Clinical trial NCT03420781
Conditions: Gastroparesis Diabetes Mellitus
Keywords: diabetic gastroparesis vomiting
Sponsor: Allergan
Start date: 2018-01-24; Completion date: 2020-10-30
Enrollment: 467 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

Detailed description:

Arms: arm 1: Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks. arm 2: Relamorelin 10 micrograms (μg) injected subcutaneously twice daily for up to 40 weeks. arm 3: Participants who received placebo-matching relamorelin injected subcutaneously twice daily for 40 weeks, followed by relamorelin 10 μg injected twice daily for up to 6 weeks in the Randomized Withdrawal (RW) Period. arm 4: Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by relamorelin injected twice daily for up to 6 weeks in the RW Period. arm 5: Participants who received relamorelin 10 μg injected subcutaneously twice daily for 40 weeks, followed by placebo-matching relamorelin injected twice daily for up to 6 weeks in the RW Period.
Interventions: intervention 1: Placebo intervention 2: Relamorelin
Intervention descriptions: intervention 1: Placebo injected twice daily intervention 2: Relamorelin 10 μg injected twice daily

Protocol documents:
Prot_002.pdf: 
NCT03420781 
 
Study ID: Study ID: RLM-MD-03 
 
Title: A 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week Randomized- 
withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic 
Gastroparesis 
 
Protocol Amendment 2 Date: 10 March 2021 


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SAP_001.pdf: 
NCT03420781 
 
Study ID: RLM-MD-03 
 
 
Title:  A 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week Randomized-
withdrawal Period to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic 
Gastroparesis 
 
Statistical Analysis Plan Amendment 1 Date: 09Dec2020 


Allergan PLC
Page 1
Relamorelin
RLM-MD-03 Statistical Analysis Plan Amendment #1 
1
Title Page
RLM-MD-03
A 46-week, Double-blind, Placebo-controlled, Phase 3 Study with a 6-week 
Randomized-withdrawal Period to Evaluate the Safety and Efficacy of 
Relamorelin in Patients with Diabetic Gastroparesis
STATISTICAL ANALYSIS PLAN - Abbreviated Clinical Study Report
Final: 1 October, 2020
Amendment #1: 9 December, 2020


Allergan PLC
Page 2
Relamorelin
RLM-MD-03 Statistical Analysis Plan Amendment #1 
2
Table of Contents
1
Title Page ........................................................................................................................................................1
2
Table of Contents ............................................................................................................................................2
2.1
List of Tables ....................................................................................................................................3
2.2
List of Figures...................................................................................................................................3
3
List of Abbreviations.......................................................................................................................................4
4
Introduction.....................................................................................................................................................5
4.1
Study Design.....................................................................................................................................5
5
Objectives......................................................................................................................................................10
6
Populations for Analyses...............................................................................................................................12
6.1
Screened Population........................................................................................................................12
6.2
Intent-to-Treat Population...............................................................................................................12
6.3
Modified Intent-to-Treat Population...............................................................................................12
6.4
Safety Population............................................................................................................................12
6.5
Randomized Withdrawal Population ..............................................................................................12
7
Participant Disposition ..................................................................................................................................13
8
Demographics and Other Baseline Characteristics........................................................................................14
9
Extent of Exposure........................................................................................................................................15
10
Efficacy Analyses..........................................................................................................................................16
10.1
Primary Efficacy Endpoints ............................................................................................................16
10.2
Secondary Efficacy Endpoints ........................................................................................................16
11
Safety Analyses.............................................................................................................................................18
11.1
Adverse Events ...............................................................................................................................18
11.2
Clinical Laboratory Parameters.......................................................................................................19
11.3
Vital Signs.......................................................................................................................................21
11.4
Electrocardiogram...........................................................................................................................21
11.5
COVID-19.......................................................................................................................................21
12
Interim Analysis ............................................................................................................................................22
13
Determination of Sample Size.......................................................................................................................23
14
Statistical Software........................................................................................................................................24
15
Data Handling Conventions ..........................................................................................................................25
15.1
Analysis Weeks and Visit Time Windows for Efficacy Analysis...................................................25
15.1.1
Analysis Weeks for Efficacy Analysis .............................................................................25
15.2
Derived Efficacy Variables.............................................................................................................26
15.3
Repeated or Unscheduled Assessments of Safety Parameters ........................................................26
15.4
Missing Date of the Last Dose of Study Treatment ........................................................................26
15.5
Missing Severity Assessment for Adverse Events..........................................................................26
15.6
Missing Date Information for Adverse Events................................................................................26


