Clinical trial NCT02914600
Conditions: Crohn's Disease
Sponsor: Galapagos NV
Start date: 2017-03-17; Completion date: 2023-08-01
Enrollment: 1188 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

Detailed description:

Arms: arm 1: Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg.

Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks). arm 2: Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg.

Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study.

Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks). arm 3: Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation.

Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).
Interventions: intervention 1: Filgotinib intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet administered orally once a day intervention 2: Tablet administered orally once a day

Protocol documents:
Prot_000.pdf: 
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CLINICAL STUDY PROTOCOL 
 
 
Study Title: 
A Long-Term Extension Study to Evaluate the Safety of 
Filgotinib in Subjects with Crohn’s Disease 
 
 
Sponsor: 
Galapagos NV 
Generaal De Wittelaan L11 A3 
2800 Mechelen, Belgium 
 
 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
129646 
2016-002763-34 
 
NCT02914600 
 
 
Indication: 
Crohn’s Disease 
 
 
Protocol ID: 
GS-US-419-3896 
Galapagos Medical Leader: 
Name: 
 
 
 
Protocol Version/Date: 
Original: 
 
15 July 2016  
Amendment 1: 
 
07 September 2016 
Amendment 2: 
 
11 November 2016 
Amendment 3: 
 
15 June 2017 
Amendment 4: 
 
09 March 2018 
Amendment 5: 
 
09 November 2018 
Amendment 5.1*:  
17 April 2019 
*Canada, Israel, France, UK, US, and VHP countries only 
Amendment 6:  
 
05 September 2019 
Amendment 7:  
 
23 March 2020 
Amendment 8:  
 
02 December 2021 
Amendment 9:  
 
23 November 2022 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document is privileged and confidential. It is the property of 
Galapagos NV and may not be used, disclosed, reproduced or otherwise disseminated within 
your organization or communicated to any third parties without the express written 
authorization of Galapagos NV. 
 




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5. 
INVESTIGATIONAL MEDICINAL PRODUCTS ............................................................. 38 
5.1. 
Randomization, Blinding and Treatment Codes ................................................. 38 
5.1.1. 
Blinding .............................................................................................. 38 
5.2. 
Description and Handling of Filgotinib and Placebo to Match (PTM) .................. 39 
5.2.1. 
Formulation ........................................................................................ 39 
5.2.2. 
Packaging and Labeling ..................................................................... 39 
5.2.3. 
Storage and Handling ......................................................................... 39 
5.3. 
Dosage and Administration ................................................................................ 40 
5.4. 
Prior and Concomitant Medications ................................................................... 40 
5.4.1. 
Allowed Concomitant Medications ...................................................... 40 
5.4.2. 
Prohibited Concomitant Medications ................................................... 41 
5.5. 
Vaccine Guidelines ............................................................................................ 42 
5.6. 
Accountability for Study Drug............................................................................. 42 
5.6.1. 
Investigational Medicinal Product Return or Disposal ......................... 42 
6. 
STUDY PROCEDURES ................................................................................................ 43 
6.1. 
Subject Enrollment and Treatment Assignment ................................................. 43 
6.2. 
Pretreatment Assessments ................................................................................ 43 
6.2.1. 
Day 1 Visit .......................................................................................... 43 
6.3. 
Treatment Assessments .................................................................................... 46 
6.3.1. 
Week 2 and Week 4 (± 3 days) ........................................................... 46 
6.3.2. 
Every 4 Weeks From Day 1 (± 7 days) ............................................... 46 
6.3.3. 
Week 12 and Then Every 12 Weeks Thereafter From Day 1 
(± 7 days) ........................................................................................... 47 
6.3.4. 
Every 24 Weeks From Day 1 (± 7 days) ............................................. 47 
6.3.5. 
Every 48 Weeks From Day 1 (± 7 days) ............................................. 48 
6.3.6. 
End of Treatment Visit ........................................................................ 48 
6.4. 
Safety ................................................................................................................ 48 
6.4.1. 
Thromboembolic Events ..................................................................... 48 
6.5. 
Post-Treatment Assessments (± 3 days) ........................................................... 48 
6.6. 
Early Termination Assessments ........................................................................ 49 
6.7. 
Assessments After Study Unblinding ................................................................. 49 
6.8. 
End of Study ...................................................................................................... 50 
6.9. 
Post Study Care ................................................................................................ 50 
6.10. 
Clinical Laboratory Assessments ....................................................................... 50 
7. 
ADVERSE EVENTS AND TOXICITY MANAGEMENT .................................................. 50 
7.1. 
Definitions of Adverse Events, Adverse Reactions, and 
Serious Adverse Events .................................................................................... 50 
7.1.1. 
Adverse Events .................................................................................. 50 
7.1.2. 
Serious Adverse Events ..................................................................... 51 
7.2. 
Assessment of Adverse Events and Serious Adverse Events ............................ 51 
7.2.1. 
Assessment of Causality for Study Drugs and Procedures ................. 51 
7.2.2. 
Assessment of Severity ...................................................................... 52 
7.3. 
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to the Sponsor ...................................................... 52 
7.3.1. 
Adverse Events .................................................................................. 53 
7.3.2. 
Serious Adverse Events ..................................................................... 53 
7.4. 
Sponsor Reporting Requirements ...................................................................... 54 
7.5. 
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events and Serious Adverse Events .................................................... 55 


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7.6. 
Toxicity Management ........................................................................................ 55 
7.6.1. 
Grades 1 and 2 Laboratory Abnormality or Clinical Event ................... 55 
7.6.2. 
Grade 3 Laboratory Abnormality or Clinical Event .............................. 55 
7.6.3. 
Grade 4 Laboratory Abnormality or Clinical Event .............................. 56 
7.7. 
Special Situations Reports ................................................................................. 56 
7.7.1. 
Definitions of Special Situations .......................................................... 56 
7.7.2. 
Instructions for Reporting Special Situations ....................................... 57 
8. 
STATISTICAL CONSIDERATIONS .............................................................................. 58 
8.1. 
Analysis Objectives and Endpoints .................................................................... 58 
8.1.1. 
Analysis Objectives ............................................................................ 58 
8.1.2. 
Primary Endpoint ................................................................................ 59 
8.1.3. 
Secondary Endpoint ........................................................................... 59 
 
 
8.2. 
Analysis Conventions ........................................................................................ 59 
8.2.1. 
Analysis Sets ...................................................................................... 59 
8.3. 
Data Handling Conventions ............................................................................... 59 
8.4. 
Demographic Data and Baseline Characteristics ............................................... 60 
8.5. 
Efficacy Analysis................................................................................................ 60 
8.6. 
Safety Analysis .................................................................................................. 60 
8.6.1. 
Extent of Exposure ............................................................................. 60 
8.6.2. 
Adverse Events .................................................................................. 61 
8.6.3. 
Laboratory Evaluations ....................................................................... 61 
8.6.4. 
Other Safety Evaluations .................................................................... 61 
8.7. 
Pharmacokinetic Analysis .................................................................................. 61 
 
 
8.9. 
Sample Size ...................................................................................................... 62 
8.10. 
Interim Analysis ................................................................................................. 62 
8.11. 
Data Monitoring Committee ............................................................................... 62 
8.12. 
Cardiovascular Safety Endpoint Adjudication Committee .................................. 62 
9. 
RESPONSIBILITIES ..................................................................................................... 63 
9.1. 
Investigator Responsibilities .............................................................................. 63 
9.1.1. 
Good Clinical Practice ........................................................................ 63 
9.1.2. 
Institutional Review Board/Independent Ethics Committee Review 
and Approval ...................................................................................... 63 
9.1.3. 
Informed Consent ............................................................................... 64 
9.1.4. 
Confidentiality ..................................................................................... 64 
9.1.5. 
Study Files and Retention of Records ................................................. 64 
9.1.6. 
Electronic Case Report Forms ............................................................ 65 
9.1.7. 
Investigational Medicinal Product Accountability and Return .............. 66 
9.1.8. 
Inspections ......................................................................................... 66 
9.1.9. 
Protocol Compliance .......................................................................... 66 
9.2. 
Sponsor Responsibilities ................................................................................... 67 
9.2.1. 
Protocol Modifications ........................................................................ 67 
9.2.2. 
Study Report and Publications............................................................ 67 
9.3. 
Joint Investigator/Sponsor Responsibilities ........................................................ 67 
9.3.1. 
Payment Reporting ............................................................................. 67 
9.3.2. 
Access to Information for Monitoring ................................................... 68 
9.3.3. 
Access to Information for Auditing or Inspections ............................... 68 
9.3.4. 
Study Discontinuation ......................................................................... 68 


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10. REFERENCES ............................................................................................................. 68 
11. APPENDICES ............................................................................................................... 70 
 
Appendix 1. Investigator Signature Page ............................................................................. 71 
Appendix 2. Study Procedures Table ................................................................................... 72 
Appendix 3. Management of Clinical and Laboratory Adverse Events ................................. 75 
Appendix 4. Crohn’s Disease Activity Index (CDAI) and Patient Reported Outcomes – 2 
items (PRO2) ................................................................................................... 76 
Appendix 5. CTCAE Grading Scale for Severity of Adverse Events ..................................... 77 
Appendix 6. Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements ............................................................................ 78 
Appendix 7. Clinical Laboratory Assessment Table ............................................................. 81 
 
 
LIST OF IN-TEXT TABLES 
 
Table 3-1. 
Dosing Regimens in LTE ................................................................................. 30 
Table 5-1. 
Prohibited Concomitant Medications ................................................................ 41 
Table 7-1. 
Grading of Adverse Event Severity .................................................................. 52 


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CLINICAL STUDY PROTOCOL HISTORY 
Clinical Study Protocol/Amendment # 
Date 
Main Rationale 
General/Country-Specific 
CSP Version 1.0 
15-Jul-2016 
Initial Clinical Study Protocol. 
General 
Amendment 1 
07-Sep-2016 
Updated Study Procedures Table and 
footnotes to reflect changes made to 
weekly visits assessments/procedures in 
the protocol. 
Protocol GS-US-419-3896 title changed 
from Open-Label to Long-Term Extension 
study. 
General 
Amendment 2 
11-Nov-2016 
Updated Study Procedures Table to reflect 
changes made to the study visit 
assessments/procedures in the protocol. 
General 
Amendment 3 
15-Jun-2017 
Updates were made in response to the 
South Korean Ministry of Food and Drug 
Safety request for the use of 200 mg in 
males in Korea to be limited to male 
subjects who had failed 2 classes of 
biologic therapies (any tumor necrosis 
factor-alpha [TNFα] antagonist and 
vedolizumab).  
Updated sections with emerging relevant 
clinical and pipeline data, and ensured 
consistency with Investigator Brochure 
(IB) Ed 12.  
Updated Study Procedures Table to reflect 
changes made to the study visit 
assessments/procedures in the protocol. 
General 
Amendment 4 
09-Mar-2018 
Clarification on inclusion/exclusion 
criteria including those surrounding 
hepatitis and tuberculosis (TB), clarified 
Day 1 visit procedures and provided 
additional flexibility for enhanced safety 
monitoring (suggested infectious workups 
for disease worsening). 
Updated the department name from Drug 
Safety and Public Health (DSPH) to 
Pharmacovigilance & Epidemiology 
(PVE) 
Updated the Study Procedures Table and 
footnotes to reflect changes made to the 


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Clinical Study Protocol/Amendment # 
Date 
Main Rationale 
General/Country-Specific 
study visit assessments/procedures in the 
protocol 
General 
Amendment 5 
09-Nov-2018 
To allow study-wide unblinding of GS-
US-419-3896 after the parent studies (GS-
US-419-4015, GS-US-419-4016 and GS-
US-419-3895) were unblinded. 
Inclusion criterion # 2 was amended to 
include a comprehensive list of the 
Gilead-sponsored Crohn’s disease (CD) 
parent studies eligible for roll-over into 
this long-term extension (LTE) study. 
General 
Amendment 5.1 
17-Apr-2019 
Updated to allow for continuation of 
concomitant vedolizumab use in subjects 
who were previously enrolled in study 
GS-US-419-4016. 
Canada, Israel, France, UK, US, and 
voluntary harmonisation procedure (VHP) 
countries 
Amendment 6 
05-Sep-2019 
Updated duration of treatment to 
432 weeks, or until filgotinib becomes 
commercially available, whichever comes 
first, to ensure continued access to 
filgotinib in subjects who have completed 
the parent study (GS-US-419-3896). 
Amended study drug interruption or 
discontinuation criteria to reflect that 
subjects with newly positive 
QuantiFERON® TB test (or centrally 
reported equivalent assay) are now 
considered for study drug interruption 
instead of permanent discontinuation. 
General 
Amendment 7 
23-Mar-2020 
Updated study unblinding language to 
clarify the unblinding process and to allow 
subject unblinding once the corresponding 
parent study (GS-US-419-4015, 
GS-US-419-4016, or GS-US-419-3895) 
was unblinded. 
Updated study drug interruption criteria to 
allow the investigator to make the 
assessment of active or latent TB infection 
based on subject’s individual risk factors 
and further evaluations per standard of 


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Clinical Study Protocol/Amendment # 
Date 
Main Rationale 
General/Country-Specific 
care upon seroconversion or sequential 
indeterminate QuantiFERON® TB tests. 
Changes were implemented at the request 
of the United States Food and Drug 
Administration (US FDA) regarding new 
safety information of other Janus kinase 
(JAK) inhibitors on the potential risk of 
thromboembolic events. 
A statement was added to clarify the 
procedures to be followed if the Data 
Monitoring Committee (DMC) 
recommended stopping the study due to 
lack of efficacy. 
General 
Amendment 8 
02-Dec-2021 
Changed sponsorship from Gilead 
Sciences, Inc. to Galapagos NV. The 
Galapagos study number 
(GLPG0634-CL-310) was added. 
General 
Amendment 9 
23-Nov-2022 
The duration of treatment and end of study 
were adapted due to the limited number of 
subjects expected to continue after 31 
January 2025 and to allow subjects from 
other filgotinib treatment studies for CD to 
be enrolled into this study. 
Dose interruption criteria regarding renal 
impairment and lymphopenia were added 
to align with the IB Edition 17, 15 Jul 
2022. 
The length of time women of childbearing 
potential should use effective 
contraception after cessation of filgotinib 
treatment was changed to align with the 
post-treatment visit. 
The requirements for male condom use 
and reporting of pregnancies in female 
partners were removed to align with the IB 
Edition 17, 15 Jul 2022. 
Monthly pregnancy testing in clinic was 
changed to allow at home testing for 
subjects outside the US to reduce the 
burden on subjects. 
General 
 


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SUMMARY OF CHANGES 
 
Amendment 9 (23-Nov-2022) 
The overall reasons for this amendment are: 
a 
To adapt the duration of treatment and end of study due to the limited number of subjects expected to 
continue after 31 January 2025 and to allow subjects from other filgotinib treatment studies for Crohn’s 
disease (CD) to be enrolled into this study. 
b 
To add dose interruption criteria regarding renal impairment and lymphopenia to align with the 
Investigator’s Brochure Edition (IB) 17, 15 Jul 2022. 
c 
To change the length of time women of childbearing potential should use effective contraception after 
cessation of filgotinib treatment to align with the post-treatment visit. 
d 
To remove the requirements for male condom use and for reporting pregnancies in female partners during 
this study to align with the IB Edition 17, 15 Jul 2022. 
e 
To allow monthly pregnancy testing either in clinic (when it coincides with a scheduled visit) or at home 
with follow-up contact for subjects outside the US to reduce the burden on subjects. 
In addition, minor updates and administrative corrections were made. 
The changes made to the clinical study protocol (CSP) GS-US-419-3896 (GLPG0634-CL-310 [DIVERSITY 
LTE]) Version 8.0, 02 December 2021, are listed below, with a brief rationale of each change and the 
applicable sections. 
Change and Rationale: The duration of treatment and end of study were adapted due to the limited number 
of subjects expected to continue after 31 January 2025 and to allow subjects from other filgotinib treatment 
studies for CD to be enrolled into this study. 
Applicable Section: 
Protocol Synopsis 
Definition of Terms (new section) 
1.3 Rationale for This Study 
1.3.1 Rationale for Dose3.2 Study Design 
3.3 Study Treatments 
3.4 Duration of Treatment 
3.7 End of Study 
4.2 Inclusion Criteria 
5.1 Randomization, Blinding and Treatment Codes 
6.2.1 Day 1 Visit 
6.3.2 (new section title) Every 4 Weeks From Day 1 (± 7 days) 
6.3.3 (new section title) Week 12 and Then Every 12 Weeks Thereafter From Day 1 (± 7 days) 
6.3.4 Every 24 Weeks From Day 1 (± 7 days) 
6.3.5 Every 48 Weeks From Day 1 (± 7 days) 
6.3.6 (new section) End of Treatment Visit 
Appendix 2. Study Procedures Table 


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Change and Rationale: A study drug interruption criterion for subjects experiencing moderate renal 
impairment (estimated creatinine clearance ≥ 35 mL/min and < 60 mL/min per Cockcroft-Gault formula) was 
added to align with the IB Edition 17, 15 Jul 2022. 
Applicable Section:  
3.5.1 Study Drug Interruption Considerations 
Change and Rationale: A study drug interruption criterion for subjects with an absolute lymphocyte count 
(ALC) < 500 cells/mm3 was added to align with the Investigator’s Brochure Edition 17, 15 Jul 2022. 
Applicable Section:  
3.5.1 Study Drug Interruption Considerations 
Change and Rationale: The length of time women of childbearing potential should use effective 
contraception after cessation of filgotinib treatment was changed to 30 days to align with the post-treatment 
visit. 
Applicable Sections: 
Protocol Synopsis 
4.3 Exclusion Criteria 
Appendix 6. Pregnancy Precautions, Definition for Female of Childbearing Potential, and Contraceptive 
Requirements 
Change and Rationale: The requirements for male subjects to use condoms and for pregnancies in female 
partners to be reported during this study were removed in alignment with the IB Edition 17, 15 Jul 2022. The 
use of a condom is not mentioned in the IB, as possible seminal transfer is not considered to lead to relevant 
systemic exposure in partners of childbearing potential. 
Applicable Sections:  
Protocol Synopsis 
4.2 Inclusion Criteria 
4.3 Exclusion Criteria 
7.7.2.1 Instructions for Reporting Pregnancies 
Appendix 6. Pregnancy Precautions, Definition for Female of Childbearing Potential, and Contraceptive 
Requirements 
Change and Rationale: The requirement for female subjects to come to the clinic for monthly pregnancy 
testing was changed for subjects outside the US to allow for testing either in the clinic (when it coincides with 
a scheduled visit) or at home with a follow-up contact in order to reduce the burden on subjects. 
Applicable Sections:  
6.3.2 (new section title) Every 4 Weeks From Day 1 (± 7 days) 
Appendix 2. Study Procedures Table 
Appendix 6. Pregnancy Precautions, Definition for Female of Childbearing Potential, and Contraceptive 
Requirements 
An overview of the changes introduced in previous amendments can be found in the separate 
protocol amendment summary of changes document for each amendment. 
 




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Target Population: 
Subjects with CD who have completed* or met protocol specified 
efficacy discontinuation criteria in a prior filgotinib treatment 
study for CD. 
*A subject is defined as completed if they have completed all 
study visits and procedures as defined in the protocol or have 
completed treatment up to the primary endpoint. 
Duration of 
Treatment: 
Subjects will receive filgotinib or placebo until filgotinib becomes 
commercially available in the country or until the end of study (31 
January 2025), whichever comes first.  All subject visits, 
including the post-treatment (PTx) visit, must be completed by 31 
January 2025 at the latest. The maximum treatment duration will 
be approximately 7.5 years. 
Diagnosis and Main 
Eligibility Criteria: 
Inclusion Criteria 
Subjects will be eligible if they meet all of the following inclusion 
criteria: 
1) Must have the ability to understand and sign a written 
informed consent form (ICF), which must be obtained prior to 
initiation of study procedures associated with this trial 
2) Criterion modified per amendment 9 
2.1)  Must have enrolled in a CD parent protocol, GS-US-419-
4015, GS-US-419-4016 or GS-US-419-3895 or any other 
Gilead/Galapagos-sponsored filgotinib treatment study for CD 
3) Females of childbearing potential must have a negative 
pregnancy test at Day 1 and must agree to continued monthly 
pregnancy testing during use of filgotinib treatment 
4) Criterion modified per amendment 9 
4.1)  Female subjects of childbearing potential who engage in 
heterosexual intercourse must agree to use protocol specified 
method(s) of contraception for the duration described in 
Appendix 6 
5) Willingness to refrain from live or attenuated vaccines during 
the study and for 12 weeks after last dose of study drug  
6) Must have completed all required procedures or met protocol 
specified efficacy discontinuation criteria in a prior filgotinib 
treatment study for CD 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria are not 
to be enrolled in the study. 


