined on the technical complaint form. 
Reporting of technical complaints to Novo Nordisk
Contact details (fax, e-mail and address) for Customer Complaint Center – refer to Attachment I
Technical complaints must be reported on a separate technical complaint form:
1.
One technical complaint form must be completed for each affected DUN
2.
If DUN is not available, a technical complaint form for each batch, code or lot number must be completed
Timelines for reporting of technical complaints to Novo Nordisk
The investigator must complete the technical complaint form in the CRF within the timelines specified in 9.2.9
If the CRF is unavailable or when reporting a technical complaint that is not subject related, the information must be 
provided on a paper form by fax, e-mail or courier to Customer Complaint Center, Novo Nordisk, within the same 
timelines as stated above. When the CRF becomes available again, the investigator must enter the information on the 
technical complaint form in the CRF.
Follow-up of technical complaints 
The investigator is responsible for ensuring that new or updated information will be recorded on the originally 
completed form.
Collection, storage and shipment of technical complaint samples
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The investigator must collect the technical complaint sample and all associated parts that were packed in the same 
DUN and notify the monitor within 5 calendar days of obtaining the sample at trial site. The sample and all 
associated parts must be sent as soon as possible to Customer Complaint Center, Novo Nordisk, together with a copy 
of the completed technical complaint form. The technical complaint sample should contain the batch, code or lot 
number and, if available, the DUN. If the technical complaint sample is unobtainable, the reason must be stated on 
the technical complaint form. If several samples are shipped in one shipment, the sample and the corresponding 
technical complaint form should be kept together.
Storage of the technical complaint sample must be done in accordance with the conditions prescribed for the product.
Reporting of technical complaints for Novo Nordisk products not included in technical complaint form
Technical complaints on Novo Nordisk products not included in the technical complaint form should be reported to 
local Novo Nordisk affiliate with a reference to trial ID.
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Appendix 7
Hypoglycaemic episodes
Novo Nordisk classification of hypoglycaemia
In normal physiology, symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L (56 
mg/dL)26. Therefore, Novo Nordisk has included hypoglycaemia with PG levels below this cut-off 
point in the definition of BG confirmed hypoglycaemia.
Novo Nordisk uses the following classification (Figure 12-1) in addition to the ADA 
classification27:
25. Severe hypoglycaemia according to the ADA classification27.
26. Symptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value 
<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
27. Asymptomatic BG confirmed hypoglycaemia: An episode that is BG confirmed by PG value 
<3.1 mmol/L (56 mg/dL) without symptoms consistent with hypoglycaemia.
28. BG confirmed hypoglycaemia: The union of 2. and 3.
29. Severe or BG confirmed symptomatic hypoglycaemia: The union of 1. and 2.
30. Severe or BG confirmed hypoglycaemia: The union of 1., 2. and 3.
For hypoglycaemic episodes reported with missing information related to the classification, the 
following applies when classifying the episode according to the Novo Nordisk classification:
x
A hypoglycaemic episode with missing information on symptoms will be classified as without 
symptoms. 
x
A hypoglycaemic episode with missing information on being able to self-treat will be regarded 
as an episode where the subject was able to self-treat and classified in accordance with the able 
to self-treat classifications.
Episodes that cannot be classified according to the above, are included in one of the following 
categories:
x
‘Novo Nordisk unclassifiable’ includes episodes where subjects were able to self-treat and with 
PG≥3.1 mmol/L (56 mg/dL) and hypoglycaemic episodes for a subject able to self-treat with 
missing PG as it is to be treated as an episode with PG>3.9 mmol/L (70 mg/dL).
x
‘Not able to self-treat – unclassifiable’ includes episodes where the subjects were not able to 
self-treat but neither of the following conditions were reported: PG≤3.9 mmol/L (70 mg/dL), 
alleviation of symptoms, seizure, unconscious/comatose or fatal.
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Hypoglycaemic
episode
PG ≤ 3.9 mmol/L 
(70 mg/dL) 
or 
Alleviation of 
symptoms 
or
Seizure, 
unconscious/
comatose or fatal 
SMPG
measurement
PG < 3.1 mmol/L
(56 mg/dL)
with symptoms
PG < 3.1 mmol/L
(56 mg/dL)
without 
symptoms
2. Symptomatic 
BG confirmed 
hypoglycaemia
3. Asymptomatic 
BG confirmed 
hypoglycaemia
Yes
No
5. Severe or 
BG confirmed 
symptomatic 
hypoglycaemia
4. BG confirmed 
hypoglycaemia
6. Severe or 
BG confirmed 
hypoglycaemia
Note: Glucose measurements are performed with capillary blood calibrated to plasma equivalent glucose values
BG: blood glucose  PG: plasma glucose  SMPG: Self-measured plasma glucose  
Subject 
able to 
treat him/
herself
1.Severe 
hypoglycaemia 
(ADA 2013)
Figure 12-1
Novo Nordisk classification of hypoglycaemia
ADA classification27 of hypoglycaemia
x
Severe hypoglycaemia: An episode requiring assistance of another person to actively administer 
carbohydrate, glucagon or take other corrective actions. PG concentrations may not be available 
during an event, but neurological recovery following the return of PG to normal is considered 
sufficient evidence that the event was induced by a low PG concentration.
x
Asymptomatic hypoglycaemia: An episode not accompanied by typical symptoms of 
hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L (70 mg/dL).
x
Documented symptomatic hypoglycaemia: An episode during which typical symptoms of 
hypoglycaemia are accompanied by a measured PG concentration ≤ 3.9 mmol/L (70 mg/dL).
x
Pseudo-hypoglycaemia: An episode during which the person with diabetes reports any of the
typical symptoms of hypoglycaemia with a measured PG concentration > 3.9 mmol/L 
(70 mg/dL) but approaching that level.
x
Probable symptomatic hypoglycaemia: An episode during which symptoms of hypoglycaemia 
are not accompanied by a PG determination but that was presumably caused by a PG 
concentration ≤ 3.9 mmol/L (70 mg/dL).
For hypoglycaemic episodes reported with missing information related to the classification, the 
following applies when classifying the episode according to the ADA classification:
x
A hypoglycaemic episode with missing information on symptoms will be classified as without 
symptoms.
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x
A hypoglycaemic episode with missing information on being able to self-treat will be regarded 
as an episode where the subject was able to self-treat and classified in accordance with the able 
to self-treat classifications
Episodes that cannot be classified according to the above, are included in one of the following 
categories
x
‘ADA unclassifiable’ includes episodes where subjects were able to self-treat and with PG>3.9 
mmol/L (70 mg/dL) or missing PG, and with no information on symptoms.
x
‘Not able to self-treat – unclassifiable’ includes episodes where the subjects were not able to 
self-treat but neither of the following conditions were reported: PG≤3.9 mmol/L (70 mg/dL), 
alleviation of symptoms, seizure, unconscious/comatose or fatal.
Hypoglycaemic 
episode 
PG ≤ 3.9 mmol/L 
(70 mg/dL) 
or 
Alleviation of 
symptoms 
or
Seizure, 
unconscious/
comatose or fatal 
SMPG
measurement
Asymptomatic 
hypoglycaemia
Documented 
symptomatic 
hypoglycaemia
Pseudo- 
hypoglycaemia
Probable 
symptomatic 
hypoglycaemia
No
Yes
No measurement 
with symptoms
PG > 3.9 mmol/L 
(70 mg/dL)
with symptoms
PG ≤ 3.9 mmol/L 
(70 mg/dL)
with symptoms
PG ≤ 3.9 mmol/L 
(70 mg/dL)
without symptoms
No
Yes
Note: Glucose measurements are performed with capillary blood calibrated to plasma equivalent glucose values
PG: plasma glucose  SMPG: Self-measured plasma glucose  
Subject 
able to 
treat him/
herself
Severe 
hypoglycaemia 
(ADA 2013)
Figure 12-2
ADA classification of hypoglycaemia
Treatment-emergent: hypoglycaemic episodes will be defined as treatment-emergent, if the onset of 
the episode occurs in the on-treatment period (see definition in Section 10.2).
Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive.
Hypoglycaemic episodes are classified according to the Novo Nordisk classification of 
hypoglycaemia and the ADA classification of hypoglycaemia.27
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Reporting of hypoglycaemic episodes:
PG should always be measured and recorded when a hypoglycaemic episode is suspected. 
All PG values:
≤3.9 mmol/L (70 mg/dL) or 
>3.9 mmol/L (70 mg/dL) occurring in conjunction with hypoglycaemic symptoms should be 
reported as a hypoglycaemic episode according to the flowchart and instructions below. When 
subject experiences a hypoglycaemic episode, subject should record the general information in 
relation to the hypoglycaemia (timing, PG measurements, symptoms etc. as described in the diary).
In case a subject is not able to fill in the diary (e.g. in case of hospitalisation or at the ‘follow-up
phone contact’), then investigator should report the hypoglycaemic episode in the CRF.
Upon onset of a hypoglycaemic episode the subject is recommended to measure PG every 15 
minutes until the self-measured plasma glucose (SMPG) value is >3.9 mmol/L (70 mg/dL) and/or 
symptoms have been resolved in accordance with current guidelines27.
Repeated SMPG measurements and/or symptoms will by default be considered as one 
hypoglycaemic episode until a succeeding SMPG value is >3.9 mmol/L (70 mg/dL) and/or 
symptoms have been resolved. One hypoglycaemic episode form is to cover these measurements 
and/or symptoms. 
In case of several low SMPG values within the hypoglycaemic episode, the lowest value is the one 
that will be reported as the SMPG value for the hypoglycaemic episode, but the start time of the 
episode will remain as the time for the first low SMPG value and/or symptom.
The lowest value measured during the hypoglycaemic episode will be reported as the PG value for 
the episode. The remaining values will be kept as source data in the diary.
A hypoglycaemic episode starting without symptoms should be updated to symptomatic if the 
subject experiences symptoms later during the episode.
If the severity of a hypoglycaemic episode worsens, only one hypoglycaemic episode should be 
reported, reflecting the most severe degree of hypoglycaemia.
Investigator must instruct subjects that the answer to the question: "Was the subject able to treat 
him/herself?" must be answered "No" for an episode requiring assistance of another person to 
actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may 
not be available during an event, but neurological recovery following the return of PG to normal is 
considered sufficient evidence that the event was induced by a low PG concentration27.