Allergan PLC
Page 3
Relamorelin
RLM-MD-03 Statistical Analysis Plan Amendment #1 
16
Changes to Analyses Specified In Protocol...................................................................................................28
17
References.....................................................................................................................................................29
2.1
List of Tables
Table 4.1–1.
Schedule of Activities: Study RLM-MD-03..............................................................................7
Table 11.2–1.
Criteria for Potentially Clinically Significant Laboratory Tests ..............................................20
Table 15.1.1–1.
Analysis Time Windows for Efficacy Analysis.......................................................................25
2.2
List of Figures
Figure 4.1–1.
RLM-MD-03 Study Schematic..................................................................................................6


Allergan PLC
Page 4
Relamorelin
RLM-MD-03 Statistical Analysis Plan Amendment #1 
3
List of Abbreviations
AE
adverse event
DG
diabetic gastroparesis
DGSSD
Diabetic Gastroparesis Symptom Severity Diary
DGSSS
Diabetic Gastroparesis Symptom Severity Score
DGSSS-SR
DGSSS Study Responder
GEBT
Gastric emptying breath test
eCRF
electronic case report form
ECG
electrocardiogram, electrocardiographic
eDiary
electronic diary
ITT
intent to treat
mITT
modified intent to treat
PCS
potentially clinically significant
QTc
QT interval corrected for heart rate
QTcB
QT interval corrected for heart rate using the Bazett formula (QTcB = QT/(RR)½)
QTcF
QT interval corrected for heart rate using the Fridericia formula (QTcF = QT/(RR)⅓)
RM
rescue medication
RW
randomized withdrawal
SAE
serious adverse event
SAP
statistical analysis plan
SI
Le Système International d’Unités (International System of Units)
SOC
system organ class
TEAE
treatment-emergent adverse event
TESAE
treatment-emergent serious adverse event


Allergan PLC
Page 5
Relamorelin
RLM-MD-03 Statistical Analysis Plan Amendment #1 
4
Introduction
The statistical analysis plan (SAP) provides a more technical and detailed elaboration of  the 
statistical analyses of the efficacy and safety data as outlined and/or specified in the final 
protocol of Study RLM-MD-03 (version dated 12 Dec 2017) and the most recent amendment 
(version dated 4 Mar 2019). 
However, the study was early terminated and only an abbreviated study report will be applied to 
this study to report only some safety analyses and along with some basic trial characteristics data 
summaries.
This SAP amendment is based on the SAP dated 1 October 2020. The major change to the SAP 
is to add descriptive analyses for the primary and secondary efficacy endpoints for the results 
posting on ClinicalTrials.gov and EudraCT (European Union Drug Regulating Authorities 
Clinical Trials Database) and add the COVID-19 data listing.
4.1
Study Design
Approximately 960 participants will enter this study at 700 study sites (globally), based on the 
assumption that 80% of participants who complete the lead-in pivotal registration studies 
RLM-MD-01 or RLM-MD-02 will elect to continue receiving the double-blind study treatment.
Approximately 480 participants to receive relamorelin and 480 participants to receive placebo 
for an additional 40 weeks in the Treatment Period, and 6 weeks in the subsequent randomized 
withdrawal period (RWP). In the RWP, participants who received relamorelin in the Treatment 
Period will be re-randomized 1:1 to either continue relamorelin or switch to placebo; participants 
who received placebo in the Treatment Period will all switch to relamorelin.
Study Duration: 46 weeks, consisting of a 40-week Treatment Period followed by a 6-week 
RWP: 

40-week Treatment Period: Participants who meet entry criteria at the end of either 
lead-in study RLM-MD-01 or RLM-MD-02 will continue to receive the same blinded 
treatment with relamorelin 10 µg or placebo BID that they received during the Treatment 
Period of the lead-in study and continue to use the electronic hand-held device for the 
first 12 weeks (84 days) of the Treatment Period as they did in the lead-in study for daily 
reporting of their symptoms via the Diabetic Gastroparesis Symptom Severity Diary 
(DGSSD) as well as their
compliance, and use of rescue medication. After Visit 4/Week 12, 
participants will continue daily reporting of compliance and use of rescue medication, but 
will report their symptoms via the DGSSD,
only during the 4 weeks preceding subsequent visits 
(Visit 5/Week 24 through Visit 7/Week 40 or Early Termination). 