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1) Subjects who are discontinued from a parent study for reasons 
other than disease worsening or lack of response or remission; 
eg, subjects who discontinue for safety or tolerability issues 
are not eligible for this study  
2) Known hypersensitivity to the study drug 
 
3) Any chronic medical condition (including, but not limited to, 
cardiac or pulmonary disease, alcohol or drug abuse) that, in 
the opinion of the Investigator or Sponsor, would make the 
subject unsuitable for the study or would prevent compliance 
with the study protocol 
4) Criterion modified per amendment 9 
4.1)  Females who may wish to become pregnant and/or plan 
to undergo egg donation or egg harvesting for the purpose of 
current or future fertilization during the course of the study 
and for at least 30 days after the last dose of study drug 
5) Criterion deleted per amendment 9 
6) Criterion modified per amendment 9 
6.1)  Females of reproductive potential who are unwilling to 
abide by protocol-specified contraceptive methods as defined 
in Appendix 6 
7) Use of prohibited concomitant medications as outlined in 
Section 5.4.2 
Study Procedures/ 
Frequency: 
Study visits with safety procedures will occur at Week 2, Week 4, 
Week 12, and then every 12 weeks thereafter. until the End of 
Treatment (EoT) visit. The EoT visit will be scheduled when 
filgotinib becomes commercially available in the country or prior 
to the end of study on 31 January 2025, whichever comes first. 
Day 1 assessments will include medical history, symptom 
directed physical examination (PE) including body weight and 
height, vital signs, safety laboratory assessments, urine pregnancy 
test (for females of childbearing potential), PRO2 and CDAI, 
adverse events (AEs) and concomitant medication assessments. 
PRO2, CDAI, symptom directed PE including body weight, vital 
signs, safety laboratory analyses, urine pregnancy test (for 
females of child-bearing potential), AEs and concomitant 
medications assessments will occur at each study visit.  
Women of child-bearing potential will require urine pregnancy 
tests every 4 weeks starting from Day 1 for the entire duration of 
the study.  
Subjects rolling over from GS-US-419-4016 will require 
complete perianal fistulae assessment every 12 weeks. 


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Urine samples will be collected at Day 1 and once every 24 
weeks. 
Peripheral Blood Mononuclear Cell (PBMC) (United States [US] 
and Canadian sites only), 
, 
, 
 
, and 
 
 will be collected at Day 1 and once 
every 24 weeks.  
 
Tuberculosis (TB) QuantiFERON® (or centrally reported 
equivalent assay) testing and 
 will be completed at Day 1 
and once every 48 weeks. A standard 12-lead electrocardiogram 
(ECG) will be performed every 48 weeks.  
Flexible sigmoidoscopy/colonoscopy collection with biopsies is 
optional per standard of care. The date of the procedure may be 
requested for accuracy of data analysis. 
Other inflammatory bowel disease (IBD) therapies 
(eg, prednisone > 30 mg) not permitted in the parent protocol are 
not allowed in this study. Refer to Section 5.4 for further details. 
Increases to or the addition of oral medications for the treatment 
of CD are allowed provided their dose does not exceed what was 
allowed in the parent protocol. 
Subjects who complete all study treatment visits or discontinue 
early will return 30 days after the last dose of study drug for PTx 
safety assessments. All subject visits, including the PTx visit, 
must be completed by 31 January 2025 at the latest. 
Test Product, Dose, and 
Mode of 
Administration: 
Filgotinib 200 mg oral tablet, once daily 
Filgotinib 100 mg oral tablet, once daily  
Dosing regimen is determined by regimen in parent study and 
reason for exiting parent study, as noted in Section 3.3. 
Reference Therapy, 
Dose, and Mode of 
Administration: 
Placebo-to-match (PTM) filgotinib 200 mg oral tablet, once daily 
PTM filgotinib 100 mg oral tablet, once daily 
Criteria for Evaluation: 
 
Safety: 
Assessments of AEs and concomitant medications will continue 
throughout the duration of the study. Safety evaluations include 
documentation of AEs, PE (symptom driven), vital signs, and 
clinical laboratory evaluations (hematology, chemistry, and 
urinalysis). An ECG will be performed every 48 weeks. 
Efficacy: 
Efficacy will be evaluated in terms of changes in PRO2 and 
CDAI scores. 




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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
5-ASA 
5-aminosalicylate 
6-MP 
6-mercaptopurine 
ADL 
Activities of Daily Living 
AE 
adverse event 
ALC 
absolute lymphocyte count 
ALT 
alanine aminotransferase 
AP 
abdominal pain 
AST 
aspartate aminotransferase 
AUC 
area under the plasma/serum/peripheral blood mononuclear cell concentration, drug 
versus time curve 
 
 
BMI 
body mass index 
CC&G 
Cockcroft-Gault 
CD 
Crohn’s disease 
CDAI 
Crohn’s Disease Activity Index 
CES 
Carboxylesterases 
CFR 
Code of Federal Regulations 
CI 
confidence interval 
CIA 
collagen-induced arthritis 
CK 
creatine kinase 
Cmax 
the maximum observed serum/plasma/peripheral blood mononuclear (PBMC) 
concentration of drug 
CMV 
Cytomegalovirus 
CNS 
central nervous system 
CPK  
creatine phosphokinase 
CrCl 
creatinine clearance 
CRO 
contract (or clinical) research organization  
CRP 
c-reactive protein 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CVEAC 
Cardiovascular Safety Endpoint Adjudication Committee 
CYP 
Cytochrome 
DAI 
disease activity index 
DMC 
Data monitoring committee 
DNA 
deoxyribonucleic acid 
DSS 
dextran sodium sulfate 
EC 
ethics committee 
ECG 
Electrocardiogram 
eCRF 
electronic case report form(s) 
EDC 
Electronic Data Capture  




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LLT 
Lower-Level Term 
LTE 
long-term extension 
mAb 
monoclonal antibody 
MACE 
major adverse cardiovascular events 
MedDRA 
Medical Dictionary for Regulatory Activities 
 
 
 
  
MTX 
Methotrexate 
NOEL 
no-observed-effect-levels 
NSAID 
Nonsteroidal Anti-inflammatory Drugs 
O&P 
ova and parasites test 
OAT 
organic anion transporters 
PBMC 
peripheral blood mononuclear cell 
PD 
Pharmacodynamic 
PE 
physical examination 
PEG 
polyethylene glycol 
PI  
principal investigator 
PK 
Pharmacokinetic 
PRO2 
Patient reported outcomes consisting of 2 items: abdominal pain severity and liquid 
stool frequency 
PT 
Preferred Term 
PTM 
Placebo-to-match 
PTx 
Post-Treatment 
Q1 
1st quartile 
Q3 
3rd quartile 
RA 
Rheumatoid Arthritis 
RNA 
ribonucleic acid 
ROC 
receiver operating characteristic 
RT-PCR 
reverse transcription polymerase chain reaction 
SADR 
serious adverse drug reaction 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SD 
standard deviation 
 
 
SI 
international system of units  
SOC 
system organ class 
SOP 
standard operating procedure 
STAT 
signal transducer and activator of transcription 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TB 
Tuberculosis 
TEAE 
treatment-emergent adverse event 
TgrasH2 
Transgenic 


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TNFα 
tumor necrosis factor-alpha 
TYK 
Tyrosine kinase 
UC 
ulcerative colitis 
UGT 
uridine 5’ diphosphate glucuronosyltransferase  
ULN 
upper limit of the normal range 
US 
United States 
 
 
WBC 
white blood cell 
 
  
 
DEFINITION OF TERMS 
 
Completed in any other 
Gilead/Galapagos-sponsored 
filgotinib treatment parent 
study for CD 
A subject is defined as completed if they have completed all study visits and 
procedures as defined in the protocol or have completed treatment up to the 
primary endpoint. 
 
 


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1. 
INTRODUCTION 
1.1. 
Background 
Crohn’s disease (CD) is a relapsing and remitting form of inflammatory bowel disease (IBD) that 
causes gastrointestinal signs and symptoms of diarrhea, abdominal pain, weight loss, and the 
passage of blood or mucous per rectum. The inflammation of CD can involve the mucosal 
surface of the gastrointestinal tract and penetrate through the full thickness of the gastrointestinal 
wall, including the serosal surface. Crohn’s disease is characterized by phenotype and location of 
involved bowel. The phenotypes include inflammatory, stricturing, and penetrating subtypes. 
Stricture formation can result in intestinal obstruction requiring surgical management. Over time, 
patients with repeated surgeries are at risk for developing short bowel syndrome and/or intestinal 
failure. Penetrating disease is characterized by fistula formation, which can be bowel to bowel, 
bowel to skin, or bowel to adjacent organ. Depending on location, penetrating disease can also 
require surgical management. Penetrating disease can also manifest with intra-abdominal 
abscess, a condition which can be life threatening if not treated early with systemic antibiotics. In 
addition, CD may affect other organ systems leading to rashes, joint pain and stiffness, fever, and 
weight loss {Baumgart 2012}. 
The incidence and prevalence of CD has been increasing, with bimodal peaks affecting young 
adults (15 to 35 years of age) and older adults aged 50 to 70 with the age of onset often occurring 
in children < 12 years of age. Although geographic variation does occur, the overall incidence of 
CD in the northern hemisphere ranges from 7 to 20 per 100,000 person years, with a 
prevalence of up to 300 per 100,000 people. In the United States (US) and Europe, up to 
1.5 million individuals may be affected and the incidence is on the rise in parts of Asia and the 
Middle East {Molodecky 2012}. 
The cause of CD is poorly understood, however a complex interplay of genetic predisposition, 
aberrant immune activation, and early infection during childhood may be involved. The 
importance of environmental triggers is suggested by increasing rates due to industrialization and 
improved domestic hygiene and sanitation. This “hygiene hypothesis” has also been implicated 
in various other autoimmune disorders {Ventham 2013}. 
To assess disease severity, a number of clinical scoring systems are utilized based upon signs, 
symptoms, laboratory parameters, imaging modalities, and endoscopy. The Crohn’s Disease 
Activity Index (CDAI) is one such scoring tool with scores ranging from 0 to over 600 based 
upon a composite of symptoms (eg, abdominal pain), signs (the presence of abdominal mass 
and weight), laboratory values (eg, hematocrit), and physician assessment amongst others. In this 
scoring system, patients with a score > 220 are defined as moderate to severe these comprise the 
patients with the greatest unmet medical need. The CDAI can also be used to determine how 
well a therapy is working, with therapeutic remission defined as a CDAI of < 150 points 
{Dignass 2010}. 


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The CDAI has 2 patient reported outcomes of interest in CD drug development: liquid or very 
soft stool frequency and abdominal pain. In the Patient Reported Outcomes (PRO2) for the 
current study, these symptoms are recorded daily for 7 days and averaged to determine sub score 
cut off values of ≤1 for abdominal pain and ≤3 for stool frequency that define clinical remission. 
As yet, the stool frequency and abdominal pain sub scores of the CDAI have not been used on 
their own in prospective clinical trials. 
A significant change in CD management and therapeutic strategy has occurred over the last 
decade. Recent therapeutic goals extend beyond symptomatic control and include long-term 
mucosal and 
 {Cheifetz 2013}. The ultimate aim is to change the natural 
course of the disease by slowing down or halting its progression, thus avoiding surgery or 
hospitalization. This is achieved by utilizing earlier, aggressive, and goal-directed therapy. Risk 
assessment and prediction by means of complex clinical, biochemical, and endoscopic markers 
has become the key to patient management, therapy optimization, and prediction of the outcome 
and side effects of medical therapy.  
Currently available biologic therapies focus on neutralizing cytokine activity or altering T-cell 
differentiation and homing Three monoclonal antibodies which inhibit tumor necrosis 
factor-alpha (TNFα), are currently marketed for the treatment of CD: infliximab (Remicade®), 
adalimumab (Humira® [approved in US and European Union {EU}]) and certolizumab pegol 
(Cimzia® [approved in US]). Vedolizumab (Entivyo®, a monoclonal antibody against 
α4β71100 integrin is also approved for moderately to severely active CD. Recently, ustekinumab 
(Stelara®), a monoclonal antibody directed against the p40 subunit of IL-23 and therefore an 
antagonist for both IL-12 and IL-23 signaling, has been approved for the treatment of CD. 
Leukocytapheresis therapy may be used in Japan {Fukunaga 2012}.Other investigational 
treatment approaches still in development include the administration of cytokines to stimulate 
innate immunity, the use of prebiotics to alter the gut flora, and blocking the IL-6 signaling 
pathway {Ito 2004, Korzenik 2016}. New treatments being tested in clinical trials includes janus 
kinase (JAK) inhibitors (eg, upadacitinib), and new biologic agents such as 
IL-23 p19 antagonists (eg, risankizumab) and a monoclonal antibody directed against β7 integrin 
(eg, etrolizumab). 
While the introduction of biologic therapies has significantly improved response rates in patients 
with moderately to severely active CD, long-term or durable remission rates are still low at 
approximately 20%. Many patients receiving biologic therapies develop neutralizing antibodies 
with resulting loss of efficacy. These agents may be associated with specific safety issues 
including but not limited to anaphylaxis, increased risk of infection including progressive 
multifocal leukoencephalopathy, and liver injury. Safe and effective treatment options which 
may be conveniently administered in a chronic setting would provide a significant treatment 
advance for patients with moderately to severely active CD. 


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1.2. 
Filgotinib (GS-6034) 
1.2.1. 
General Information 
Janus kinases (JAKs) are intracellular cytoplasmic tyrosine kinases (TYKs) that transduce 
cytokine signaling from membrane receptors through signal transducer and activator of 
transcription (STAT) to the nucleus of cells. JAK inhibitors block the signaling of various 
cytokines, growth factors, and hormones, including the proinflammatory cytokine interleukin 
(IL)-6. Four different types of JAKs are known, JAK1, JAK2, JAK3, and TYK2 which interact 
with different sets of membrane receptors. Inhibition of JAKs is a promising therapeutic option 
for a range of inflammatory conditions including rheumatoid arthritis (RA) and CD. 
Filgotinib (GS-6034, formerly known as GLPG0634) is a potent and selective inhibitor of JAK1. 
Filgotinib is approved in the European Union (EU), Japan, and Great Britain for treatment of 
moderate to severe active RA in adult patients. It is also approved for the treatment of 
moderately to severely active ulcerative colitis (UC) in adults in the EU, Japan and Great Britain. 
The compound has shown good preliminary efficacy in CD patients in Phase 2 studies. 
In humans, filgotinib is metabolized to form one major active metabolite, GS-829845. Though 
the potency of this metabolite is lower than the parent molecule, the overall exposure and peak 
plasma concentration in humans is higher than seen in all tested animal species. As a 
consequence, dedicated pharmacology and toxicology studies have been performed with 
GS-829845. Results from pharmacodynamics (PD) testing in healthy volunteers suggest that the 
clinical activity of filgotinib could result from the combination of the parent molecule and the 
metabolite. 
For further information on filgotinib, refer to the current Investigator’s Brochure (IB). 
1.2.2. 
Preclinical Pharmacology and Toxicology 
Filgotinib and its metabolite, GS-829845 have been extensively characterized in nonclinical 
studies. This program includes cellular assays demonstrating potency and selectivity of the 
compound against JAK1; efficacy studies in rats and mice; repeat-dose toxicity studies 
(up to 26 weeks in the rat and 39 weeks in the dog), in vitro and in vivo safety pharmacology and 
genetic toxicology studies, and reproductive toxicology studies in rats and rabbits.  
Additional toxicology studies conducted include phototoxicity studies and dose-range finding 
studies in support of a definitive juvenile toxicity study. A definitive juvenile toxicology study in 
rats is ongoing.  


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1.2.2.1. 
Nonclinical Pharmacology 
In cellular assays, filgotinib inhibits JAK1 signaling with the concentration of an inhibitor that is 
required for 50% inhibition (IC50) values of ≥ 179 nM, and demonstrates 30-fold selectivity over 
JAK2 in a human whole blood assay. Filgotinib has been profiled against 451 kinases and it is 
highly selective for JAK1; only 2.5% of kinases were inhibited ≥ 50% at 50-fold higher 
concentration than IC50 for JAK1. Broad receptor profiling (~70 receptors, ion channels, 
transporters and enzymes) did not reveal any off-target liabilities of the compound. Filgotinib 
demonstrated high potency in the rat collagen-induced arthritis (CIA) model as well as in the 
mouse dextran sulfate sodium (DSS)-induced colitis model, the latter of which is detailed below. 
The major human metabolite of filgotinib GS-829845 exhibits a similar JAK1 selectivity profile 
but is approximately 10-fold less potent as compared to parent filgotinib in vitro. 
The efficacy of filgotinib was evaluated in a prophylactic setting of the chronic mouse Dextran 
DSS model in two separate studies. Both studies evaluated oral dose levels of 10 and 30 mg/kg 
once daily. In addition to assessments of clinical score (disease activity index [DAI] and colon 
lesion score), serum markers of inflammation, immunohistochemical analysis, and expression of 
various chemokines and cytokines known to be altered in CD and UC patients were also 
evaluated in the distal colon of these mice.  
In both studies, the DAI score, which takes into account body weight loss, rectal bleeding, and 
stool consistency, was reduced by filgotinib in a dose-dependent manner, demonstrating that 
filgotinib protected mice against colitis induced by DSS. Histology of the colon revealed a 
filgotinib-mediated dose-related reduction in colon lesion score, correlating with reductions in 
DAI score.  
Additional end points evaluated across the DSS colitis model studies confirmed the suppression 
of various inflammatory markers including serum levels of C-reactive protein (CRP) and 
myeloperoxidase (MPO) and expression of IL-6 and TNFα (by reverse transcription polymerase 
chain reaction [RT-PCR]) by filgotinib. Immunohistochemical analysis of the colon confirmed 
inhibition of the JAK-STAT pathway by filgotinib as evidenced by a reduction of DSS-induced 
STAT3 phosphorylation. 
1.2.2.2. 
Safety Pharmacology 
Filgotinib and GS-829845 had no relevant effects on cardiovascular parameters 
(human ether-a-go-go [hERG] and dog telemetry studies), apart from a slight non-adverse 
increase in heart rate and arterial pressure with GS-829845 at exposures 8-fold that of the peak 
serum concentration (Cmax) in subjects with CD treated with 200 mg once daily filgotinib. There 
were no relevant effects on electrocardiogram (ECG) and QT. Filgotinib and GS-829845 had no 
effects on the respiratory system and central nervous system (CNS). 
1.2.2.3. 
Key Nonclinical Distribution, Metabolism, and Excretion Data 
Filgotinib demonstrates good oral bioavailability in mice, rats, dogs, and mini-pigs but less in 
monkeys. Plasma protein binding is low (< 70%) in all species, including humans. 


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The pharmacokinetics (PK) of filgotinib is generally dose proportional without gender 
differences. No accumulation occurs with repeated dosing. The mean terminal half-life after oral 
administration is 4 hours and 5 hours in rats and dogs, respectively. 
In the rat, filgotinib showed a rapid and even distribution throughout the body. High 
concentrations were observed only in the gastrointestinal (GI) tract and urinary bladder. 
Filgotinib does not penetrate into CNS tissues. The distribution of filgotinib indicates some 
affinity for melanin-containing tissues. 
Excretion is nearly complete within 24 hours (rat) and 48 hours (dog) post-dosing. In the rat, 
fecal and urinary excretion accounted for 40% and 53% of the administered dose, respectively, 
with a bile secretion of about 15%. In the dog, fecal excretion was the primary route of excretion, 
accounting for 59% of the administered dose, with urinary excretion accounting for 25%. 
In vitro metabolism studies in all species revealed one major metabolite (GS-829845). The 
formation of GS-829845 is mediated by carboxylesterases (CES) and is not dependent on 
cytochrome P450 (CYP). 
In vitro experiments have shown that drug-drug interactions with filgotinib and GS-829845 are 
unlikely. There is no inhibition or induction of CYPs or uridine 5’- diphosphate -
glucuronosyltransferase (UGTs), and no relevant inhibition of key drug transporters, including 
organic anion transporters (OATs), by filgotinib or GS-829845. OCT2 was inhibited by both 
filgotinib (IC50: 8.7 μM) and GS-829845 (IC50: 67 μM). The clinical relevance of the IC50 values 
for inhibition of OCT2 will be further evaluated. MATE1 was also weakly inhibited by filgotinib 
(IC50: 94 μM) and GS-829845 (IC50: >100 μM). Filgotinib was found to be a substrate of P-
glycoprotein (P-gp). 
1.2.2.4. 
Nonclinical Toxicology 
In repeat oral dose toxicity studies in both rats and dogs, the primary target tissues identified for 
filgotinib were the lymphoid tissues which are expected based on the pharmacology of JAK 
inhibition. Additional filgotinib-related findings were observed in the male reproductive organs 
of both species, and in the incisor teeth of rats only. Effects on the lymphoid system were fully 
reversible. Testicular toxicity demonstrated partial reversibility; however, sperm counts 
remained low. When using the mean exposure (AUC) at the NOAELs for the most sensitive 
species (the dog), the exposure margins compared to a 200 mg once daily dose of filgotinib in 
CD subjects are 2.5, 1.9, and 3.6-fold for the 26-week and 39-week chronic toxicity studies and 
the 39-week targeted exposure toxicity study, respectively. 
GS-829845-related findings in the repeat-dose toxicity studies were generally similar to those of 
the parent filgotinib; however, no testicular toxicity was noted following administration of 
GS-829845. 
Filgotinib and GS-829845 were non-genotoxic when evaluated in the bacterial mutagenicity 
assay, the in vitro mouse lymphoma mutagenicity assay, and the rat bone marrow micronucleus 
assay. 