Additional information (e.g. description of symptoms, alleviation of symptoms, seizure, coma, 
fatal) in relation to these severe hypoglycaemic episodes must be recorded.
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Oral carbohydrates must not be given if the subject is unconscious. 
For low SMPG values for hypoglycaemic episodes where the subject was able to self-treat: If a 
hypoglycaemic episode form is not completed within 7 calendar days of the SMPG measurement, 
the episode should be reported on a hypoglycaemic episode form with as much information as 
possible. Novo Nordisk will not query for additional data except for the start date, SMPG value and 
whether the subject was able to self-treat due to decreased validity of such data28, 29
The subject must be re-trained in how to report hypoglycaemic episodes if the investigator identifies 
low SMPG values not reported as hypoglycaemic episodes.
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Appendix 8
NN9535-4191 Clinical Trial Report Synopsis
CTR synopsis
NAME OF SPONSOR
Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Denmark
NAME OF ACTIVE SUBSTANCE
Semaglutide 
Trial registration ID-number
NCT02461589
UTN – U1111-1159-4923
IND number – 79,754
EudraCT number – 2014-003196-39
TITLE OF TRIAL
Dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with 
type 2 diabetes
INVESTIGATORS
One principal investigator was appointed at each of the 139 trial sites in the trial. The following were designated 
signatory investigators for the trial, and were responsible for reviewing and approving the clinical trial report:
x
x
TRIAL SITES
The trial was conducted at 139 sites in 10 countries as follows:
Austria: 3 sites; Canada: 8 sites; Czech Republic 9 sites; Germany: 7 sites; Malaysia: 5 sites; Russian Federation: 7 
sites; Serbia: 9 sites; South Africa: 7 sites; United Kingdom: 13 sites; United States: 71 sites.
PUBLICATIONS
No publications were available at the time of this clinical trial report synopsis.
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TRIAL PERIOD
Initiation date: 21 September 2015
Completion date: 13 October 2016
DEVELOPMENT PHASE
Phase 2
DATA CUT-OFF DATE
The results presented reflect the data available in the clinical database as of 07 December 2016 
DATE OF THE REPORT
16 May 2017
OBJECTIVES
Primary objective:
x To compare the efficacy of 4 dose-levels of semaglutide administered subcutaneously (s.c.) once daily (OD) 
versus placebo on glycaemic control after 26 weeks of treatment.
Secondary objectives:
x To compare the efficacy of semaglutide administered s.c. OD versus liraglutide on glycaemic control after 26 
weeks of treatment.
x To compare semaglutide administered s.c. OD versus placebo and liraglutide on other parameters of efficacy, 
patient reported outcomes, safety and tolerability after 26 weeks of treatment.
METHODOLOGY
This was a 26-week multicentre, randomised, 13-arm, dose-finding trial investigating the efficacy and safety of 
semaglutide administered s.c. OD versus placebo and liraglutide in subjects diagnosed with type 2 diabetes (T2D) 
treated with diet and exercise with or without metformin. Subjects randomised to the 12-arm groups (double-blinded 
within dose level) followed a fixed-dosing regimen and a flexible dose-escalation regimen based on tolerability was 
explored for semaglutide in an open-label setting for subjects in the 13th treatment arm. For all treatment arms, 
semaglutide, liraglutide, or placebo was added on to their previous, stable therapy consisting of diet and exercise with 
or without metformin. 
The trial consisted of a 2-week screening period, up to 16 weeks of a dose-escalation period in the fixed-dose arms 
followed by a minimum of 10 weeks of maintenance therapy, and a 7-week follow-up period. The total trial duration 
for individual subjects participating in the trial was 35 weeks. For the fixed-dose groups, the dose was not to be 
changed in the remaining treatment period after the maintenance dose was reached. For the open-label semaglutide 
treatment arm, a flexible dose-escalation regimen based on gastrointestinal (GI) tolerability was followed.
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After the screening visit, eligible subjects were randomised in a 2:2:1 manner to either the semaglutide, liraglutide, or 
placebo arm in one out of four volume-matched dose levels (50 μL, 100 μL, 200 μL, and 300 μL). Subjects were to 
initiate treatment with either 0.05 mg of semaglutide (50 μL), 0.30 mg of liraglutide (50 μL), or 50 μL of placebo. 
Subjects in the lowest dose-volume (50 μL) did not follow a dose-esclation regimen.The doses in the fixed-dose 
groups were escalated from an initial dose of 0.05 mg and maintained for 4 weeks prior to escalating to the next dose, 
and continued up to 12 weeks. The highest dose for any trial subject would be 0.30 mg semaglutide administered OD 
(300 μL), or 1.80 mg liraglutide administered OD (300 μL). All subjects used NovoPen® 4 durable device for trial 
product administration. Metformin was considered a non-investigational medicinal product and was not supplied by 
Novo Nordisk.
Similar to the fixed dose-escalation arms, subjects in the open-label arm would start treatment at 0.05 mg 
semaglutide OD (50 μL) and 4-week dose-escalation steps would be used by default. However, based on the 
investigator’s assessment, the dose level would be temporarily reduced in subjects with poor GI tolerability. Subjects 
experiencing moderate/severe nausea or vomiting for at least 3 days in the week preceding the planned visit/phone 
contact would be required to reduce the dose to the previous dose level. Dose reductions were to be only decided at 
planned visits/phone contacts. Subjects who experienced moderate/severe nausea or vomiting already at the lowest 
dose level were required to stay at least 4 additional weeks at the lowest dose from the decision point before 
reconsidering dose-escalation. An additional, mandatory safety visit was only applicable for subjects in the flexible 
dose-escalation arm who had been dose-escalated at week 20. No dose-escalations were allowed after week 22.
If necessary, for safety reasons suspected to be due to trial product, unacceptable intolerability or at request of 
subject, the trial product could be discontinued (without withdrawing the subject from the trial) at the investigator’s 
discretion. For premature treatment discontinuations, treatment was not to be re-initiated, except in cases where 
suspicion of acute pancreatitis was ruled out. Subjects discontinuing trial product prematurely were to be called in for 
an ‘end of treatment - premature discontinuation visit’ as soon as possible and for a ‘follow-up - premature 
discontinuation visit’ 7 weeks after last dose of trial product. Furthermore, subjects with unacceptable 
hyperglycaemia were to be offered rescue medication and trial product was to be prematurely discontinued.
An external data monitoring committee (DMC) was not constituted for this trial. An independent external event 
adjudication committee (EAC) was constituted to perform ongoing adjudication, standardisation, and assessment of 
selected events. The purpose of the adjudication was to consistently confirm events by independent external medical 
experts according to standardised criteria.
NUMBER OF SUBJECTS PLANNED AND ANALYSED
A total of 1280 subjects were planned for screening and 704 planned for randomisation. In total, 1096 and 706 
subjects were actually screened and randomised, respectively.
Sema
0.05 
mg
N (%)
Sema
0.10 
mg
N (%)
Sema
0.20 
mg
N (%)
Sema
0.30 
mg
N (%)
Lira
0.30 
mg
N (%)
Lira
0.60 
mg
N (%)
Lira
1.20 
mg
N (%)
Lira
1.80 
mg
N (%)
Placebo
N (%)
Sema
flex
N (%)
Total
N (%)
Screened
1096
Randomised
64
63
65
63
64
64
64
65
129
65
706
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Exposed
FAS/SAS 
64 
(100.0)
63 
(100.0)
65
(100.0)
63 
(100.0)
64 
(100.0)
64 
(100.0)
64 
(100.0)
65 
(100.0)
129 
(100.0)
64 
(98.5)
705 
(99.9)
Treatment 
completers
53 
(82.8)
56 
( 88.9)
52 
(80.0)
53 
(84.1)
52 
(81.3)
56 
(87.5)
51 
(79.7)
56 
(86.2)
95 
(73.6)
58 
(90.6)
582 
(82.6)
Premature 
treatment 
discontinuation
11 
(17.2)
7
(11.1)
13 
(20.0)
10 
(15.9)
12 
(18.8)
8
(12.5)
13 
(20.3)
9
(13.8)
34 
(26.4)
6
(9.4)
123 
(17.4)
Trial completers 
58 
(90.6)
61 
(96.8)
60 
(92.3)
58 
(92.1)
62 
(96.9)
61 
(95.3)
58 
(90.6)
60 
(92.3)
123 
(95.3)
60 
(93.8)
661 
(93.8)
Premature 
withdrawal at or 
after premature 
treatment 
discontinuation 
6
(9.4)
2
(3.2)
4
(6.2)
5
(7.9)
2
(3.1)
2
(3.1)
6
(9.4)
5
(7.7)
5
(3.9)
2
(3.1)
39 
(5.5)
Premature 
withdrawal after 
treatment 
completion 
1
(1.5)
1
(1.6)
1
(0.8)
2
(3.1)
5
(0.7)
Abbreviations: N: Number of subjects, %: Percentages of subjects, FAS: Full Analysis Set, SAS: Safety Analysis Set; Sema: semaglutide, Lira: liraglutide; flex: 
flexible dose 
DIAGNOSIS AND MAIN CRITERIA FOR INCLUSION
Main inclusion criteria: Male or female, age ≥18 years at the time of signing informed consent; subjects diagnosed 
with T2D at least ≥90 days prior to screening; subjects should be on stable diabetes treatment consisting of diet and 
exercise with or without metformin (≥1500 mg daily or maximum tolerated dose documented in the patient medical 
record) for at least 90 days prior to screening. Glycated haemoglobin (HbA1c): 53-86 mmol/mol (7.0-10.0%) (both 
inclusive). Body mass index (BMI): 25.0 – 40.0 kg/m2 (both inclusive).
Main exclusion criteria: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-
bearing potential and not using adequate contraceptive methods throughout the trial including the 7-week follow-up 
period (adequate contraceptive measures as required by local regulation or practice). Any condition which, in the 
opinion of the investigator, might jeopardise subject safety or compliance with the protocol; treatment with any 
medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days 
before screening (an exception is short-term insulin treatment for acute illnesses for a total of ≤14 days). Anticipated 
initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to 
affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids). History of pancreatitis (acute 
or chronic). Screening calcitonin ≥50 ng/L. Family or personal history of Multiple Endocrine Neoplasia Type 2 
(MEN2) or Medullary Thyroid Carcinoma (MTC). Uncontrolled hypertension (defined as systolic blood pressure 
≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) at screening. If white-coat hypertension is suspected at the 
screening visit, repeated measurement at the screening visit is allowed. Severe to moderate renal impairment defined 
as GFR, estimated <60 ml/min/1.73 m2 per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Within 
the past 180 days before screening any of the following: myocardial infarction, stroke or hospitalisation for unstable 
angina or transient ischemic attack. Currently planned coronary, carotid or peripheral artery revascularisation. 