6-week RWP: At the end of the 40-week Treatment Period, participants who were on 
relamorelin will be randomized (1:1) either to continue relamorelin treatment or switch to 
placebo BID treatment. Participants who received placebo during the Treatment Period 
will be allocated to receive relamorelin 10 µg BID. Participants will continue to use the 
electronic hand-held device daily for reporting of their symptoms via the DGSSD as well 


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as their 
compliance, and use of rescue medication.
Study schematic and schedule of evaluations for Study RLM-MD-03 are presented in 
Figure 4.1–1 and Table 4.1–1 respectively.
Figure 4.1–1.
RLM-MD-03 Study Schematic


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Table 4.1–1.
Schedule of Activities: Study RLM-MD-03


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5
Objectives
The primary objectives are:

To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in 
this study (ie, after a total of 24 weeks of treatment—12 weeks from lead-in study 
RLM-MD-01 or RLM-MD-02 and 12 weeks from the current study) in participants with DG 
with respect to the following core signs and symptoms of DG:
○
Nausea
○
Abdominal Pain
○
Bloating
○
Postprandial fullness

To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in 
this study (ie, after a total of 24 weeks of  treatment—12 weeks from lead-in study 
RLM-MD-01 or RLM-MD-02 and 12 weeks from the current study) in participants with DG 
with respect to vomiting frequency
The secondary objectives are:

To compare the efficacy of relamorelin with that of placebo after 12 weeks of treatment in 
this study (ie, after a total of 24 weeks of treatment—12 weeks from lead-in study 
RLM-MD-01 or RLM-MD-02 and 12 weeks from the current study) in participants with DG 
with respect to the following individual symptoms of the Diabetic Gastroparesis Symptom 
Severity Score (DGSSS):
○
Nausea
○
Abdominal Pain
○
Bloating
○
Postprandial fullness

To compare the efficacy of relamorelin with placebo after 40 weeks of treatment in this study 
(ie, after a total of 52 weeks of treatment—12 weeks from the lead-in study RLM-MD-01 or 
RLM-MD-02 and 40 weeks from the current study ) in participants with DG with respect to 
the following core signs and symptoms of DG:
○
Nausea
○
Abdominal Pain
○
Bloating
○
Postprandial fullness


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
To compare the efficacy of relamorelin with placebo after 40 weeks of treatment  in this 
study (ie, after a total of 52 weeks of treatment—12 weeks from the lead-in study 
RLM-MD-01 or RLM-MD-02 and 40 weeks from the current study ) in participants with DG 
with respect to vomiting frequency

To demonstrate maintenance of efficacy after continuation versus discontinuation after 
52 weeks of relamorelin treatment during the 6-week Randomized Withdrawal Period (RWP)

To compare the safety of relamorelin with placebo in participants with DG


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6
Populations for Analyses
6.1
Screened Population
The Screened Population will consist of all participants who sign informed consent form.
6.2
Intent-to-Treat Population
The Intent-to-Treat (ITT) Population will consist of all participants who enter the 40-week 
Treatment Period (ie, participants who are dispensed study treatment at Visit 1 of this study).
6.3
Modified Intent-to-Treat Population
The Modified Intent-to-Treat (mITT) Population will consist of all participants in the ITT 
population who have ≥ 1 postbaseline assessment of DGSSD. 
6.4
Safety Population
The Safety Population will consist of all participants in the ITT population who received ≥ 1 
administration of study treatment.
The Safety Population will be used for all safety analyses. Participants will be analyzed 
according to the treatments they are planned during the study.
6.5
Randomized Withdrawal Population
The Randomized Withdrawal (RW) Population will consist of all participants who are re-
randomized or assigned to a treatment of the RW Period and receive ≥ 1 administration of study 
treatment during the RW Period. For the RW Period, there are 3 treatment sequences as follows:
1. Placebo - 10 μg (Placebo BID in the Treatment Period, followed by Relamorelin 10 μg BID 
in the RW Period)
2. 10 μg - 10 μg (Relamorelin 10 μg BID in the Treatment Period, followed by Relamorelin 
10 μg BID in the RW Period)
3. 10 μg - Placebo (Relamorelin 10 μg BID in the Treatment Period, followed by placebo BID 
in the RW Period)
For the analyses based on RW Population, participants will be analyzed according to the 
treatments they are planned in the lead-in studies RLM-MD-01 and RLM-MD-02 and the RW 
period.


