Clinical trial NCT04964986
Conditions: Short Bowel Syndrome
Keywords: Intestinal Failure SBS SBS-IF CIC Colon-in-Continuity
Sponsor: VectivBio AG
Start date: 2021-06-14; Completion date: 2023-06-06
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the trial is to evaluate the safety of apraglutide in adult subjects with SBS-IF and CIC.

Detailed description:
This is an international, multicenter trial to evaluate the safety of apraglutide in adult participants with SBS-IF and CIC. The active pharmaceutical ingredient is apraglutide, an investigational glucagon-like peptide-2 (GLP-2) analogue. The trial consists of an evaluation period of 52 weeks.

Arms: arm 1: All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks.
Interventions: intervention 1: Apraglutide
Intervention descriptions: intervention 1: Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 


 
 
 
Confidential 
 
VectivBio AG 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
 
PROTOCOL TA799-013 
 A multicenter, open-label, metabolic balance study to evaluate the effects of 
apraglutide on intestinal absorption in adult subjects with short bowel syndrome, 
intestinal failure (SBS-IF), and colon-in-continuity (CIC) 
 
Protocol Code:  
TA799-013 
SAP Version:  
FINAL v3.0 
SAP Date:  
12DEC2022 
Author:  
 
 
 
 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 2 of 50 
DOCUMENT HISTORY 
VERSION HISTORY 
Version # 
Version Date 
v1.0 
23JUN2022 
V2.0 
22JUL2022 
V3.0 
12DEC2022 
REVISION HISTORY 
Version # 
Chapter 
Revision Summary 
Reason(s) for Revision 
V1.0 
N/A 
New 
N/A 
V2.0 
Section 6 Interim 
Analysis 
Removed the plan/scope of 
preliminary data analysis and added 
the scope of interim analysis (IA). 
The Sponsor has 
decided a change in the 
analysis plan due to the 
timing of preliminary 
data analysis and the 
first protocol-defined 
interim analysis. 
 
Section 9.2 
Definition of 
Baseline, Trial 
Visits, and Visit 
Windows 
Clarified analysis timepoints for 
citrulline and apraglutide plasma 
concentration data analysis. 
This is to provide clarity 
for analysis. 
 
Section 9.8.3 
Laboratory Data 
Added the derivation rule for the 
safety lab results with > or < prefix. 
This is to provide clarity 
for analysis. 
 
Section 9.8.6 
PK/PD 
Removed the derivation rule for 
apraglutide plasma concentrations 
below the lower limit of 
quantification (LLOQ) in case of 
being taken before the first dose of 
trial treatment since such a sample 
timepoint is not applicable according 
to the schedule of assessment. 
This is to provide clarity 
for analysis. 
V3.0 
throughout 
Added Appendix 4 Addendum to 
Statistical Analysis Plan (SAP) to 
refer Note to File (NTF) issued by 
Sponsor throughout this document 
for the changes of SAP for the 
second interim analysis and final 
analysis.   
To incorporate Sponsor 
issued NTF into this 
SAP. 
 
Section 10 
Documented the change of analysis 
plan for Adverse Event of Special 
Interest (AESI) due to the NTF 
To document the 
change from the 
protocol-defined 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 3 of 50 
Version # 
Chapter 
Revision Summary 
Reason(s) for Revision 
issued by Sponsor. 
planned analysis. 
 
Approval 
signature page 
VectivBio Approver changed from 
 
Change in 
Biostatistician 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 4 of 50 
APPROVAL SIGNATURES 
STUDY TITLE: A multicenter, open-label, metabolic balance study to evaluate the 
effects of apraglutide on intestinal absorption in adult subjects with short bowel 
syndrome, intestinal failure (SBS-IF), and colon-in-continuity (CIC) 
 
PROTOCOL NUMBER: TA799-013 
SAP FINAL v3.0, 12DEC2022 
 
PSI 
AUTHOR: 
 Principal Statistician 
Electronically signed & dated 
REVIEWED BY: 
 Group Leader Biostatistics 
Electronically signed & dated 
REVIEWED BY: 
 Lead Project Manager 
Electronically signed & dated 
 
VectivBio 
APPROVED BY: 
Director, Program Statistician 
Electronically signed & dated 
APPROVED BY: 
 VP, Head of Clinical 
Development 
Electronically signed & dated 
 
 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 5 of 50 
TABLE OF CONTENTS 
1. 
LIST OF ABBREVIATIONS ......................................................................................................................... 7 
2. 
INTRODUCTION .......................................................................................................................................... 9 
3. 
TRIAL OBJECTIVES .................................................................................................................................... 9 
3.1 
Primary Objective ................................................................................................................ 9 
3.2 
Secondary Objectives .......................................................................................................... 9 
3.3 
Exploratory Objectives ....................................................................................................... 10 
3.4 
Experimental Objectives .................................................................................................... 10 
4. 
TRIAL DESCRIPTION ................................................................................................................................ 10 
4.1 
Trial Design ........................................................................................................................ 10 
4.2 
Trial Treatment .................................................................................................................. 10 
4.2.1 
Considerations on IMP dose reduction and temporary discontinuation of IMP . 11 
5. 
SAMPLE SIZE AND POWER CALCULATION .......................................................................................... 11 
6. 
INTERIM ANALYSIS .................................................................................................................................. 11 
6.1 
Data Monitoring Committee ............................................................................................... 12 
7. 
ENDPOINTS ............................................................................................................................................... 12 
7.1 
Primary Endpoint ............................................................................................................... 12 
7.2 
Secondary Endpoints ........................................................................................................ 12 
7.3 
Exploratory Endpoints ....................................................................................................... 13 
8. 
ANALYSIS POPULATIONS ....................................................................................................................... 14 
8.1 
Full Analysis Set ................................................................................................................ 14 
8.2 
Safety Analysis Set ............................................................................................................ 14 
9. 
ANALYTICAL PLAN AND STATISTICAL METHODS .............................................................................. 15 
9.1 
General Conventions and Statistical Considerations ........................................................ 15 
9.2 
Definition of Baseline, Trial Visits, and Visit Windows ....................................................... 15 
9.3 
Handling of Missing Data ................................................................................................... 16 
9.4 
Subject Disposition ............................................................................................................ 17 
9.5 
Protocol Deviations ............................................................................................................ 17 
9.6 
Subject Characteristics ...................................................................................................... 18 
9.6.1 
Baseline and Demographic Characteristics ....................................................... 18 
9.6.2 
Medical and Surgical History .............................................................................. 18 
9.6.3 
Prior and Concomitant Medication and Interventions ........................................ 18 
9.7 
Efficacy Endpoints and Analysis ........................................................................................ 19 
9.7.1 
Analysis of Primary Endpoint ............................................................................. 19 
9.7.2 
Analysis of Secondary Endpoints....................................................................... 19 
9.7.3 
Analysis of Exploratory Efficacy Endpoints ........................................................ 22 
9.7.4 
Sensitivity Analysis to the Efficacy analyses ...................................................... 24 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 6 of 50 
9.8 
Safety Endpoints and Analysis .......................................................................................... 24 
9.8.1 
Exposure to Trial Treatment ............................................................................... 25 
9.8.2 
Adverse Events .................................................................................................. 25 
9.8.3 
Laboratory Data ................................................................................................. 26 
9.8.4 
Vital Signs and Other Safety Parameters .......................................................... 26 
9.8.5 
Immunogenicity Assessments ............................................................................ 27 
9.8.6 
PK/PD ................................................................................................................. 27 
10. 
DEVIATIONS FROM ANALYSIS DESCRIBED IN THE PROTOCOL ....................................................... 27 
11. 
PROGRAMMING SPECIFICATIONS ......................................................................................................... 28 
12. 
REFERENCE .............................................................................................................................................. 29 
APPENDIX 1: SCHEDULE OF ASSESSMENTS .................................................................................................. 30 
APPENDIX 2: SCORING METHOD FOR 
.................................................................................................... 40 
APPENDIX 3: SPONSOR-DEFINED LIST OF PREFERRED TERMS .................................................................. 44 
APPENDIX 4: ADDENDUM TO STATISTICAL ANALYSIS PLAN ....................................................................... 50 
 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 7 of 50 
1. 
List of Abbreviations 
ADA 
Anti-Drug Antibodies 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
ATC 
 
Anatomical Therapeutic Chemical 
BMI 
Body Mass Index 
BSFS 
Bristol Stool Form Scale 
CI 
Confidence Interval 
CIC 
Colon-in-Continuity 
CTCAE 
Common Terminology Criteria for Adverse Events 
Ctrough 
Trough plasma concentration 
D/BHQ 
Dietary/Bowel Habit Questionnaire 
DEXA 
Dual-Energy X-ray Absorptiometry 
DMC 
Data Monitoring Committee 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form  
EDC 
Electronic Data Capture 
EOT 
End of Trial 
FAS 
Full Analysis Set 
GI 
Gastrointestinal 
GLP-2 
Glucagon-like Peptide 2 
GMT 
Good Morning Time 
GNT 
Good Night Time 
IA 
Interim Analysis 
ICF 
Informed Consent Form 
IMP 
Investigational Medicinal Product 
LLOQ 
Lower Limit of Quantification 
LTE 
Long-term Safety and Clinical Outcomes Extension Trial 
MB 
Metabolic Balance 
MedDRA 
Medical Dictionary for Regulatory Activities 
MQ 
Medical Questionnaire 
MRI 
Magnetic Resonance Imaging 
nAb 
Neutralizing Antibody 
PD 
Pharmacodynamic 
PGIC 
Patient Global Impression of Change 
PGI-PSI 
Patient Global Impression of Parenteral Support Impact 
PGI-SPS 
Patient Global Impression of Satisfaction with Parenteral Support 
PGIS 
Patient Global Impression of Severity 
PGI-TS 
Patient Global Impression of Treatment Satisfaction 
PK 
Pharmacokinetic 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 8 of 50 
PN 
Parenteral Nutrition 
PopPK 
Population Pharmacokinetic 
PRO 
Patient Reported Outcomes 
PS 
Parenteral Support 
 