Patients presently classified as being in New York Heart Association (NYHA) Class III or IV.
Main treatment discontinuation criteria: Safety concerns suspected to be related to the trial products or 
unacceptable intolerance to the treatment.
Withdrawal criterion: Subjects could electively withdraw from the trial at any time by withdrawal of informed 
consent.
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TRIAL PRODUCTS, DOSE AND MODE OF ADMINISTRATION, BATCH NUMBER
Trial Product
Dose
Administration Route
Batch Number
Expiry Date
Semaglutide 1.0 mg/mL, 3 mL
0.05, 0.10, 0.20, or 0.30 mg daily
Subcutaneous injection
EW5G922
27 April 2017
Liraglutide, 6.0 mg/mL, 3 mL
0.30, 0.60, 1.20 or 1.80 mg daily
Subcutaneous injection
EW5F506
14 July 2017
Placebo, 0 mg/mL, 3 mL
0 mg daily
Subcutaneous injection
DW5D550
29 March 2017
DURATION OF TREATMENT
26 weeks
CRITERIA FOR EVALUATION – EFFICACY
HbA1c, body weight, fasting plasma glucose, and systolic and diastolic blood pressure.
CRITERIA FOR EVALUATION – SAFETY
Treatment-emergent adverse events (TEAEs, including pre-defined medical events of special interest adjudicated by 
an independent external adjudication committee), hypoglycaemic episodes, pulse rate, and laboratory safety 
variables.
STATISTICAL METHODS
Power calculation
The sample size calculation was based on a comparison of change from baseline to end-of-treatment at week 26 in 
HbA1c between the highest dose of semaglutide OD and the four pooled placebo arms. The assumed treatment effect 
of the highest dose of semaglutide relative to placebo at week 26 was an average of 0.65% improvement in HbA1c.
Due to premature treatment discontinuations, however, this effect could not be expected to manifest itself as the 
statistical model’s estimated treatment effect. A 50% smaller effect was assumed in the 30% of subjects assumed to 
discontinue treatment prematurely leading to a placebo-adjusted treatment effect of 0.55%, which was the value used 
in the sample size calculation. With the above assumptions, 64 subjects would be allocated to each of the semaglutide 
and liraglutide arms and twice that number of subjects to the pooled placebo (32 subjects in each arm) to yield a 90% 
power in order to detect a difference between the highest semaglutide dose and the pooled placebo arms at a Type I 
error rate of 5% 
(2-sided). Thus, the total sample size would be (9×64) + (4×32) = 704 subjects.
Definition of analysis sets
The full analysis set (FAS) included all randomised subjects exposed to at least one dose of trial product. Subjects in 
the FAS would contribute to the evaluation ‘as randomised’. The safety analysis set (SAS) included all randomised 
subjects exposed to at least one dose of trial product. Subjects in the SAS would contribute to the evaluation ‘as 
treated’.
Observation periods
In-trial: The time period in which a subject was considered a trial participant and where data were collected 
systematically. The ‘in-trial’ observation period included observations recorded at or after randomisation and not 
after the last subject-investigator contact, which was scheduled to take place 7 weeks after planned last dose of trial 
product at a follow-up visit. This period was used for supportive analyses of both efficacy and safety.
On-treatment: The observation period where the subject was expected to be treated and exposed to randomised 
treatment. This was the primary observation period for examination of safety endpoints including adjudicated events, 
electrocardiograms (ECGs), and adverse events (AEs) including hypoglycaemic episodes.
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On-treatment until rescue medication: This observation period was a subset of the ‘on-treatment’ observation period. 
To avoid potential confounding of initiation of anti-diabetic rescue therapies on efficacy endpoints, observations that 
were collected until initiation of permanent anti-diabetic rescue therapies were excluded from this observation 
period. ‘On-treatment until rescue’ observation period would be used when examining efficacy endpoints and was 
the observation period used for the primary analysis. Specifically, it included observations recorded at or after date of 
first dose of trial product and not after the first occurrence of the last dose of trial product plus the 7-days visit 
window or date of initiation of rescue therapy. This period was the primary observation period for examination of 
efficacy endpoints.
Statistical analysis
Primary endpoint: change from baseline in HbA1c after 26 weeks of treatment
This analysis was based on FAS and observations within the ‘on-treatment until rescue medication’ period. All post-
baseline measurements obtained at scheduled visits were analysed by a standard mixed model for repeated 
measurement (MMRM). In the primary analysis, all continuous data were evaluated using a standard MMRM 
analysis model with treatment, stratification factor (metformin use at baseline) and region as fixed factors, and the 
corresponding baseline value as covariate. The four placebo groups were pooled into one placebo arm. Missing data 
were assumed to be missing-at-random (MAR).
Supportive secondary efficacy endpoints
Change from baseline to week 26 in:
x
Body weight
x
Fasting plasma glucose (FPG)
x
Systolic and diastolic blood pressure (SBP and DBP, respectively)
for the following pre-specified treatment comparisons:
x
Semaglutide 0.05 mg/day vs. Placebo 
x
Semaglutide 0.10 mg/day vs. Placebo
x
Semaglutide 0.20 mg/day vs. Placebo
x
Semaglutide 0.30 mg/day vs. Placebo
x
Liraglutide 0.30 mg/day vs. Placebo
x
Liraglutide 0.60 mg/day vs. Placebo
x
Liraglutide 1.20 mg/day vs. Placebo
x
Liraglutide 1.80 mg/day vs. Placebo
x
Semaglutide 0.05 mg/day vs. Liraglutide 0.30 mg/day 
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x
Semaglutide 0.10 mg/day vs. Liraglutide 0.60 mg/day 
x
Semaglutide 0.20 mg/day vs. Liraglutide 1.20 mg/day 
x
Semaglutide 0.30 mg/day vs. Liraglutide 1.80 mg/day
Continuous endpoints were analysed separately using the standard MMRM model as for the primary endpoint but 
with the associated baseline value as a covariate. The same estimated treatment differences (ratios) as presented for 
the primary endpoint were presented with two sided p-values and 95% confidence intervals
Sensitivity analyses
To evaluate the robustness of the conclusions of the primary analysis, pre-specified sensitivity analyses were 
performed for change in HbA1c and change in body weight at 26 weeks. These pre-specified sensitivity analyses 
investigated the sensitivity of the results due to the impact of missing values. For the primary analysis, the ‘on-
treatment until rescue medication’ observation period was used for three of the sensitivity analyses (analysis of 
covariance [ANCOVA] based on last available observation carried forward [LOCF] analysis, complete case 
[MMRM-based] analysis, and the placebo and comparator-based imputation models based on the pattern mixture 
model [PMM]).
Subjects who after 26 weeks treatment achieved (yes/no):
x
HbA1c <7.0% (<53 mmol/mol) American Diabetes Association (ADA) target
x
HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target
These endpoints were analysed separately using a logistic regression model presenting odds ratio and 95% CI for the 
odds ratio and associated p-value. The model included treatment, region, and stratification variable (diet and exercise 
with or without metformin) as fixed effects and baseline value as covariate. Missing response data at 26 weeks were 
imputed from the MMRM used to analyse the two original continuous endpoints.
Supportive secondary safety endpoints
x
Treatment-emergent AEs (TEAEs) were summarised descriptively. TEAEs, along with all other safety 
endpoints, were analysed using SAS. A TEAE was defined as an event that had an onset date (or increase in 
severity) during the on-treatment observation period. TEAEs were summarised descriptively in terms of the 
number of subjects with at least one event (N), the percentage of subjects with at least one event (%), the number 
of events (E) and the event rate (R) per 100 patient-years of exposure (PYE).
x
Episodes of hypoglycaemia were classified according to the Novo Nordisk A/S and the ADA classification of 
hypoglycaemia. Treatment-emergent episodes of hypoglycaemia were summarised descriptively and presented 
as the episode rate per 100 PYE. 
x
Pre-defined groups of AEs of special interest were evaluated based on Medical Dictionary for Regulatory 
Activities (MedDRA) searches (version 19.0). These groups were defined by Novo Nordisk A/S Global Safety 
and consisted of pre-specified preferred terms.
x
Pulse rate was analysed with the standard MMRM.
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x
Laboratory assessments were summarised and evaluated by descriptive statistics using the SAS.
Importantly, for data presentation of all endpoints, the word ‘significant’ is only used if supported by a statistical
analysis and a p-value < 0.05.