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Participant Disposition
Screen failures (ie, participants who signed informed consent form, but did not enter the 40-week 
Treatment Period (ie, participants who were not dispensed study treatment at Visit 1 of this 
study)) and the associated reasons will be tabulated by treatment group and pooled across 
treatment group for the Screened Population. The number and percentage of participants who 
complete the double-blind Treatment Period and of participants who prematurely discontinue 
during the same period will be presented for each treatment group and pooled across treatment 
groups for the ITT Population. The reasons for premature discontinuation from the double-blind 
Treatment Period as recorded on the termination pages of the electronic case report forms will be 
summarized (number and percentage) by treatment group and pooled across treatment groups. 
All participants who prematurely discontinue during the double-blind Treatment Period will be 
listed by discontinuation reason.
Similar to the double-blind Treatment Period, the number and percentage of patients who are re-
randomized into the RW Period, complete the RW Period, and prematurely discontinue from the 
RW Period will be presented overall and by treatment sequence for the RW Population. Reason 
for premature discontinuation from the RW Period as recorded on the trial completion forms of 
the eCRFs will be summarized (number and percentage) by treatment sequence.
The number and percentage with significant protocol deviations in the double-blind Treatment 
Period and in RW Period will be presented by treatment group and overall and by treatment 
sequence for the ITT Population and the RW Population, respectively.


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8
Demographics and Other Baseline Characteristics
Demographic parameters (eg, age, age group, race, ethnicity, sex, geographic region), using the 
demographic and baseline data from lead-in studies RLM-MD-01 and RLM-MD-02, will be 
summarized in total and by treatment group for the Safety Population and RW Population.
Abnormalities in participants’ medical and surgical histories will be coded using the Medical 
Dictionary for Regulatory Activities, version 23.1 or newer. A data listing for medical and 
surgical histories will be presented.
Prior medication is defined as any medication started before the date of the first dose of double-
blind study treatment from the lead-in studies RLM-MD-01 and RLM-MD-02. Concomitant 
medication is defined as any medication taken on or after the date of the first dose of double-
blind study treatment in this study. 
The WHO Drug Dictionary, Version B2 March 2017 or newer, will be used to classify prior and 
concomitant medications by WHO Drug Anatomical/Therapeutic/Chemical (ATC) category and 
drug preferred name. A data listing for prior and concomitant medications will be presented.


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9
Extent of Exposure 
A listing of the investigational product dosing records will be provided for ITT population.


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Efficacy Analyses
The efficacy analyses for the double-blind Treatment Period will be based on the mITT 
Population. For the RW Period, the efficacy analyses will be based on the RW Population. Since 
the study was early terminated, only descriptive analyses for the primary and secondary efficacy 
endpoints will be performed.
Most efficacy parameters will be derived from the DGSSD, a 7-item, patient-reported daily diary 
designed to assess the severity of 6 core signs and symptoms of DG—nausea, abdominal pain, 
postprandial fullness, bloating, vomiting, and early satiety—and the frequency of vomiting 
episodes. For purposes of the analyses, weekly values will be calculated from the daily e-diary 
data. For weeks with less than 4 days of available DGSSD data, weekly values will be set to 
missing. The Day 1 for the efficacy endpoints in the double-blind treatment period of this study 
is the Day 84 of lead-in studies RLM-MD-01/02. Day 1 for the efficacy endpoints in the RW 
period is the re-randomization date.
For all analyses, the baseline is the baseline value from the lead-in study RLM-MD-01 or RLM-
MD-02, derived from the DGSSD, will be the average of the two weekly values from the two-
week Run-in period of the lead-in studies.  
10.1
Primary Efficacy Endpoints

Change from Baseline to Week 12 in Weekly DGSSS: Baseline is the baseline value 
from the lead-in study RLM-MD-01 or RLM-MD-02 and Week 12 is the 12th week of 
the 40-week Treatment Period (Days 78 to 84).  