 
PT 
Preferred Term 
QOL 
Quality of Life 
QTcF 
QT Interval corrected according to Fridericia’s formula 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS 
Safety Analysis Set 
SBS 
Short Bowel Syndrome 
SBS-IF 
Short Bowel Syndrome with Intestinal Failure 
SBS-IF-CIC-QOL 
Short Bowel Syndrome with Intestinal Failure and Colon-in-Continuity Quality 
of Life questionnaire 
SBS-IF-TI-QOL 
Short Bowel Syndrome with Intestinal Failure - Treatment Impacts - Quality of 
Life questionnaire 
SC 
Subcutaneous 
SCFA 
Short Chain Fatty Acid 
SoA 
Schedule of Assessments 
SOC 
System Organ Class 
TEAE 
Treatment-Emergent Adverse Events 
TESAE 
Treatment-Emergent Serious Adverse Events 
TFL 
Tables, Figures, and Listings 
VRS 
Verbal Response Scale 
WHODD 
World Health Organization Drug Dictionary 
 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 9 of 50 
2. 
Introduction 
This statistical analysis plan (SAP) describes the planned statistical analysis for the TA799-013 
trial based on the protocol version 4.0 (dated February 7, 2022), titled “A multicenter, open-
label, metabolic balance study to evaluate the effects of apraglutide on intestinal absorption in 
adult subjects with short bowel syndrome, intestinal failure (SBS-IF), and colon-in-continuity 
(CIC)”, and based on the latest electronic case report forms (eCRF) prior to approval of this 
document. 
After the SAP version 2.0 was finalized on 22 July 2022, Sponsor decided to make changes to 
analysis plans for the upcoming second interim analysis (IA) and final analysis and issued Note 
to File (NTF; Topic: TA799-013 Statistical Analysis Plan) on December 6, 2022, rather than 
updating SAP itself considering the scope of changes. It was agreed between Sponsor and PSI 
to attach the NTF as addendum to this SAP (See Appendix 4: Addendum to Statistical Analysis 
Plan). These changes stated in the NTF supersede any other sections in this SAP and Mock-Up 
Tables, Figures, and Listings (TFL) document. 
Two (2) sites have enrolled subjects in this trial; a French site (2 subjects enrolled) and a 
Belgian site (7 subjects enrolled).  Recruitment in this trial is now closed. On February 7, 2022 
VectivBio issued protocol version 4 which was approved by the Belgian Ethics Committee, but 
rejected by the French Ethics Committee. The French site continues to operate under protocol 
version 3 (dated September 3, 2021).     
This SAP describes differences in the endpoints and objectives between the two protocol 
amendments (protocol versions 3 and 4). The analysis itself will be performed as per protocol 
amendment 4 for all subjects. 
3. 
Trial Objectives 
3.1 
PRIMARY OBJECTIVE 
• 
To evaluate the safety and tolerability of apraglutide (applicable to the protocol version 
4) 
• 
To evaluate the efficacy of apraglutide in increasing intestinal energy absorption 
assessed by bomb calorimetry in relation to metabolic balance (MB) assessments 
(applicable to the protocol version 3) 
3.2 
SECONDARY OBJECTIVES 
• 
To evaluate fluid, electrolytes, calories, and macronutrient absorption indicative of 
clinical efficacy (applicable to the protocol version 4) 
• 
To evaluate fluid, electrolytes, and macronutrient absorption indicative of clinical efficacy 
(applicable to the protocol version 3) 
• 
To evaluate the efficacy of apraglutide in reducing the administered volume per week of 
parenteral support (PS) from baseline  
• 
To evaluate the safety and tolerability of apraglutide (applicable to the protocol version 
3) 
• 
To assess apraglutide plasma concentrations to inform the population pharmacokinetic 
(PopPK) model 
• 
To evaluate citrulline plasma concentrations to inform the PopPK/Pharmacodynamic 
(PD) analysis  


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 10 of 50 
3.3 
EXPLORATORY OBJECTIVES 
• 
To evaluate other selected parameters indicative of clinical efficacy 
3.4 
EXPERIMENTAL OBJECTIVES 
• 
To investigate predictors and underlying mechanisms on the effect of apraglutide by 
studying intestinal permeability, gastrointestinal (GI) motility, mucosal gene expression 
and mucosa-associated and luminal microbiota 
4. 
Trial DESCRIPTION 
4.1 
TRIAL DESIGN 
This is a repeated-dose, open-label trial investigating the efficacy, safety, PD, and 
pharmacokinetics (PK) of apraglutide in subjects with SBS-IF and CIC. The subjects will receive 
a subcutaneous (SC) dose of 2.5 mg or 5 mg apraglutide once weekly for 52 weeks. Safety 
follow-up assessments will be performed 4 weeks (± 1 week) after the last dose.  
Subjects will undergo three 72-hour MB evaluations at baseline, Week 4, and Week 48. For the 
first 4 weeks, up to the completion of the second MB study, the PS should not be changed. PS 
volume can be reduced for safety reasons but all possible attempts should be made to return to 
the baseline PS prescription for the second MB period. 
Subjects that do not complete the baseline and 4-week MB evaluation and/or do not receive all 
4 doses of Investigational Medicinal Product (IMP), per protocol, may be replaced. Subjects that 
withdraw after the 4-week MB evaluation may not be replaced. 
At each visit, starting after Week 4, the PS volume will be reviewed and adjusted by the 
investigator taking into account the protocol-defined algorithm for PS volume reduction, based 
on changes in urine output of 10% or greater. 
For subjects with change in urine output not higher than 10%, cases will be adjudicated by the 
participating investigators who will review the clinical status of participants to assess if PS 
volume reduction is warranted. The three investigators will make recommendations for the 
safety of subjects and with the objective to standardize and harmonize decisions on PS volume 
reduction and weaning across the three sites. 
The safety follow-up is planned at the end of trial (EOT) visit, 4 weeks after the last IMP dose. If 
trial treatment is discontinued permanently, assessments will be performed at EOT visit, 4 
weeks after the last dose. If the subject enters the long-term Safety and Clinical Outcomes 
extension trial (LTE, TA799-012), no EOT assessments will occur. 
In case a subject discontinues or withdraws prematurely from the trial treatment for any reason 
after receiving at least one dose of IMP, subjects will be asked to continue to participate in the 
trial beyond the EOT visit according to the schedule of assessments (with the exception of IMP 
administration). 
The schedule of assessments are found in Appendix 1: Schedule of Assessments. 
4.2 
TRIAL TREATMENT 
A single 2.5 mg dose (for subjects with body weight less than 50 kg at most recent trial visit) or 
5 mg dose (for subjects with body weight 50 kg or more at most recent trial visit) of apraglutide 
will be administered by SC injection once weekly during a treatment period of 52 weeks.  
IMP should be administered on the same day of the week based on the first administration at 
Week 0 (Visit 3), with a window of ±24 hours, i.e., the administration could be done up to 


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24hours earlier or later than per schedule. On days when the subject will be at the site, the IMP 
must be administered at the site. Change of dosing is only allowed at each clinic visit. Between 
visits, IMP can be either self-administered at home or by a family member/caregiver, or 
administered at the clinic.  
4.2.1 CONSIDERATIONS ON IMP DOSE REDUCTION AND TEMPORARY DISCONTINUATION OF 
IMP  
If the Investigator reduces the IMP dose due to safety reasons, documentation as an adverse 
event (AE) is required. If the Investigator reduces or temporarily discontinues the IMP, 
resumption of the IMP or return to the prescribed dose must be based on the medical condition 
of the subject and the Investigator’s clinical judgment.  
Reduction of the IMP can be from 5.0 mg to 2.5 mg or from 2.5 mg to 0 mg. No other dose 
adjustments are allowed. The Investigator should attempt to return to the per protocol dose as 
soon as the medical condition of the subject allows. If the subject does not continue to tolerate 
the per protocol dose, the Investigator may choose to resume IMP administration at the lower 
dose of 2.5 mg weekly.  
There is no limit to the number of dose reductions for an individual subject during the trial. 
However, the Investigator should discuss with the subject and use their clinical judgment to 
determine if it is safe and appropriate for the subject to continue if numerous IMP 
discontinuations and/or reductions have been required.  
Changes and discontinuations must be discussed with the Medical Monitor. If the subject’s 
medical condition allows, this discussion may occur prior to changes but may occur afterwards if 
this is not possible (e.g., an AE necessitating an immediate halt). The final decision to reduce or 
discontinue the IMP will be that of the Investigator.  
Dose changes and the rationale will be documented in the medical records, in the subject diary 
(for IMP administration at the subject’s home) and in the eCRF. Missed doses will not be made 
up for, i.e., the treatment period will not be prolonged due to temporary discontinuation. 
Reporting as a protocol deviation is required. 
5. 
SAMPLE SIZE AND POWER CALCULATION 
No formal sample size calculation has been performed for this trial. This trial is to enroll 
approximately 10 subjects. This is considered sufficient to provide adequate information about 
the general safety, tolerability, efficacy, PD and PK of the compound at this stage of 
development. 
6. 
INTERIM ANALYSIS  
Interim analyses will be performed after the last subject completes Week 4 and another after the 
last subject completes Week 24. 
All data except for Anti-Drug Antibodies (ADA) data will be included in the first IA, hence 
excluding ADA, it is planned to produce all planned tables and listings (except for figures) for the 
first IA.  
For IA, all available data points by the data snapshot will be included in the analysis while some 
may remain missing at the time of IA snapshot. The additional changes to this plan can be 
found in Appendix 4: Addendum to Statistical Analysis Plan. 
Additional interim analyses may be performed by the sponsor at any time. 