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In embryofetal development studies, filgotinib and GS-829845 caused embryolethality and 
teratogenicity in rats and rabbits. Teratogenicity was observed at exposures slightly higher or 
similar to the human exposure at 200 mg once daily of filgotinib in subjects with CD. 
Administration of filgotinib did not affect female fertility but impaired fertility was observed in 
male rats at exposures approximately 12-fold the human exposure at 200 mg of filgotinib in 
subjects with CD. GS-829845 did not have any effects on fertility parameters in either male or 
female rats. 
In an in vitro phototoxicity study in 3T3 cells, the metabolite GS-829845 was positive for 
phototoxic potential and results with filgotinib were equivocal. A follow-up in vivo rat 
phototoxicity assay revealed a lack of phototoxic potential for both compounds. 
1.2.3. 
Clinical Trials of Filgotinib 
An overview of exposure and clinical studies conducted with filgotinib is available in the IB. 
1.2.3.1. 
Phase 2 Study in Crohn’s Disease (GLPG0634-CL-211, FITZROY) 
A Phase 2, randomized, double-blind, placebo-controlled, multicenter study with filgotinib was 
performed in subjects with active CD with evidence of mucosal ulceration {Vermeire 2017}. In 
Part 1, a total of 174 subjects were randomized (3:1) to receive either filgotinib 200 mg once 
daily or placebo for 10 weeks. Based on their clinical response in Part 1, subjects in Part 2 either 
continued their current treatment or were reassigned to a different treatment for an additional 
10 weeks. 
The efficacy of filgotinib was assessed by evaluating clinical remission (defined as CDAI 
score < 150), clinical response (defined as a decrease in CDAI of at least 100 points from 
baseline), and endoscopic response (defined as a decrease of at least 50% from baseline in the 
SES-CD score). 
The primary end point of the study was met: at Week 10, 60 of 128 subjects (46.9%) who 
received filgotinib achieved clinical remission versus 10 of 44 subjects (22.7%) who received 
placebo, a difference of 24.1% (P-value = 0.0077). In addition, filgotinib treatment was 
associated with increases in the proportion of subjects with clinical and endoscopic response 
compared with placebo.  
Overall, the safety profile of filgotinib in CD subjects was consistent with prior studies.  
For additional details about the efficacy and safety of filgotinib in CD, reference is made to the 
IB. 
1.3. 
Rationale for This Study 
A need for safer, better tolerated, durable efficacious therapies for patients with CD exists. 
Despite significant uptake in the use of anti-TNF agents, tolerability of anti-TNFs due to allergic 
and autoimmune reactions, lack of durable response, and significant increased risk of infection 
remain problematic. Filgotinib is a once daily, oral therapy that may prove efficacious without 
the risk of allergic and autoimmune phenomena observed with anti-TNF agents.  


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This is a long-term extension study (GS-US-419-3896; Galapagos Study ID GLPG0634-CL-310 
[DIVERSITY LTE]) to provide treatment with filgotinib for subjects with moderately to severely 
active CD (who have completed or met protocol specified efficacy discontinuation criteria in a 
prior filgotinib treatment study for CD) until filgotinib becomes commercially available in the 
country or until the end of study (31 January 2025), whichever comes first.. 
The purpose of this study is to observe the safety of long-term therapy and to ensure continued 
access to study drug for subjects who responded in the parent protocol of filgotinib. In addition, 
the study provides an open-label alternative at the highest possible dose (excluding males who 
are not dual-biologic refractory in the US and Korea, refer to Section 3.3 for further information) 
for subjects who had disease worsening or lack of response in the parent study. 
1.3.1. 
Rationale for Dose 
In Phase 2 trials in RA, pooled data with an exposure – response analysis demonstrated a 
dose-dependent increase in efficacy up to 200 mg total daily dose. In the Phase 2 study of CD, 
subjects treated in the 200 mg arm showed favorable response and remission rates 
(47% remission over 23% placebo and 59% response over 41% placebo). Remission rates at 
Week 20 for subjects who failed placebo for the first 10 weeks and commenced 100 mg from 
Weeks 10 to 20 was slightly lower (32%) though response rate was comparable (59%), 
indicating some level of efficacy at the 100 mg dose. These results are consistent with the 
relationship observed between filgotinib exposures and inhibition of pSTAT1 activation 
(ex-vivo) following single and multiple filgotinib doses, where maximal inhibition of pSTAT1 
activation (~78%) was achieved at or above 200 mg total daily dose and intermediate inhibition 
(~47%) at 100 mg {Namour 2015}. pSTAT1 data, in conjunction with considerations around the 
margin for nonclinical testicular findings, suggests assessing doses above 200 mg is not 
indicated. The presence of response in CD subjects in the exploratory 10 to 20 week arm of 
Study GLPG0634-CL-211, and study of multiple doses (ie, 100 mg and 200 mg once daily) in 
the present study will enable establishment of an appropriate nominal dose and determine the 
dose with the most favorable risk/benefit profile for CD subjects. The present study will ensure 
continued access to blinded dosing for specific subjects (those who complete a respective parent 
protocol through the end of that study). After the corresponding parent study (GS-US-419-4015, 
GS-US-419-4016, or GS-US-419-3895 [Galapagos Study ID: GLPG0634-CL-309]) is 
unblinded, subjects enrolled in the present study may be unblinded. Subjects who enroll from a 
parent study and receive blinded treatment in the DIVERSITY LTE study will have their 
DIVERSITY LTE treatment assignment unblinded when the parent study is unblinded. Subjects 
will continue on the same dose of open-label filgotinib as they had been receiving in blinded 
treatment. Subjects on placebo treatment will discontinue study drug and study participation. In 
addition, the present study allows open-label access at the highest possible dose for subjects who 
were non-responders or experienced disease worsening on blinded dosing in a parent study. At 
no time will males in the US and Korea who are not dual biologic refractory receive 200 mg.  
Subjects enrolled from other filgotinib treatment studies for CD will receive open-label 200 mg 
filgotinib daily. Reference is made to Section 3.3 for details about dosing regimen and definition 
of being dual biologic refractory. 


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1.4. 
Risk/Benefit Assessment for the Study 
Crohn’s disease is a progressive and potentially life-threatening disease with few treatment 
options, many of which result in primary or secondary nonresponse. Inflammatory bowel disease 
may lead to increased risk of gastrointestinal malignancies, impairment in quality of life, and 
ultimate need for life-altering surgery. Current treatment options are limited in ability to establish 
mucosal healing and clinical remission and have significant safety and efficacy limitations; for 
example, biologics have significant immunogenic risks and steroids are associated with increased 
morbidity and mortality. Remission rates are generally low when compared to placebo rates 
across most therapies for IBD. There remains substantial unmet need in IBD, particularly in 
moderate to severe disease. The lifelong nature of IBD increases the probability that subjects 
have cycled through various therapies, leaving few approved options. 
Nonclinical studies in rats and dogs identified lymphoid tissues and testes as target organs for 
filgotinib in long-term repeat-dose toxicity studies. Although decreased lymphocyte numbers 
observed in nonclinical studies have not been seen in clinical studies, hematological 
assessment will be performed throughout the present study to ensure this potential risk is 
appropriately monitored. In both rats and dogs, microscopic findings in the testes included germ 
cell depletion and degeneration, with reduced sperm content and increased cell debris in the 
epididymis and reduction in fertility in male rats. The dog was determined to be the most 
sensitive species. When using the (AUC at the NOAELs for dogs in the 26-week and 39-week 
chronic toxicity studies, and the 39 week targeted exposure toxicity study, the exposure margins 
compared with the highest proposed clinical dose of 200 mg once daily are 2.5, 1.9 and 3.6-fold 
respectively, in subjects with CD. A male safety study is planned to examine the potential effect 
of filgotinib on sperm/ejaculate parameters. Pending those results, the use of 200 mg in males in 
the US and Korea with CD or UC will be limited to subjects who have failed at least 
two biologic therapies (any TNFα antagonist and vedolizumab). Refer to the IB for further 
information about nonclinical and clinical testicular findings.  
Filgotinib has shown an increase of embryofetal malformations in rats and rabbits at exposures 
similar to, or slightly higher than, exposures associated with a 200 mg once daily dose in CD 
subjects, the use of highly effective contraception in the subject population is expected to 
mitigate this risk. 
JAK inhibition is expected to increase the risk of infection based on mechanism of action. Across 
the global studies in filgotinib, in general, active treated arms have increased incidences of 
infection versus placebo. In the present protocol, treatment interruption and discontinuation 
considerations surrounding infections are incorporated and sites and investigators will be trained 
regarding such circumstances. All subjects will be screened for tuberculosis (TB) and subjects 
with clinically significant active infections will be excluded. Malignancy has been reported in 
subjects on filgotinib; in the present trial, subjects will be required to have up to date colorectal 
cancer screening and surveillance and subjects with recent malignancies will be excluded as 
outlined in the inclusion criteria in the parent study. For further details about infections and 
malignancies, please refer to the IB. 
The potential benefits of JAK inhibition include improvement in clinical symptoms and mucosal 
and 
. JAK inhibition may be efficacious in the treatment of IBD based on 






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1) Failed any TNFα antagonist and vedolizumab at the time of randomization in studies 
GS-US-419-3895, GS-US-419-4015, and GS-US-419-4016, or 
2) Failed any TNFα antagonist and are taking vedolizumab at the time of randomization into the 
GS-US-419-4016 study.  
Details on dosing regimen for LTE are noted below in Table 3-1. 
Table 3-1. Dosing Regimens in LTE 
Dose in parent study 
Reason for exiting parent 
study 
Dose in LTE 
Dose in LTE after  
LTE Unblinding  
All Females, Non-US males and US & Korea dual refractory males 
200 mg filgotinib, 
blinded 
Study completed to end 
200 mg filgotinib + PTM 
100 mg (blinded dosing) 
200 mg filgotinib, 
open- label 
100 mg filgotinib, 
blinded 
Study completed to end 
100 mg filgotinib + PTM 
200 mg (blinded dosing) 
100 mg filgotinib, 
open-label 
Placebo, blinded 
Study completed to end 
PTM 100 mg + PTM 
200 mg (blinded dosing) 
Discontinue study drug 
200 mg filgotinib, open-
label/ blinded 
Completed treatment up to 
primary endpoint 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
Placebo, open-label/ 
blinded 
Completed treatment up to 
primary endpoint 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
blinded 
Disease worsening and/or 
failure to meet 
response/remission criteria 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
100 mg filgotinib, 
blinded 
Disease worsening and/or 
failure to meet 
response/remission criteria 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
Placebo, blinded 
Disease worsening and/or 
failure to meet 
response/remission criteria 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
Study completed to end 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
Study completed to end 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
Disease worsening and/or 
failure to meet 
response/remission criteria 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
Disease worsening and/or 
failure to meet 
response/remission criteria 
200 mg filgotinib, 
open-label 
200 mg filgotinib, 
open-label 


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Dose in parent study 
Reason for exiting parent 
study 
Dose in LTE 
Dose in LTE after  
LTE Unblinding  
US & Korea Males who have not failed at least two biologic therapies (any TNFα and vedolizumab) 
100 mg filgotinib, 
blinded 
Study completed to end 
100 mg filgotinib 
(blinded dosing) 
100 mg filgotinib, 
open-label 
Placebo, blinded 
Study completed to end 
PTM 100 mg (blinded 
dosing) 
Discontinue study drug 
100 mg filgotinib, 
blinded 
Disease worsening and/or 
failure to meet 
response/remission criteria 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
Placebo, blinded 
Disease worsening and/or 
failure to meet 
response/remission criteria 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
Study completed to end 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open-label 
Disease worsening and/or 
failure to meet 
response/remission criteria 
100 mg filgotinib, 
open-label 
100 mg filgotinib, 
open- label 
Abbreviations: LTE=long-term extension; PTM=placebo-to-match 
3.4. 
Duration of Treatment 
Subjects will receive filgotinib or placebo until filgotinib becomes commercially available in the 
country or until the end of study (31 January 2025), whichever comes first. All subject visits, 
including the PTx visit, must be completed by 31 January 2025 at the latest. The maximum 
treatment duration will be approximately 7.5 years. 
3.5. 
Criteria for Study Drug Interruption or Discontinuation  
3.5.1. 
Study Drug Interruption Considerations 
The medical monitor should be consulted prior to study drug interruption when medically 
feasible. 
Study drug interruption should be considered in the following circumstances; prior to resumption 
of study drug, the investigator should discuss the case with the medical monitor: 
• Intercurrent illness that would, in the judgment of the investigator, affect assessments of 
clinical status to a significant degree. 
• Subject is scheduled for elective or emergency surgery (excluding minor skin procedures 
under local or no anesthesia); timing of study drug pausing should be determined in 
consultation with the medical monitor. 
• Any subject who develops a new infection during the study should undergo prompt and 
complete diagnostic testing appropriate for an immunocompromised individual, and the 
subject should be closely monitored.  


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• Subjects with newly positive (converted) or 2 indeterminate QuantiFERON® TB test 
(or centrally reported equivalent assay) result(s) should interrupt study drug dosing and be 
evaluated for active TB and latent TB by the investigator per local standard of care. An 
indeterminate result should be repeated once and the second result (if positive or negative) 
will be accepted. Positive or negative results must not be repeated. 
• Subjects diagnosed with latent TB (ie, a subject who has newly identified positive diagnostic 
TB test result, in which active TB has been ruled out) may initiate an adequate course of 
prophylaxis as per local standard of care; appropriate, ongoing, prophylactic treatment for 
latent TB must be initiated for a minimum of 4 weeks prior to the continuation of study 
medication. Subjects may resume study drug after investigator’s consultation with medical 
monitor. 
• Subjects with positive or 2 indeterminate QuantiFERON® test result(s) who are determined 
as having neither latent nor active TB infection may continue participation in the study after 
consultation and approval from medical monitor. Any subject with active TB must be 
discontinued from the study. Subjects who were previously treated for TB with a complete 
and adequate course of therapy as per local standard of care and as verified by the 
investigator do not need to have yearly QuantiFERON® tests. Subjects previously treated for 
TB should be screened at least yearly for signs and symptoms consistent with reactivation of 
TB. Any subject with active TB should be discontinued from the study. 
• After a confirmed laboratory change representing moderate renal impairment (estimated 
creatinine clearance [CrCl] ≥ 35 mL/min and < 60 mL/min per Cockcroft-Gault [CC&G] 
formula) at any time during the study, the following actions should be taken by the 
investigator and documented: 
⎯ Establish possible underlying condition and initiate appropriate action to resolve. 
⎯ Retest CrCl within 8 weeks. 
⎯ Carefully consider individual benefit/risk of continuation of filgotinib 200 mg once daily 
in relation to the observation. 
⎯ If continuation of filgotinib 200 mg once daily is not considered appropriate, interrupt 
treatment until retest confirms CrCl ≥ 60 mL/min. 
⎯ The investigator/designee should assess individual subject benefit/risk with regards to re-
initiation of treatment after repeat or prolonged interruptions, or if re-initiation is not 
considered appropriate. 
• For subjects with confirmed absolute lymphocyte count (ALC) less than 500 cells/mm3, 
retest within 3 to 7 days, filgotinib should be interrupted until grade returns to ≤ Grade 2 
(more than 500 cells/mm3). If ALC does not return to ≤ Grade 2 within 4 weeks or returns to 
less than 500 cells/mm3 following re-challenge with filgotinib, then filgotinib should be 
permanently discontinued and the subject managed according to local practice. 


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NOTE: During the time of study drug interruption for any of the above, the subject may continue 
to have study visits and to take part in procedures and assessments, if deemed medically 
appropriate by the investigator. 
The medical monitor should consult the medical leader as needed. 
3.5.2. 
Study Drug Discontinuation Considerations 
The medical monitor should be consulted prior to study drug discontinuation when medically 
feasible.  
Study drug must be permanently discontinued in the following instances: 
• Any opportunistic infection 
• Any serious infection that requires antimicrobial therapy or hospitalization, or any infection 
that meets SAE reporting criteria 
• Febrile neutropenia (temperature > 38.3°C or a sustained temperature of > 38°C for more 
than one hour) with absolute neutrophil count of < 1,000/mm3 
• Symptomatic anemia (eg, signs/symptoms including pallor, shortness of breath, new heart 
murmur, palpitations, lethargy, fatigue) with hemoglobin < 7.5 g/dL, or if transfusion is 
indicated regardless of hemoglobin value 
• Complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or 
CNS involvement) 
• Evidence of active HCV during the study, as evidenced by HCV RNA positivity 
• Evidence of active HBV during the study, as evidenced by HBV DNA positivity 
• Any thromboembolic event that meets SAE reporting criteria 
• Unacceptable toxicity, or toxicity that, in the judgment of the investigator, compromises the 
subject’s ability to continue study-specific procedures or is considered to not be in the 
subject’s best interest 
• Subject request to discontinue for any reason 
• Subject noncompliance 
• Pregnancy during the study; refer to Section 7.7.2.1 and Appendix 6 
• Discontinuation of the study at the request of the Sponsor, a regulatory agency or an 
institutional review board or independent ethics committee (IRB/IEC) 
• Subject use of prohibited concurrent therapy may trigger study drug discontinuation; 
consultation should be made with the medical monitor. 


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• Laboratory criteria: After becoming aware of any of the below described abnormal laboratory 
changes occurring at any one time, an unscheduled visit (ie, sequential visit) should occur to 
retest within 3 to 7 days (except creatinine, which should be retested 7 to 14 days apart). 
⎯ 2 sequential neutrophil counts < 750 neutrophils/mm3 (international system units [SI]: 
< 0.75 × 109 cells/L) 
⎯ 2 sequential platelet counts < 75,000 platelets/mm3(SI: < 75.0 × 109 cells/L) 
⎯ 2 sequential aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 
> 3 times the upper limit of normal range (ULN) and at least one of the following 
confirmed values:  
■ total bilirubin > 2× ULN 
■ international normalized ratio (INR) > 1.5 
■ or accompanied by symptoms consistent with hepatic injury.  
For any subject with an initial AST or ALT elevation > 3× ULN, at the time of the 
second confirmatory draw, an INR, prothrombin time (PT) and partial thromboplastin 
time (PTT) must also be drawn. 
⎯ 2 sequential AST or ALT elevations > 5× ULN 
⎯ 2 sequential values for estimated CrCl < 35 mL/min based on the Cockcroft-Gault 
(CC&G) formula 
Male 
[(140–age in years) × (weight in kg)]/[72 × (serum creatinine in mg/dL)] 
= CLcr (mL/min) 
Female [(140–age in years) × (weight in kg) × 0.85]/[72 × (serum creatinine in mg/dL)] 
= CLcr (mL/min) 
• Subjects who were receiving blinded placebo at the time of study unblinding 
• Subjects are free to withdraw from the study at any time without providing reason(s) for 
withdrawal and without prejudice to further treatment. The reason(s) for withdrawal will be 
documented in the electronic case report form (eCRF).  
• Subjects who permanently discontinue study drug for any reason should discuss their 
continued care plan with their physicians.  
• Subjects who permanently discontinue study drug for pregnancy should not continue in the 
study; if there are any questions regarding permanent discontinuation, these should be 
discussed with the Sponsor. 


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• Subjects withdrawing from the study should complete Early Termination (ET), followed by 
PTx assessments 30 days after the last dose of study drug. 
Reasonable efforts will be made to contact subjects who are lost to follow-up. All contacts and 
contact attempts must be documented in the subject’s file. 
The Sponsor has the right to terminate the study at any time in case of safety concerns or if 
special circumstances concerning the study medication or the company itself occur, making 
further treatment of subjects impossible. In this event, the investigator(s) and relevant authorities 
will be informed of the reason for study termination. 
The medical monitor should consult the medical leader as needed. 
3.6. 
Disease Worsening Criteria 
Subjects meeting the following criteria should be considered to be discontinued from the study. 
• Any subject with significant disease worsening or lack of response to therapy based on 
investigator judgment may discontinue study drug at any time during the LTE 
• Disease worsening based on change in CDAI score may also be used to guide discontinuation 
of the subject: eg, increase in CDAI ≥100 from Day 1 in present study and CDAI >220 at 
2 consecutive visits.  
⎯ The disease worsening visits may include unscheduled visits (eg, a study visit followed 
by an unscheduled visit, or 2 sequential unscheduled visits). 
• If a subject experiences significant worsening of underlying CD, which requires any of the 
prohibited medications (refer to Section 5.4.2), or surgical intervention at any point during 
the study, treatment discontinuation should be considered at investigator’s discretion, in 
consultation with medical monitor if feasible (refer to Section 3.5.2).  
• A stool sample will be obtained for culture for pathogenic bacteria, ova and parasite 
evaluation, and C. difficile toxin assay, when a subject becomes symptomatic, including 
worsening or return of disease activity. 
3.7. 
End of Study 
End of Study is defined as last subject last visit. This will be when filgotinib becomes 
commercially available in the country or 31 January 2025, whichever comes first. All subject 
visits, including the PTx visit, must be completed by 31 January 2025 at the latest. 
3.8. 
Post Study Care 
Post study care is at the discretion of the treating investigator or physician. 