Vomiting Week-12 Responder: Vomiting Week-12 Responder is defined as a 
participant with zero weekly vomiting episodes during each of the last 6 weeks of the 
first 12 weeks of the 40-week Treatment Period. 
A participant will be considered as Vomiting Week 12 non-Responder if the weekly number of 
vomiting episodes is missing from the diary for any of the last 6 weeks of the first 12 weeks of 
the 40-week Treatment Period.
10.2
Secondary Efficacy Endpoints

Nausea Week 12 responder: Nausea responder defined as a participant who has a ≥ 2-point 
improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of 
the 40-week Treatment Period

Abdominal pain Week 12 responder: Abdominal pain responder defined as a participant who 
has a ≥ 2-point improvement in the weekly symptom score at each of the last 6 weeks of the 
first 12 weeks of the 40-week Treatment Period

Bloating Week 12 responder: Bloating responder defined as a participant who has a ≥ 2-point 
improvement in the weekly symptom score at each of the last 6 weeks of the first 12 weeks of 
the 40-week Treatment Period


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
Postprandial fullness Week 12 responder: Postprandial fullness responder defined as a 
participant who has a ≥ 2-point improvement in the weekly symptom score at each of the last 
6 weeks of the first 12 weeks of the 40-week Treatment Period  

Change from Baseline to Week 40 in Average Weekly DGSSS: Average weekly scores are 
derived as the average of the weekly scores from Week 37 to Week 40 

Change from Baseline to Week 46 in Average Weekly DGSSS: Average weekly scores are 
derived as the average of the weekly scores from the six weeks of the Randomized Withdraw 
Period

Change from Baseline to Week 40 in Vomiting Frequency: Average weekly number of 
vomiting episodes are derived as the average of the weekly number of vomiting episodes 
from Week 37 to Week 40 

Change from Baseline to Week 46 in Vomiting Frequency: Average weekly number of 
vomiting episodes are derived as the average of the weekly number of vomiting episodes 
from the six weeks of the Randomized Withdraw Period

Vomiting Week 40 Responder: Vomiting responder defined as a participant with zero weekly 
vomiting episodes during each of the last 4 weeks of the 40-week Treatment Period(Week 37 
to Week 40)


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11
Safety Analyses
The safety analysis for the double-blind Treatment Period will be performed using the Safety 
Population. For the RW Period, the safety analysis will be performed using the RW Population. 
The safety parameters will include adverse events (AEs), clinical laboratory, electrocardiogram, 
and vital sign parameters. 
The Day 1 for the safety analyses in the double-blind treatment period is the date of the first 
double-blind study treatment in this study. Day 1 for the safety analyses in the RW period is the 
re-randomization date.
11.1 Adverse Events
Adverse events will be coded by system organ class and preferred term using the Medical 
Dictionary for Regulatory Activities (MedDRA), version 23.0 or newer.
An AE will be considered a treatment-emergent adverse event (TEAE) for the study if it was 
present after the first dose of study intervention or was present before the date of the first dose of 
study intervention and increased in severity or became serious after the first dose of study 
treatment during the study. Per case report form instructions, a new AE record will be created 
with a new AE onset date for any AE that worsens. Therefore, TEAEs can simply be identified 
as those AEs with recorded onset date on or after the date of the first dose of study intervention 
and within 30 days of the last dose of study intervention in the study. An AE that occurs more 
than 30 day after the last dose of study drug in the study will not be counted as a TEAE for the 
study. 
An AE will be considered a treatment-emergent SAE (TESAE) if it is a TEAE that also is an
SAE.
All TEAEs related summary will be presented by treatment group for the Treatment Period and 
by treatment sequence for the RW Period separately. A TEAE will only be counted in the 
double-blind treatment period if it starts between the date of the first dose of study treatment 
(inclusive) in the double-blind treatment period and the date of the first dose of study treatment 
(exclusive) in the RW period or within 30 days of the date of the last dose of study treatment in 
the double-blind treatment period if the patient did not enter the RW period. A TEAE will only 
be counted in the RW period if it starts on or after the first dose of study treatment in the RW 
period and within 30 days of the date of the last dose of study treatment in the RW period.
The number and percent of participants with TEAEs, TEAEs leading to discontinuation from 
study, Deaths, SAEs and TESAEs will be presented by treatment group for the Treatment Period, 
and by treatment sequence for the RW Period separately.