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6.1 
DATA MONITORING COMMITTEE  
Ongoing safety surveillance will be performed by the Data Monitoring Committee (DMC) that is 
performing safety surveillance for the TA799-007 and TA799-012 trials, which is using the same 
IMP. The data from these 3 studies will be used to perform an overall safety evaluation for 
apraglutide.  
Details on the composition and conduct with regards to open and closed sessions, tasks and 
responsibilities of the DMC will be described in a separate DMC charter. 
7. 
ENDPOINTS 
7.1 
PRIMARY ENDPOINT 
The following primary endpoints are applicable to the protocol version 4: 
• 
Adverse events (system organ class, frequency, and severity) 
• 
Adverse events of special interest (AESIs) 
o Injection site reaction  
o Gastrointestinal obstruction  
o Gallbladder, biliary and pancreatic disease  
o Fluid overload  
o Colorectal polyps  
o Malignancies 
• 
Clinical chemistry, hematology, hemostasis, ADA, and urine analysis 
The following primary endpoint is applicable to the protocol version 3: 
• 
Absolute change in absorption of energy over MB periods from baseline to Week 48 
7.2 
SECONDARY ENDPOINTS  
Efficacy endpoints related to PS volume  
• 
Relative change from baseline in actual weekly PS volume at Weeks 4, 24 and 52  
• 
Absolute change from baseline in actual weekly PS volume at Weeks 24 and 52  
• 
Subjects who achieve a reduction of at least 1 day per week of PS from baseline at 
Weeks 24 and 52  
• 
Clinical responders (20% reduction of PS volume from baseline) at Weeks 24 and 52  
• 
Subjects reaching enteral autonomy at Weeks 24 and 52  
• 
Energy reduction in the Parenteral Nutrition (PN) from baseline at Weeks 24 and 52  
Efficacy endpoint related to nutritional, fluid (wet weight) and electrolyte absorption  
• 
Absolute change in absorption of energy over MB periods from baseline to Week 48 
(applicable to the protocol version 4) 
• 
Relative change in absorption of energy over MB periods from baseline at Week 48  
• 
Change in absorption of macronutrients over MB periods from baseline at Week 48  


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• 
Absolute change in absorption of energy over MB periods from baseline at Week 4  
• 
Change in absorption of macronutrients over MB periods from baseline at Week 4  
• 
Changes in urine output and urinary electrolytes (sodium, potassium, calcium and 
magnesium) over MB periods from baseline at Week 4 and at Week 48  
Patient reported outcomes (PRO) 
• 
Changes from baseline in 
 at Weeks 24 and 52  
• 
Patient Global Impression of Change (PGIC) at Weeks 24 and 52  
• 
Changes from baseline in Patient Global Impression of Treatment Satisfaction (PGI-TS) 
at Weeks 24 and 52 
• 
Changes from baseline in Patient Global Impression of Satisfaction with PS (PGI-SPS) 
at Week 24 and 52 
• 
Changes from baseline in Patient Global Impression of PS Impact (PGI-PSI) at Week 24 
and 52.  
PK/PD related endpoints  
• 
Trough plasma concentration  
• 
Plasma citrulline levels 
Safety endpoints (applicable to the protocol version 3) 
• 
AESI 
• 
Clinical chemistry, hematology, hemostasis, ADAs, and urine analysis  
• 
AEs 
7.3 
EXPLORATORY ENDPOINTS 
Endpoints related to nutritional status  
• 
Changes from baseline in lean body mass, bone mineral content and fat mass by Dual-
Energy X-ray Absorptiometry (DEXA) scan from baseline at Weeks 4, 24, and 48  
• 
Change in body weight from baseline at Weeks 4, 24, and 48 (applicable to the protocol 
version 4) 
• 
Change in body weight from baseline at Weeks 24 and 48 (applicable to the protocol 
version 3) 
• 
Change in dietary intake of wet weight (oral solid food, oral fluid), energy, 
macronutrients, and electrolytes (sodium, potassium, calcium and magnesium) from 
baseline at Weeks 4 and 48  
• 
Change in fecal excretion of wet weight (feces), energy, macronutrients, and electrolytes 
(sodium, potassium, calcium and magnesium) from baseline at Weeks 4 and 48  
Endpoints related to efficacy  
• 
Change from baseline in the total time per day that subjects infuse PS at Weeks 24 and 
52  
• 
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considered as baseline since assessments are to be performed prior to dosing on the day of the 
first IMP administration according to the schedule of assessments in the protocol.  
For evaluation of MB parameters, all relevant data measured over the MB period at the 
scheduled visit will be considered as the analysis timepoint. This applies to baseline, Week 4, 
and Week 48. The detailed derivation of baseline MB period data can be found in Section 
9.7.Except for EOT visit data for efficacy analyses, by-visit efficacy data will be analyzed based 
on eCRF visits.  
For all efficacy analyses, the EOT visit data will be mapped to a visit as defined below and will 
be only used to replace any missing by-visit efficacy data: 
Table 9.2.1: Data Mapping Scheme 
Visit  
Analysis timepoint  
Target day* 
  
4 
Week 2  
Day 15  
 
5 
Week 4  
Day 29  
  
6 
Week 8  
Day 57 
 
7  
Week 12  
Day 85 
 
8 
Week 16  
Day 113 
 
9 
Week 20  
Day 141 
 
10 
Week 24  
Day 169 
 
11 
Week 28  
Day 197 
 
12 
Week 32  
Day 225 
 
13 
Week 36 
Day 253 
 
14 
Week 40 
Day 281 
 
15 
Week 44 
Day 309 
 
16 
Week 48  
Day 337 
 
17 
Week 52 
Day 365 
 
*based on the relative days from the first trial treatment where the relative days from the first trial treatment = date of assessment or 
event – date of first trial treatment + 1, when both dates are known for assessments or events started on or after the day of the first 
trial treatment. (e.g., Relative Study Day 1 = the first study dosing day) 
For safety data analysis, by-visit data will be analyzed based on the assigned analysis visit 
based on the data mapping scheme above. If more than one assessment falls into allowed time 
window the closest to the target date will be used. If two values are equidistant from the planned 
visit/assessment date, the first value will be used. 
The citrulline and apraglutide plasma concentration data will be analyzed by scheduled visit 
based on eCRF visit (including EOT where applicable). 
9.3 
HANDLING OF MISSING DATA 
In general, missing values will not be replaced, and observed values will be used for analyses 
unless specified in the sections below.  
For the calculation of duration of SBS disease history, if there are any partial dates of SBS 
disease history, the first day and/or month of the year will be assumed for a missing day and/or 
month for the purpose of duration calculation based on the worst case scenario approach. 
For medication or therapeutic interventions with imprecise/partial date(s), the first day/month of 
the year will be assumed for unknown day/month of the start date, and the last day/month of the 


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year will be assumed for unknown day/month of the stop date to categorize medications or 
therapeutic interventions as concomitant for the worst case scenario. 
For events with imprecise/partial date(s), unless the start or end date of the known month or 
year is before the date of the first trial treatment, all events will be deemed as treatment-
emergent adverse events (TEAEs) as opposed to pre-existing AEs. 
For analyses of safety, missing data about AE relationship to trial treatment, intensity, 
seriousness, and outcome will be assumed to be ‘related to the trial treatment’, ‘severe’, 
‘serious’, and ‘not recovered/not resolved’, respectively, based on the worst case scenario.    
For analyses of efficacy, weekly PS data from diary may be missing in case of PS being 
‘weaned off’.  In this case, missing weekly PS diary data (e.g. volume, frequency, total time of 
infusion etc.) will be imputed to 0 for analyses based on ‘weaned off’ information according to 
the PS prescription eCRF. Once ‘weaned off’ is recorded in eCRF at a visit, sites are not asked 
to repeat this data in the next visit. Hence, for analysis, ‘weaned off’ data will be carried forward 
to the next analysis timepoint(s) where applicable based on subjects’ visit information until 
indicated otherwise (i.e. no longer reported as ‘weaned off’). 
9.4 
SUBJECT DISPOSITION 
Number of subjects who were screened and screen-failures (along with reasons) will be 
summarized for all screened subjects. The percentages will be calculated based on the total 
number of subjects screened.  
This table will also document the number and percentages of subjects enrolled, enrolled but not 
treated, in the SAS, and in the FAS. The percentages will be calculated based on the number of 
subjects screened. The enrolled subjects will be identified as subjects who signed the informed 
consent form (ICF) and have met all eligibility criteria. The number (%) of subjects screened and 
enrolled will be also summarized by country. 
The number (%) of subjects who completed the trial treatment and prematurely discontinued 
from trial treatment will be tabulated, along with reasons for discontinuation. The number (%) of 
subjects who entered and did not enter 4-week safety follow-up will be presented, along with 
reasons for not entering follow-up. The 4-week safety follow-up completion status will be 
summarized with counts and percentages, along with the reason for not completing for subjects 
who have not completed the safety follow-up. The number (%) of subjects continuing with trial 
visits after withdrawal and subjects who agreed to provide PS administration details to the 
investigator will also be tabulated in the same table. For such subjects, the extended follow-up 
(observation) completion status will also be summarized with counts and percentages, along 
with the reason for not completing trial visits or PS data collection after permanent withdrawal of 
trial treatment. 
The above tabulations will be produced for the SAS and FAS separately.  
All disposition data will be listed.  
A listing of eligibility and enrollment will be prepared for all screened subjects. A separate listing 
will be prepared to document subjects excluded from efficacy analysis.  
9.5 
PROTOCOL DEVIATIONS 
Deviations will be collected by the clinical team during the trial conduct and reviewed by the 
sponsor as outlined in the most current Protocol Deviations Management Plan. The deviations 
will be classified as major or minor. 
Protocol deviations will be tabulated for the SAS. Summaries will include number and 