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4. 
SUBJECT POPULATION 
4.1. 
Number of Subjects and Subject Selection 
Approximately 1000 subjects who meet eligibility criteria at Day 1 will receive filgotinib or 
placebo. 
4.2. 
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study. 
1) Must have the ability to understand and sign a written ICF, which must be obtained prior to 
initiation of study procedures associated with this trial 
2) Criterion modified per amendment 9 
2.1) Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016, 
GS-US-419-3895 or any other Gilead/Galapagos-sponsored filgotinib treatment study 
in CD 
3) Females of childbearing potential must have a negative pregnancy test at Day 1 and must 
agree to continued monthly pregnancy testing during use of filgotinib treatment 
4) Criterion modified per amendment 9 
4.1) Female subjects of childbearing potential who engage in heterosexual intercourse must 
agree to use protocol specified method(s) of contraception for the duration described 
as described in Appendix 6 
5) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks 
after last dose of study drug 
6) Must have completed all required procedures or met protocol specified efficacy 
discontinuation criteria in a prior filgotinib treatment study for CD 
4.3. 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 
1) Subjects who are discontinued from a parent study for reasons other than disease worsening, 
or lack of response or remission; eg, subjects who discontinue for safety or tolerability issues 
are not eligible for the present study 
2) Known hypersensitivity to the study drug 


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3) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, 
alcohol or drug abuse) that, in the opinion of the Investigator or Sponsor, would make the 
subject unsuitable for the study or would prevent compliance with the study protocol 
4) Criterion modified per amendment 9 
4.1) Females who may wish to become pregnant and/or plan to undergo egg donation or 
egg harvesting for the purpose of current or future fertilization during the course of the 
study and for at least 30 days after the last dose of study drug 
5) Criterion deleted per amendment 9 
6) Criterion modified per amendment 9 
6.1) Females of reproductive potential who are unwilling to abide by protocol-specified 
contraceptive methods as defined in Appendix 6 
7) Use of prohibited concomitant medications as outlined in Section 5.4.2 
5. 
INVESTIGATIONAL MEDICINAL PRODUCTS 
5.1. 
Randomization, Blinding and Treatment Codes 
In the event of a medical emergency where breaking the blind is required to provide medical care 
to the subject, the investigator may obtain treatment assignment directly from the interactive web 
response system (IWRS) for that subject. The Sponsor recommends but does not require that the 
investigator contact the medical monitor before breaking the blind. Treatment assignment should 
remain blinded unless that knowledge is necessary to determine subject emergency medical care. 
The rationale for unblinding must be clearly explained in source documentation and on the 
eCRF, along with the date on which the treatment assignment was obtained. The investigator is 
requested to contact the medical monitor promptly in case of any treatment unblinding. 
Blinding of study treatment is critical to the integrity of this clinical trial; therefore, if a subject’s 
treatment assignment is disclosed to the investigator, the subject will have study treatment 
discontinued (unless study-wide unblinding occurs or is specific to subjects previously enrolled 
in a given parent study [GS-US-419-4015, GS-US-419-4016, GS-US-419-3895, or any other 
Gilead/Galapagos-sponsored filgotinib treatment study for CD]). All subjects will be followed 
until study completion unless consent to do so is specifically withdrawn by the subject. 
The Sponsor may independently unblind cases for expedited reporting of suspected unexpected 
serious adverse reactions (SUSARs). 
5.1.1. 
Blinding 
During the blinded treatment phase, subjects and all personnel directly involved in the conduct of 
the study will be blinded to treatment assignment. Specified personnel may be unblinded based 
on their study role. Study drug will be dispensed by the study pharmacist, or designee, in a 
blinded fashion to the subjects. Individuals in Clinical Packaging & Labeling or Clinical Supply 


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Management who have an Unblinded Inventory Manager role in the IWRS for purposes of study 
drug inventory management will remain unblinded. Individuals responsible for safety signal 
detection, investigational new drug safety reporting, and/or expedited reporting of SUSARs may 
be unblinded to individual case data and/or group level summaries. External (ie, contract 
research organizations) Biostatisticians and Programmers will be unblinded to verify treatment 
assignment and to support data monitoring committee data review if needed. Regulatory Quality 
and Compliance personnel in Research and Development may also be unblinded for purposes of 
supporting Quality Assurance activities and/or Regulatory Agency inspections. 
5.2. 
Description and Handling of Filgotinib and Placebo to Match 
(PTM) 
5.2.1. 
Formulation  
Filgotinib is available as 200 mg and 100 mg strength tablets. Filgotinib tablets, 200 mg and 
100 mg are beige, debossed with “GSI” on one side and “200” or “100” on the other, 
capsule-shaped, biconvex, film-coated tablets for clinical use. Each tablet contains the equivalent 
of 200 mg or 100 mg filgotinib free base in the form of filgotinib maleate. In addition to the 
active ingredient, filgotinib tablets contain the following inactive ingredients: microcrystalline 
cellulose, lactose monohydrate, fumaric acid, pregelatinized starch, silicon dioxide, magnesium 
stearate, macrogol/polyethylene glycol (PEG) 3350, polyvinyl alcohol, talc, titanium dioxide, 
iron oxide yellow, and iron oxide red. 
Placebo-to-match (PTM) filgotinib 200 mg and 100 mg tablets are identical to the respective 
active tablets, in appearance. PTM filgotinib 200 mg and 100 mg tablets contain the following 
inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, 
magnesium stearate, macrogol/PEG 3350, polyvinyl alcohol, talc, titanium dioxide, iron oxide 
yellow, and iron oxide red. 
5.2.2. 
Packaging and Labeling  
Filgotinib and PTM filgotinib tablets are packaged in white, high density polyethylene (HDPE) 
bottles. Each bottle contains 30 tablets, silica gel desiccant and polyester packing material. Each 
bottle is enclosed with a white, continuous thread, child-resistant polypropylene screw cap fitted 
with an induction-sealed, aluminum-faced liner. 
Study drugs to be distributed to centers in the US, EU and other participating countries shall be 
labeled to meet applicable requirements of the US Food and Drug Administration (FDA), EU 
Guideline to Good Manufacturing Practice − Annex 13 (Investigational Medicinal Products), 
and/or other local regulations, as applicable. 
5.2.3. 
Storage and Handling  
Filgotinib and PTM filgotinib tablets should be stored at controlled room temperature of 
25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Storage 
conditions are specified on the label. Until dispensed to the subjects, all bottles of study drugs 
should be stored in a securely locked area, accessible only to authorized site personnel. 


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To ensure the stability and proper identification, study drugs should not be stored in a container 
other than the container in which they were supplied. Consideration should be given to handling, 
preparation, and disposal through measures that minimize drug contact with the body. 
Appropriate precautions should be followed to avoid direct eye contact or exposure when 
handling. 
5.3. 
Dosage and Administration 
The study medication will consist of 200 mg and 100 mg filgotinib tablets and PTM 200 mg and 
100 mg filgotinib tablets for oral administration, to be taken once a day. 
For missed dose(s) of study medication, subjects should be instructed to take the missed dose(s) 
of study medication as soon as possible during the same day. If the missed dose is not taken on 
the original day, then subjects should not take the missed dose and the missed dose should be 
returned to the study drug bottle. Subjects should be cautioned not to double the next dose 
(ie, taking the missed dose of study drug with that day’s dose). 
5.4. 
Prior and Concomitant Medications 
At each study visit, the study center will record any and all concomitant medications taken by the 
subject since the last visit or during the visit (as applicable). All concomitant medications 
(prescription, peri-procedural medications, over-the-counter medications, including vaccines, 
vitamins, herbal, dietary supplements, and minerals) must be recorded in the concomitant 
therapy section of the eCRF. 
Effective current therapies should not be discontinued for the sole purpose of participating in this 
study. Subjects may receive medications as supportive care or to treat AEs as deemed necessary 
by the Investigator or the subject’s physician. Should subjects have a need to initiate treatment 
with any excluded concomitant medication, the medical monitor should be consulted prior to 
initiation of the new medication. In instances where an excluded medication is initiated prior to 
discussion with the Sponsor, the Investigator should notify the Sponsor as soon as he/she is 
aware of the use of the excluded medication. 
5.4.1. 
Allowed Concomitant Medications 
Doses for allowed concomitant medications for CD must remain within the acceptable dose 
limits from the parent protocol. Steroids cannot exceed prednisone at a prescribed dose of 
30 mg/day equivalents. Discontinuation or dose modifications within the limits of allowed doses 
are permitted at the discretion of the investigator. 
The allowed medications for CD are as follows: 
• Oral 5-ASA compounds  
• Azathioprine, 6-MP, or MTX* 
• Oral corticosteroid therapy (prednisone at ≤ 30 mg/day or budesonide at a dose 
of ≤ 9 mg/day) 


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• Antidiarrheals for chronic diarrhea 
• Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) consistent with 
subject’s standard low-dose regimen or cyclic therapy 
*Subjects enrolling into this study from the GS-US-419-4016 study and are taking concomitant 
vedolizumab may continue to take vedolizumab during their participation in this study. These 
subjects cannot take concomitant azathioprine, 6-MP, or MTX. 
5.4.2. 
Prohibited Concomitant Medications 
The prohibited medications are as follows: 
Table 5-1. Prohibited Concomitant Medications 
Drug Class 
Agents Disallowed 
Strong P-gp Inducersa 
Anticonvulsants 
Phenobarbital, phenytoin, carbamazepine 
Antimycobacterials 
Rifabutin, rifapentine, rifampin 
Herbal/Natural Supplements 
St. John’s wort, danshen (Salvia Miltiorrhiza) 
Prohibited IBD Medications 
Corticosteroids 
Dose equivalent to > 30 mg/day of prednisone 
TNFα antagonist 
Infliximab, adalimumab, golimumab, certolizumab, or biosimilar agent 
Integrin antagonist 
Vedolizumabb and natalizumab 
Interleukin antagonist 
Ustekinumab 
JAK inhibitor 
Any JAK inhibitors including but not limited to tofacitinib, baricitinib, 
and upadacitinib 
Other (non-biologic) 
Cyclosporine, thalidomide, tacrolimus, leflunomide and any 
investigational agent 
Investigational biologics 
Any investigational biologic agent 
Lymphocyte-depleting therapies 
Alemtuzumab, cyclophosphamide, total lymphoid irradiation, rituximab, 
and any other lymphocyte-depleting therapy 
Other Prohibited Medications 
Chronic Nonsteroidal 
Anti-inflammatory Drugs (NSAIDs)c  
Aspirin, ibuprofen, naproxen, diclofenac, indomethacin, 
COX-2 inhibitors 
Other biologicsd 
Antibody based or other systemic biologics, eg, denosumab, trastuzumab 
Abbreviations: COX-2=Cyclooxygenase-2; JAK=Janus Kinase; NSAID=Nonsteroidal Anti-inflammatory Drugs; TNFα=tumor 
necrosis factor-alpha 
a 
May decrease study drug exposure and are excluded to avoid potential reduction in study drug activity. Pharmacokinetic 
(PK) results indicate that filgotinib is a P-gp substrate, as a single dose of 200 mg itraconazole (a potent P-gp inhibitor) 
increased filgotinib Cmax by 64% and AUCinf by 45% and had no effect on the major, active metabolite GS-829845. 
b 
Subjects enrolling into this study from the GS-US-419-4016 study and are taking concomitant vedolizumab may continue to 
take vedolizumab during their participation in this study. 
c 
Occasional use of NSAIDs for transient symptoms and daily use of aspirin up to 162.5 mg for the purpose of cardiovascular 
prophylaxis are permitted. 
d 
Other biologics may be allowed with the approval of the medical monitor 


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5.5. 
Vaccine Guidelines 
• Prior to study participation, it is recommended that the subject’s vaccinations be brought up 
to date according to local vaccination standards. 
• Live or attenuated vaccines (including, but not limited to varicella and inhaled flu vaccine) 
are prohibited within 30 days of Day 1, throughout the study, and for 12 weeks after the 
last dose of study drug. 
• Subjects should be advised to avoid routine household contact with persons vaccinated with 
live/attenuated vaccine components. General guidelines suggest that a study subject’s 
exposure to household contacts should be avoided for the below stated time periods: 
⎯ Varicella or attenuated typhoid fever vaccination–avoid contact for 4 weeks following 
vaccination 
⎯ Oral polio vaccination–avoid contact for 6 weeks following vaccination 
⎯ Attenuated rotavirus vaccine–avoid contact for 10 days following vaccination 
⎯ Inhaled flu vaccine–avoid contact for 1 week following vaccination 
• Inactivated vaccines (such as inactivated flu vaccines) should be administered according to 
local vaccination standards whenever medically appropriate; however, there are no available 
data on the concurrent use of filgotinib and its impact on immune responses following 
vaccination. 
5.6. 
Accountability for Study Drug  
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug. This includes acknowledgement of receipt of each shipment of study drug (quantity and 
condition). All used and unused study drug dispensed to subjects must be returned to the site. 
Study drug accountability records will be provided to each study site to: 
• Record the date received and quantity of study drug 
• Record the date, subject number, subject initials, the study drug number dispensed 
• Record the date, quantity of used and unused study drug returned, along with the initials of 
the person recording the information 
5.6.1. 
Investigational Medicinal Product Return or Disposal 
Please refer to Section 9.1.7. 


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6. 
STUDY PROCEDURES 
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows.  
The investigator must document any deviation from protocol procedures and notify the Sponsor 
or contract research organization (CRO). 
6.1. 
Subject Enrollment and Treatment Assignment 
Subjects who meet the eligibility criteria at Day 1 will be enrolled. Dosing regimen is determined 
by regimen in parent study and reason for exit (reference Section 3.3. for details).  
6.2. 
Pretreatment Assessments 
6.2.1. 
Day 1 Visit 
LTE Day 1 Rollover from GS-US-419-3895 
Subjects that meet protocol specified non-response criteria based on Week 10 assessments in the 
GS-US-419-3895 study may enter this study after completing the Week 11 visit procedures in 
the GS-US-419-3895 study. After LTE consent is obtained, complete all Day 1 LTE procedures 
that are not duplicates of Week 11 procedures in the GS-US-419-3895 study.  
Subjects that meet the protocol specified disease worsening criteria in the GS-US-419-3895 
study may enter the LTE study after completing the visit procedures on the GS-US-419-3895 
study. The Day 1 LTE visit must occur within a 10 day window from the confirmatory visit that 
determined their disease worsening status in the GS-US-419-3895 study. After LTE consent is 
obtained, complete all Day 1 LTE procedures. 
Subjects that potentially meet protocol specified disease worsening criteria based on Week 58 
assessments in the GS-US-419-3895 study must have their Day 1 LTE within a 10 day window 
from the Week 58 visit, while awaiting laboratory results in order to complete the CDAI 
calculation. The potential meeting of protocol specified disease worsening criteria occurs if the 
second consecutive visit coincides with the Week 58 visit. All Week 58 procedures must be 
completed from the GS-US-419-3895 study. After LTE consent is obtained, complete all Day 1 
LTE procedures that are not duplicates of Week 58 procedures in the GS-US-419-3895 study. 
Subjects that complete Week 58 and do not meet protocol specified disease worsening criteria in 
the GS-US-419-3895 study may enter this study after completing the Week 58 procedures in the 
GS-US-419-3895 study. After LTE consent is obtained, complete all Day 1 LTE procedures that 
are not duplicates of Week 58 procedures in the GS-US-419-3895 study. 
LTE Day 1 Rollover from GS-US-419-4015 or GS-US-419-4016 
Subjects that are non-responders based on Week 10 assessments in the prior study must return 
for the Day 1 LTE visit within 10 days of Week 10. All Day 1 LTE procedures must be 
completed. 


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Subjects that met protocol specified disease worsening criteria in the prior study should have 
their Day 1 LTE visit within a 10 day window from the confirmatory visit that determined their 
disease worsening status. All Day 1 LTE procedures must be completed. 
Subjects that have completed the prior study up to and including Week 24 and did not meet 
protocol specified disease worsening criteria in the prior study should have their Day 1 LTE visit 
on the same day as Week 24. All Week 24 procedures must be completed along with any 
non-duplicate Day 1 LTE procedures.  
Subjects that flare at the time of their Week 24 visit may require visit rescheduling in order to 
have confirmation of disease worsening status. Under these circumstances, the Day 1 LTE visit 
cannot be scheduled until their final status is known. At this time, the Day 1 LTE visit should be 
scheduled within a 10 day window from the confirmatory visit to determine disease worsening 
status. 
LTE Day 1 Rollover from any other filgotinib treatment study for CD 
Subjects that have completed* a Gilead/Galapagos-sponsored parent study may enter this study 
up to 30 days after completing the end of study procedures in the parent study. After LTE 
consent is obtained, complete all Day 1 LTE procedures. 
*A subject is defined as completed if they have completed all study visits and procedures as 
defined in the protocol or have completed treatment up to the primary endpoint. 
Please refer to the Phase 2 studies’ subject rollover manual for details on rollover procedures. 
Day 1 LTE Procedures 
Subjects will be screened to ensure eligibility, and if confirmed, subjects will be enrolled on the 
same day and study drug dispensed. The following will be performed and documented at this 
visit: 
• Obtain written informed consent 
• Review inclusion/exclusion criteria and other protocol restrictions (Sections 4.2 and 4.3) 
• Review medical history (ongoing AEs from prior filgotinib treatment studies should be 
recorded as medical history) 
• Review AEs and concomitant medications 
• TB Assessment QuantiFERON® (or centrally reported equivalent assay)  
• Review electronic diary (e-Diary) for completion from prior filgotinib treatment study when 
available and remind subjects of diary instructions 
• Collect the variables to calculate CDAI score (reference Appendix 4) 
⎯ Site enters patient assessments from Day 1 visit 
⎯ CDAI score calculated centrally after all components have been captured electronically 


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• Baseline PRO2 (reference Appendix 4) – centrally calculated using the patient reported 
symptoms of stool frequency and abdominal pain captured in the electronic diary 
• Symptom-directed physical examination (PE)  
• Transfer a copy of the subject’s last perianal fistulae assessment into source documentation 
(for subjects rolling over from GS-US-419-4016 only)  
• Obtain weight and height  
• Obtain vital signs (resting blood pressure, respiratory rate, pulse, and temperature) 
• Obtain blood samples (reference Study Procedures Table [Appendix 2]) 
⎯ HBV Surveillance Guidelines 
■ Subjects with positive HBcAb and HBV DNA < LLOQ in a parent CD protocol will 
require ongoing HBV DNA monitoring every 3 months during this study. These 
subjects may also require prophylactic treatment per investigator discretion in 
accordance with local guidelines/standard of care.   
■ In Japan and where required by local guidelines, subjects with positive HBcAb and/or 
positive HBsAb but with HBV DNA < LLOQ in a parent CD protocol will require 
ongoing HBV DNA monitoring every 4 weeks for at least 12 months after starting 
study drug in accordance with local guidelines during this study.   
■ Any subject who has HBV DNA ≥ LLOQ during the study will be discontinued 
(reference Section 3.5.2). 
• 
 
 
 
• Obtain stool samples (reference Study Procedures Table [Appendix 2])  
• Obtain urine sample (reference Study Procedures Table [Appendix 2]) 
⎯ Sample will be used for urinalysis and pregnancy test (for females of childbearing 
potential only) 
• Administer 
 surveys to subject 
• Enter subject information in the IWRS to receive assignment 
• Dispense study drug as directed by the IWRS 
• Instruct the subject on the packaging, storage, and administration of the study drug 
• Document first dose in LTE for the subject–If a subject has already taken study drug for that 
day within the parent protocol, first dose should take place on Day 2. 


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Please refer to Section 7 Adverse Events and Toxicity Management for details regarding the 
reporting of AEs and SAEs. 
6.3. 
Treatment Assessments 
6.3.1. 
Week 2 and Week 4 (± 3 days) 
On Week 2 and Week 4, the following evaluations are to be completed: 
• Review AEs and concomitant medications 
• Review e-Diary for completion and remind subjects of diary instructions 
• Collect the variables to calculate CDAI score (reference Appendix 4)  
⎯ Site enters patient assessments at each visit 
⎯ CDAI score calculated centrally after all components have been captured electronically 
• PRO2 (reference Appendix 4) – calculated centrally  
• Symptom-directed PE  
• Obtain weight  
• Obtain vital signs (resting blood pressure, respiratory rate, pulse, and temperature) 
• Obtain blood samples (reference Study Procedures Table [Appendix 2]) 
• Obtain urine sample (reference Study Procedures Table [Appendix 2]) 
⎯ Pregnancy test (for females of child-bearing potential only) –Week 4 only 
• Dispense study drug as directed by the IWRS–Week 4 only 
6.3.2. 
Every 4 Weeks From Day 1 (± 7 days) 
Once every 4 weeks from Day 1 until EoT or early discontinuation, women of childbearing 
potential must have a urine pregnancy test. The test will be performed at home or in the clinic if 
it coincides with a scheduled visit. In case of home urine pregnancy testing, the site will contact 
the subject to obtain the results and will record the information in the eCRF. For subjects in the 
US, all pregnancy tests will be carried out in the clinic. If any pregnancy test is positive, study 
drug should be immediately interrupted and the subject should have a serum pregnancy test in 
clinic. 