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The number and percentage of participants reporting TEAEs in each treatment group for the 
Treatment Period, by treatment sequence for the RW Period, will be tabulated by system organ 
class (SOC) and preferred term and further categorized by the investigator's assignment of 
severity. If more than 1 AE is coded to the same preferred term for the same participant, the 
participant will be counted only once for that preferred term using the greatest severity for the 
summarization. Additionally, the number and percentage of participants reporting treatment 
related TEAEs and treatment related TESAEs in each treatment group for the Treatment Period, 
by treatment sequence for the RW Period, will be tabulated by system organ class (SOC) and 
preferred term.
In addition, separate tabular displays for participants who died, participants with SAEs, 
participants with TEAEs leading to discontinuation from study will be presented.
11.2 Clinical Laboratory Parameters
Clinical laboratory test values from all assessments (including those from unscheduled or repeat 
assessments) will be considered potentially clinically significant (PCS) if they meet either the 
lower-limit or higher-limit PCS criteria listed in Table 11.2–1. 
The number and percentage of participants who have PCS postbaseline clinical laboratory values 
will be tabulated by treatment group for the Treatment Period and by treatment sequence for the 
RW Period. The percentages will be calculated relative to the number of participants with 
available non-PCS baseline values and at least 1 postbaseline assessment for periods. The 
numerator will be the total number of participants with available non-PCS baseline values and at 
least 1 PCS postbaseline value by treatment group for the Treatment Period and by treatment 
sequence for the RW Period.


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Table 11.2–1.
Criteria for Potentially Clinically Significant Laboratory Tests
Parameter
SI Unit
Lower Limit
Higher Limit
CHEMISTRY
Albumin
g/L
< 0.9 * LLN
> 1.1 * ULN
Alanine Aminotransferase 
(ALT)
U/L
—
≥ 3 * ULN
Alkaline Phosphatase
U/L
—
≥ 3 * ULN
Aspartate Aminotransferase 
(AST)
U/L
—
≥ 3 * ULN
Calcium
mmol/L
< 0.9 * LLN
> 1.1 * ULN
Chloride
mmol/L
< 0.9 * LLN
> 1.1 * ULN
Cholesterol
mmol/L
—
> 1.6 * ULN
Creatinine
μmol/L
—
> 1.3 * ULN
Potassium
mmol/L
< 0.9 * LLN
> 2.0 * ULN
Glucose, Fasting
mmol/L
< 0.9 * LLN
> 2.5 * ULN
Glycohemoglobin A1C
%
Increase of ≥ 0.5%
Glycohemoglobin A1C
%
Increase of ≥ 1%
Sodium
mmol/L
< 0.9 * LLN
> 1.1 * ULN
Total Bilirubin
μmol/L
—
> 1.5 * ULN
Total Protein
g/L
< 0.9 * LLN
> 1.1 * ULN
Triglycerides, Fasting
mmol/L
—
≥ 3 * ULN
Urea (BUN)
mmol/L
—
> 1.2 * ULN
Magnesium
mmol/L
< 0.9 * LLN
> 1.1 * ULN
Bicarbonate
mmol/L
< 0.9 * LLN
> 1.1 * ULN
Phosphate
mmol/L
< 0.9 * LLN
> 1.1 * ULN
Uric Acid
μmol/L
< 0.9 * LLN
> 1.1 * ULN
HEMATOLOGY
Basophils Absolute 
Cell Count
109/L
—
> 3 * ULN
Eosinophils Absolute 
Cell Count
109/L
—
> 3 * ULN
Hematocrit
Ratio
< 0.9 * LLN
> 1.1 * ULN
Hemoglobin
g/L
< 0.9 * LLN
> 1.1 * ULN
Lymphocytes Absolute Cell 
Count 
109/L
< 0.8 * LLN
> 1.5 * ULN
MCH
PG
—
> 3 * ULN
MCHC
G/L
—
> 3 * ULN
MCV
fL
< 0.9 * LLN
> 1.1 * ULN
Monocytes Absolute Cell 
Count
109/L
—
> 3 * ULN
Neutrophils Absolute 
Cell Count
109/L
< 0.8 * LLN
> 1.5 * ULN
Platelet Count
109/L
< 0.5 * LLN
> 1.5 * ULN