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percentage of subjects with at least one major deviation, with at least one minor deviation, and 
at least one major deviation of each category.  
A separate summary of protocol deviations related to COVID-19 will be presented for the SAS. 
A listing of all protocol deviations will be produced.  
9.6 
SUBJECT CHARACTERISTICS 
9.6.1 BASELINE AND DEMOGRAPHIC CHARACTERISTICS 
Summary tables will include age (in years), sex (including child-bearing potential and reason, if 
applicable e.g., surgically sterile, post-menopausal, other), race, ethnicity, and country. Weight 
(kg) and height (cm) will also be tabulated together with body mass index (BMI) (kg/m2). The 
BMI will be calculated using weight in kg, divided by height in m2. 
Listings of all baseline and demographic characteristics will be produced.  
9.6.2 MEDICAL AND SURGICAL HISTORY  
Medical and surgical history will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA; version 24.0 or higher). The number and percentage of subjects having at least one 
medical and/or surgical history record will be presented, along with summaries by System 
Organ Class (SOC) and preferred term (PT). 
All medical and surgical history data collected in the eCRF will be listed. 
A summary of SBS disease history will be presented, and this will include the cause of SBS, 
time from SBS diagnosis, time from PS initiation, length of remnant small bowel (cm), length of 
remnant colon in percentage (%) according to Cummings classification, time from major 
intestinal surgery which led to SBS, time from last continuity surgery, and whether ileocecal 
valve has been preserved. The durations will be derived as follows: 
• 
Time from SBS diagnosis (months) = (date of ICF signed – date of SBS diagnosis 
+1)/30.4375. Refer to Section 9.3 for handling of the imprecise date of SBS diagnosis. 
• 
Time from PS initiation (months) = (date of ICF signed – date of PS initiation 
+1)/30.4375. Refer to Section 9.3 for handling of the imprecise date of PS initiation. 
• 
Time from major intestinal surgery which led to SBS (months) = (date of ICF signed – 
date of major intestinal surgery which led to SBS +1)/30.4375. Refer to Section 9.3 for 
handling of the imprecise date of major intestinal surgery which led to SBS. 
• 
Time from last continuity surgery (months) = (date of ICF signed – date of last 
continuity surgery +1)/30.4375. Refer to Section 9.3 for handling of the imprecise date 
of last continuity surgery. 
All SBS disease and gastrointestinal (GI) health history data will also be listed. 
9.6.3 PRIOR AND CONCOMITANT MEDICATION AND INTERVENTIONS 
All medication records will be categorized as either prior or concomitant medications for 
analyses. Concomitant medications are any ongoing medications at the time of the first trial 
treatment or any medications started on or after the date of the first trial treatment. Prior 
medications are any medications that ended prior to the date of the first trial treatment.  
Prior and concomitant medications will be coded by World Health Organization Drug Dictionary 
(WHODD; version March 2021 Format B3 or higher) and summarized in separate tables by 


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Anatomical Therapeutic Chemical (ATC) classification 2, ATC classification 4, and PT.  
Moreover, there will be a separate summary for concomitant antibiotic and non-antibiotic 
medications. The antibiotics will be identified by ATC codes starting with J01 or J04.  
A subject data listing will be prepared to document all medications, and there will be a flag to 
identify prior vs. concomitant medications. 
Similarly, there will be a subject data listing to document all therapeutic interventions reported. 
9.7 
EFFICACY ENDPOINTS AND ANALYSIS 
In addition to the efficacy analyses defined below, for all continuous efficacy endpoints for the 
protocol defined analysis timepoints, mean change from baseline to the respective analysis 
timepoint will be presented with a p-value based on the paired t-test and 95% confidence 
interval (CI) for the mean change from baseline based on t-distribution. The 95% confidence 
interval (CI) for the mean change from baseline will be done for both absolute and relative 
change from baseline. Due to the relatively small sample size, one-sample (paired) Hodges-
Lehmann median estimator for non-parametric estimate of change from baseline to the 
respective analysis timepoint, will be computed with the corresponding 95% CI.  
Subject data listings will be prepared to document efficacy data, such as results from MB 
parameters, wet weight during the MB period, and DEXA scan. This will be supplemented by 
listings based on data from the MB period summary, including hospital admission information 
and drinking menu.  
All data from the PS diary or PS infusion will also be listed to document efficacy data. This will 
be supplemented by listings using data from PS prescription, PS evening diary, urine sample for 
sodium analysis, change in eating/appetite, drinking diary, stool assessment, Bristol stool form 
scale diary, and stool frequency diary.   
There will be separate subject data listings for PRO data from questionnaires, such as the 
, SBS-IF-TI-QOL, SBS-IF-CIC-QOL, Patient Global Impression of Severity (PGI-S), PGIC, 
PGI-TS, PGI-SPS, and PGI-PSI. 
9.7.1 ANALYSIS OF PRIMARY ENDPOINT 
There is no primary efficacy endpoint for this study. 
9.7.2 ANALYSIS OF SECONDARY ENDPOINTS 
9.7.2.1 
ANALYSIS OF SECONDARY ENDPOINTS RELATED TO PS VOLUME 
Subject diary data will be used to obtain PS volume information for analyses. Subjects are to 
complete diary prior to a scheduled visit. If a subject’s e-dairy data is not available, PS data 
recorded at the site will be used for analyses. If a subject has issues/difficulties using the e-
diary, PS volume data will be captured in the paper diary and will be entered into the electronic 
data capture (EDC) system at a trial visit. 
The relative as well as absolute change in actual weekly PS volume from baseline to every 4 
weeks until Week 52 will be summarized by descriptive statistics. p-values and Hodges-
Lehmann median estimator along with 95% CI will be produced for Week 24 and Week 52 as 
defined in the introduction of Section 9.7. The sum of daily PS volume (including extra fluids) 
from weekly PS diary data recorded for the corresponding analysis timepoint will be used for 
analysis.  
The proportion (%) of subjects who have achieved a reduction of at least 1 day per week of PS 
from baseline at every 4 weeks until Week 52 will be produced. Subjects will be considered to 


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have a reduction of at least one day per week of PS from baseline (incl. extra fluids) if the 
number of days with PS from weekly PS diary data recorded for the corresponding analysis 
timepoint is smaller compared to the number of days with PS from weekly PS diary data for the 
baseline. 
In addition, the proportion (%) of clinical responders (20% reduction of PS volume from 
baseline) at every 4 weeks until Week 52 will be produced. Subjects will be considered to be a 
clinical responder if the relative change from baseline in weekly PS volume is ≤ -20% for the 
corresponding visit. 
For above analyses, missing weekly PS data from diary (e.g. volume, frequency, etc) will be 
imputed to 0 in case of PS being weaned off (Refer to Section 9.3.). 
Moreover, the proportion (%) of subjects with enteral autonomy at every 4 weeks until Week 52 
will be produced using eCRF data. Once ‘weaned off’ is recorded in eCRF at a visit, sites are 
not asked to repeat this data in the next visit. Hence, for analysis, ‘weaned off’ data will be 
carried forward to the next analysis timepoint(s) where applicable based on subjects’ visit 
information until indicated otherwise (i.e. no longer reported as ‘weaned off’) and enteral 
autonomy will be identified when there are at least two consecutive wean off records for 
analysis timepoints (after considering carried forward wean-off records) except for Week 52. For 
Week 52, enteral autonomy will be identified by ‘weaned off’ data reported at Week 52 since 
there is no subsequent/further analysis timepoint. 
For PS compliance measure, the percent change in actual weekly PS volume from the 
prescribed weekly PS volume and the difference in actual days per week of PS from prescribed 
days per week of PS will be assessed for each post-baseline timepoint as well as for overall 
using the average per subject. The percent change in actual weekly PS volume from the 
prescribed weekly PS volume is calculated as (actual weekly PS volume minus prescribed 
weekly PS volume) x 100, divided by prescribed weekly PS volume for the corresponding 
timepoint. The difference in actual days per week of PS from prescribed days per week of PS 
(day) is calculated as actual days per week of PS minus prescribed days per week of PS. 
The energy reduction in the PN from baseline at every 4 weeks until Week 52 will be assessed 
by descriptive statistics of the absolute and relative change in the total energy prescription data 
from baseline to analysis timepoints. p-values and Hodges-Lehmann median estimator along 
with 95% CI will be produced for Week 24 and Week 52 as defined in the introduction of Section 
9.7. If it is reported that PS is weaned off at the given analysis timepoint, the total energy 
prescription data will be considered as 0 for analysis.  
9.7.2.2 
ANALYSIS OF SECONDARY ENDPOINTS RELATED TO NUTRITIONAL, FLUID (WET 
WEIGHT) AND ELECTROLYTE ABSORPTION 
The absolute change in absorption of energy, over MB periods from baseline to Week 48 will be 
summarized by descriptive statistics. 
The absorption will be defined as dietary intake minus output from fecal excretion over a 72-
hour MB period at a given analysis timepoint. Hence, the absorption of energy will be calculated 
as energy intake minus energy output data (as collected on MB Results eCRF). Since dietary 
intake and fecal excretion are to be measured daily, i.e. up to 3 measurements may contribute 
to absorption calculations, the average over all available daily absorption measurements over 
the 72-hour period will be used for analysis. In other words, absorption data will be derived by 
average of all available intake minus average of all available excretion, regardless of whether 
there is a case in which either energy intake or energy output data are missing in a daily 
measurement. 