DEMOGRAPHY OF TRIAL POPULATION
Sema
0.05mg
Sema
0.10 
mg
Sema
0.20 
mg
Sema
0.30 mg
Lira
0.30 mg
Lira
0.60 mg
Lira
1.20 mg
Lira
1.80 mg
Placebo
Sema
flex
Total
N
64
63
65
63
64
64
64
65
129
65
706
Female, N 
(%)
31 
(48.44)
28 
(44.44)
22 
(33.85)
31 
(49.21)
35 
(54.69)
32 
(50.00)
30 
(46.88)
32 
(49.23)
57 
(44.19)
28 
(43.75)
326 
(46.24)
Age (years)
[min-max]
57.5
57.5
58.4
54.8
57.2
59.5
53.7
55.8
57.1
54.8
56.7
[28-74]
[36-76]
[34-
74]
[31-76]
[35-77]
[32-76]
[25-77]
[32-74]
[29-79]
[33-79]
[25-79]
HbA1c (%), mean 
[min-max]
7.87
7.91
7.96
8.23
8.06
8.12
8.14
8.07
8.12
8.10
8.06
[6.7-
9.8]
[6.3-
10.0]
[6.7-
9.9]
[6.9-
10.3]
[6.8-
10.4]
[6.80-
9.9]
[6.5-
10.3]
[6.6-
10.0]
[6.6-
10.8]
[6.7-
10.1]
[6.3-
10.8]
FPG (mmol/L), 
mean
[min-max]
9.26
8.97
9.20
9.67
9.32
9.34
9.91
9.18
9.67
9.82
9.45
[5.9-
16.3]
[3.3-
17.4]
[5.6-
16.4]
[4.3-
15.6]
[5.2-
17.5]
[5.5-
16.9]
[5.2-
16.6]
[5.5-
16.4]
[4.5-
23.1]
[6.3-
20.6]
[3.25-
23.12]
Diabetes 
duration (years)
[min-max]
6.55
8.12
7.16
6.49
8.10
6.77
6.93
6.63
7.12
8.00
7.18
[0.3-
17.5]
[0.4-
36.1]
[0.3-
25.9]
[0.38-
21.0]
[0.3-
44.9]
[0.6-
24.1]
[0.5-
23.1]
[0.3-
22.8]
[0.4-
20.8]
[0.4-
35.9]
[0.3-
44.9]
Body weight 
(kg)
[min-max]
93.44
92.40
98.07
94.82
92.25
92.68
96.67
93.40
93.98
95.29
94.28
[55.3-
132.9]
[63.9-
133.0]
[63.9-
140.6]
[54.8-
136.1]
[66.4-
137.5]
[63.0-
127.6]
[53.6-
155.6]
[59.6-
151.5]
[58.8-
148.5]
[52.6-
129.5]
[52.6-
155.6]
BMI (kg/m2)
[min-max]
32.32
32.40
32.83
33.10
32.94
33.02
33.29
32.06
32.76
33.22
32.79
[25.2-
39.9]
[24.6-
39.7]
[24.8-
40.0]
[24.4-
40.8]
[24.9-
40.1]
[25.4-
39.9]
[25.1-
39.7]
[24.7-
40.3]
[24.8-
40.2]
[25.1-
39.8]
[24.4-
40.8]
Sema
0.05mg
Sema
0.10 
mg
Sema
0.20 
mg
Sema
0.30 
mg
Lira
0.30 
mg
Lira
0.60 
mg
Lira
1.20 
mg
Lira
1.80 
mg
Placebo
Sema
flex
Total
Ethnicity; N (%)
Not Hispanic or 
Latino
55 
(85.94)
56 
(
88.89)
59 
(
90.77)
59 
( 93.65)
57 
( 89.06)
58 
( 90.63)
58 
( 90.63)
57 
( 87.69)
113 
( 87.60)
57 
( 89.06)
629 
(89.22)
Race; N (%)
American 
Indian or Alaska 
native
1
(1.54)
1 (1.56)
2 (0.28)
Asian
6
( 9.38)
9
(14.29)
5
( 7.69)
7
( 11.11)
4
(  6.25)
2
(  3.13)
4
(  6.25)
11 
( 16.92)
14 
( 10.85)
4
(  6.25)
66 
(9.36)
Black or African 
American
9
(14.06)
4
( 6.35)
6
(9.23)
11 
(17.46)
4
(6.25)
4
(6.25)
6
(9.38)
4
(6.15)
11 
(8.53)
4
(6.25)
63 
(8.94)
White
49 
(76.56)
50 
(79.37)
51 
(78.46)
44 
(69.84)
53 
(82.81)
56 
(87.50)
54 
(84.38)
48 
(73.85)
103 
(79.84)
52 
(81.25)
560 
(79.43)
Other
2
(3.08)
1 (1.59)
2 (3.13)
2 (3.13)
2 ( 
3.08)
1 ( 
0.78)
4 ( 
6.25)
14 
(1.99)
Renal function; N (%)
Normal
36 
(56.25)
34 
(53.97)
34 
(52.31)
43 
(68.25)
39 
(60.94)
33 
(51.56)
44 
(68.75)
45 
(69.23)
78 
(60.47)
46 
(71.88)
432 
(61.28)
Mild
28 
(43.75)
28 
(44.44)
31 
(47.69)
20 
(31.75)
24 
(37.50)
31 
(48.44)
19 
(29.69)
20 
(30.77)
51 
(39.53)
18 
(28.13)
270 
(38.30)
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Version:
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Moderate
1
(1.59)
1 (1.56)
1 (1.56)
3 (0.43)
Abbreviations: N: Number of subjects, %: Percentage of subjects, BMI: Body mass index, HbA1c: glycosylated haemoglobin,
FPG: fasting plasma glucose; Sema: semaglutide; Lira: liraglutide; Flex: flexible dose
EFFICACY RESULTS
Primary endpoint: change from baseline in HbA1c after 26 weeks of treatment
Treatment with semaglutide significantly improved glycaemic control after a 26-week treatment period as compared 
with placebo or liraglutide. 
x
A dose-dependent significant reduction in HbA1c was obtained with semaglutide as compared with placebo, with 
estimated treatment differences (ETDs) ranging from 
-1.04%-points [-1.30; -0.77]95%CI for semaglutide 0.05 mg vs. placebo to 
-1.86%-points [-2.12; -1.60]95%CI for semaglutide 0.30 mg vs. placebo.
x
A significant reduction in HbA1c was obtained with semaglutide as compared with each volume-matched 
liraglutide dose with ETDs of -0.55%-points [-0.85; -0.25]95%CI for semaglutide 0.05 mg vs. liraglutide 0.30 mg; 
to -0.57%-points [-0.87; -0.27]95%CI for semaglutide 0.30 mg vs. liraglutide 1.80 mg. Overall, semaglutide led to 
reductions in HbA1c between -1.05%-points and -1.88%-points from a mean baseline of 8.06% compared to (-
0.50 to -1.31)%-points for liraglutide and -0.02%-points for placebo. 
x
At week 26, a -1.67%-points reduction in HbA1c was obtained with the open-label semaglutide flexible dose 
group, with an ETD of -1.64%-points [-1.89; -1.39]95%CI as compared to placebo.
x
The robustness of the primary analysis was supported by three sensitivity analyses that showed significantly 
better glycaemic control with similar, dose-dependent, and significant ETDs, ranging -0.86%-points [-1.12; -
0.60]95%CI to -1.02%-points [-1.31; -0.73]95%CI for semaglutide 0.05 mg vs. placebo and -1.54%-points [-1.80; -
1.28]95%CI to 
-1.80%-points [-2.09; -1.50]95%CI for semaglutide 0.30 mg vs. placebo.
x
The dose response modelling potency of semaglutide was 28-fold higher than liraglutide with an estimated 
treatment ratio (ETR) of 27.59 [18.52; 41.11]95%CI for HbA1c, as liraglutide 1.80 mg was equipotent to 
semaglutide 0.062 mg.
Supportive secondary efficacy endpoint: change from baseline in body weight after 26 weeks of treatment
Treatment with semaglutide led to significantly greater weight loss after a 26-week treatment period as compared 
with placebo or liraglutide.
x
A dose-dependent significant reduction in body weight was obtained with semaglutide as compared with 
placebo, with ETDs ranging from 
-1.53 kg [-2.76; -0.31]95%CI for semaglutide 0.05 mg vs. placebo to 
-7.00 kg[-8.23; -5.77]95%CI for semaglutide 0.30 mg vs. placebo.
x
A significant reduction in body weight was obtained with semaglutide as compared with each volume-matched 
liraglutide dose with ETDs of -1.26 kg [-2.67; -0.14]95%CI for semaglutide 0.05 mg vs. liraglutide 0.30 mg to 
-4.48 kg [-5.89; -3.08]95%CI for semaglutide 0.30 mg vs. liraglutide 1.80 mg. Overall, semaglutide led to weight 
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loss between -2.76 kg and -8.23 kg from a mean baseline weight of 94.18 kg compared to -1.50 to -3.75 kg for 
liraglutide and -1.23 kg for placebo.
x
At week 26, a -6.42 kg reduction in body weight was observed with the open-label semaglutide flexible dose 
group, with an ETD of -5.15 kg [-6.47; -3.84]95%CI as compared to placebo.
x
The robustness of the primary analysis was supported by three sensitivity analyses that showed significantly 
better weight loss with similar, dose-dependent, and significant ETDs, ranging from 
-1.33 kg [-2.52; -0.14]95%CI to -1.48 kg [-2.72; -0.24]95%CI for semaglutide 0.05 mg vs. placebo and 
-6.45 kg [-7.65; -5.24]95%CI to -6.66 kg [ -7.93; -5.39]95%CI for semaglutide 0.30 mg vs. placebo.
x
The dose response modelling showed that the potency of semaglutide was 30-fold higher than liraglutide with an 
ETR of 29.81 [17.65; 50.35]95%CI for body weight, as liraglutide 1.80 mg was equipotent to semaglutide 0.06 mg.
Other supportive secondary efficacy endpoints
x
HbA1c treatment targets were achieved by larger proportions of subjects in the semaglutide groups compared 
with placebo or liraglutide groups, and the odds for reaching both targets were significantly higher with 
semaglutide when compared with placebo or liraglutide:
x
HbA1c ≤6.5% (AACE target) was achieved by a greater proportion of subjects with semaglutide (43-73%) 
when compared with liraglutide (14-42%) or placebo (6%). Approximately 67% of subjects in the open-
label semaglutide flexible group achieved this target. The estimated odds ratios ranged from 
10.95 [4.55; 26.36]95%CI for semaglutide 0.05 mg vs. placebo to 
59.58 [23.22; 152.88]95%CI for semaglutide 0.30 mg vs. placebo; and from 
4.31 [1.79; 10.39]95%CI for semaglutide 0.05 mg vs. liraglutide 0.30 mg to 
5.16 [2.33; 11.44]95%CI for semaglutide 0.30 mg vs. liraglutide 1.80 mg.
x
HbA1c <7.0% (ADA target) was achieved by a greater proportion of subjects with semaglutide (58-89%) 
when compared with liraglutide (33-62%) or placebo (13%). Approximately 84% of subjects in the open-
label semaglutide flexible group achieved this target. The estimated odds ratios ranged from 
10.34 [4.77; 22.43]95%CI for semaglutide 0.05 mg vs. placebo to 
101.61 [36.05; 286.39]95%CI for semaglutide 0.20 mg vs. placebo; and from 
2.64 [1.21; 5.76]95%CI for semaglutide 0.05 mg vs. liraglutide 0.30 mg to 
9.01 [3.31; 24.56]95%CI for semaglutide 0.20 mg vs. liraglutide 1.20 mg.
x
A greater reduction in FPG levels from baseline to week 26 was observed with semaglutide compared with 
either placebo or liraglutide with ETDs ranging from 
-1.80 mmol/L [-2.32; -1.27]95%CI for semaglutide 0.05 mg vs. placebo to 
-2.97 mmol/L [-3.50; -2.44]95%CI for semaglutide 0.30 mg vs. placebo; and from 
-0.79 mmol/L [-1.39; -0.19]95%CI for semaglutide 0.05 mg vs. liraglutide 0.30 mg to 
-1.58 mmol/L [-2.19; -0.98]95%CI for semaglutide 0.20 mg vs. liraglutide 1.20 mg.