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6.3.3. 
Week 12 and Then Every 12 Weeks Thereafter From Day 1 (± 7 days) 
On Week 12 and then every 12 weeks thereafter from Day 1 until EoT or early discontinuation, 
the following evaluations are to be completed: 
• Review AEs and concomitant medications 
• Review e-Diary for completion and remind subjects of diary instructions 
• Collect the variables to calculate CDAI score (reference Appendix 4)  
⎯ Site enters patient assessments at each visit 
⎯ CDAI score calculated centrally after all components have been captured electronically 
• PRO2 (reference Appendix 4) – calculated centrally  
• Symptom-directed PE  
• Complete perianal fistulae assessment (for subjects rolling over from GS-US-419-4016 only)  
• Obtain weight  
• Obtain vital signs (resting blood pressure, respiratory rate, pulse, and temperature) 
• Obtain blood samples (reference Study Procedures Table [Appendix 2]) 
• Dispense study drug as directed by the IWRS 
6.3.4. 
Every 24 Weeks From Day 1 (± 7 days) 
Once every 24 weeks from Day 1 until EoT or early discontinuation, the following evaluations 
are to be completed: 
• Obtain fasting (8 hours with no food or drink except water) blood samples (reference Study 
Procedures Table [Appendix 2]) 
• Obtain stool samples (reference Study Procedures Table [Appendix 2]) 
 
  
• Obtain urine sample for urinalysis (reference Study Procedures Table [Appendix 2]) 


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6.3.5. 
Every 48 Weeks From Day 1 (± 7 days) 
Once every 48 weeks from Day 1 until EoT or early discontinuation, the following evaluations 
are to be completed: 
• TB Assessment (See Section 3.5.1 for further information) 
• Perform 12-lead ECG 
 
6.3.6. 
End of Treatment Visit 
The EoT visit will be scheduled when filgotinib becomes commercially available in the country 
or prior to the end of study on 31 January 2025, whichever comes first. 
The same assessments as for the Early Termination visit should be performed at the EoT visit 
(Section 6.6). 
6.4. 
Safety 
6.4.1. 
Thromboembolic Events 
Subjects experiencing a thromboembolic event should be evaluated for the overall risk of 
recurrent thromboembolism and referred to a specialist for further testing as appropriate 
(including but not limited to evaluation for an underlying inherited hypercoagulable state).  
6.5. 
Post-Treatment Assessments (± 3 days) 
All subjects must complete the Post-Treatment (PTx) assessments 30 days after the last dose of 
study drug. 
The following evaluations are to be completed: 
• Symptom-directed PE 
• Complete perianal fistulae assessment (for subjects rolling over from GS-US-419-4016 only)  
• Obtain weight  
• Review AEs and concomitant medications 
• Obtain vital signs (resting blood pressure, respiratory rate, pulse and temperature) 
• Obtain blood samples (reference Study Procedures Table [Appendix 2]) 
• Obtain urine sample (reference Study Procedures Table [Appendix 2]) 


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⎯ Sample will be used for pregnancy test (for females of childbearing potential only) 
6.6. 
Early Termination Assessments  
Early termination assessments should occur after the corresponding parent study is unblinded for 
all subjects who were receiving placebo. In addition, early termination assessments should occur 
for any subject who discontinues the study due to meeting study drug discontinuation criteria 
(see Section 3.5.2 Study Drug Discontinuation Considerations).  
The following evaluations are to be completed: 
• Review AEs and concomitant medications 
• Obtain vital signs (resting blood pressure, respiratory rate, pulse and temperature) 
• Symptom-directed PE  
• Complete perianal fistulae assessment (for subjects rolling over from GS-US-419-4016 only)  
• Obtain weight  
• Obtain blood samples (reference Study Procedures Table [Appendix 2]) 
• Obtain urine sample (reference Study Procedures Table [Appendix 2])  
⎯ Sample will be used for pregnancy test (for females of childbearing potential only) 
• Collect the variables to calculate CDAI score (reference Appendix 4)  
⎯ Site enters patient assessments at each visit 
⎯ CDAI score calculated centrally after all components have been captured electronically 
• PRO2 (reference Appendix 4) – calculated centrally 
6.7. 
Assessments After Study Unblinding  
After study unblinding, subjects who were receiving placebo will discontinue study drug and 
study participation. Subjects should attend the clinic at their next scheduled study visit or earlier 
during an unscheduled visit and undergo the early termination assessments as described in 
Section 6.6 followed by the PTx assessments 30 days after the last dose of study drug (see 
Section 6.5). 
After study unblinding, subjects who were receiving active filgotinib will continue to receive the 
same dose (as received blinded) of open-label filgotinib dosing. Subjects should attend the clinic 
at their next scheduled study visit and complete study procedures as per their next scheduled 
study visit.  


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6.8. 
End of Study 
Please refer to Section 3.7. 
6.9. 
Post Study Care 
Please refer to Section 3.8. 
6.10. 
Clinical Laboratory Assessments 
Please refer to Appendix 7. 
7. 
ADVERSE EVENTS AND TOXICITY MANAGEMENT 
7.1. 
Definitions of Adverse Events, Adverse Reactions, and 
Serious Adverse Events 
7.1.1. 
Adverse Events 
An adverse event (AE) is any untoward medical occurrence in a clinical study subject 
administered an investigational product, which does not necessarily have a causal relationship 
with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or 
disease temporally associated with the use of an investigational product, whether or not 
considered related to the investigational product. Adverse Events may also include pre- or 
post-treatment complications that occur as a result of protocol specified procedures, lack of 
efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that 
increase in severity or change in nature during or as a consequence of participation in the clinical 
study will also be considered AEs. 
An AE does not include the following: 
• Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion. 
The condition that led to the procedure may be an adverse event and must be reported. 
• Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen 
• Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions) 
• Overdose without clinical sequelae (See Section 7.7.1) 
• Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
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7.1.2. 
Serious Adverse Events 
A serious adverse event (SAE) is defined as an event that, at any dose, results in the following: 
• Death 
• Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.) 
• In-patient hospitalization or prolongation of existing hospitalization 
• Persistent or significant disability/incapacity 
• A congenital anomaly/birth defect 
• A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. For the avoidance of doubt, infections resulting from contaminated 
investigational product will be considered a medically important event and subject to 
expedited reporting requirements. 
7.2. 
Assessment of Adverse Events and Serious Adverse Events 
The investigator or qualified sub-investigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments. 
7.2.1. 
Assessment of Causality for Study Drugs and Procedures 
The investigator or qualified sub-investigator is responsible for assessing the relationship to IMP 
therapy using clinical judgment and the following considerations: 
• No: Evidence exists that the adverse event has an etiology other than the IMP. For SAEs, an 
alternative causality must be provided (eg, pre-existing condition, underlying disease, 
intercurrent illness, or concomitant medication). 
• Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product. 
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of adverse event reporting.  


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The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations: 
• No: Evidence exists that the adverse event has an etiology other than the study procedure. 
• Yes: The adverse event occurred as a result of protocol procedures (eg, venipuncture) 
7.2.2. 
Assessment of Severity 
The severity of AEs will be graded using the modified Common Terminology Criteria for 
Adverse Events (CTCAE), Version 4.03. For each episode, the highest grade attained should be 
reported. 
If a CTCAE criterion does not exist, the investigator should use the grade or adjectives: 
Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) or 
Grade 5 (fatal) to describe the maximum intensity of the adverse event. For purposes of 
consistency with the CTCAE, these intensity grades are defined in Table 7-1 and Appendix 5. 
Table 7-1. Grading of Adverse Event Severity 
Grade 
Adjective 
Description 
Grade 1 
Mild 
Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated 
Grade 2 
Moderate 
Local or noninvasive intervention indicated; limiting age-appropriate instrumental 
ADL 
Grade 3 
Severe 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-
care ADL 
Grade 4 
Life-threatening 
Urgent intervention indicated 
Grade 5 
Death 
Death related AE 
* 
Activities of Daily Living (ADL) Instrumental ADL refer to opening preparing meals, shopping for groceries or clothes, 
using the telephone, managing money, etc.  
** Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden  
7.3. 
Investigator Requirements and Instructions for Reporting Adverse 
Events and Serious Adverse Events to the Sponsor 
Requirements for collection prior to initiation of Day 1 LTE IMP: 
After informed consent, but prior to initiation of Day 1 LTE IMP, the following types of events 
should be reported on the eCRF: all SAEs and adverse events related to protocol mandated 
procedures. 


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7.3.1. 
Adverse Events 
Non-serious Adverse Events that occur prior to initiation of Day 1 LTE IMP: 
After LTE informed consent is signed, but prior to initiation of Day 1 LTE IMP, all non-serious 
AEs related to LTE protocol-mandated procedures must be reported on the LTE electronic case 
report form (eCRF). 
All other non-serious events that occur after LTE informed consent is signed, but prior to 
initiation of Day 1 LTE IMP, should be reported on the parent Study eCRFs. 
Non-serious Adverse Events that occur after initiation of Day 1 LTE IMP:  
Following initiation of Day 1 LTE IMP, all non-serious AEs, regardless of cause or relationship, 
until 30 days after last administration of LTE IMP, must be reported on the LTE eCRF. 
All AEs should be followed up until resolution or until the adverse event is stable, if possible. 
The Sponsor may request that certain AEs be followed beyond the protocol defined follow-up 
period. 
7.3.2. 
Serious Adverse Events 
Serious Adverse Events that occur prior to initiation of Day 1 LTE IMP: 
After LTE informed consent is signed, but prior to initiation of Day 1 LTE IMP, all SAEs related 
to LTE protocol-mandated procedures must be reported on the LTE eCRF. 
All other SAEs that occur after informed consent is signed for the parent study, but prior to 
initiation of Day 1 of the LTE IMP must be reported in the parent study eCRF.  
Serious Adverse Events that occur after initiation of Day 1 LTE IMP: 
All SAEs, regardless of causal relationship, must be reported to LTE study eCRF and the 
Sponsor from initiation of Day 1 of the LTE IMP and throughout the duration of the LTE study 
(including the protocol-required post treatment follow-up period).  
General SAE Guidance: 
Any SAEs and deaths that occur after the post-treatment follow-up visit but within 30 days of the 
last dose of study IMP, regardless of causality, should also be reported.  
Investigators are not obligated to actively seek SAEs after the protocol defined follow-up period. 
However, if the investigator learns of any SAEs that occur after study participation has 
concluded and the event is deemed relevant to the use of IMP, he/she should promptly document 
and report the event to the Sponsor. 
• All AEs and SAEs will be recorded in the eCRF database within the timelines outlined in the 
eCRF completion guideline.  


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• At the time of study start, SAEs may be reported using a paper serious adverse event 
reporting form. During the study conduct, sites may transition to an electronic SAE (eSAE) 
system. 
Electronic Serious Adverse Event Reporting Process 
• Site personnel record all SAE data in the eCRF database and from there transmit the SAE 
information to the Sponsor within 24 hours of the investigator’s knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines. 
• If for any reason it is not possible to record the SAE information electronically, ie, the eCRF 
database is not functioning, record the SAE on the paper serious adverse event reporting 
form and submit within 24 hours as described below. 
Email:  
DIVERSITYLTE_safety@glpg.com 
• As soon as it is possible to do so, any SAE reported via paper must be transcribed into the 
eCRF Database according to instructions in the eCRF completion guidelines. 
• If an SAE has been reported via a paper form because the eCRF database has been locked, 
no further action is necessary. 
• For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers. 
• Additional information may be requested to ensure the timely completion of accurate safety 
reports. 
• Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s eCRF and the event description section of the SAE form. 
7.4. 
Sponsor Reporting Requirements 
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations (CFR), the EU Clinical Trials Directive (2001/20/EC) and relevant updates, 
and other country-specific legislation or regulations, the Sponsor may be required to expedite to 
worldwide regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), 
or SUSARs. In accordance with the EU Clinical Trials Directive (2001/20/EC), the Sponsor or a 
specified designee will notify worldwide regulatory agencies and the relevant IRB/IEC in 
concerned Member States of applicable SUSARs as outlined in current regulations.  
Assessment of expectedness for SAEs will be determined by the Sponsor or designee using 
reference safety information specified in the investigator's brochure (IB) or relevant local label as 
applicable.  


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All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study IMP. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 
7.5. 
Clinical Laboratory Abnormalities and Other Abnormal 
Assessments as Adverse Events and Serious Adverse Events   
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (eg, clinical chemistry, hematology, and urinalysis) independent of the underlying 
medical condition that require medical or surgical intervention or lead to investigational 
medicinal product interruption or discontinuation must be recorded as an AE, as well as an SAE, 
if applicable. In addition, laboratory or other abnormal assessments (eg, ECG, x-rays, vital signs) 
that are associated with signs and/or symptoms must be recorded as an AE or SAE if they meet 
the definition of an AE (or SAE) as described in Sections 7.1.1 and 7.1.2. If the laboratory 
abnormality is part of a syndrome, record the syndrome or diagnosis (ie, anemia) not the 
laboratory result (ie, decreased hemoglobin). 
Severity should be recorded and graded according to the CTCAE Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities (Appendix 5). For AEs associated with laboratory 
abnormalities, the event should be graded on the basis of the clinical severity in the context of 
the underlying conditions; this may or may not be in agreement with the grading of the 
laboratory abnormality. 
7.6. 
Toxicity Management 
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3, and as outlined below. 
Refer to Section 3.5, Criteria for Study Drug Interruption or Discontinuation, for additional 
specific discontinuation criteria. Specific toxicity discontinuation criteria in Section 3.5 
supersede below general toxicity guidelines, and in general, where discrepancy is present, the 
more conservative criteria apply. The medical monitor should be consulted prior to study drug 
discontinuation when medically feasible. 
7.6.1. 
Grades 1 and 2 Laboratory Abnormality or Clinical Event 
Continue study drug at the discretion of the investigator. 
7.6.2. 
Grade 3 Laboratory Abnormality or Clinical Event 
• For a Grade 3 clinically significant laboratory abnormality or clinical event, IMP may be 
continued if the event is considered to be unrelated to IMP. 
• For a Grade 3 clinical event, or clinically significant laboratory abnormality confirmed by 
repeat testing, that is considered to be related to IMP, IMP should be withheld until the 
toxicity returns to ≤ Grade 2. 


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• If a laboratory abnormality recurs to ≥ Grade 3 following re-challenge with IMP and is 
considered related to IMP, then IMP should be permanently discontinued and the subject 
managed according to local practice. Recurrence of laboratory abnormalities considered 
unrelated to IMP may not require permanent discontinuation. 
7.6.3. 
Grade 4 Laboratory Abnormality or Clinical Event 
For a Grade 4 clinical event or clinically significant Grade 4 laboratory abnormality confirmed 
by repeat testing that is considered related to IMP, IMP should be permanently discontinued and 
the subject managed according to local practice. The subject should be followed as clinically 
indicated until the laboratory abnormality returns to baseline or is otherwise explained, 
whichever occurs first. A clinically significant Grade 4 laboratory abnormality that is not 
confirmed by repeat testing should be managed according to the algorithm for the new toxicity 
grade. 
Investigational medicinal product may be continued without dose interruption for a clinically 
non-significant Grade 4 laboratory abnormality (eg, Grade 4 creatine kinase [CK] after strenuous 
exercise or triglyceride elevation that is nonfasting or that can be medically managed) or a 
clinical event considered unrelated to IMP. 
Treatment-emergent toxicities will be noted by the investigator and brought to the attention of 
the medical monitor, who will have a discussion with the investigator and decide the appropriate 
course of action. Whether or not considered treatment-related, all subjects experiencing AEs 
must be monitored periodically until symptoms subside, any abnormal laboratory values have 
resolved or returned to baseline levels or they are considered irreversible, or until there is a 
satisfactory explanation for the changes observed. Any questions regarding toxicity management 
should be directed to the medical monitor. The medical monitor should consult the medical 
leader as needed. 
7.7. 
Special Situations Reports 
7.7.1. 
Definitions of Special Situations 
Special situation reports include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, product complaints, counterfeit or falsified 
medicine, and pregnancy reports regardless of an associated AE. 
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of an investigational product while the medication is in the 
control of a health care professional, patient, or consumer. Medication errors may be classified as 
a medication error without an AE, which includes situations of missed dose; medication error 
with an AE; intercepted medication error; or potential medication error. 
Abuse is defined as persistent or sporadic intentional excessive use of an investigational product 
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Misuse is defined as any intentional and inappropriate use of an investigational product that is 
not in accordance with the protocol instructions or the local prescribing information. 
An overdose is defined as an accidental or intentional administration of a quantity of an 
investigational product given per administration or cumulatively which is above the maximum 
recommended dose as per protocol or in the product labeling (as it applies to the daily dose of the 
subject in question). In cases of a discrepancy in drug accountability, overdose will be 
established only when it is clear that the subject has taken the excess dose(s). Overdose cannot 
be established when the subject cannot account for the discrepancy except in cases in which the 
investigator has reason to suspect that the subject has taken the additional dose(s). 
Occupational exposure is defined as exposure to an investigational product as a result of one's 
professional or non-professional occupation.  
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction. 
Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial.  
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through an investigational product. 
Product complaint is defined as complaints arising from potential deviations in the manufacture, 
packaging, or distribution of the investigational product. 
Counterfeit or falsified medicine: Any investigational product with a false representation of: 
a) its identity, b) its source, or c) its history. 
7.7.2. 
Instructions for Reporting Special Situations 
7.7.2.1. 
Instructions for Reporting Pregnancies 
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study drug and throughout the study, including the post study drug follow-up period, 
to DIVERSITYLTE_safety@glpg.com using the pregnancy report form within 24 hours of 
becoming aware of the pregnancy.  
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on the mechanism 
of pregnancy reporting. 
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons. 
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the AE term. 


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A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.3. Furthermore, any SAE occurring as an adverse pregnancy outcome post study must 
be reported to DIVERSITYLTE_safety@glpg.com. 
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to DIVERSITYLTE_safety@glpg.com using the 
pregnancy outcome report form. If the end of the pregnancy occurs after the study has been 
completed, the outcome should be reported directly to DIVERSITYLTE_safety@glpg.com.  
Refer to Appendix 6 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements. 
7.7.2.2. 
Reporting Other Special Situations 
All other special situation reports must be reported on the special situations report form and 
forwarded to DIVERSITYLTE_safety@glpg.com within 24 hours of the investigator becoming 
aware of the situation. These reports must consist of situations that involve study drug, but do not 
apply to concomitant medications.  
Special situations involving concomitant medications do not need to be reported on the special 
situations report form; however, special situations that result in AEs due to a concomitant 
medication, must be reported as an AE.  
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation. 
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on special 
situations reporting. 
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE eCRF and/or the SAE report form. Details of the symptoms and 
signs, clinical management, and outcome will be reported, when available. 
8. 
STATISTICAL CONSIDERATIONS 
8.1. 
Analysis Objectives and Endpoints 
8.1.1. 
Analysis Objectives 
The primary analysis objective is: 
• To observe the long-term safety of filgotinib in subjects who have completed or met protocol 
specified discontinuation criteria in a prior filgotinib treatment study for CD 
The secondary analysis objective is: 
• To evaluate the effect of filgotinib on PRO2 and CDAI scores 






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8.6.2. 
Adverse Events 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term 
(HLT), Preferred Term (PT), and Lower-Level Term (LLT) will be attached to the clinical 
database. 
Treatment-Emergent Adverse Events (TEAEs) are defined as 1 or both of the following: 
• Any AEs with an onset date of on or after the study drug start date and no later than 30 days 
after permanent discontinuation of study drug 
• Any AEs leading to premature discontinuation of study drug 
Summaries (number and percentage of subjects) of TEAEs by SOC and PT will be provided. 
TEAEs will also be summarized by relationship to study drug and severity. In addition, TEAEs 
leading to premature discontinuation of study drug will be summarized and listed. 
8.6.3. 
Laboratory Evaluations 
Selected laboratory data (using conventional units) will be summarized using only observed data. 
Absolute value and change from baseline at all scheduled time points will be summarized. 
Graded laboratory abnormalities will be defined using the grading scheme defined in the 
CTCAE. 
Incidence of treatment-emergent laboratory abnormalities defined as values that increase at least 
one toxicity grade from baseline at any time post baseline will be summarized. If baseline data 
are missing, then any graded abnormality (ie, at least a Grade 1) will be considered treatment 
emergent. 
8.6.4. 
Other Safety Evaluations 
Individual data for PE findings, prior and concomitant medications and medical history will be 
provided. Vital signs measurements will be listed by subject and summarized by incidence of 
events/abnormalities or descriptive statistics as appropriate. 
8.7. 
Pharmacokinetic Analysis 
Not applicable. 
8.8. 
 
 
  




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• Myocardial Infarction 
• Stroke 
• Arterial thromboembolism 
• Venous thromboembolism (eg, deep venous thrombosis, pulmonary embolism) 
Further details will be specified in the CVEAC Charter.  
9. 
RESPONSIBILITIES 
9.1. 
Investigator Responsibilities 
9.1.1. 
Good Clinical Practice 
The investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki, International Council for Harmonisation (ICH) guidelines, or with the 
laws and regulations of the country in which the research is conducted, whichever affords the 
greater protection to the study subject. These standards are consistent with the EU Clinical Trials 
Directive 2001/20/EC and GCP Directive 2005/28/EC. 
The investigator will ensure adherence to the basic principles of GCP, as outlined in 
21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, and 
21 CFR, part 56. 
The investigator and all applicable sub-investigators will comply with 21 CFR, Part 54, 
providing documentation of their financial interest or arrangements with the Sponsor, or 
proprietary interests in the investigational drug under study. This documentation must be 
provided prior to the investigator’s (and any sub-investigator’s) participation in the study. The 
investigator and sub-investigator agree to notify the Sponsor of any change in reportable interests 
during the study and for 1 year following completion of the study. Study completion is defined 
as the date when the last subject completes the protocol-defined activities. 
9.1.2. 
Institutional Review Board/Independent Ethics Committee Review and 
Approval 
The investigator (or Sponsor as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the subject (such as 
advertisements, subject information sheets, or descriptions of the study used to obtain informed 
consent) to an IRB/IEC. The investigator will not begin any study subject activities until 
approval from the IRB/IEC has been documented and provided as a letter to the investigator. 
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study subjects. 