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Similar derivations will be applied for absorption of each of the other MB parameters, such as 
macronutrients (fat, carbohydrate, nitrogen, and protein).  
Similarly, the wet weight absorption will be calculated as average of all wet weight input (oral 
solid + drinks) minus average of all wet weight output (only using feces) under assumption of 
1mL = 1g for oral fluids.  
Descriptive statistics will be produced for analyses of the following endpoints using absolute and 
relative change from baseline: 
• Relative change in absorption of energy and wet weight over the MB period from baseline to 
Week 48.  
• Absolute change in absorption of energy and wet weight over the MB period from baseline to 
Week 4 (See above for the derivation of absorption of energy). 
• Change in absorption of macronutrients (fat, carbohydrate, and protein) over the MB period 
from baseline to Week 4 and to Week 48 (See above for the derivation of absorption of 
macronutrients).  
• Change in urinary electrolytes (calcium, magnesium, sodium, potassium, urea, and 
creatinine) over the MB periods from baseline to Week 4 and Week 48. Since urinary 
electrolytes data are expected to be measured over the 72-hour MB period, the average of 
all available results will be used for analyses for each MB parameter at a given analysis 
timepoint.  
• Change in urine volume over the MB periods from baseline to Week 4 and Week 48. This 
analysis will be based on average daily urine volume data derived as per Balance Period 
Calculations eCRF since the average daily urine volume should be calculated based on 
investigator’s decision on which 48 hours of the 72 hour metabolic balance study collection to 
be used.  
p-values and Hodges-Lehmann median estimator along with 95% CI will be produced for 
absolute and relative change from baseline where applicable as defined in the introduction of 
Section 9.7 for the above analysis timepoints. If a measurement of absorption yields a negative 
value, such a measurement result will be regarded as invalid and treated as non-evaluable for 
the relative change analysis. In the analysis dataset, such cases will not be flagged as analysis 
records since it is considered non-evaluable for the relative change analysis. 
The following figures will be provided for energy absorption: 
• 
Line graph using individual observations by timepoint 
• 
Line graph using individual relative change from baseline by timepoint 
• 
Cumulative distribution of change from baseline 
• 
Change from baseline – mean (95%CI) by timepoint 
• 
Relative change from baseline (%) – mean (95%CI) by timepoint 
Figures will be repeated for other MB parameters, absorption of wet weight, fat, carbohydrate, 
and protein. 
In addition, the absolute and relative change from baseline in average daily urine volume 
(derived as per Balance Period Calculations eCRF) will be also summarized for other 
timepoints. The number of subjects with an increase or decrease from baseline of more than 
10% will be tabulated by analysis visit up to Week 52.  




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9.7.3.2 
ANALYSIS OF EXPLORATORY ENDPOINTS RELATED TO EFFICACY 
The following exploratory endpoints related to efficacy will be analyzed by descriptive statistics 
using the absolute change from baseline.  
• Change in the total time per day that subjects infuse PS from baseline to every 4 weeks until 
Week 52 (to be derived based on the total time of PS infusion (including extra fluid) from 
weekly PS diary data recorded for the corresponding analysis timepoint, divided by 7). p-
values and Hodges-Lehmann median estimator along with 95% CI will be produced for Week 
24 and Week 52 as defined in the introduction of Section 9.7; Note: For handling of missing 
weekly PS data from diary in case of PS being weaned off, refer to Section 9.3. 
• Change in the total time per week that subjects infuse PS from baseline to every 4 weeks 
until Week 52 (to be derived based on the total time of PS infusion (including extra fluid) from 
weekly PS diary data recorded for the corresponding analysis timepoint). p-values and 
Hodges-Lehmann median estimator along with 95% CI will be produced for Week 24 and 
Week 52 as defined in the introduction of Section 9.7; Note: For handling of missing weekly 
PS data from diary in case of PS being weaned off, refer to Section 9.3. 
• Change in electrolytes, minerals, macronutrients and other contents of the PS from baseline 
to every 4 weeks until Week 52. This is to be derived using each of the following prescription 
data at the given analysis timepoint. If it is reported that PS is weaned off at a given analysis 
timepoint, the data will be considered as 0 for analysis.  
• 
Total energy lipid 
• 
Total energy glucose 
• 
Total energy amino acids  
• 
Magnesium concentration 
• 
Potassium concentration 
• 
Sodium concentration 
p-values and Hodges-Lehmann median estimator along with 95% CI will be produced for Week 
24 and Week 52 as defined in the introduction of Section 9.7.  
In addition, for analysis of change in in electrolytes, minerals, macronutrients and other contents 
of the PS, the relative change from baseline will be also summarized. 
9.7.3.3 
ANALYSIS OF EXPLORATORY ENDPOINTS RELATED TO PRO 
For analyses of PRO using SBS-IF-CIC-QOL, the change in scores from baseline to scheduled 
visit will be summarized by descriptive statistics. p-values and Hodges-Lehmann median 
estimator along with 95% CI will be produced for Week 24 and Week 52 as defined in the 
introduction of Section 9.7.  
For analyses of PRO using SBS-IF-TI-QOL, PS impact subscale and GLP-2 impact subscale 
scores will be summarized by scheduled visit using descriptive statistics along with the 
descriptive statistics of two item values in Part 2 regarding GLP-2 impact. 
For SBS-IF-CIC-QOL, it is assumed that the score will be calculated by taking the mean of the 
14 items. For SBS-IF-TI-QOL, it is assumed that two subscale scores will be calculated, PS 
impact, and GLP-2 impact. The PS impact subscale will be calculated for the subjects with CIC 
by taking the mean of items 1 to 10 in Part 1. The GLP-2 impact subscale will be calculated by 
taking the mean of items 1 and 2 in Part 2.  
In case at least one item is missing (i.e. not reported), the mean will not be calculated with the 




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9.8.1 EXPOSURE TO TRIAL TREATMENT 
The extent of trial treatment exposure will be summarized descriptively by the following: 
• Trial treatment duration (weeks). To be derived as follows: (date of last trial treatment – date 
of first trial treatment +1)/7, when both dates are known. 
• Cumulative treatment exposure (mg). To be based on the total amount of trial medication 
taken by a subject as determined using diary and information provided by sites.   
• Compliance (%). To be calculated as follows: [total amount of drug taken by a subject (based 
on diary and site information)/ ((number of weeks when a subject was assigned a dose of 2.5 
mg)*2.5 + (number of weeks when a subject was assigned a dose of 5 mg)*5)]*100, where 
the number of weeks for the assigned dose will be calculated as follows: (stop date of the 
respective dose – start date of the respective dose +1)/7, rounded up to the next higher 
integer to represent the planned number of weeks for the assigned dose.  
The compliance will be also summarized categorically by >=80% and <80%.  
The frequency (%) of dose reductions and trial treatment discontinuation will be summarized as 
a part of safety analyses (See Section 9.8.2)  
All IMP administration data will be listed.  
9.8.2 ADVERSE EVENTS 
AEs that started on or after the first trial treatment will be categorized as TEAEs; whereas AEs 
that started on or after signing ICF but prior to first trial treatment will be categorized as pre-
treatment AEs. 
TEAEs reported as definitely, probably, or possibly related to the trial treatment will be deemed 
as trial treatment-related TEAEs for the purpose of reporting.  
On-treatment AEs will be defined as any AE recorded in the trial database, started on or after 
the  first trial treatment until 4 weeks from the last trial treatment (i.e., date of last trial treatment 
+28 days inclusive). 
AESI will be programmatically derived based on Appendix 3: Sponsor-Defined List of Preferred 
Terms. As ongoing pharmacovigilance could reveal new relevant Standardize MedDRA Queries 
(SMQs) or Customer Queries (CQs), the final selection will be determined at the data review 
meeting prior to database lock. The additional changes to this plan can be found in Appendix 4: 
Addendum to Statistical Analysis Plan. 
All AEs will be coded using MedDRA version 24.0 or higher. 
An overall summary of AEs will be presented, which will include the incidence (%) of subjects 
with at least one pre-treatment AE, TEAE, treatment-emergent serious adverse event (TESAE), 
treatment-emergent AESI (programmatically derived as described above), trial treatment-related 
TEAE, trial treatment-related TESAE, TEAE leading to trial treatment dose increased,  dose 
reduction of trial treatment, dose interruption of trial treatment, permanent discontinuation of trial 
treatment, not entering 4 weeks of safety follow-up, follow-up discontinuation, AE leading to 
death, and on-treatment AE along with the number of events. 
The incidence (%) of subjects experiencing AEs for the following categories will be further 
summarized by SOC and PT in separate tables: 
• TEAE  