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Table 11.2–1.
Criteria for Potentially Clinically Significant Laboratory Tests
Parameter
SI Unit
Lower Limit
Higher Limit
Red Blood Cell Count
(Erythrocyte Count)
1012/L
< 0.9 * LLN
> 1.1 * ULN
White Blood Cell Count
109/L
< 0.7 * LLN
> 1.5 * ULN
URINALYSIS
pH
< 0.9 * LLN
> 1.1 * ULN
Specific Gravity
—
> 1.1 * ULN
LLN: Lower limit of normal value provided by the laboratory.
ULN: Upper limit of normal value provided by the laboratory.
11.3 Vital Signs
A listing for vital signs (heart rate (HR), respiratory rate, systolic and diastolic blood pressure 
(BP), temperature, and body weight) at each visit will be presented.
11.4 Electrocardiogram
A listing for electrocardiographic(ECG) parameters (HR, RR interval, PR interval, QRS interval, 
QT interval, and QTc) at each assessment time point will be presented. The QTc will be 
calculated using Fridericia and/or Bazett correction.
11.5 COVID-19
A listing of participants with visits impacted due to COVID-19 for the ITT population will be 
provided.


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12
Interim Analysis
No interim analysis is planned for this study.


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13
Determination of Sample Size
The study is early terminated; and the original study primary objectives are no longer applicable. 
The original study design considers the enrollment of this study depending upon the drop-out 
rates in the pivotal studies RLM-MD-01 and RLM-MD-02.  Assuming 300 participants per arm 
in each study and a drop-out rate of 20% in each of the pivotal studies, it is expected that 
approximately 960 participants (480 participants in each arm) will enter the study. Further, 
assuming that the drop-out rate will also be 20% by Week 12 in this study, it is expected that 
there will be 384 participants per treatment group at Week 12. This sample size will provide 99% 
power to detect a statistically significant difference in response rate between treatment and 
placebo in both the 4-symptom composite DGSSS endpoint (assuming a placebo rate of 14% and 
a treatment rate of 35%) and in the vomiting response endpoint (assuming a placebo rate of 11% 
and a treatment rate of 26%) at Week 12. The assumed response rates were those calculated from 
study RM-131-009.


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14
Statistical Software
Statistical analyses will be performed using version 9.4 (or newer) of SAS on a Linux operating 
system.


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Data Handling Conventions
15.1
Analysis Weeks and Visit Time Windows for Efficacy Analysis
15.1.1
Analysis Weeks for Efficacy Analysis
Table 15.1.1–1 below presents the analysis weeks assigned for the efficacy analysis of the 
participant daily diary data related to DGSSD. These analysis weeks will be used in the 
calculations for all week-based endpoints (eg, weekly DGSSS, weekly vomiting frequency, 
individual symptoms weekly scores etc.).
Table 15.1.1–1.
Analysis Time Windows for Efficacy Analysis
Period
Analysis Week
Begins
Ends
Treatment Period
Week 1 
Day 1, Day 84 of lead-in 
studies RLM-MD-01/02
Day 7
Week 2 
Day 8
Day 14
Week 3 
Day 15 
Day 21
Week 4 
Day 22
Day 28 
Week 5 
Day 29
Day 35
Week 6 
Day 36 
Day 42
Week 7 
Day 43
Day 49 
Week 8 
Day 50
Day 56
Week 9 
Day 57 
Day 63
Week 10
Day 64
Day 70 
Week 11 
Day 71
Day 77 
Week 12 
Day 78
Day 84
.....
Week k 
Day (k-1)x7 + 1
Day k x 7
.....
Week 40 
Day 274
Day 280 (or Day of last dose)
RW
Week 1 
RW Day 1, the day of re-
randomization
RW Day 7
Week 2
RW Day 8
RW Day 14 
Week 3
RW Day 15
RW Day 21
Week 4 
RW Day 22 
RW Day 28
Week 5
RW Day 29
RW Day 35 
Week 6
RW Day 36
RW Day 42 (or Day of last 
RW dose) 
For the RW Period, diary day is calculated as (diary date - date of re-randomization + 1). For the 
Treatment Period, diary day is calculated as (diary date – the date of Day 1 in Treatment 
Period + 1). 