The ETDs in mg/dL ranged from 
-32.37 mg/dL [-41.85; -22.89]95%CI for semaglutide 0.05 mg vs. placebo to 
-53.50 mg/dL [-63.05; -43.95]95%CI for semaglutide 0.30 mg vs. placebo; and from 
-14.25 mg/dL [-25.07; -3.44]95%CI for semaglutide 0.05 mg vs. liraglutide 0.30 mg to 
-28.56 mg/dL [-39.50; -17.62]95%CI for semaglutide 0.20 mg vs. liraglutide 1.20 mg
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x
At week 26, a -3.40 mmol/L reduction in FPG was obtained with the open-label semaglutide flexible dose 
group, which was greater than fixed-dose semaglutide 0.20 mg (-2.64 mmol/L) but lower than the fixed-
dose semaglutide 0.30 mg group (-3.53 mmol/L).
x
The dose-response modelling showed that the potency of semaglutide was 38-fold higher than liraglutide 
with an ETR of 37.67 [21.49; 66.03]95%CI) for FPG, as liraglutide 1.80 mg was equipotent to 
semaglutide 0.05 mg.
x
Systolic blood pressure levels at week 26 were significantly improved with semaglutide 0.30 mg (-10.02 mmHg) 
as compared with placebo (-2.42 mmHg) and liraglutide 1.80 mg (-3.58 mmHg) with ETDs of 
-7.60 mmHg [-11.35; -3.8]95%CI between semaglutide 0.30 mg and placebo, and 
-6.44 mmHg [-10.66; -2.22]95%CI between semaglutide 0.30 mg and liraglutide 1.80 mg.
x
At week 26, a -6.62 mmHg decrease in SBP was obtained for the open-label semaglutide flexible dose 
group, which was less than the fixed-dose semaglutide 0.30 mg group (-9.85 mmHg).
x
Diastolic blood pressure levels at week 26 were significantly improved with semaglutide 0.30 mg (-3.88 mmHg) 
as compared with placebo (-0.64 mmHg) and liraglutide 1.80 mg (0.36 mmHg) with ETDs of 
-3.24 mmHg [-5.82; -0.66]95%CI between semaglutide 0.30 mg and placebo, and 
-4.23 mmHg [-7.13; -1.33]95%CI between semaglutide 0.30 mg and liraglutide 1.80 mg
x
At week 26, a -1.58 mmHg decrease in DBP was obtained for the open-label semaglutide flexible dose 
group, which was less than the fixed-dose semaglutide 0.30 mg group (-4.02 mmHg).
SAFETY RESULTS
During the 26 weeks of treatment, semaglutide, liraglutide, and placebo were generally safe and well tolerated. 
Overall AE safety profile
x
One (1) fatal event was reported with liraglutide 1.80 mg (due to ‘acute myocardial infarction’) that was assessed 
as unlikely related to treatment.
x
Overall, low proportions of subjects across all treatment groups reported serious adverse events (SAEs) (3.1% to 
9.4% in semaglutide, 1.6% to 10.8% in liraglutide, 3.1% in placebo, and 6.3% in the open-label semaglutide 
flexible group.There was no consistent pattern in reported SAEs across treatment groups or preferred terms 
(PTs). Incidences of SAEs were mainly driven by events within the system organ class (SOC) ‘cardiovascular 
disorders’, infections and infestations’, and ‘neoplasms’ in descending order, with highest frequency reported in 
semaglutide 0.05 mg and liraglutide 1.80 mg. 
x
Adverse events were reported by comparable proportions of subjects among the fixed-dose groups, but at a 
higher rate in all doses of semaglutide than either liraglutide or placebo during the on-treatment period, with the 
highest proportion and rates in the open-label semaglutide flexible dose group:
x
semaglutide 0.05 mg: 62.5%; 538 events per 100 PYE
x
semaglutide 0.10 mg: 69.8%; 590 events per 100 PYE
x
semaglutide 0.20 mg: 73.8%; 590 events per 100 PYE
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x
semaglutide 0.30 mg: 73.0%; 642 events per 100 PYE
x
liraglutide 0.30 mg: 76.6%; 402 events per 100 PYE
x
liraglutide 0.60 mg: 67.2%; 515 events per 100 PYE
x
liraglutide 1.20 mg: 70.3%; 420 events per 100 PYE
x
liraglutide 1.80 mg: 76.9%; 521 events per 100 PYE
x
placebo: 72.9%; 375 events per 100 PYE
x
open-label semaglutide flexible group: 82.8%; 719 events per 100 PYE
x
The differences in AEs were mostly related to gastrointestinal AEs (GIAEs), infections and infestations, nervous 
system disorders, musculoskeletal and connective tissue disorders, and metabolism and nutrition disorders.
x
Overall in all treatment groups, the majority of AEs reported were of mild or moderate severity (in total, 96.4% 
or 2092 events of 2171). Overall, few severe events were reported across all groups (total 31 events of 2171). 
Majority of subjects reporting AEs had recovered or were recovering, with or without sequalae, from the 
majority of the reported AEs at the end of the trial, with only 315 of 2171 events not having been resolved by the 
end of the trial, with highest incidence in liraglutide 0.60 mg within the ‘musculoskeletal and connective tissue 
disorders’ SOC and lowest in the semaglutide 0.30 mg group ‘gastrointestinal disorders’ SOC. 
x
The most frequently reported AEs with semaglutide and liraglutide were within the SOC ‘gastrointestinal 
disorders’, whereas the most frequently reported AEs in subjects treated with placebo were within the SOC 
‘infections and infestations’.
x
The proportion of subjects with AEs leading to premature treatment discontinuation was generally higher with 
placebo (10.9%) than semaglutide (6.3% to 9.2%), liraglutide (3.1% to 7.8%), or the open-label semaglutide 
flexible group (4.7%). The number of AEs leading to premature treatment discontinuation in the semaglutide and 
liraglutide groups was predominantly due to a higher frequency of subjects experiencing gastrointestinal AEs. 
For the placebo group, premature discontinuations were mainly due to hyperglycaemia. In some cases, subjects 
had hyperglycaemic episodes requiring rescue medication, thus these events were included in the ‘lack of 
efficacy’ category as the primary reason of premature treatment withdrawal and not under ‘adverse event’ in the 
end-of-trial form. This discrepancy was more apparent in the subject disposition reporting for the liraglutide and 
placebo groups, since a greater proportion of subjects in those groups reported ‘lack of efficacy’ as compared to 
semaglutide groups. It should be noted that subject disposition was based on end-of-trial form while AEs leading 
to withdrawal information was based on AE summary form. 
x
The proportion of subjects discontinuing treatment due to AEs in the open-label semaglutide flexible group was 
similar to the fixed-dose semaglutide groups.
x
The dose response modelling showed that the potency of semaglutide was 7.5 (ETR: 7.43 [2.36; 23.33]95%CI) for 
treatment discontinuation due to AEs as liraglutide 1.80 mg was equipotent to semaglutide 0.24 mg.
Hypoglycaemia
x
No ‘severe’ hypoglycaemic episodes (as defined by the ADA classification) were reported.
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x
‘Severe or blood glucose (BG)-confirmed symptomatic’ hypoglycemic episodes (as defined by Novo Nordisk 
classification) were reported by 2 subjects (3.1%) with semaglutide 0.05 mg, 2 subjects (3.2%) with 
semaglutide 0.10 mg, 3 subjects (4.6%) with semaglutide 0.20 mg, 2 subjects (3.2%) with semaglutide 0.30 mg; 
2 subjects (3.1%) with liraglutide 0.60 mg, 1 subject (1.6%) with liraglutide 1.20 mg, 3 subjects (4.6%) with 
liraglutide 1.8 mg; 4 subjects (3.1%) with placebo; and 2 subjects (3.1%) with the open-label semaglutide 
flexible group.
x
No significant differences were observed in the proportion of subjects experiencing ‘severe or BG-confirmed 
symptomatic’ hypoglycaemia between semaglutide and liraglutide or placebo groups.
Safety areas of interest
x
Gastrointestinal disorders
x
Gastrointestinal disorders were the most frequently reported AEs with semaglutide and liraglutide, with 
higher reporting in semaglutide with a dose effect observed. Similar proportions of subjects reported GIAEs 
in the fixed-dose semaglutide 0.30 mg (54.0%) and the open-label semaglutide flexible dose groups 
(56.3%).The most frequently (≥5%) reported GIAEs were ‘nausea’, ‘diarrhoea’, ‘vomiting’, ‘constipation’ 
and ‘dyspepsia’ in descending order, with ‘nausea’ and ‘diarrhoea’ reported at a higher rate and by a higher 
proportion of subjects with semaglutide doses than with the liraglutide or placebo.
x
The proportions of subjects reporting the most frequent PTs (respectively for fixed-dose semaglutide; 
liraglutide; placebo; and the open-label semaglutide flexible dose group) were as follows: 
nausea (17.2% to 25.4%; 9.4% to 20.0%; 4.7%; and 39.1%)
diarrhoea (10.9% to 25.4%; 7.8% to 10.8%; 10.9%; and 17.2%)
vomiting (6.3% to 9.5%; 1.6% to 10.9%, 2.3%; and 9.4%)
x
The majority of the events occurred within the initial 12 weeks of treatment and the median duration of the 
GIAEs were slightly higher with semaglutide than liraglutide or placebo, and varied across types of events. 
x
The majority of GIAEs were largely mild or moderate in severity and 2 subjects (1 on semaglutide 0.10 mg 
[‘anal fistula’] and 1 on placebo [‘epiploic appendagitis’]) reported gastrointestinal SAEs.
x
All reported GIAEs in the semaglutide 0.30 mg OD group, a dose level for which Novo Nordisk has had no 
previous experience in humans, were non-serious, mild-to-moderate in severity, and only one AE 
(‘dyspepsia’) led to drug withdrawal. None of the GIAEs reported in the open-label semaglutide flexible 
dose group were serious, majority were mild-to-moderate in severity, and only 2 AEs (‘impaired gastric 
emptying’ and ‘abdominal pain’) led to drug withdrawal. 