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• Treatment-emergent AESI (programmatically derived) 
• Trial treatment-related TEAE 
• TEAE by severity 
• On-treatment AE 
• TESAE 
• Non-serious TEAE 
• Trial treatment-related TESAE 
Subjects may report more than one event per coded term. For incidence (%) of subjects, 
subjects will be counted only once per given SOC or per given PT within SOC. This will also 
apply to the analysis of TEAEs by severity based on the highest severity. Note: For the 
summary of treatment-emergent AESI, AESI categories will be used for analysis instead of 
SOC. The additional changes to this plan can be found in Appendix 4: Addendum to Statistical 
Analysis Plan. 
All AEs will be listed. There will be separate listings for AESIs, SAEs and for AEs leading to 
permanent discontinuation of trial treatment. All AE listings will include a flag to indicate pre-
treatment AE vs. TEAE. 
9.8.3 LABORATORY DATA 
For laboratory panels (hematology, chemistry, and hemostasis), summary statistics of observed 
and change from baseline values will be produced by analysis visit up to Week 52 for all 
continuous variables. For laboratory results reported with a prefix, for example "<" or ">", the 
value derived from the reported results without a prefix will be analyzed. 
Shift tables will display the cross tabulation of Common Terminology Criteria for Adverse Events 
(CTCAE) grades (based on version 5.0 or higher) from the baseline to worst post-baseline 
based on the maximum post-baseline grade during the treatment and safety follow-up periods 
considering both scheduled and unscheduled post-baseline values. The percentages will be 
calculated based on the number of subjects assessed who have both baseline and post-
baseline results.  
All laboratory data for hematology & hemostasis, chemistry, urinalysis, endocrinology, and 
serology will be listed. 
There will be separate listings for hematology & hemostasis, and chemistry data with clinically 
significant results.  
9.8.4 VITAL SIGNS AND OTHER SAFETY PARAMETERS 
For vital signs (systolic and diastolic blood pressure, heart rate, and temperature) and weight, 
summary statistics of observed and changes from baseline values will be presented by analysis 
visit up to Week 52.  
All height, weight, and vital signs data will be listed.  
Similarly, for each electrocardiogram (ECG) parameter (RR interval, PR interval, QRS interval, 
QT interval, QTcF interval), summary statistics of observed and changes from baseline values 
will be presented by analysis visit. In addition, ECG interpretation results will be summarized by 
frequency (%) for each analysis visit up to Week 52. 
All ECG data will be listed.  


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All physical examination data will be listed.  
The relative change from baseline in urine volume (%) will be summarized by analysis visit up to 
Week 52. The change from baseline and percent change from baseline will be calculated using 
the average daily urine volume data as per the Balance Period Calculations eCRF.  
Subject data listings will be prepared to document data from the 48-hour urine collection diary, 
24-hour urine collection diary, balance period calculations, post-PS volume reduction safety 
evaluation, and PS adjudication. 
There will be a separate listing to document PS volume details upon withdraw from trial visits for 
subjects who have permanently discontinued from trial treatment.  
The investigator narratives data will be listed. 
Colonoscopy/colonography data will be listed. 
9.8.5 IMMUNOGENICITY ASSESSMENTS 
Immunogenicity assessments will be analyzed descriptively using the following categories 
based on SAS:   
• 
Number (%) of subjects with an ADA-positive sample at baseline and at post-baseline.  
Percentages will be calculated based on the number of subjects assessed with a 
determinant baseline ADA sample or at least one determinant post-baseline ADA 
sample, respectively. 
• 
Number (%) of subjects with an ADA-positive sample cross-reactive to endogenous 
GLP-2 at baseline and at post-baseline. Percentages will be calculated based on the 
number of subjects assessed with a determinant baseline ADA sample or at least one 
determinant post-baseline ADA sample, respectively. 
• 
Number (%) of subjects with a neutralizing antibody (nAb)-positive sample at baseline or 
at post-baseline. Percentages will be calculated based on the number of subjects 
assessed with a determinant baseline nAb sample or at least one determinant post-
baseline nAb sample, respectively. 
• 
Number (%) of subjects with a nAb-positive sample cross-reactive to endogenous GLP-2 
at baseline and post-baseline. Percentages will be calculated based on the number of 
subjects assessed with a determinant baseline nAb sample or at least one determinant 
post-baseline nAb sample, respectively. 
The above analyses will be performed based on availability of immunogenicity assessment 
data. 
All immunogenicity assessment data will be listed. 
9.8.6 PK/PD 
Descriptive statistics will be used to summarize the predose and post-dose apraglutide plasma 
concentrations and plasma citrulline levels by scheduled visit. All apraglutide plasma 
concentrations and plasma citrulline levels data will be listed. 
Any exploratory PK analysis and PK/PD modelling will be described in a separate document. 
10. DEVIATIONS FROM ANALYSIS DESCRIBED IN THE PROTOCOL 
The following update has been made from the planned analysis defined in the protocol to align 
the safety analysis plan as defined in the TA799-007 study. 


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• 
In the protocol, TEAE is defined as all AEs occurring after first dose of trial medication 
and up to the 4 weeks follow-up visit. However, for the safety analysis, TEAE will be 
defined as any adverse events that started on or after the first dose of trial medication 
(i.e. no longer depends on 4 weeks follow-up visit). 
There is one deviation from the planned analysis described in the protocol. According to the 
protocol, the primary endpoint AESIs are to be derived based on SMQ or CQs. Sponsor issued 
NTF (See Appendix 4: Addendum to Statistical Analysis Plan), to clarify that AESI will be 
identified by using the investigator’s assessment, reported in eCRF for analysis.  
In addition, the following list contains typographical error (typo) corrections from the protocol 
that have been made to this SAP for clarity: 
• 
The protocol refers to ‘change in absolute absorption’. It is clarified in SAP that this 
refers to ‘absolute change from baseline’ in comparison to ‘relative change in 
absorption’. Note: This SAP uses ‘absolute change from baseline’ and ‘change from 
baseline’ interchangeably. 
• 
One of the secondary efficacy endpoints defined in the protocol is ‘clinical responder at 
Week 52’ but unlike the protocol synopsis and Section 1.5.2.2 of the protocol, Section 
7.1.2 of the protocol indicated Week 48 instead of Week 52. This typo has been 
corrected to Week 52 in this SAP.  
• 
One of the efficacy endpoints defined in the protocol is ‘change in dietary intake of wet 
weight, energy, macronutrients, fluid, electrolytes (sodium, potassium, calcium, and 
magnesium) from baseline at Week 4 and Week 48’, but this ‘fluid’ is a part of weight as 
oral fluid; hence, this text, ‘fluid’, is omitted in this SAP. 
• 
One of the efficacy endpoints defined in the protocol is “change in fecal excretion of wet 
weight, energy, macronutrients, fluid and electrolytes (sodium, potassium, calcium, and 
magnesium) from baseline at Week 4 and Week 48”, but this “fluid” is a part of wet 
weight (urine), which has already been covered by urine output as a part of the 
secondary efficacy endpoint; hence, the text, ‘fluid’, is omitted in this SAP. 
• 
The protocol states the sensitivity analysis excluding subjects missing more than 20% of 
the planned injections prior to the time of analysis, and the number of injections leading 
to exclusion are to be 1 at Week 4, 6 at Week 24, and 11 at Week 52, but this text has 
been corrected to “…. 1 at Week 4, 5 at Week 24, and 10 at Week 48”, respectively, in 
order to exclude subjects missing more than 20% of the planned injections prior to the 
corresponding analysis timepoint. 
• 
One of the exploratory endpoints defined in the protocol stated “change in body weight 
from baseline at Week 24 and Week 52”, but the protocol synopsis refers to “Week 48”.  
This has been consistently referred to as Week 48 in the SAP for the efficacy endpoint, 
although the change in body weight from baseline to Week 52 will be also summarized 
for safety analyses.  
• 
One of secondary endpoints related to PRO is ‘PGIC at Week 24 and Week 52 ’ but 
unlike the protocol synopsis and Section 7.1.2, Section 1.5.2.2 of the protocol indicated 
as ‘change in PGIC’ where it should only be referred as ‘PGIC’. This typo has been 
corrected in this SAP.  
• 
SBS-IF-TI-QOL data collection has been removed from baseline according to the 
protocol amendment version 3 dated 03SEP2021, hence the change from baseline 
analysis defined as the endpoint has been updated to ‘observed’. 
11. PROGRAMMING SPECIFICATIONS 
All outputs will be produced using SAS version 9.4 or a later version. 


