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9.1.3. 
Informed Consent 
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study and before undertaking any study-related procedures. The 
investigator must use the most current IRB/IEC-approved consent form for documenting written 
informed consent. Each informed consent (or assent as applicable) will be appropriately signed 
and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by IRB/IEC or 
local requirements. 
9.1.4. 
Confidentiality 
The investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only subject initials, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form or biological sample submitted to the Sponsor, IRB/IEC, or laboratory. Laboratory 
specimens must be labeled in such a way as to protect subject identity while allowing the results 
to be recorded to the proper subject. Refer to specific laboratory instructions or in accordance 
with local regulations. NOTE: The investigator must keep a screening log showing codes, and 
names for all subjects screened and for all subjects enrolled in the trial. Subject data will be 
processed in accordance with all applicable regulations.  
The investigator agrees that all information received from the Sponsor, including but not limited 
to the IB, this protocol, eCRF, the IMP, and any other study information, remain the sole and 
exclusive property of the Sponsor during the conduct of the study and thereafter. This 
information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from the 
Sponsor. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain. 
9.1.5. 
Study Files and Retention of Records 
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents. 
The investigator’s study file will contain the protocol/amendments, eCRF and query forms, 
IRB/IEC and governmental approval with correspondence, informed consent, drug records, staff 
curriculum vitae and authorization forms, and other appropriate documents and correspondence. 
The required source data should include sequential notes containing at least the following 
information for each subject: 
• Subject identification (name, date of birth, gender); 


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• Documentation that subject meets eligibility criteria, ie, history, PE, and confirmation of 
diagnosis (to support inclusion and exclusion criteria); 
• Documentation of the reason(s) a consented subject is not enrolled 
• Participation in study (including study number); 
• Study discussed and date of informed consent; 
• Dates of all visits; 
• Documentation that protocol specific procedures were performed; 
• Results of efficacy parameters, as required by the protocol; 
• Start and end date (including dose regimen) of IMP, including dates of dispensing and return; 
• Record of all AEs and other safety parameters (start and end date, and including causality 
and severity); 
• Concomitant medication (including start and end date, dose if relevant; dose changes); 
• Date of study completion and reason for early discontinuation, if it occurs. 
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (ie, US, Europe, or Japan) and until there are no pending or planned marketing 
applications in an ICH region; or, if no application is filed or if the application is not approved 
for such indication, until 2 years after the investigation is discontinued and regulatory authorities 
have been notified. Investigators may be required to retain documents longer if specified by 
regulatory requirements, by local regulations, or by an agreement with the Sponsor. The 
investigator must notify the Sponsor before destroying any clinical study records. 
Should the investigator wish to assign the study records to another party or move them to another 
location, the Sponsor must be notified in advance. 
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and the Sponsor to 
store these records securely away from the site so that they can be returned sealed to the 
investigator in case of an inspection. When source documents are required for the continued care 
of the subject, appropriate copies should be made for storage away from the site. 
9.1.6. 
Electronic Case Report Forms 
For each subject consented, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. The eCRF should 
be completed on the day of the subject visit to enable the Sponsor to perform central monitoring 
of safety data. The Eligibility Criteria eCRF should be completed only after all data related to 


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eligibility have been received. Subsequent to data entry, a study monitor will perform source data 
verification within the electronic data capture (EDC) system. Original entries as well as any 
changes to data fields will be stored in the audit trail of the system. Prior to database lock (or any 
interim time points as described in the clinical data management plan), the investigator will use 
his/her log in credentials to confirm that the forms have been reviewed, and that the entries 
accurately reflect the information in the source documents. The eCRF captures the data required 
per the protocol schedule of events and procedures. System-generated or manual queries will be 
issued to the investigative site staff as data discrepancies are identified by the monitor or the data 
management staff, who routinely review the data for completeness, correctness, and consistency. 
The site coordinator is responsible for responding to the queries in a timely manner, within the 
system, either by confirming the data as correct or updating the original entry, and providing the 
reason for the update (eg, data entry error). At the conclusion of the trial, the Sponsor will 
provide the site with a read-only archive copy of the data entered by that site. This archive must 
be stored in accordance with the records retention requirements outlined in Section 9.1.5. 
9.1.7. 
Investigational Medicinal Product Accountability and Return 
Where possible, IMP should be destroyed at the site. At the start of the study, the study monitor 
will evaluate each study center’s IMP disposal procedures and provide appropriate instruction for 
disposal or return of unused IMP supplies. If the site has an appropriate standard operating 
procedure (SOP) for drug destruction as determined by the Sponsor, the site may destroy used 
(empty or partially empty) and unused IMP supplies as long as performed in accordance with the 
site’s SOP. This can occur only after the study monitor has performed drug accountability during 
an on-site monitoring visit.  
A copy of the site’s IMP Disposal SOP or written procedure (signed and dated by the Principal 
Investigator [PI] or designee) will be obtained for the Sponsor site files. If the site does not have 
acceptable procedures in place, arrangements will be made between the site and the Sponsor 
(or the Sponsor’s representative) for return of unused study drug supplies.  
If IMP is destroyed on site, the investigator must maintain accurate records for all IMPs 
destroyed. Upon study completion, copies of the IMP accountability records must be filed at the 
site. Another copy will be returned to the Sponsor. 
The study monitor will review IMP supplies and associated records at periodic intervals. 
9.1.8. 
Inspections 
The investigator will make available all source documents and other records for this trial to the 
Sponsor’s appointed study monitors, to IRBs/IECs, or to regulatory authority or health authority 
inspectors. 
9.1.9. 
Protocol Compliance 
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. 


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9.2. 
Sponsor Responsibilities 
9.2.1. 
Protocol Modifications 
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by the Sponsor. The investigator must submit all protocol modifications to the 
IRB/IEC in accordance with local requirements and receive documented IRB/IEC approval 
before modifications can be implemented. 
9.2.2. 
Study Report and Publications 
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies). The 
Sponsor will ensure that the report meets the standards set out in the ICH Guideline for Structure 
and Content of CSRs (ICH E3). Note that an abbreviated report may be prepared in certain cases.  
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met: 
• The results of the study in their entirety have been publicly disclosed by or with the consent 
of the Sponsor in an abstract, manuscript, or presentation form or the study has been 
completed at all study sites for at least 2 years 
• The investigator will submit to the Sponsor any proposed publication or presentation along 
with the respective scientific journal or presentation forum at least 30 days before submission 
of the publication or presentation.  
• No such communication, presentation, or publication will include the Sponsor’s confidential 
information (See Section 9.1.4). 
• The investigator will comply with the Sponsor’s request to delete references to its 
confidential information (other than the study results) in any paper or presentation and agrees 
to withhold publication or presentation for an additional 60 days in order to obtain patent 
protection if deemed necessary. 
9.3. 
Joint Investigator/Sponsor Responsibilities 
9.3.1. 
Payment Reporting 
Investigators and their study staff may be asked to provide services performed under this 
protocol, eg, attendance at Investigator’s Meetings. If required under the applicable statutory and 
regulatory requirements, the Sponsor will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical trial payments, meal, travel 
expenses or reimbursements, consulting fees, and any other transfer of value. 


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9.3.2. 
Access to Information for Monitoring 
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
eCRF. 
The monitor is responsible for routine review of the eCRF at regular intervals throughout the 
study to verify adherence to the protocol and the completeness, consistency, and accuracy of the 
data being entered on them. The monitor should have access to any subject records needed to 
verify the entries on the eCRF. The investigator agrees to cooperate with the monitor to ensure 
that any problems detected through any type of monitoring (central, on site) are resolved. 
9.3.3. 
Access to Information for Auditing or Inspections 
Representatives of regulatory authorities or of the Sponsor may conduct inspections or audits of 
the clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the medical monitor immediately. The investigator agrees to provide 
to representatives of a regulatory agency or the Sponsor access to records, facilities, and 
personnel for the effective conduct of any inspection or audit. 
9.3.4. 
Study Discontinuation 
Both the Sponsor and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the appropriate 
regulatory authority(ies), IRBs, and IECs. In terminating the study, the Sponsor and the 
investigator will assure that adequate consideration is given to the protection of the subjects’ 
interests. 
10. 
REFERENCES 
Baumgart DC, Sandborn WJ. Crohn's disease. Lancet 2012;380 (9853):1590-605. 
Cheifetz AS. Management of active Crohn disease. JAMA 2013;309 (20):2150-8. 
Dignass A, Van Assche G, Lindsay JO, Lemann M, Soderholm J, Colombel JF, et al. The second 
European evidence-based Consensus on the diagnosis and management of Crohn's 
disease: Current management. Journal of Crohn's & colitis 2010;4 (1):28-62. 
Fukunaga K, Matsumoto T. Current status and future perspectives of leukocytapheresis for 
inflammatory bowel disease. J Gastroenterol Hepatol 2012;27 (6):997-1003. 
Ito H, Takazoe M, Fukuda Y, Hibi T, Kusugami K, Andoh A, et al. A pilot randomized trial of a 
human anti-interleukin-6 receptor monoclonal antibody in active Crohn's disease. 
Gastroenterology 2004;126 (4):989-96; discussion 47. 
Khanna R, Zou G, D'Haens G, Feagan BG, Sandborn WJ, Vandervoort MK, et al. A 
retrospective analysis: the development of patient reported outcome measures for 


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the assessment of Crohn's disease activity. Aliment Pharmacol Ther 2015;41 
(1):77-86. 
Korzenik JR. Investigational therapies in the medical management of Crohn disease. Available 
at: www.uptodate.com/contents/4076. UpToDate 2016. 
Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, et al. Increasing incidence 
and prevalence of the inflammatory bowel diseases with time, based on 
systematic review. Gastroenterology 2012;142 (1):46-54 e42; quiz e30. 
Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, et al. 
Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib 
(GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. 
Clin Pharmacokinet 2015;54 (8):859-74. 
Sandborn WJ, Feagan BG, Hanauer SB, Lochs H, Lofberg R, Modigliani R, et al. A review of 
activity indices and efficacy endpoints for clinical trials of medical therapy in 
adults with Crohn's disease. Gastroenterology 2002;122 (2):512-30. 
Ventham NT, Kennedy NA, Nimmo ER, Satsangi J. Beyond gene discovery in inflammatory 
bowel disease: the emerging role of epigenetics. Gastroenterology 2013;145 
(2):293-308. 
Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, et al. Clinical 
remission in patients with moderate-to-severe Crohn's disease treated with 
filgotinib (the FITZROY study): results from a phase 2, double-blind, 
randomised, placebo-controlled trial. Lancet 2017;389:266-75. 
 
 


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11. 
APPENDICES 
Appendix 1. Investigator Signature Page 
Appendix 2. Study Procedures Table 
Appendix 3. Management of Clinical and Laboratory Adverse Events 
Appendix 4. Crohn’s Disease Activity Index (CDAI) and Patient Reported Outcomes – 2 
items (PRO2) 
Appendix 5. CTCAE Grading Scale for Severity of Adverse Events 
Appendix 6. Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements 
Appendix 7. Clinical Laboratory Assessment Table 
 


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Appendix 1. Investigator Signature Page 
 
GALAPAGOS NV 
GENERAAL DE WITTELAAN L11 A3 
2800 MECHELEN 
BELGIUM 
 
STUDY ACKNOWLEDGEMENT 
 
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with 
Crohn’s Disease 
GS-US-419-3896 (GLPG0634-CL-310 [DIVERSITY LTE]),  
Amendment 9, 23 November 2022 
This protocol has been approved by Galapagos NV. The following investigator signature 
documents this approval. An electronic signature of the sponsor’s responsible person is provided 
at the end of the document. 
  
 
 
Signature 
 
 
 
Date 
 
 
INVESTIGATOR STATEMENT 
 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Galapagos NV. I will discuss this material with them to ensure that they 
are fully informed about the drugs and the study. 
 
 
 
Principal Investigator Name (Printed) 
 
Signature 
 
 
 
 
Date 
 
Site Number 


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Appendix 2. Study Procedures Table 
Study Procedures 
Day 1a 
Week 2 
Week 4 
Every 
4 Weeks 
from 
Day 1 
Week 12 
and then 
every 
12 Weeks 
from Day 
1 Clinic 
Visit 
Every 
24 Weeks 
from 
Day 1 
Clinic 
Visit 
Every 
48 Weeks 
from 
Day 1 
Clinic 
Visit 
Early 
Termination 
(ET) / End 
of 
Treatment 
Visit 
Post-
Treatment 
(PTx)b 
 
± 3 days 
± 3 days 
± 7 days 
± 7 days 
± 7 days 
± 7 days 
 
± 3 days 
Written Informed Consent 
X 
 
 
 
 
 
 
 
 
Review Inclusion/Exclusion 
Criteria  
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Symptom-Directed Examination 
(as needed) 
X 
X 
X 
 
X 
 
 
X 
X 
Perianal fistulae assessment 
(for subjects rolling over from 
GS-US-419-4016 only) c 
 
 
 
 
X 
 
 
X 
X 
Vital Signsd 
X 
X 
X 
 
X 
 
 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
Weight  
X 
X 
X 
 
X 
 
 
X 
X 
Hematology 
X 
X 
X 
 
X 
 
 
X 
X 
Chemistry 
X 
X 
X 
 
X 
 
 
X 
X 
Lipid Profile (fasting)e 
 
 
 
 
 
X 
 
 
 
Urinalysis 
X 
 
 
 
 
X 
 
 
 
Pregnancy Testf 
X 
 
X 
X 
 
 
 
X 
X 
HBV DNA monitoring (Japan)g 
X 
 
X 
X 
 
 
 
 
 
HBV DNA monitoring (other 
regions)h 
X 
 
 
 
X 
 
 
 
 




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a 
Day 1 visit for this study may occur at the same time as the final scheduled treatment visit of the prior filgotinib study or up to 30 days after completing the end of study 
procedures in the parent study, see Section 6.2.1. All procedures necessary for the final visit in the prior filgotinib study will be completed as well as any additional 
procedures required for this study. Procedures that are duplicates of the final visit from prior filgotinib study do not need to be performed again for this protocol. Day 1 may 
be delayed up to 10 days. If Day 1 of LTE is not the same as the last study visit of the prior study, a full set of Day 1 procedures should be performed. If a subject has already 
taken study drug for that day within the parent protocol, first dose should take place on Day 2.  
b 
The Post-Treatment (PTx) Visit should occur 30 days after the last dose of study drug. 
c 
The perianal fistula assessment entails tracking the clinical status of draining external openings of perianal fistulae that were identified at baseline of Study GS-US-419-4016. 
For additional details on the perianal assessment, refer to the Perianal Fistula Assessment Manual 
d 
Vital signs include resting blood pressure, respiratory rate, pulse, and temperature. 
e 
Fasting means no food or drink except water, for 8 hours 
f 
Females who are of childbearing potential only. A urine pregnancy test must be completed every 4 weeks at a minimum. The test will be performed at home or in the clinic if 
it coincides with a scheduled visit. In case of home urine pregnancy testing, the site will contact the subject to obtain the results and will record the information in the eCRF. 
For subjects in the US, all pregnancy tests will be carried out in the clinic. If any pregnancy test is positive, study drug should be immediately interrupted and the subject 
should have a serum pregnancy test in clinic.  
g 
In Japan, subjects with negative HBsAg, positive HBcAb and/or positive HBsAb in a parent CD protocol require HBV DNA monitoring every 4 weeks in accordance with 
local guidelines (Section 6.2.1).  
h 
In other regions, subjects with negative HBsAg and positive HBcAb require HBV DNA monitoring every 3 months in accordance with local guidelines (Section 6.2.1)  
i 
Subjects who were previously treated for TB do not need to have yearly QuantiFERON® (or centrally reported equivalent assay) tests but should be screened at least yearly 
for signs and symptoms of reactivation. 
j 
 
k 
 
l 
At Day 1 visit, review diary of subject reported components from parent study, if available. Subjects should begin filling out the Diary at the Day 1 visit and continue to fill it 
out throughout the study. 
m 
Colonoscopy with biopsies is optional per standard of care. The date of the procedure may be requested for accuracy of data analysis. 
n 
 
o 
Ongoing AEs from previous filgotinib studies should be recorded as medical history. Collection of AEs and SAEs related to protocol-mandated procedures will begin once 
informed consent is signed and will continue through the Post-Treatment (PTx) Visit. 


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Appendix 3. Management of Clinical and Laboratory Adverse Events 
 
 
Grade 1 
Grade 4 
Grade 3 
Grade 2 
May continue 
dosing at the 
discretion of the 
investigator 
Repeat lab to 
confirm toxicity 
grade 
Repeat lab to 
confirm toxicity 
grade 
If confirmed and possibly and/or probably related to 
investigational medicinal products: 
 
1.
Withhold investigational medicinal products until  
 Grade 2 
2.
Restart all investigational medicinal products at full dose 
If confirmed and unrelated to 
investigational medicinal 
products, dosing may continue at 
the discretion of the investigator 
If confirmed and 
possibly or probably 
related to 
investigational 
medicinal products, 
discontinue 
investigational 
medicinal products 
dosing permanently 
and follow at 
periodic intervals at 
least weekly until a 
return to baseline or 
is otherwise 
explained 
If Grade 3 or 4 recurrence that is confirmed and possibly or 
probably related to investigational medicinal products, 
discontinue all investigational medicinal products dosing 
permanently 
If Grade 3 or 4 recurrence that is considered unrelated to 
investigational medicinal products, continue all 
investigational medicinal products at the same dose at the 
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Appendix 4. Crohn’s Disease Activity Index (CDAI) and Patient Reported Outcomes – 2 
items (PRO2) 
The Crohn’s Disease Activity Index (CDAI) will be calculated as follows: 
Variable no. 
Variable 
Variable description 
Multiplier 
1 
Liquid or very soft stool 
Daily stool count is summed for 7 days 
2 
2 
Abdominal pain 
Sum of 7 days of daily ratings as 
5 
0 = none, 1 = mild, 2 = moderate, 3 = severe 
3 
General wellbeing 
Sum of 7 days of daily ratings as 
7 
0 = generally well, 1 = slightly below par, 2 = poor, 
3 = very poor, 4 = terrible 
4 
Complications 
Number of listed complications: 
20 each 
Arthritis or arthralgia 
Erythema nodosum, pyoderma gangrenosum or 
aphthous stomatitis 
Iritis or uveitis 
Anal fissures or fistulae or abscess 
Other fistula 
Fever over 37.8°C [100°F] during past week 
5 
Use of anti-diarrheal 
medications 
Use of diphenoxylate or loperamide or other opiate 
for diarrhea 
30 
0 = No, 1 = Yes 
6 
Abdominal mass 
0 = none, 2 = questionable, 5 = definite 
10 
7 
Hematocrit* 
Males: 47 – Hct [%] 
Females: 42 – Hct [%] 
6 × 
difference 
* Result must be greater than or equal to 0. If 
negative result enter 0 
8 
Weight* 
Percentage deviation from standard weight 
1 
(1 – weight / standard weight) × 100 
* Limit of -10 
CDAI score 
 
 
TOTAL 
CDAI = Crohn’s Disease Activity Index; Hct = hematocrit 
{Sandborn 2002} 
The patient reported outcomes of liquid or very soft stool and abdominal pain (PRO2) score will 
be assessed as follows:  
Variable 
no. 
Variable 
Variable description 
1 
Liquid or very soft stool 
Mean of the daily stool count for 7 days 
2 
Abdominal pain 
Mean of 7 days of daily ratings as 
0 = none, 1 = mild, 2 = moderate, 3 = severe 
{Khanna 2015} 
Each PRO2 score will be rounded to the nearest integer for determination of eligibility and calculation of endpoints. 


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Appendix 5. CTCAE Grading Scale for Severity of Adverse Events 
Please refer to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, 
which can be found at: 
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf  
For AEs associated with laboratory abnormalities, the event should be graded on the basis of the 
clinical severity in the context of the underlying conditions; this may or may not be in agreement 
with the grading of the laboratory abnormality. 
The only modification to the CTCAE criteria is the addition of a Grade 1 upper respiratory 
infection as follows: 
CTCAE 
V4.0 
Term 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
CTCAE V4.03 
AE Term 
Definition 
Upper 
respiratory 
infection 
Mild 
symptoms; 
symptomatic 
relief 
(eg, cough 
suppressant, 
decongestant) 
Moderate 
symptoms; 
oral 
intervention 
indicated 
(eg, antibiotic, 
antifungal, 
antiviral) 
IV antibiotic, 
antifungal, or 
antiviral 
intervention 
indicated; 
radiologic, 
endoscopic, 
or operative 
intervention 
indicated 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Death 
A disorder 
characterized by 
an infectious 
process 
involving the 
upper respiratory 
tract 
(nose, paranasal 
sinuses, pharynx, 
larynx, or 
trachea). 
 