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15.2
Derived Efficacy Variables
Weekly scores for nausea, abdominal pain, postprandial fullness, bloating, vomiting severity and
early satiety will be the average of the corresponding non-missing daily scores if a participant 
has at least 4 non-missing daily scores during each week (See section 15.1 for definition of 
analysis weeks). Weekly score will be set to missing if there are less than 4 days with non-
missing diary data during a week.
Weekly DGSSS is derived as the sum of the weekly DGSSD items of nausea, abdominal pain, 
postprandial fullness, and bloating. The range of DGSSS is from 0 to 40 with 40 indicating the 
worst possible. If any one of weekly items of nausea, abdominal pain, postprandial fullness, and 
bloating, is missing, then the weekly  DGSSS will be set to missing.
Weekly assessment for vomiting frequency is calculated as the total number of vomiting 
episodes during a week (normalized for the number of days with non-missing responses). i.e.: 
Weekly number of vomiting episodes = (total number of vomiting episodes in the 
week)*(7 days / (number of days with non-missing responses in the week)).
The weekly number of vomiting episodes is set to missing if there are less than 4 days with non-
missing diary data during the week.  
15.3 Repeated or Unscheduled Assessments of Safety Parameters
All postbaseline assessments will be used for PCS value determination, and all assessments will 
be presented in the data listings.
15.4 Missing Date of the Last Dose of Study Treatment
When the date of the last dose of study drug is missing in specific period, all efforts should be 
made to obtain the date from the Investigator. If it is still missing after all efforts have been 
made, the last diary date in the specific period will be used as the last dose date.
15.5 Missing Severity Assessment for Adverse Events
If severity is missing for an AE that started before the date of the first dose of study drug
product, an intensity of mild will be assigned. If severity is missing for an AE that started on or 
after the date of the first dose of study drug, an intensity of severe will be assigned. The imputed 
values for severity assessment will be used for the incidence summary; the values will be shown 
as missing in the data listings.
15.6 Missing Date Information for Adverse Events
The following imputation rules apply to cases in which the start date is incomplete (ie, partial 
missing) for AEs.


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Missing day and month

If the year is the same as the year of the date of the first dose of study drug, then the day 
and month of the date of the first dose of study drug will be assigned to the missing 
fields.

If the year is prior to the year of the date of the first dose of study drug, then December 
31 will be assigned to the missing fields.

If the year is after the year of the date of the first dose of study drug, then January 1 will 
be assigned to the missing fields.
Missing month only

The day will be treated as missing and both month and day will be replaced according to 
the above procedure.
Missing day only

If the month and year are the same as the month and year of the date of the first dose of 
study drug, then the date of the first dose of study drug will be assigned to the missing 
day.

If either the year is before the year of the date of the first dose of study drug or if both 
years are the same but the month is before the month of the date of the first dose of study 
drug, then the last day of the month will be assigned to the missing day.

If either the year is after the year of the date of the first dose of study drug or if both years 
are the same but the month is after the month of the date of the first dose of study drug, 
then the first day of the month will be assigned to the missing day.
If the stop date is complete and the imputed start date as above is after the stop date, the start 
date will be imputed by the stop date.
If the start date is completely missing and the stop date is complete, then the following algorithm 
is used to impute the start date:

If the stop date is after the date of the first dose of study drug, the date of the first dose of 
study drug will be assigned to the missing start date.

If the stop date is before the date of the first dose of study drug, the stop date will be 
assigned to the missing start date.


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Changes to Analyses Specified In Protocol
The study was early terminated and only an abbreviated study report will be applied to this 
study, for which only minimum efficacy analyses will be implemented. As such, this document 
is an abbreviated statistical analysis plan for only selected study disposition, demographics,
safety parameters and selected descriptive efficacy analyses.


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References
There are no references.


Electronic Signatures
User
Date
Justification
10-Dec-2020
21:38:50
(GMT)
Manager Approval
10-Dec-2020
17:11:43
(GMT)
Subject Matter Expert Approval
10-Dec-2020
22:20:03
(GMT)
Document Originator Approval
10-Dec-2020
17:45:16
(GMT)
Subject Matter Expert Approval
09-Dec-2020
20:55:43
(GMT)
Subject Matter Expert Approval