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Table 2: Schedule of Assessments for Metabolic Balance Periods (Visits 2 (Baseline), 5, and 16) 
 
 
Metabolic balance period 
Procedure 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Admission to hospital 
X 
(at least 16 h prior to MB 
samples collection start) 
 
 
 
 
Hospital discharge 
 
 
 
 
X 
  
Confirmation of eligibility1 
X 
Baseline only 
 
 
 
X 
Baseline only 
Review all subject diary information 
since last visit 
X 
 
 
 
 
Adverse events 
X 
X 
X 
X 
X 
Concomitant medication 
X 
X 
X 
X 
X 
Investigator narrative 
X 
 
 
 
 
GI health history 
X 
 
 
 
 
Physical examination 
X 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
Vital signs (blood pressure, heart 
rate, axillary temperature)2 
X 
X 
X 
X 
X 
Clinical chemistry 
X 
 
 
 
 
Hematology 
X 
 
 
 
 
Hemostasis 
X 
 
 
 
 
Urinalysis 
X 
 
 
 
 
Pregnancy test (premenopausal 
women) 
X 
 
 
 
 
Citrulline blood sample 
X 
 
 
 
 
Blood samples for PK (Visits 5 and 
16) 1 
 
Pre-dose (within 30 min 
prior to dosing) 
24 h (±2 h), 30 h (±2 h), 
48h (±2 h), 
72 h (±2 h), 
Blood sample ADA, nAb 
X 
 
 
 
 


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Metabolic balance period 
Procedure 
Day 1 
Day 2 
Day 3 
Day 4 
Day 5 
Fasting 
X  
(start 22:00 ±30 min) 
X  
(until start of MB 
collections) 
 
 
 
Urinate & defecate – prior to MB 
collection start1 
 
X 
 (-30 min) 
 
 
 
Urinate & defecate – end of MB 
period 
 
 
 
 
X  
(-30 min) 
Body weight2 
X 
X 
 
X 
 
X 
 
X 
 
Start of MB collection2 
 
X  
Time of IMP3 (+15 min) 
 
 
 
Collection of urine 
 
X 
X 
X 
X 
Collection of feces 
 
X 
X 
X 
X 
Collection of duplicate food and 
drinks 
 
X 
X 
X 
X 
End of MB collection 
 
 
 
 
72 h from start 
(±1 h) 
Change in appetite 
X 
 
 
 
 
Confirm drinking menu 
X 
Baseline only 
 
 
 
 
Adhere to agreed upon drinking 
menu 
 
X 
X 
X 
X 
Define baseline PS type, volume, 
content 
X 
Baseline only 
 
 
 
 
Fixed baseline PS type, volume and 
content (baseline & Visit 5) 
 
X 
X 
X 
X 
DEXA Scan 
 
X4 
 
 
 
Patient reported outcomes (PRO) 
 
X 
(13:00-18:00) 
 
 
 










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APPENDIX 3: SPONSOR-DEFINED LIST OF PREFERRED TERMS 
AESI Category 
SMQ or CQ 
SMQ Scope 
Gallbladder, biliary and pancreatic disease 
SMQ Biliary system related investigations, signs and symptoms 
Broad+Narrow 
Gallbladder, biliary and pancreatic disease 
SMQ Biliary tract disorders  
Narrow 
Gallbladder, biliary and pancreatic disease 
SMQ Gallbladder related disorders  
Narrow 
Gallbladder, biliary and pancreatic disease 
SMQ Gallstone related disorders  
Narrow 
Gallbladder, biliary and pancreatic disease 
PT: Pancreatic disorder  
  
Gallbladder, biliary and pancreatic disease 
PT: Pancreatic duct dilatation  
  
Gallbladder, biliary and pancreatic disease 
PT: Pancreatic duct obstruction  
  
Gallbladder, biliary and pancreatic disease 
PT: Pancreatic enzyme abnormality  
  
Gallbladder, biliary and pancreatic disease 
PT: Pancreatic toxicity  
  
Gallbladder, biliary and pancreatic disease 
PT: Bile duct obstruction  
  
Gallbladder, biliary and pancreatic disease 
PT: Bile duct stone  
  
Gallbladder, biliary and pancreatic disease 
PT: Obstructive pancreatitis  
  
Gallbladder, biliary and pancreatic disease 
PT: Sphincter of Oddi dysfunction  
  
Gallbladder, biliary and pancreatic disease 
PT: Cholestasis  
  
Gallbladder, biliary and pancreatic disease 
PT: Cholestasis of pregnancy  
  
Gallbladder, biliary and pancreatic disease 
PT: Deficiency of bile secretion  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatitis cholestatic  
  
Gallbladder, biliary and pancreatic disease 
PT: Hyperbilirubinaemia  
  
Gallbladder, biliary and pancreatic disease 
PT: Jaundice  
  
Gallbladder, biliary and pancreatic disease 
PT: Jaundice acholuric  
  
Gallbladder, biliary and pancreatic disease 
PT: Jaundice cholestatic  
  
Gallbladder, biliary and pancreatic disease 
PT: Jaundice extrahepatic obstructive  
  
Gallbladder, biliary and pancreatic disease 
PT: Jaundice hepatocellular  
  
Gallbladder, biliary and pancreatic disease 
PT: Neonatal cholestasis  
  
Gallbladder, biliary and pancreatic disease 
PT: Ocular icterus  
  
Gallbladder, biliary and pancreatic disease 
PT: Parenteral nutrition associated liver disease  
  
Gallbladder, biliary and pancreatic disease 
PT: Yellow skin  
  
Gallbladder, biliary and pancreatic disease 
PT: Biliary polyp  
  
Gallbladder, biliary and pancreatic disease 
PT: Biloma  
  
Gallbladder, biliary and pancreatic disease 
PT: Biloma rupture  
  
Gallbladder, biliary and pancreatic disease 
PT: Cholaemia  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatobiliary disease  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatobiliary infection  
  
Gallbladder, biliary and pancreatic disease 
PT: Hypercholia  
  
Gallbladder, biliary and pancreatic disease 
PT: Liver disorder  
  
Gallbladder, biliary and pancreatic disease 
PT: Oedema due to hepatic disease  
 
Gallbladder, biliary and pancreatic disease 
PT: Bilirubin excretion disorder  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatic function abnormal  
  


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AESI Category 
SMQ or CQ 
SMQ Scope 
Gallbladder, biliary and pancreatic disease 
PT: Hypertransaminasaemia  
  
Gallbladder, biliary and pancreatic disease 
PT: Cholestatic liver injury  
  
Gallbladder, biliary and pancreatic disease 
PT: Drug-induced liver injury  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatitis  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatitis acute  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatitis toxic  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatocellular injury  
  
Gallbladder, biliary and pancreatic disease 
PT: Hepatotoxicity  
  
Gallbladder, biliary and pancreatic disease 
PT: Liver injury  
  
Gallbladder, biliary and pancreatic disease 
PT: Mixed liver injury  
  
Gallbladder, biliary and pancreatic disease 
PT: Non-alcoholic steatohepatitis  
  
Gallbladder, biliary and pancreatic disease 
PT: Nonalcoholic fatty liver disease  
  
Gallbladder, biliary and pancreatic disease 
PT: Steatohepatitis  
  
Gastrointestinal obstructions 
SMQ Gastrointestinal obstruction  
Narrow 
Gastrointestinal obstructions 
SMQ Gastrointestinal perforation, ulcer, haemorrhage, 
obstruction non-specific findings/procedures 
Broad+Narrow 
Gastrointestinal obstructions 
PT: Intestinal obstruction  
  
Malignancies 
SMQ Malignancy related conditions  
Narrow 
Malignancies 
SMQ Malignancy related therapeutic and diagnostic 
procedures  
Narrow 
Malignancies 
SMQ Malignant or unspecified tumours 
Narrow 
Colorectal polyps 
PT: Anal polyp  
  
Colorectal polyps 
PT: Anorectal haemangioma  
  
Colorectal polyps 
PT: Appendix adenoma  
  
Colorectal polyps 
PT: Benign anorectal neoplasm  
  
Colorectal polyps 
PT: Benign duodenal neoplasm  
  
Colorectal polyps 
PT: Benign gastric neoplasm  
  
Colorectal polyps 
PT: Benign gastrointestinal neoplasm  
  
Colorectal polyps 
PT: Benign mesenteric neoplasm  
  
Colorectal polyps 
PT: Benign neoplasm of islets of Langerhans  
  
Colorectal polyps 
PT: Benign oesophageal neoplasm  
  
Colorectal polyps 
PT: Benign pancreatic neoplasm  
  
Colorectal polyps 
PT: Benign peritoneal neoplasm  
  
Colorectal polyps 
PT: Benign small intestinal neoplasm  
  
Colorectal polyps 
PT: Colon adenoma  
  
Colorectal polyps 
PT: Duodenal polyp  
  
Colorectal polyps 
PT: Gastric adenoma  
  
Colorectal polyps 
PT: Gastric cyst  
  
Colorectal polyps 
PT: Gastric haemangioma  
  
Colorectal polyps 
PT: Gastric leiomyoma  
  
Colorectal polyps 
PT: Gastric polyps  
  


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AESI Category 
SMQ or CQ 
SMQ Scope 
Colorectal polyps 
PT: Gastrointestinal polyp  
  