x
The dose response modelling showed that the potency of semaglutide was 13 (ETR: 12.81 [6.22; 
26.36]95%CI) for proportion of subjects reporting at least 1 GIAE as liraglutide 1.80 mg was equipotent to 
semaglutide 0.14 mg.
x
Cardiovascular disorders
x
There were 18 EAC-confirmed events in 9 subjects in the trial. Twelve (12) CV events in 7 subjects were 
confirmed during the on-treatment observation period (4 events in 2 subjects in semaglutide 0.05mg, 6 
events in 3 subjects in liraglutide 1.80 mg, 1 event in 1 subject in placebo, and 1 event in the open-label 
semaglutide flexible dose group). Two (2) additional events in semaglutide 0.05 mg and 2 events in 
liraglutide 1.20 mg were EAC-confirmed in the in-trial observation period and 2 events in liraglutide 1.20 
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mg occurred after end of trial. Six (6) EAC-confirmed events in 5 subjects were MACEs (4 acute 
myocardial infarction events in 3 subjects, 1 cardiovascular death, and 1 stroke). 
x
A total of 68 cardiovascular disorder events were captured by the MedDRA search and reported in 48 
subjects, with varied frequencies across all groups (4.8% to 9.4% in semaglutide; 4.7% to 12.3% in 
liraglutide; 7.0% in placebo; and 4.7% in the open-label semaglutide flexible dose group).).
x
There were a total of 17 cardiovascular SAEs in 11 subjects (4 events in 2 subjects in semaglutide 0.05 mg; 
1 event in semaglutide 0.20 mg; 1 event in semaglutide 0.30 mg; 2 events in 1 subject in liraglutide 1.20 
mg; 6 events in 3 subjects in liraglutide 1.80 mg; 2 events in 2 subjects in placebo; and 1 event in the open-
label semaglutide flexible dose group). Majority of these CV SAEs were severe, none were assessed as 
likely related to treatment. With the exception of the fatal event in liraglutide 1.80 mg (due to ‘acute 
myocardial infarction’) and ischaemic stroke event in the open-label semaglutide flexible dose group, all 
subjects recovered from these SAEs, all subjects recovered from these SAEs. No differences were apparent 
in type and frequency of events among the treatment groups.
x
After 26 weeks of treatment, the estimated mean pulse rate increased with all treatment groups, except 
placebo and semaglutide 0.05 mg, albeit to a greater level with liraglutide 1.20 mg (5 bpm) and liraglutide 
1.80 mg (4 bpm). Increases in semaglutide were 1-3 bpm, compared to 1 bpm for placebo. The increase in 
pulse rate from baseline to end of treatment were only significant for higher doses of liraglutide versus 
placebo, with ETDs in bpm of 4.52 [1.68; 7.36]95%CI and 2.85 [0.07; 5.36]95%CI with liraglutide 1.20 mg and 
1.80 mg, respectively. 
x
Overall, the proportion of subjects with ECG abnormalities was similar among the treatment groups for the 
majority of the abnormality categories and the majority of the measurements were ‘normal’ at baseline and 
persisted at week 26 (77.1-90.0%) and week 33 (77.1%-86.7%) with no apparent differences between 
treatment groups. Three (3) ECG-related AEs and 1 ‘blood pressure increased’ event were reported; all of 
which were non-serious, mild, and unlikely related to trial product
x
Pancreatitis
x
One (1) event of ‘pancreatitis chronic’ and 1 ‘pancreatic enzymes increased’ event were sent for 
adjudication, both of which were non-confirmed by the EAC; no other events were identified by the Novo 
Nordisk pre-defined preferred term query (NN PTQ) search, nor considered adjudicable. 
x
One (1) non-serious, mild, ‘pancreatitis chronic’ event was identified by the MedDRA search, from which 
the subject 
x
Mean lipase and amylase activities from baseline to end of treatment (week 26) were significantly increased 
for semaglutide and liraglutide groups as compared to placebo. The vast majority of the subjects had 
enzyme activities <2xULN throughout the trial, and most of the subjects with lipase activity >5xULN 
(upper limit of normal) and amylase activity >2xULN, only had single incidences of outliers. Only 1 
subject, treated with liraglutide 0.60 mg, had elevated amylase (>2xULN) and lipase (>5xULN) activities 
during treatment, and did not report any concurrent gastrointestinal AEs, hepatobiliary or pancreatitis-
related AEs. 
x
Hepatobiliary disorders
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x
Gallbladder disorder adverse events were reported in 3 subjects (single events in liraglutide 0.30 mg, 
liraglutide 1.80 mg, and placebo). All 3 events were identified via MedDRA search and were reported 
within the SOC ‘hepatobiliary disorders’ as ‘cholelithiasis’ or ‘hydrocholecystis’ (PT). All 3 events were 
non-serious, mild in severity, resulted in no change in treatment dosage, were assessed as unlikely related to 
trial product, two of the subjects had 
 from these events by the end of the trial, and none of 
these events led to premature treatment discontinuation. 
x
Sixteen (16) hepatic disorders were identified via MedDRA search and reported mostly as single events, 
distributed across groups, all of which were non-serious, mild-to-moderate in severity, and only 1 event in a 
placebo-treated subject led to premature treatment discontinuation. 
x
In general, there was a fluctuating pattern in the levels of liver tests, but no mean increases were observed. 
There were 11 cases of outliers in liver function tests: 2 subjects with outliers of alanine aminotransferase
>5xULN (both treated with placebo); 4 subjects with outlier of aspartate aminotransferase >5xULN (1 with 
semaglutide 0.30 mg, 1 with liraglutide 0.60 mg, and 2 with placebo); and 1 subject with outlier of total 
bilirubin >3xULN (semaglutide 0.30 mg). No outliers of alkaline phosphatase >5xULN (>675 U/L) were 
detected. The mean changes for all 4 liver function parameters from baseline were comparable among 
treatment groups and were not considered clinically relevant.
x
One (1) subject (semaglutide 0.30 mg) had concurrent elevation of AST >3xULN and total bilirubin 
>2xULN. Alternative aetiology was present 
, thus did not qualify as a Hy’s law 
case.
x
Neoplasms
x
Overall, the proportions of subjects as well as the number of EAC-confirmed neoplasms were low (5 events 
in 5 subjects; 1.19 events per 100 PYE [0.7%]) and primarily occurred as single events in single subjects 
and were generally equally distributed with regards to type (tissue or organ of origin) across the treatment 
groups: (1 subject each with semaglutide 0.05 mg [‘pancreatic carcinoma’]; semaglutide 0.30 mg [‘spinal 
meningioma’]; liraglutide 0.60 mg [‘basal cell skin carcinoma]; liraglutide 1.80 mg [‘prostate 
adenocarcinoma]; and with open-label semaglutide flexible dose [‘clear cell renal cell carcinoma’]). Four 
(4) events were malignant neoplasms and 1 was benign (‘spinal meningioma’); no pre-malignant/carcinoma 
in situ/ borderline or unclassified neoplasm events were confirmed by the EAC.
x
With respect to the MedDRA search of subjects experiencing at least one event, 21 neoplasm-related events 
were identified in 18 subjects distributed across most groups: 2 events in 2 subjects with semaglutide 0.05 
mg (3.1%), 3 events in 2 subjects in semaglutide 0.20 mg (3.1%), 3 events in 3 subjects in semaglutide 0.30 
mg (4.8%), 1 event in liraglutide 0.30 mg (1.6%), 4 events in 4 subjects in liraglutide 0.60 mg (6.3%), 3 
events in 3 subjects with liraglutide 1.80 mg (4.6%), 1 event in placebo (0.8%), and 4 events in 2 subjects in 
the open-label semaglutide flexible dose group (3.1%). Of the 21 events, 7 were serious, 3 were severe, 18 
were mild-to-moderate in severity, 1 was assessed as possibly related to treatment, 20 were unlikely 
treatment-related, dose was not changed for 19 events, and none led to premature discontinuation of trial 
product. 
x
No thyroid neoplasms were EAC-confirmed in this trial.
x
Thyroid disorders
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x
There was 1 EAC-confirmed event of thyroid disease requiring thyroidectomy (‘post-procedural 
hypothyroidism’) in a subject treated with placebo. This event was non-serious, moderate in severity, 
unlikely related to treatment, did not result in dose change, did not lead to premature treatment 
discontinuation, and from which the subject had 
 by the end of the trial.
x
Ten (10) thyroid disease AEs were captured by the pre-defined MedDRA search, 8 of which were in the on-
treatment period, 1 additional event in the in-trial observation period, and 1 event 13 days prior to 
randomisation. These events were distributed across treatment groups. One clinical laboratory AE (CLAE; 
‘blood calcitonin increased’) was reported by one subject treated with liraglutide 1.80 mg, from which the 
subject 
. 
x
A total of 7 subjects (4 with semaglutide and 3 with placebo) had at least 1 calcitonin value >20 ng/L during 
the trial; 6 of which occurred at the screening visit. There were no other clinically relevant changes in mean 
and individual calcitonin levels throughout the treatment period within or between treatment groups.
x
Renal disorders
x
Few AEs captured by the broad standardised MedDRA queries (SMQ) search ‘acute renal failure’ were 
reported during the trial (7 events in 6 subjects: 5 events in 4 subjects treated with semaglutide and 3 events 
in liraglutide). All events were non-serious, all but 1 were mild-or-moderate in severity, 6 were unlikely 
related to treatment, none led to premature treatment discontinuation, 2 subjects reported concurrent 
dehydration, and subjects 
 from 6 of the 7 events.
x
There were no clinically relevant changes in any renal laboratory parameters or urinalyses over time, 
within, and across treatment groups, with comparable changes in eGFR observed in all groups.
x
Immunogenicity-related AEs and injection site reactions
x
In total, 25 allergic reaction events were reported by 25 subjects (6 events per 100 PYE [3.5%]). Nineteen 
(19) events related to skin disorders distributed across all groups except semaglutide 0.05 mg and 
liraglutide 1.20 mg; 3 events related to immune system disorders; 2 respiratory, thoracic, and mediastinal 
disorder; and 1 event related to gastrointestinal disorders. All events were non-serious, majority were mild-
to-moderate in severity, unlikely related to trial product and resulted in no change in drug dosage, and the 
majority of the subjects 
 from these events by the end of the trial.