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Appendix 6. Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements 
The administration of filgotinib in embryofetal animal development studies resulted in decreased 
numbers of viable rat fetuses, increased resorptions, and visceral and skeletal malformations. 
Similar effects were noted in the rabbit. A safety margin relative to human exposure has not been 
identified. Pregnancy is contraindicated during use of filgotinib. 
For participation in this study, the use of highly effective contraception is required as outlined 
below for all subjects who are of childbearing potential. In addition, during the study women of 
childbearing potential must have at minimum a urine pregnancy test every 4 weeks. 
• 
Definitions 
⎯ Definition of Childbearing Potential 
For the purposes of this study, a female-born subject is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming post-menopausal, unless 
permanently sterile or with medically documented ovarian failure. Women who do not meet 
below criteria for being post-menopausal, are not permanently sterile, or do not have medically 
documented ovarian failure must have pregnancy testing as outlined by the protocol.  
Women are considered to be in a postmenopausal state when they are > 54 years of age with 
cessation of previously occurring menses for > 12 months without an alternative cause. 
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female subject of any age. Bilateral tubal ligation is not considered 
permanent sterilization. 
⎯ Definition of Male Fertility 
For the purposes of this study, a male-born subject is considered fertile after the initiation of 
puberty unless permanently sterilized by bilateral orchidectomy or has medical documentation of 
permanent male infertility. Vasectomy is not considered permanent sterilization. 
• 
Contraception for Female Subjects 
⎯ Study Drug Effects on Pregnancy and Hormonal Contraception 
Filgotinib is contraindicated in pregnancy as there is a possibility of human 
teratogenicity/fetotoxicity in early pregnancy based on non-clinical data. Data from a drug-drug 
interaction study of filgotinib and hormonal contraceptives (GS-US-417-3916) have 
demonstrated coadministration with filgotinib did not alter the pharmacokinetics of 
representative hormonal contraceptives levonorgestrel/ethinyl estradiol. 
For female subjects, hormonal contraceptives will be permitted as a form of contraception when 
used in conjunction with a barrier method (preferably a male condom). Details are outlined 
below. 
Please refer to the latest version of the filgotinib IB for additional information. 


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⎯ Contraception for Female Subjects of Childbearing Potential 
The inclusion of female subjects of childbearing potential requires the use of highly effective 
contraceptive measures. Women must have a negative pregnancy test at the Day 1 visit of the 
LTE. Pregnancy tests will be performed at monthly intervals thereafter. In the event of a delayed 
menstrual period (> one month between menstruations), a pregnancy test must be performed to 
rule out pregnancy. This is true even for women of childbearing potential with infrequent or 
irregular periods.  
Female subjects must agree to continue to use one of the following methods from Screening 
(parent study) until 30 days following the last dose of study drug.  
• Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the subject’s preferred and usual 
lifestyle. 
Or 
• Consistent and correct use of 1 of the following methods of birth control listed below.  
⎯ Intrauterine device (IUD) with a failure rate of < 1% per year 
⎯ Tubal sterilization 
⎯ Essure micro-insert system (provided confirmation of success 3 months after procedure) 
⎯ Vasectomy in the male partner (provided that the partner is the sole sexual partner and 
had confirmation of surgical success 3 months after procedure) 
Female subjects, who wish to use a hormonally based method, must use it in conjunction with a 
barrier method; the barrier method is to be used either by the female subject or by her male 
partner. Female subjects who utilize a hormonal contraceptive as one of their birth control 
methods must have consistently used the same method for at least three months prior to study 
dosing. Hormonally-based contraceptives and barrier methods permitted for use in this protocol 
are as follows: 
• Hormonal methods (each method must be used with a barrier method, preferably male 
condom) 
⎯ Oral contraceptives (either combined estrogen/progestin or progesterone only) 
⎯ Injectable progesterone 
⎯ Implants of levonorgestrel 
⎯ Transdermal contraceptive patch 
⎯ Contraceptive vaginal ring 


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• Barrier methods (each method must be used with a hormonal method) 
⎯ Male or female condom with or without spermicide 
⎯ Diaphragm with spermicide 
⎯ Cervical cap with spermicide 
⎯ Sponge with spermicide 
All female subjects must also refrain from egg donation and in vitro fertilization during treatment 
and until at least 30 days after the last study drug dose. 
• 
Unacceptable Birth Control Methods 
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method (LAM). Female condom and male condom should not be used 
together. 
• 
Procedures to be Followed in the Event of Pregnancy 
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 30 days of last study drug dose. Subjects who 
become pregnant or who suspect that they are pregnant during the study must report the 
information to the investigator and discontinue study drug immediately.  
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.7.2.1. 
• 
Pregnancy Testing 
All females of childbearing potential will have urine pregnancy testing every 4 weeks during 
their study participation. The test will be performed at home or in the clinic if it coincides with a 
scheduled visit. In case of home urine pregnancy testing, the site will contact the subject to 
obtain the results and will record the information in the eCRF. For subjects in the US, all 
pregnancy tests will be carried out in the clinic. If a urine pregnancy test is positive, the subject 
should stop study drug immediately, contact the investigator, and have confirmatory serum 
pregnancy test in clinic. 


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Appendix 7. Clinical Laboratory Assessment Table 
Hematology 
Chemistry 
Urinalysis 
Other 
Hematocrit 
Hemoglobin 
Platelet count 
Red blood cell (RBC) 
count 
White blood cell (WBC) 
count 
Differentials (absolute 
and percentage), 
including: 
Lymphocytes 
Monocytes 
Neutrophils 
Eosinophils 
Basophils 
Reticulocyte count 
Mean corpuscular volume 
(MCV) 
Alkaline phosphatase 
Aspartate 
aminotransferase (AST) 
Alanine aminotransferase 
(ALT) 
Total bilirubin 
Direct and indirect 
bilirubin 
Total protein 
Albumin 
Bicarbonate 
Blood urea nitrogen 
(BUN) 
Calcium 
Chloride 
Serum creatinine 
Creatinine clearance 
CC&G 
Glucose 
Phosphorus 
Magnesium 
Potassium 
Sodium 
Creatine Phosphokinase 
(CPK) 
Appearance: 
Blood 
Color 
Glucose 
Leukocyte esterase 
pH 
Protein 
Urobilinogen 
 (
) 
 
 
 
 
Bacterial stool culture 
C-diff toxin 
Ova and parasites 
(O&P) 
 
 
 
Serum Immunoglobulin 
QuantiFERON® (or 
centrally reported 
equivalent assay)  
Prothrombin time (PT) 
Partial Thromboplastin 
time (PTT) 
International Normalized 
Ratio (INR) 
HBV DNA 
Pregnancy 
In females of 
childbearing potential: 
Urine pregnancy 
Serum pregnancy 
Fasting Lipids 
Triglycerides 
Cholesterol and its 
subfractions (high-density 
lipoprotein [HDL] and 
low density lipoprotein 
[LDL]) 
 



SAP_001.pdf: 
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Confidentiality Statement 
The information contained in this document is privileged and confidential. It is the property of Galapagos NV and 
may not be used, disclosed, reproduced or otherwise disseminated within your organization or communicated to any 
third parties without the express written authorization of Galapagos NV. 
 
 
 
STATISTICAL ANALYSIS PLAN  
Project Number: 
GLPG0634 
 
Study Number: 
GS-US-419-3896 (GLPG0634-CL-310) 
Study Title: 
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in 
Subjects with Crohn’s Disease 
Development Phase: 
3 
Status: 
Final 
Version: 
2.0 
Date: 
1-Aug-2023 
EudraCT: 
2016-002763-34 
IND: 
129646 
Sponsor: 
Galapagos NV, Generaal De 
Wittelaan L11 A3, 2800 
Mechelen, Belgium 
 
Biostatistician: 
   
Medical Leader: 
 


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TABLE OF CONTENTS 
TABLE OF CONTENTS .............................................................................................................................................. 2 
LIST OF ABBREVIATIONS ........................................................................................................................................ 5 
1. 
INTRODUCTION ................................................................................................................................................ 7 
1.1. 
Study Objectives ...................................................................................................................................... 7 
1.2. 
Study Design ............................................................................................................................................ 7 
1.3. 
Sample Size and Power ............................................................................................................................ 8 
2. 
TYPE OF PLANNED ANALYSIS ...................................................................................................................... 9 
2.1. 
Interim Analyses ...................................................................................................................................... 9 
2.2. 
Final Analysis .......................................................................................................................................... 9 
3. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES ............................................................................ 10 
3.1. 
Analysis Sets .......................................................................................................................................... 10 
3.1.1. 
All Enrolled Analysis Set ..................................................................................................... 10 
3.1.2. 
Safety Analysis Set ............................................................................................................... 10 
 
 
3.2. 
Subject Grouping ................................................................................................................................... 11 
3.3. 
Strata and Covariates .............................................................................................................................. 11 
3.4. 
Subgroup Analyses ................................................................................................................................. 11 
3.5. 
Multiple Comparisons ............................................................................................................................ 11 
3.6. 
Missing Data and Outliers ...................................................................................................................... 11 
3.6.1. 
Missing Data ........................................................................................................................ 11 
3.6.2. 
Outliers ................................................................................................................................. 12 
3.7. 
Data Handling Conventions and Transformations ................................................................................. 12 
3.8. 
Analysis Visit Windows ......................................................................................................................... 12 
3.8.1. 
Definition of Study Day ....................................................................................................... 12 
3.8.2. 
Analysis Visit Windows ....................................................................................................... 13 
3.8.3. 
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window ................................................................................................................................ 16 
3.8.4. 
Definition of Baseline .......................................................................................................... 16 
4. 
SUBJECT DISPOSITION .................................................................................................................................. 17 
4.1. 
Subject Enrollment and Disposition ....................................................................................................... 17 
4.2. 
Extent of Study Drug Exposure and Adherence ..................................................................................... 18 
4.2.1. 
Duration of Exposure to Study Drug .................................................................................... 18 
4.2.2. 
Adherence to Study Drug ..................................................................................................... 18 
4.2.2.1. 
On-Treatment Adherence ............................................................................... 19 
4.3. 
Protocol Deviations ................................................................................................................................ 19 
4.4. 
Assessment of COVID-19 (Coronavirus Disease 2019) and Ukrainian Conflict Impact....................... 20 
4.4.1. 
Study Drug or Study Discontinuation .................................................................................. 20 
4.4.2. 
Study Drug Interruption ....................................................................................................... 20 
4.4.3. 
Protocol Deviations .............................................................................................................. 20 
4.4.4. 
Missed or Virtual Visits ....................................................................................................... 20 
4.4.5. 
Adverse Events ..................................................................................................................... 21 
4.4.6. 
Comments ............................................................................................................................ 21 
5. 
BASELINE CHARACTERISTICS .................................................................................................................... 22 
5.1. 
Demographics and Baseline Characteristics .......................................................................................... 22 
5.2. 
Other Baseline Characteristics ............................................................................................................... 22 
5.3. 
Medical History ...................................................................................................................................... 23 
6. 
EFFICACY ANALYSES ................................................................................................................................... 24 








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PRO2 
patient reported outcome consisting of 2 items: abdominal pain severity and liquid stool 
frequency 
PT 
preferred term 
PTx 
post-treatment 
Q1 
first quartile  
Q3 
third quartile 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SE 
standard error 
 
 
SMQ 
Standardized MedDRA Query 
SOC 
system organ class 
TE 
treatment-emergent 
TEAE 
treatment-emergent adverse event 
TFLs 
tables, figures, and listings 
ULN 
upper limit of normal 
V-Day 
visit day 
VAS 
Visual Analogue Scale 
VTE 
venous thromboembolism 
WHO 
World Health Organization 
 
 
 




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will discontinue study drug and study participation. Subjects who exit a parent study due to 
disease worsening or failure to meet response or remission criteria will receive open-label 200 
mg filgotinib, with the exception of US and Korea males in this category who were not 
considered biologic refractory who will receive open-label 100 mg filgotinib. 
This study includes: 
• Day 1 
• Treatment Visits: Week 2, Week 4, Week 12, and then every 12 weeks thereafter 
• Post-Treatment (PTx) safety assessments (30 days after the last dose of study drug) for 
subjects who complete all study treatment visits or discontinue early 
For additional details, please see the Schedule of Assessments in Appendix 1.  
1.3. 
Sample Size and Power 
No formal hypothesis testing is planned for this study and sample size calculation is not 
conducted. All subjects who have completed or met protocol-specified efficacy discontinuation 
criteria in a parent study (GS-US-419-4015, GS-US-419-4016, or GS-US-419-3895) may enroll 
in this study. The projected number of subjects enrolled is approximately 1000. 


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2. 
TYPE OF PLANNED ANALYSIS 
2.1. 
Interim Analyses 
Prior to the final analysis, interim analyses may be performed for regulatory submission and/or 
for publication purposes. The first interim analysis is planned to align with the final analysis of 
Study GS-US-419-3895, at which time this study will be unblinded. 
Interim analyses may present a subset of the analyses included in this analysis plan. 
2.2. 
Final Analysis 
The final analysis will be performed after all subjects have completed the study.  


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3. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES 
All analyses described in this SAP will include data from the LTE study (GS-US-419-3896) 
exclusively, not from the corresponding parent studies, except for subgroup analyses based on 
parent study completion status. Consequently, any reference to study drug (e.g., first dosing date) 
implies study drug administered in Study GS-US-419-3896, unless specifically stated otherwise.   
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of subjects in each category will be presented; for continuous variables, 
the number of subjects (n), mean, standard deviation (SD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented. 
By-subject listings will be presented for all subjects in the All Enrolled Analysis Set and sorted 
by subject identification (ID) number, visit date, and time (if applicable). Data collected on log 
forms, such as adverse events (AEs), will be presented in chronological order within the subject. 
The treatment group to which subjects were assigned at enrollment will be used in the listings. 
Age (on the first dosing day in the LTE), sex at birth, race, and ethnicity will be included in the 
listings, as space permits. 
3.1. 
Analysis Sets 
Analysis sets define the subjects to be included in an analysis. Analysis sets and their definitions 
are provided in this section. The analysis set will be identified and included as a subtitle of each 
table, figure, and listing. 
For each analysis set, the number and percentage of subjects eligible for inclusion, as well as the 
number and percentage of subjects who were excluded and the reasons for their exclusion (if 
available), will be summarized by treatment group. 
A listing of reasons for exclusion from analysis sets (if applicable) will be provided by subject. 
3.1.1. 
All Enrolled Analysis Set 
All Enrolled Analysis Set includes all subjects who enrolled into this study as recorded in the 
Enrollment eCRF. 
3.1.2. 
Safety Analysis Set 
The Safety Analysis Set includes all subjects who took at least 1 dose of study drug in Study GS-
US-419-3896. This is the primary analysis set for safety and efficacy analyses. 




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For missing last dosing date of study drug, imputation rules are described in Section 4.2. 
Imputation and calculation rules for missing patient diary data are described in Section 6.1. The 
handling of missing or incomplete dates for AE onset is described in Section 7.1.6.2, and for 
concomitant medications in Section 7.4. 
3.6.2. 
Outliers 
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data, including outliers, will be included in the data 
analysis, unless otherwise specified. 
3.7. 
Data Handling Conventions and Transformations 
In general, age (in years) on the date of the first dose of study drug will be used for analyses and 
presented in listings. If an enrolled subject was not dosed with any study drug, the enrollment 
date will be used instead of the first dosing date of study drug. If only the birth year is collected 
on the CRF, “01 July” will be used for the unknown birth day and month for the purpose of age 
calculation. If only birth year and month are collected, “15” will be used for the unknown birth 
day. 
Non-pharmacokinetic data that are continuous in nature but are less than the lower limit of 
quantitation (LOQ) or above the upper LOQ will be imputed as follows: 
• A value that is 1 unit less than the lower LOQ at the same precision level of the originally 
reported value will be used to calculate descriptive statistics if the datum is reported in the 
form of “ x” (where x is considered the lower LOQ). For example, if the values are reported 
as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to calculate summary 
statistics. An exception to this rule is any value reported as < 1 or < 0.1, etc. For values 
reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be used to calculate 
summary statistics. 
• A value that is 1 unit above the upper LOQ will be used to calculate descriptive statistics if 
the datum is reported in the form of “> x” (where x is considered the upper LOQ). Values 
with decimal points will follow the same logic as above. 
• The lower or upper LOQ will be used to calculate descriptive statistics if the datum is 
reported in the form of “≤ x” or “≥ x” (where x is considered the lower or upper LOQ, 
respectively). 
3.8. 
Analysis Visit Windows 
3.8.1. 
Definition of Study Day 
The First Dosing Date is defined as the date when subjects take the first dose of study drug in 
this study, as recorded in the Study Drug Administration eCRF.  










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4. 
SUBJECT DISPOSITION 
4.1. 
Subject Enrollment and Disposition 
Key study dates (ie, first subject enrolled, last subject enrolled, last subject last visit for the 
primary endpoint, and last subject last visit for the clinical study report) will be provided. 
A summary of subject enrollment will be provided by treatment group for each country, 
investigator within a country, and overall. The summary will present the number and percentage 
of subjects enrolled. For each column, the denominator for the percentage calculation will be the 
total number of subjects analyzed for that column. 
A summary of subject disposition will be provided by treatment group. This summary will 
present the number of subjects in each of the categories listed below: 
• All Enrolled Analysis Set 
⎯ By parent study (GS-US-419-4015, GS-US-419-4016, or GS-US-419-3895) 
⎯ By reason for exiting parent study, i.e., either completed to end, due to failure to meet 
response/remission criteria at W10 or due to protocol-specified disease worsening)  
• Safety Analysis Set 
 
• Continuing study drug (for analysis other than the final analysis) 
• Completed study drug 
• Did not complete study drug with reasons for premature discontinuation of study drug 
• Continuing study (for analysis other than the final analysis) 
• Completed study 
• Did not complete the study with reasons for premature discontinuation of study 
For the status of study drug and study completion and reasons for premature discontinuation, the 
number and percentage of subjects in each category will be provided. The denominator for the 
percentage calculation will be the total number of subjects in the Safety Analysis Set 
corresponding to that column. 
The following by-subject listings will be provided by subject ID number in ascending order to 
support the above summary tables: 
• Reasons for premature study drug or study discontinuation 


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• Lot number and kit ID of assigned study medication 
4.2. 
Extent of Study Drug Exposure and Adherence 
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug and the level of adherence relative to the study drug regimen specified in the protocol. 
If subjects are continuing study drug at the data cutoff date for an interim analysis, the data 
cutoff date will be used to impute the last dosing date for the calculation of duration of exposure 
to study drug and adherence to the study drug. 
4.2.1. 
Duration of Exposure to Study Drug 
Total duration of exposure to study drug will be defined as last dosing date minus first dosing 
date plus 1, regardless of any temporary interruptions in study drug administration, and will be 
expressed in weeks using up to 1 decimal place (eg, 4.5 weeks). If the last study drug dosing date 
is missing (for subjects that have stopped treatment or the study as indicated by a study 
disposition record), the latest date among the treatment (study) disposition date, clinical visit 
date, laboratory sample collection date, and vital signs assessment date that occurred during the 
on-treatment period (i.e., after exposure start date) will be used for subjects included in the final 
analyses or the last available date in the database snapshot at the time of an interim analysis. 
If month and year of the last dose are known, and the last study drug dosing date imputed above 
is different from the month collected, the last date of that month will be used. If only year of the 
last dose is known, and the last study drug dosing date imputed above is after the year collected, 
the last date of that year will be used; if the last study drug dosing date imputed above is before 
the year collected, the first date of that year will be used. 
The total duration of exposure to study drug will be summarized using descriptive statistics and 
using the number (ie, cumulative counts) and percentage of subjects exposed through the following 
time periods: 1 day, 2 weeks, 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 52 weeks, 60 
weeks, and then every 12 weeks from Week 60. Summaries will be provided by treatment group for 
the Safety Analysis Set. 
No formal statistical testing is planned. 
4.2.2. 
Adherence to Study Drug 
The total number of tablets taken will be summarized using descriptive statistics.  
The presumed total number of tablets taken by a subject will be determined by the data collected 
on the drug accountability CRF using the following formula: 
𝑇𝑜𝑡𝑎𝑙 𝑁𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑇𝑎𝑏𝑙𝑒𝑡𝑠 𝑇𝑎𝑘𝑒𝑛= ቀ෍𝑁𝑜. 𝑜𝑓 𝑇𝑎𝑏𝑙𝑒𝑡𝑠 𝐷𝑖𝑠𝑝𝑒𝑛𝑠𝑒𝑑ቁ−ቀ෍𝑁𝑜. 𝑜𝑓 𝑇𝑎𝑏𝑙𝑒𝑡𝑠 𝑅𝑒𝑡𝑢𝑟𝑛𝑒𝑑ቁ  