Colorectal polyps 
PT: Gastrointestinal polyp haemorrhage  
  
Colorectal polyps 
PT: Gastrointestinal tract adenoma  
  
Colorectal polyps 
PT: Intestinal angioma  
  
Colorectal polyps 
PT: Intestinal cyst  
  
Colorectal polyps 
PT: Intestinal polyp  
  
Colorectal polyps 
PT: Intra-abdominal haemangioma  
  
Colorectal polyps 
PT: Intraductal papillary mucinous neoplasm  
  
Colorectal polyps 
PT: Large intestine fibroma  
  
Colorectal polyps 
PT: Large intestine polyp  
  
Colorectal polyps 
PT: Oesophageal cyst  
  
Colorectal polyps 
PT: Oesophageal papilloma  
  
Colorectal polyps 
PT: Oesophageal polyp  
  
Colorectal polyps 
PT: Rectal adenoma  
  
Colorectal polyps 
PT: Rectal polyp  
  
Colorectal polyps 
PT: Small intestine polyp  
  
Injection site reactions 
PT: Administration site abscess  
  
Injection site reactions 
PT: Administration site abscess sterile  
  
Injection site reactions 
PT: Administration site anaesthesia  
  
Injection site reactions 
PT: Administration site atrophy  
  
Injection site reactions 
PT: Administration site bruise  
  
Injection site reactions 
PT: Administration site calcification  
  
Injection site reactions 
PT: Administration site cellulitis  
  
Injection site reactions 
PT: Administration site coldness  
  
Injection site reactions 
PT: Administration site cyst  
  
Injection site reactions 
PT: Administration site dermatitis  
  
Injection site reactions 
PT: Administration site discharge  
  
Injection site reactions 
PT: Administration site discolouration  
  
Injection site reactions 
PT: Administration site discomfort  
  
Injection site reactions 
PT: Administration site dryness  
  
Injection site reactions 
PT: Administration site dysaesthesia  
  
Injection site reactions 
PT: Administration site eczema  
  
Injection site reactions 
PT: Administration site erosion  
  
Injection site reactions 
PT: Administration site erythema  
  
Injection site reactions 
PT: Administration site exfoliation  
  
Injection site reactions 
PT: Administration site extravasation  
  
Injection site reactions 
PT: Administration site fibrosis  
  
Injection site reactions 
PT: Administration site granuloma  
  
Injection site reactions 
PT: Administration site haematoma  
  
Injection site reactions 
PT: Administration site haemorrhage  
  


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AESI Category 
SMQ or CQ 
SMQ Scope 
Injection site reactions 
PT: Administration site hyperaesthesia  
  
Injection site reactions 
PT: Administration site hypersensitivity  
  
Injection site reactions 
PT: Administration site hypertrophy  
  
Injection site reactions 
PT: Administration site hypoaesthesia  
  
Injection site reactions 
PT: Administration site indentation  
  
Injection site reactions 
PT: Administration site induration  
  
Injection site reactions 
PT: Administration site infection  
  
Injection site reactions 
PT: Administration site inflammation  
  
Injection site reactions 
PT: Administration site injury  
  
Injection site reactions 
PT: Administration site irritation  
  
Injection site reactions 
PT: Administration site ischaemia  
  
Injection site reactions 
PT: Administration site laceration  
  
Injection site reactions 
PT: Administration site lymphadenopathy  
  
Injection site reactions 
PT: Administration site macule  
  
Injection site reactions 
PT: Administration site mass  
  
Injection site reactions 
PT: Administration site necrosis  
  
Injection site reactions 
PT: Administration site nerve damage  
  
Injection site reactions 
PT: Administration site nodule  
  
Injection site reactions 
PT: Administration site oedema  
  
Injection site reactions 
PT: Administration site pain  
  
Injection site reactions 
PT: Administration site pallor  
  
Injection site reactions 
PT: Administration site papule  
  
Injection site reactions 
PT: Administration site paraesthesia  
  
Injection site reactions 
PT: Administration site phlebitis  
  
Injection site reactions 
PT: Administration site photosensitivity reaction  
  
Injection site reactions 
PT: Administration site plaque  
  
Injection site reactions 
PT: Administration site pruritus  
  
Injection site reactions 
PT: Administration site pustule  
  
Injection site reactions 
PT: Administration site rash  
  
Injection site reactions 
PT: Administration site reaction  
  
Injection site reactions 
PT: Administration site recall reaction  
  
Injection site reactions 
PT: Administration site scar  
  
Injection site reactions 
PT: Administration site swelling  
  
Injection site reactions 
PT: Administration site thrombosis  
  
Injection site reactions 
PT: Administration site ulcer  
  
Injection site reactions 
PT: Administration site urticaria  
  
Injection site reactions 
PT: Administration site vasculitis  
  
Injection site reactions 
PT: Administration site vesicles  
  
Injection site reactions 
PT: Administration site warmth  
  
Injection site reactions 
PT: Injection site abscess  
  


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AESI Category 
SMQ or CQ 
SMQ Scope 
Injection site reactions 
PT: Injection site abscess sterile  
  
Injection site reactions 
PT: Injection site anaesthesia  
  
Injection site reactions 
PT: Injection site atrophy  
  
Injection site reactions 
PT: Injection site bruising  
  
Injection site reactions 
PT: Injection site calcification  
  
Injection site reactions 
PT: Injection site cellulitis  
  
Injection site reactions 
PT: Injection site coldness  
  
Injection site reactions 
PT: Injection site cyst  
  
Injection site reactions 
PT: Injection site deformation  
  
Injection site reactions 
PT: Injection site dermatitis  
  
Injection site reactions 
PT: Injection site discharge  
  
Injection site reactions 
PT: Injection site discolouration  
  
Injection site reactions 
PT: Injection site discomfort  
  
Injection site reactions 
PT: Injection site dryness  
  
Injection site reactions 
PT: Injection site dysaesthesia  
  
Injection site reactions 
PT: Injection site eczema  
  
Injection site reactions 
PT: Injection site erosion  
  
Injection site reactions 
PT: Injection site erythema  
  
Injection site reactions 
PT: Injection site exfoliation  
  
Injection site reactions 
PT: Injection site extravasation  
  
Injection site reactions 
PT: Injection site fibrosis  
  
Injection site reactions 
PT: Injection site granuloma  
  
Injection site reactions 
PT: Injection site haematoma  
  
Injection site reactions 
PT: Injection site haemorrhage  
  
Injection site reactions 
PT: Injection site hyperaesthesia  
  
Injection site reactions 
PT: Injection site hypersensitivity  
  
Injection site reactions 
PT: Injection site hypertrophy  
  
Injection site reactions 
PT: Injection site hypoaesthesia  
  
Injection site reactions 
PT: Injection site induration  
  
Injection site reactions 
PT: Injection site infection  
  
Injection site reactions 
PT: Injection site inflammation  
  
Injection site reactions 
PT: Injection site injury  
  
Injection site reactions 
PT: Injection site irritation  
  
Injection site reactions 
PT: Injection site ischaemia  
  
Injection site reactions 
PT: Injection site laceration  
  
Injection site reactions 
PT: Injection site lymphadenopathy  
  
Injection site reactions 
PT: Injection site macule  
  
Injection site reactions 
PT: Injection site mass  
  
Injection site reactions 
PT: Injection site necrosis  
  
Injection site reactions 
PT: Injection site nerve damage  
  


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
       Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 49 of 50 
AESI Category 
SMQ or CQ 
SMQ Scope 
Injection site reactions 
PT: Injection site nodule  
  
Injection site reactions 
PT: Injection site oedema  
  
Injection site reactions 
PT: Injection site pain  
  
Injection site reactions 
PT: Injection site pallor  
  
Injection site reactions 
PT: Injection site papule  
  
Injection site reactions 
PT: Injection site paraesthesia  
  
Injection site reactions 
PT: Injection site phlebitis  
  
Injection site reactions 
PT: Injection site photosensitivity reaction  
  
Injection site reactions 
PT: Injection site plaque  
  
Injection site reactions 
PT: Injection site pruritus  
  
Injection site reactions 
PT: Injection site pustule  
  
Injection site reactions 
PT: Injection site rash  
  
Injection site reactions 
PT: Injection site reaction  
  
Injection site reactions 
PT: Injection site recall reaction  
  
Injection site reactions 
PT: Injection site scar  
  
Injection site reactions 
PT: Injection site swelling  
  
Injection site reactions 
PT: Injection site telangiectasia  
  
Injection site reactions 
PT: Injection site thrombosis  
  
Injection site reactions 
PT: Injection site ulcer  
  
Injection site reactions 
PT: Injection site urticaria  
  
Injection site reactions 
PT: Injection site vasculitis  
  
Injection site reactions 
PT: Injection site vesicles  
  
Injection site reactions 
PT: Injection site warmth  
  
Injection site reactions 
PT: Injection site hypoaesthesia  
  
Injection site reactions 
PT: Application site hypersensitivity  
  
Injection site reactions 
PT: Immediate post-injection reaction  
  
Injection site reactions 
PT: Skin reaction  
  
Injection site reactions 
PT: Anaphylactic reaction  
  
Injection site reactions 
PT: Anaphylactic shock  
  
Injection site reactions 
PT: Anaphylactoid reaction  
  
Injection site reactions 
PT: Anaphylactoid shock  
  
Fluid overload 
PT: Fluid overload  
  
Fluid overload 
PT: Hypervolaemia  
  
Fluid overload 
PT: Oedema  
  
 
 
 
 
 


Statistical Analysis Plan: TA799-013 
Review Status: FINAL
 
       Version: 3.0 
 
Version Date: 12DEC2022 
Confidential  
 
 
 
 
 
 
 
 
 
Page 50 of 50 
APPENDIX 4: ADDENDUM TO STATISTICAL ANALYSIS PLAN 
Refer to NTF issued by Sponsor on 06DEC2022 (Topic: TA799-013 Statistical Analysis Plan) 
and linked to this version of SAP via eTMF.