x
One (1) subject in the open-label semaglutide flexible group tested positive for anti-semaglutide antibodies 
at all visits; all samples were negative for antibodies cross-reacting with endogenous glucagon-like peptide-
1 (GLP-1). This subject with anti-semaglutide-positive antibodies at follow-up did not show neutralising 
effects to semaglutide and there was no indication of a treatment-induced anti-semaglutide antibody 
response. 
x
Four (4) events of immune complex disease were reported by 4 subjects (1 event per 100 PYE [0.6%]): 
‘nephritis’ (semaglutide 0.10 mg), ‘proteinuria’ (liraglutide 1.20 mg), ‘protein urine present’ (semaglutide 
0.10 mg), and ‘seizure’ (liraglutide 0.60 mg). Three (3) of the 4 events were non-serious, mild-to-moderate 
in severity, one event was an SAE, none led to premature treatment discontinuation, and all subjects 
 from these 4 events.
x
Thirty five (35) events of injection site reactions were reported by 20 subjects (8 events per 100 PYE 
[2.8%]) distributed across all groups except semaglutide 0.05 mg, with highest rate reported in liraglutide 
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0.60 mg (29 events per 100 PYE). The most commonly reported PTs were ‘injection site bruising’ (14 
events in 7 subjects), ‘injection site pain’ (7 events in 6 subjects), and ‘injection site haemorrhage’ (4 events 
in 4 subjects); with 11 AEs reported in 2 subjects treated with liraglutide 0.60 mg. All 35 events were non-
serious, mild-to-moderate in severity, majority were possibly or probably related to trial product, did not 
result in dose change, subjects recovered from all but 1 event, and none led to premature treatment 
discontinuation.
x
Medication errors
x
There were a total of 5 medication error AEs reported in 5 subjects (3 events in 3 subjects treated with 
semaglutide 0.05 mg (‘incorrect dose administered’ and ‘overdose’ and ‘injury associated with device’); 1 
event in liraglutide 0.30 mg (‘accidental overdose’); and 1 event in liraglutide 0.60 mg; (‘accidental 
overdose’). All the events were non-serious, mild-or-moderate in severity, 4 of the 5 events were unlikely 
related to treatment, and subjects recovered from all AEs.
x
Overdose
x
There were 3 overdose AEs in 3 subjects in the trial, single events in semaglutide 0.05 mg (‘overdose’), 
liraglutide 0.30 mg (‘accidental overdose’), and liraglutide 0.60 mg; (‘accidental overdose’). All the events 
were non-serious, mild-or-moderate in severity, 2 of the 3 events were unlikely related to treatment, and 
subjects recovered from all AEs.
x
Suspected transmission of infectious agent
x
No events of suspected transmission of infectious agent via trial product were reported for this trial.
x
Rare events
x
There was 1 rare event 
 identified in a subject treated with liraglutide 1.80 mg. 
The AE was non-serious, mild, unlikely related to treatment, and from which the subject 
x
Diabetic retinopathy
x
There were a total of 11 diabetic retinopathy events reported in 6 subjects (single subjects in 
semaglutide 0.10 mg and 0.30 mg; liraglutide 0.30 mg, 0.60 mg, 1.20 mg, and open-label semaglutide 
flexible group) in the trial in the following PTs: ‘diabetic retinopathy’ (6 events in 4 subjects), ‘macular 
oedema’ (2 events in 2 subjects), ‘maculopathy’ (1 event), ‘retinal detachment’ (2 events in 1 subject). Two 
(2) of the AEs reported were serious events (‘retinal detachment’ in a subject in the liraglutide 1.20 mg 
group). None of the diabetic retinopathy events were assessed as related to respective treatment.
Other clinical laboratory evaluations, physical examination and pregnancies
x
For biochemistry or haematology laboratory parameters not presented in the safety areas of interest, no clinically 
relevant changes were observed.
x
No clinically relevant treatment differences were observed in physical examination findings or fundoscopy.
x
Two (2) pregnancy cases were reported in this trial. One subject treated with semaglutide 0.05 mg, with a history 
of an uncomplicated pregnancy, was treated for 
 days and was discontinued from treatment on trial day 
 
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upon positive pregnancy test. This subject had a spontaneous abortion at trial day 
. The subject reported mild 
nausea on trial day 
, possibly related to treatment, 
. The second subject 
treated with liraglutide 1.80 mg had a positive pregnancy test at the end-of-treatment visit, and no AEs were 
reported in connection to the pregnancy. The subject delivered a healthy 
 child on 
 at 
gestational week 
 and days; no health problems, congentinal abnormalities, or receipt of replacement 
medications have been reported for the infant at 1 month of age.
CONCLUSIONS
In this 26-week multicentre, randomised, double-blinded (within dose level), dose-finding trial, the following is 
concluded:
x
Semaglutide administered once-daily effectively lowered HbA1c and body weight significantly more than 
placebo and dose-matched liraglutide at week 26.
x
Significantly greater reduction in HbA1c from baseline to week 26 was seen with semaglutide 0.30 mg 
(-1.88%-points) than liraglutide 1.80 mg (-1.31%-points) and placebo (-0.02%-points).
x
Significantly greater reductions in body weight was seen with semaglutide 0.30 mg (-8.23 kg) than 
liraglutide 1.80 mg (-3.75 kg) and placebo (-1.23 kg).
x
Semaglutide administered once-daily at doses up to 0.30 mg was well tolerated and no unanticipated safety 
concerns were identified.
x
Dose-response modelling indicated greater efficacy with semaglutide versus liraglutide, whereas the overall 
tolerability was similar between the two treatments.
The trial was conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice and EN ISO 
14155 Part 1 and 2, and 21 CFR 312.120.
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Appendix 9
Country-specific requirements 
Section 6.1 Inclusion criteria
For Japan:
Age ≥ 20 years at the time of signing informed consent.
Section 7.5 Preparation/Handling/Storage/Accountability
For Japan: According to Japanese GCP, storage and drug accountability of the trial products at the 
study site is not in charge of Investigator, but in charge of the head of study site. 
The head of study site should assign some or all the responsibilities for accountability of the trial 
products at the sites to a trial product storage manager (a pharmacist in principle). The trial product 
storage manager should control and take accountability of the trial products in accordance with 
procedures specified by the sponsor. The head of study site or the trial product storage manager 
must ensure the availability of proper storage conditions, and record and evaluate the temperature. 
Section 9 Trial assessments and procedures
For US and Canada only: This trial will include an option for subjects to complete an anonymised 
questionnaire, ‘Study Participant Feedback Questionnaire’ for subjects to provide feedback on their 
clinical trial experience at the beginning (V1), the middle (V7) and the end (V10) of the trial. 
Individual subject level responses will not be reviewed by investigators. Responses would be used 
by the sponsor to understand where improvements can be made in the clinical trial process. This 
questionnaire does not collect data about the subject's disease, symptoms, treatment effect or 
adverse events and therefore would not be considered trial data or entered into the trial database.
Appendix 3 Trial governance considerations
For Japan: A seal is accepted as a signature.
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Appendix 10 Protocol amendment history
The protocol amendment summary of changes table for the current protocol version is located 
directly before the table of contents.
Protocol version. 2, including version 1: 05 July 2019, global
This amendment is considered to be substantial based on the criteria set forth in Article 10(a) of 
Directive 2001/20/EC of the European Parliament and the Council of the European Union1.
Overall rationale for preparing protocol version 2:
Section # and name
Description of change
Brief rationale
7.7 Concomitant 
medication 
Update on the concomitant 
medication section to reflect 
stable background treatment 
throughout the trial.
To clarify the requirements for 
stable background medication 
during the trial, further to 
established eligibility criterion 
and protocol recommended initial 
dose reduction of sulphonylurea.
9.4.3 Eye 
examination
Text added to specify that at the 
end of treatment visit the eye 
examination result should be 
available and that the examination 
can be performed within 3 weeks 
prior to the end of treatment visit.
To clarify the timing of the 
availability of the eye 
examination result at the end of 
treatment visit. The extended 
window of availability will also 
facilitate data collection.
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Global and country key Novo Nordisk staff
Attachments I and II (if applicable) to the protocol are located in the Trial Master File.
Content: Global key staff and Country key staff
CONFIDENTIAL
Date:
Novo Nordisk
Version:
Status:
Once-weekly Semaglutide
Trial ID: NN9535-4506
Clinical Trial Report
Appendix 16.1.1
08 December 2020
1.0
Final
CONFIDENTIAL


Protocol Amendment No.1
CONFIDENTIAL
Date:
31 May 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EUdraCT Number: 2018-004529-96
Page:
1 of 6
Protocol Amendment
No.1
to Protocol, version 1.0
dated 21 March 2019
Trial ID: NN9535-4506
Efficacy and safety of semaglutide 2.0 mg s.c. once-weekly compared to semaglutide 1.0 mg 
s.c. once-weekly in subjects with type 2 diabetes
Trial phase: 3b
Applicable to Czech Republic
This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.
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This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.


Protocol Amendment No.1
CONFIDENTIAL
Date:
31 May 2019
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Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
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EUdraCT Number: 2018-004529-96
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Table of Contents   
1
Introduction including rationale for the protocol amendment...........................................................3
2
Changes ................................................................................................................................................3
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Version:
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1
Introduction including rationale for the protocol amendment
This Protocol Amendment 1 was created based on the requirements of Czech Regulatory Authority 
(SUKL) and is applicable for the Czech Republic only. Since reproductive toxicity has been 
demonstrated during preclinical studies, Czech Regulatory Authority requires women with 
childbearing potential to use only a highly reliable methods of contraception (Pearls index <1), 
which does not include a two-barrier method. This requirement is in line with the recommendation 
of „Recommendations related to contraception and pregnancy testing in clinical trials“, which can 
be located at:
http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/
2014_09_HMA_CTFG_Contraception.pdf. 
Therefore, adequate modification of recommended contraceptive methods in the Protocol –
Appendix 5 has been done.
In this protocol amendment:
!
Any new text is written in italics.
!
Any text deleted from the protocol is written using strike through.
2
Changes
Appendix 5 Contraceptive guidance and collection of pregnancy information
It must be recorded in the CRF whether female subjects are of childbearing potential. 
Definitions
Woman of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile. 
Women in the following categories are not considered WOCBP
1. Premenarcheal 
2. Premenopausal female with one of the following:
!
Documented hysterectomy
!
Documented bilateral salpingectomy
!
Documented bilateral oophorectomy
Note: Documentation can come from the site personnel’s review of subject’s medical 
records, medical examination or medical history interview.
3. Postmenopausal female
!
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high Follicle Stimulating Hormone (FSH) level in the 
postmenopausal range may be used to confirm a postmenopausal state in women not 
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using hormonal contraception or Hormonal Replacement Therapy (HRT). However, 
in the absence of 12 months of amenorrhea, a single Follicle-Stimulating Hormone 
(FSH measurement is insufficient. 
!
Females on HRT and whose menopausal status is in doubt will be required to use 
one of the non-hormonal highly effective contraception methods if they wish to 
continue their HRT during the trial. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before trial enrolment.
Contraception guidance
Male subjects 
No contraception measures are required for male subjects as the risk of teratogenicity/fetotoxicity 
caused by transfer of semaglutide in seminal fluid is unlikely. 
Female subjects
Female subjects of childbearing potential are eligible to participate if they agree to use methods of 
contraception consistently and correctly as described in table(s) below:
Table 12-3
Highly effective contraceptive methods
Highly effective contraceptive methods that are user dependent a and b
Failure rate of <1% per year when used consistently and correctly. 
Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation 
! oral
! intravaginal
! transdermal
Progestogen only hormonal contraception associated with inhibition of ovulation
! oral 
! injectable 
Highly effective methods that are user independent b
Implantable progestogen only hormonal contraception associated with inhibition of ovulation 
! Intrauterine Device (IUD)
! Intrauterine hormone-releasing System (IUS)
! Bilateral tubal occlusion
Vasectomised partner 
A vasectomised partner is a highly effective contraception method provided that the partner is the sole male sexual 
partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used. 
Sexual abstinence b
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse 
during the entire period of risk associated with the trial product. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the subject. 
Notes: 
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent with 
local regulations regarding the use of contraceptive methods for subjects participating in clinical trials. 
b Contraception should be utilised during the treatment period and for at least 7 weeks after the last dose of trial 
product.
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Protocol Amendment No.1
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Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EUdraCT Number: 2018-004529-96
Page:
5 of 6
In certain cases, it is accepted to use double barrier methods (a condom combined with an occlusive 
cap (e.g. diaphragm) with/without the use of spermicide). This should only be allowed in females 
with:
1. known intolerance to the highly effective methods mentioned in Table 12-3 or where the use 
of any of the listed highly effective contraceptive measures are contraindicated in the 
individual subject, and/or
2. if the risk of initiating treatment with a specific highly effective method outweighs the 
benefit for the female.
Justification for accepting double barrier method should be at the discretion of the investigator 
taking into consideration his/her knowledge about the female’s medical history, concomitant illness, 
concomitant medication and observed AEs. The justification must be stated in the medical records.
Pregnancy testing
!
WOCBP should only be included after a negative highly sensitive urine pregnancy test.
!
Additional urine pregnancy testing should be performed at every site visit (every 4-8 weeks) 
during the treatment period, at the end of treatment and after the 7 weeks follow-up period 
after the end of treatment, according to the flow chart.
!
Pregnancy testing should be performed whenever a menstrual cycle is missed or when 
pregnancy is otherwise suspected.
!
All subjects will be provided with a pregnancy test prior to the phone visits to perform them 
prior to the phone call, not only if pregnancy is suspected. 
Collection of pregnancy information 
Female subjects who become pregnant 
!
Investigator will collect pregnancy information on any female subject, who becomes 
pregnant while participating in this trial.
!
Information will be recorded on the appropriate form and submitted to Novo Nordisk within 
14 calendar days of learning of a subject's pregnancy.
!
Subject will be followed to determine the outcome of the pregnancy. The investigator will 
collect follow-up information on subject and neonate, which will be forwarded to Novo 
Nordisk. Generally, follow-up will not be required for longer than 1 month beyond the 
delivery date.
!
Any termination of pregnancy will be reported, regardless of foetal status (presence or 
absence of anomalies) or indication for procedure.
!
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication 
or elective termination of a pregnancy will be reported as an AE or SAE. 
!
A spontaneous abortion is always considered to be an SAE and will be reported as such.
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CONFIDENTIAL


Protocol Amendment No.1
CONFIDENTIAL
Date:
31 May 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
UTN: U1111-1224-5162
Status:
Final
EUdraCT Number: 2018-004529-96
Page:
6 of 6
!
Any SAE occurring as a result of a post-trial pregnancy which is considered 
possibly/probably related to the trial product by the investigator will be reported to Novo 
Nordisk as described in Appendix 4. While the investigator is not obligated to actively seek 
this information in former subjects, he or she may learn of an SAE through spontaneous 
reporting. 
Any female subject who becomes pregnant while participating in the trial will discontinue trial 
product.
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CONFIDENTIAL


Protocol Amendment no 2
CONFIDENTIAL
Date:
05 July 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
Status:
Final
Page:
1 of 5
Protocol Amendment
no 2
to Protocol, version 1
dated 21 March 2019
Trial ID: NN9535-4506
Efficacy and safety of semaglutide 2.0 mg s.c. once-weekly compared to semaglutide 1.0 mg 
s.c. once-weekly in subjects with type 2 diabetes
Trial phase: 3b
Applicable to all countries
This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.
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CONFIDENTIAL
This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.


Protocol Amendment no 2
CONFIDENTIAL
Date:
05 July 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
Status:
Final
Page:
2 of 5
Table of Contents  
1
Introduction including rationale for the protocol amendment...........................................................3
2
Changes ................................................................................................................................................3
2.1
Section 7.7 Concomitant medication..........................................................................................3
2.2
Section 9.4.3 Eye examination...................................................................................................4
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CONFIDENTIAL


Protocol Amendment no 2
CONFIDENTIAL
Date:
05 July 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
Status:
Final
Page:
3 of 5
1
Introduction including rationale for the protocol amendment
This protocol is amended for the following reasons: 
!
To clarify requirements for stable background medication during the trial, further to established 
eligibility criterion and protocol recommended initial dose reduction of sulphonylurea
!
To clarify the timing of the availability of the eye examination result at the end of treatment 
visit. The extended window of availability will also facilitate data collection.
In this protocol amendment:
!
Any new text is written in italics.
!
Any text deleted from the protocol is written using strike through.
2
Changes
2.1
Section 7.7 Concomitant medication
Any medication (including over-the-counter or prescription medicines) other than the trial product 
that the subject is receiving at the time of the first visit or receives during the trial must be recorded 
along with:
!
Trade name or generic name
!
Indication
!
Dates of administration including start and stop dates
!
Dose (only to be recorded for anti-hyperglycaemic medication)
Treatment with metformin and SU is considered non-investigational medicinal products and should 
be used according to their respective labels and will be used open-label throughout the trial.
To mitigate SU induced hypoglycaemia, subjects treated with SU will be asked to reduce the SU 
dose by approximately 50% at the discretion of the investigator, from randomisation. In case of 
persistent hyperglycaemia, glycaemic rescue treatment could be initiated as described in Section 
After signing the informed consent, subjects must continue their anti-diabetic background 
medication (metformin with or without SU) throughout the entire trial. 
To mitigate SU-induced hypoglycaemia, subjects treated with SU should, at the discretion of the 
investigator, reduce the SU dose at randomisation by approximately 50%.
Apart from the initial dose reduction of SU, background medication dose should remain at the same 
dose level and with the same frequency during the entire treatment period unless glycaemic rescue 
treatment is needed (as described in Section 8.1.2) or safety concern related to the use of 
background medications arises.
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CONFIDENTIAL


Protocol Amendment no 2
CONFIDENTIAL
Date:
05 July 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
Status:
Final
Page:
4 of 5
In addition, all background medication:
!
is considered to be non-investigational medicinal product.
!
will not be provided by Novo Nordisk A/S, except if required by local regulations and not in 
contradiction to local regulations.
!
should be used in accordance with standard of care and current approved label in the 
individual country.
!
should not exceed the maximum approved dose in the individual country.
Investigators can switch OAD treatment within the same drug class, e.g. in case specific drugs 
become unavailable. 
Any change in concomitant medication, including switch of OAD treatment within the same drug 
class, must be recorded at each visit. If a change is due to an AE, then this must be reported 
according to Section 9.2
2.2
Section 9.4.3 Eye examination
Subjects with uncontrolled and potentially unstable diabetic retinopathy or maculopathy are not 
eligible, as this indicates retinopathy that has recently progressed to a level that requires 
intervention or is approaching intervention but has yet to be brought under control.
Results of an eye examination performed by an ophthalmologist or another suitably qualified 
healthcare provider must be available and evaluated by the investigator before randomisation to
assess eligibility. The eye examination should be performed as a fundus photography (e.g. 2-field
60 degree or better, colour or red-free) or by slit-lamp biomicroscopy examination (e.g. using a pre-
corneal or corneal contact lens examination). Pharmacological pupil-dilation is a requirement unless 
using a fundus photography camera specified for non-dilated examination.
If the subject had such an eye examination performed within 90 days prior to screening, the 
investigator may base his/her evaluation upon the results of that examination. The examination must
be repeated before randomisation if the subject has experienced worsening of visual function since
the last examination. If the applicable eye examination was performed before the subject signed the
informed consent form, it must be documented that the reason for performing the examination was
not related to this trial.
After randomisation an eye examination performed according to the above must be performed as 
per the flowchart in Section 2. Results must be available at V10 (end of treatment visit). An eye 
examination performed within 3 weeks prior to V10 is acceptable, provided no clinical symptoms 
suggestive of eye disease have occurred in the meantime.
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CONFIDENTIAL


Protocol Amendment no 2
CONFIDENTIAL
Date:
05 July 2019
Novo Nordisk
Trial ID: NN9535-4506
Version:
1.0
Status:
Final
Page:
5 of 5
The investigator should indicate the outcome of each eye examination. Relevant findings prior to 
randomisation must be recorded as concomitant illness/medical history, while relevant findings 
occurring after randomisation should be reported as an AE, if applicable according to Section 9.2
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CONFIDENTIAL