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If the bottle was not returned, it is assumed that the subject took all the study drug tablets from 
the dispensed bottle. The number of tablets returned will be imputed as zero for the given bottle 
for study drug adherence calculation purposes. 
For calculation of the total number of tablets taken for the purposes of interim analyses (ie, prior 
to the return of all drug bottles), it will be assumed that each subject took the recommended daily 
dose from the dispensed bottle(s) until either the date of discontinuation, death or data cutoff date 
(whichever is earliest).  
If the bottle has not been returned yet when the interim analysis is conducted, the number of 
tablets returned will be imputed as total pill count in the dispensed bottle – (the last dosing date – 
the last bottle dispensed date +1) for the given bottle for study drug adherence calculation 
purposes. 
4.2.2.1. 
On-Treatment Adherence 
The level of on-treatment adherence to the study drug regimen will be determined by the total 
amount of study drug taken relative to the total amount of study drug expected to be taken during 
a subject’s actual on-treatment period based on the study drug regimen. 
The level of on-treatment adherence will be expressed as a percentage using the following 
formula:  
𝑂𝑛−𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡 𝐴𝑑ℎ𝑒𝑟𝑒𝑛𝑐𝑒 (%) = ൬
𝑇𝑜𝑡𝑎𝑙 𝐴𝑚𝑜𝑢𝑛𝑡 𝑜𝑓 𝑆𝑡𝑢𝑑𝑦 𝐷𝑟𝑢𝑔 𝑇𝑎𝑘𝑒𝑛
𝑆𝑡𝑢𝑑𝑦 𝐷𝑟𝑢𝑔 𝐸𝑥𝑝𝑒𝑐𝑡𝑒𝑑 𝑡𝑜 𝑏𝑒 𝑇𝑎𝑘𝑒𝑛 𝑜𝑛 𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡൰𝑥100 
Descriptive statistics for the level of on-treatment adherence with the number and percentage of 
subjects belonging to adherence categories (eg, < 80%, ≥ 80 to < 90%, ≥ 90% to <120, ≥120) 
will be provided by treatment group for the Safety Analysis Set.  
No formal statistical testing is planned. 
A by-subject listing of study drug intake and drug accountability will be provided separately by 
subject ID number (in ascending order) and visit (in chronological order). 
4.3. 
Protocol Deviations  
Subjects who did not meet the eligibility criteria for study entry but enrolled in the study, will be 
summarized regardless of whether they were exempted by the sponsor or not. The summary will 
present the number and percentage of subjects who did not meet at least 1 eligibility criterion and 
the number of subjects who did not meet specific criteria by treatment group based on the All 
Enrolled Analysis Set. A by-subject listing will be provided for those subjects who did not meet at 
least 1 eligibility (inclusion or exclusion) criterion. The listing will present the eligibility criterion 
(or criteria if more than 1 deviation) that subjects did not meet and related comments, if collected. 
Protocol deviations occurring after subjects entered the study are documented during routine 
monitoring. The number and percentage of subjects with important protocol deviations by 


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deviation category (eg, eligibility criteria, informed consent) will be summarized by treatment 
group for the All Enrolled Analysis Set. A by-subject listing will be provided for those subjects 
with important protocol deviations.  
4.4. 
Assessment of COVID-19 (Coronavirus Disease 2019) and Ukrainian 
Conflict Impact 
This study was ongoing during the COVID-19 pandemic and the conflict in Ukraine, which have 
an impact on study conduct. Some subjects were unable to attend onsite visits due to shelter-in-
place guidelines, site closures, or other public health measures in response to these situations. 
This section describes how the impact on study conduct will be handled in the analysis. 
4.4.1. 
Study Drug or Study Discontinuation  
Summaries of reasons for discontinuing study drug or study due to COVID-19 will be provided 
by treatment group and overall, similar to the summary described in the subject enrollment and 
disposition section (see Section 4.1).   
By-subject listing of reasons for premature study drug or study discontinuation due to 
COVID-19 will be provided if applicable. 
4.4.2. 
Study Drug Interruption  
Summaries of number of subjects with study drug interruption due to COVID-19 will be 
provided by treatment group, if applicable. 
By-subject listings of study drug administration for subjects with study drug interruption due to 
COVID-19 will be provided, if applicable. 
4.4.3. 
Protocol Deviations  
Summaries of important protocol deviations due to COVID-19 will be provided, similar to the 
summary described in the protocol deviations section (Section 4.3). 
By-subject listings will be provided for subjects with important protocol deviations related to 
COVID-19 and the Ukrainian conflict, if applicable.  
4.4.4. 
Missed or Virtual Visits  
Summaries of subjects with missed or virtual visits due to the COVID-19 pandemic  will be 
provided for each scheduled study visit by treatment group and overall, for the All Enrolled 
Analysis Set. For each visit, the summaries will present the number and percentage of subjects 
who missed the visit due to COVID-19 or had a virtual visit due to COVID-19. For each column, 
the denominator for the percentage calculation will be the total number of subjects in the All 
Enrolled Analysis Set for that column. 


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Overall summaries of the number and percentage of subjects with missed or virtual visits (eg, 
subjects with at least 1 missed or virtual visit, subjects with 1, 2, 3 or more missed or virtual 
visits) due to COVID-19 will be provided by treatment group and overall, for the All Enrolled 
Analysis Set. The denominator for the percentage calculation will be the total number of subjects 
in the All Enrolled Analysis Set for that column. 
By-subject listings of subjects with missed or virtual visits due to COVID-19 will be provided by 
subject ID number in ascending order. 
Information regarding missed or virtual visits due to COVID-19 will be collected as free text in 
the CRF comment fields. The determination of missed or virtual visits due to COVID-19 will be 
done using Natural Language Processing (NLP) to search the CRF comment fields. A detailed 
explanation of the algorithm is given in Appendix 3. 
4.4.5. 
Adverse Events 
By-subject listings will be provided for subjects with adverse events of COVID-19, as 
determined by COVID-19 Standardized MedDRA Query (SMQ) narrow search. 
4.4.6. 
Comments 
A by-subject listing of all comments related to the Ukrainian conflict will be provided. 
 




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⎯ Concomitant use of systemically absorbed corticosteroid and/or immunomodulator, 
including: a) systemically absorbed corticosteroid only, b) immunomodulator only, 
c) both, and d) neither 
⎯ Prednisone equivalence dose for subjects who are on systemically absorbed corticosteroid 
(mg/day) 
⎯ Prednisone equivalence dose level for subjects who are on systemically absorbed 
corticosteroid (> 0 to 10 mg/day, > 10 to 20 mg/day, > 20 to 30 mg/day, > 30 mg/day) 
⎯ 5-aminosalicylates (yes, no) 
These baseline characteristics will be summarized by treatment group and overall using 
descriptive statistics for continuous variables and using number and percentage of subjects for 
categorical variables. The summary of these baseline characteristics will be provided for the 
Safety Analysis Set. In addition, this summary will be provided for the induction non-responders 
(see Section 3.4), overall, and by prior exposure to biologic agents.  
No formal statistical testing is planned. 
A by-subject listing of other baseline characteristics will be provided by subject ID number in 
ascending order. 
5.3. 
Medical History 
Adverse events which occurred in a parent study and were ongoing when subject took the first 
dose in this LTE study were recorded as medical history for Study GS-US-419-3896, excluding 
AEs occurred after Study GS-US-419-3896 informed consent is signed and prior to initiation of 
Day 1 Study GS-US-419-3896 IMP but related to Study GS-US-419-3896 protocol-mandated 
procedures. 
General medical history data will be collected at enrollment and listed only. General medical 
history data will be coded using the current version of Medical Dictionary for Regulatory 
Activities (MedDRA). 


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6. 
EFFICACY ANALYSES 
6.1. 
General Considerations 
The efficacy analysis will be conducted on the Safety Analysis Set, defined in Section 3.1.2, 
unless otherwise specified.  
6.1.1. 
Calculation of CDAI and PRO2 Scores 
The CDAI system is a composite index of 8 disease activity variables with scores ranging from 0 
to over 600 based upon a composite of symptoms (eg, abdominal pain), signs (the presence of 
abdominal mass and weight), laboratory values (eg, hematocrit), and physician assessment 
amongst others. The CDAI has 3 PRO components: liquid or very soft stool frequency, 
abdominal pain and general wellbeing. The total CDAI score is calculated as a weighted sum of 
all 8 component subscores. Clinical remission by CDAI is defined as CDAI score < 150 points. 
If subjects have 1 or more of the 8 component subscores missing, then the subjects will be 
considered as having insufficient data to determine remission status and their total CDAI score 
will be considered missing.  
 
The PRO2 instrument has 2 components: liquid or very soft stool frequency subscore and 
abdominal pain subscore. Clinical remission by PRO2 is defined as an abdominal pain score ≤1 
and liquid or very soft stool frequency ≤ 3. If either subscore is missing, the subject will be 
considered as having insufficient data to determine clinical remission status by PRO2. 
For further information on the CDAI/PRO2 and calculation rules at baseline and postbaseline, 
reference is made to Appendix 2. 
6.2. 
Efficacy Endpoints 
6.2.1. 
Definition of the Efficacy Endpoints 
The secondary endpoints of this study are change in CDAI and PRO2 scores from baseline. 
 
 
6.2.2. 
Analysis of the Efficacy Endpoints 
CDAI and PRO2 
 
Descriptive statistics and 95% CI based on normal approximation will be used to summarize the 
absolute values and change from baseline values in CDAI and PRO2 scores by analysis visit and 
treatment group using observed values. Mean absolute values of each score with 95% CI will be 
plotted over all analysis visits by treatment group. Mean change from baseline values of each 
score with 95% CI will also be plotted. 
 
 








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• 
  
 
 
 


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7. 
SAFETY ANALYSES 
7.1. 
Adverse Events and Deaths 
7.1.1. 
Adverse Event Dictionary 
Clinical and laboratory AEs will be coded using a recent version of MedDRA. System organ 
class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and 
lower-level term (LLT) will be provided in the AE dataset. 
7.1.2. 
Adverse Event Severity 
The severity of AEs was graded using the modified Common Terminology Criteria for Adverse 
Events (CTCAE), version 4.03. For each episode, the highest grade attained should be reported. 
If a CTCAE criterion does not exist, the investigator should use the grade or adjectives: 
Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) or 
Grade 5 (fatal) to describe the maximum intensity of the adverse event. For purposes of 
consistency with the CTCAE, these intensity grades are defined in the protocol in Table 7-1 and 
Appendix 5. The severity grade of events for which the investigator did not record severity will be 
categorized as “missing” for tabular summaries and data listings. The missing category will be 
listed last in summary presentation. 
7.1.3. 
Relationship of Adverse Events to Study Drug 
Related AEs are those for which the investigator selected “Related” on the AE CRF to the 
question of “Related to Study Treatment.” Events for which the investigator did not record 
relationship to study drug will be considered related to study drug for summary purposes. 
However, by-subject data listings will show the relationship as missing. 
7.1.4. 
Action Taken With Study Drug 
Action taken is recorded for multiple study treatments on the AE CRF. In adverse event 
summaries a worst-case approach will be applied using all available information. For example, if 
for at least one of the study treatments “Drug Withdrawn” was recorded, the AE will be 
categorized as “leading to premature discontinuation of study drug”. 
7.1.5. 
Serious Adverse Events 
Serious adverse events (SAEs) will be identified and captured as SAEs if the AEs met the 
definitions of SAEs that were specified in the study protocol. SAEs captured and stored in the 
clinical database will be reconciled with the SAE safety database before data finalization. 


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7.1.6. 
Treatment-Emergent Adverse Events  
7.1.6.1. 
Definition of Treatment-Emergent Adverse Events 
Treatment-emergent adverse events (TEAEs) are defined as 1 or both of the following: 
• Any AEs with an onset date on or after the study drug start date and no later than 30 days 
after permanent discontinuation of study drug 
• Any AEs leading to premature discontinuation of study drug. 
7.1.6.2. 
Incomplete Dates 
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met: 
• The AE onset date is the same as or after the month and year (or year) of the first dosing date 
of study drug, and 
• The AE onset date is the same as or before the month and year (or year) of the date 
corresponding to 30 days after the date of the last dose of study drug  
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent. 
7.1.7. 
Summaries of Adverse Events and Deaths 
Treatment-emergent AEs will be summarized based on the Safety Analysis Set. 
No formal statistical testing is planned. 
7.1.7.1. 
Summaries of AE incidence in Combined Severity Grade Subsets  
A brief, high-level summary of the number and percentage of subjects who experienced at least 
1 TEAE in the categories described below will be provided by treatment group. All deaths 
observed in the study will also be included in this summary. 
The number and percentage of subjects who experienced at least 1 TEAE will be provided and 
summarized by SOC, PT, and treatment group. The same summary is provided for the other AE 
categories described below. 


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• TEAEs with Grade 3 or higher  
• TEAEs with Grade 2 or higher 
• Treatment-emergent (TE) treatment-related AEs 
• TE treatment-related AEs with Grade 3 or higher  
• TE treatment-related AEs with Grade 2 or higher 
• TE SAEs 
• TE treatment-related SAEs  
• TEAEs leading to premature discontinuation of study drug 
• TEAEs leading to premature discontinuation of study 
• TE AEs leading to death (ie, outcome of death) 
• TEAEs leading to temporary interruption of study drug 
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed in descending order of frequency, first by SOC, then by PT and then 
alphabetically. For summaries by severity grade, the most severe grade will be used for those 
AEs that occurred more than once in an individual subject during the study.  
In addition to the above summary tables, the following TEAEs will be summarized by PT only, 
in descending order of total frequency: 
• TEAEs 
• TEAEs with Grade 3 or higher  
• TE SAEs 
• TEAEs leading to premature discontinuation of study drug. 
In addition, data listings will be provided for the following: 
• All AEs, indicating whether the event is treatment emergent 
• All SAEs 
• All Deaths 
• All SAEs leading to death (ie, outcome of death) 


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• All AEs with severity of Grade 3 or higher 
• All AEs leading to premature discontinuation of study drug 
• All AEs leading to premature discontinuation of study 
• All AEs leading to temporary interruption of study drug 
In addition, an XML file will be created to support EUDRACT reporting for the final analysis 
containing serious AEs, non-serious AEs and non-serious AEs occurring in at least 5% of 
subjects in at least one treatment arm, either at system organ class level or at PT level. (This 
XML file will be created in-house). 
7.1.8. 
Adverse Events of Interest   
Adverse events of interest (AEI) include infections, gastrointestinal perforations, herpes zoster, 
malignancies (excluding non-melanoma skin cancers), non-melanoma skin cancers, major 
adverse cardiovascular events (MACE), and thromboembolic events. Summaries of the 
following treatment-emergent AEI will be produced to enhance the analysis of safety data.  
• Events of infections presented in the following subcategories: 
⎯ AEs of infections, utilizing all AEs in the MedDRA Infections and Infestations SOC 
⎯ AEs of serious infections, using all AEs in the MedDRA Infections and Infestations SOC 
that are classified as SAEs 
⎯ AEs of herpes zoster, utilizing an MST list developed by the Sponsor 
⎯ AEs of opportunistic infections, utilizing a narrow scope SMQ 
• AEs of malignancies, excluding non-melanoma skin cancers, utilizing an MST list developed 
by the Sponsor  
• AEs of non-melanoma skin cancers, utilizing an MST list developed by the Sponsor 
• AEs of gastrointestinal perforation, utilizing an MST list developed by the Sponsor 
• AEs of MACE, utilizing a positively adjudicated event list, presented in the following 
subcategories (Section 7.1.8.1): 
⎯ Cardiovascular (CV) death 
⎯ Non-fatal myocardial infarction (MI) 
⎯ Non-fatal stroke 
• AEs of arterial systemic thromboembolism (ASTE), utilizing a positively adjudicated event 
list (Section 7.1.8.1) 


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• AEs of venous thromboembolism (VTE), utilizing a positively adjudicated event list, 
presented in the following subcategories (Section 7.1.8.1): 
⎯ Venous Thrombotic and Embolic Events 
⎯ Other 
The number and percentage of subjects with a reported event will be summarized for each 
treatment group by PT for each AEI category. Data listings for AEI will also be provided. 
A by-subject listing for subjects with potential events for adjudication (MACE, ASTE, and VTE) 
and their respective adjudication results will be provided. 
A by-subject listing of thromboembolic history and risk factors will be provided for subjects with 
potential events for adjudication (MACE, ASTE, and VTE). 
7.1.8.1. 
Cardiovascular Safety Endpoint Adjudication Committee 
An independent cardiovascular safety endpoint adjudication committee (CVEAC) was formed to 
periodically review and adjudicate all potential MACE and thromboembolic events in a blinded 
manner. To identify potential MACE and thromboembolic events, the following AEs were sent 
for adjudication. Refer to the Cardiovascular Event Adjudication Charter for more details. 
• All AEs leading to death 
• CV events (meeting seriousness criteria), utilizing an MST list developed by the Sponsor 
• MI, utilizing a narrow scope SMQ 
• Unstable angina (meeting hospitalization criteria), utilizing an MST list developed by the 
Sponsor 
• Transient ischemic attack, utilizing an MST list developed by the Sponsor 
• Stroke, utilizing an MST list developed by the Sponsor 
• Cardiac failure (meeting hospitalization criteria), utilizing an MST list developed by the 
Sponsor 
• Percutaneous coronary intervention, utilizing an MST list developed by the Sponsor 
• Embolic and thrombotic events, utilizing a narrow scope SMQ 
The CVEAC will review the above AEs, and related clinical data to adjudicate whether the 
criteria for MACE (CV death, MI, and/or stroke), ASTE, and VTE have been met for each AE. 


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7.2. 
Laboratory Evaluations 
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to the last dose of study drug plus 30 days 
for subjects who have permanently discontinued study drug, or all available data at the time of 
the database snapshot for subjects who were ongoing at the time of an interim analysis. The 
analysis will be based on values reported in conventional units. When values are below the LOQ, 
they will be listed as such, and the closest imputed value will be used for the purpose of 
calculating summary statistics as specified in Section 3.7. Hemolized test results will not be 
included in the analysis, but they will be listed in by-subject laboratory listings. 
A by-subject listing for laboratory test results will be provided by subject ID number and time 
point in chronological order for hematology, serum chemistry, urinalysis, lipid profile, and serum 
immunoglobulin separately. Values falling outside of the relevant reference range and/or having 
a severity grade of 1 or higher on the CTCAE severity grade will be flagged in the data listings, 
as appropriate. 
Hematocrit results collected from local laboratories due to COVID-19 impact will not be 
included in the safety laboratory summary, but will be included in the listing with a flag to 
indicate which records were collected at local laboratories. 
No formal statistical testing is planned. 
7.2.1. 
Summaries of Numeric Laboratory Results 
Descriptive statistics will be provided by treatment group for each laboratory test specified in the 
study protocol within hematology and chemistry panels including creatinine clearance, and also 
laboratory tests from lipids panel (under fasting status) including total cholesterol, LDL, HDL, 
triglycerides, non-HDL cholesterol (total cholesterol minus HDL cholesterol), LDL/HDL ratio, 
and total immunoglobulin (Ig), IgA, IgM, and IgG, as follows: 
• Baseline values  
• Values at each postbaseline time point 
• Change from baseline at each postbaseline time point 
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of study drug. Change from baseline to a postbaseline visit will be defined 
as the visit value minus the baseline value. The mean, median, Q1, Q3, minimum, and maximum 
values will be displayed to the reported number of digits; SD values will be displayed to the 
reported number of digits plus 1. 
Median (Q1, Q3) of the observed change from baseline values for aspartate aminotransferase 
(AST), alanine aminotransferase (ALT), total bilirubin, alkaline phosphatase, serum creatine, 
creatinine clearance, creatine phosphokinase, white blood cell count, absolute neutrophils, 


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absolute lymphocytes, hemoglobin, platelets, total cholesterol, LDL, HDL, total Ig, IgG, IgA, 
and IgM, will be plotted using a line plot by treatment group and time point. 
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3. 
7.2.2. 
Graded Laboratory Values 
The CTCAE Version 4.03 will be used to assign toxicity grades (0 to 4) to laboratory results for 
analysis. Grade 0 includes all values that do not meet the criteria for an abnormality of at least 
Grade 1. For laboratory tests with criteria for both increased and decreased levels, analyses for 
each direction (ie, increased, decreased) will be presented separately.  
7.2.2.1. 
Treatment-Emergent Laboratory Abnormalities 
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last 
dose of study drug plus 30 days for subjects who permanently discontinued study drug, or the 
last available date in the database snapshot for subjects who were still on treatment at the time of 
an interim analysis. If the relevant baseline laboratory value is missing, any abnormality of at 
least Grade 1 observed within the time frame specified above will be considered treatment 
emergent. 
7.2.2.2. 
Treatment-Emergent Marked Laboratory Abnormalities 
Treatment-emergent marked laboratory abnormalities are defined as values that increase from 
baseline by at least 3 toxicity grades at any postbaseline time point, up to and including the date 
of the last dose of study drug plus 30 days for subjects who permanently discontinued study drug 
or the last available date in the database snapshot for subjects who were still on treatment at the 
time of an interim analysis. If the relevant baseline laboratory value is missing, any Grade 3 or 4 
values observed within the timeframe specified above will be considered treatment-emergent 
marked abnormalities. 
7.2.2.3. 
Summaries of Laboratory Abnormalities 
The following summaries (number and percentage of subjects) for treatment-emergent laboratory 
abnormalities will be provided by lab test and treatment group; subjects will be categorized 
according to the most severe postbaseline abnormality grade for a given lab test: 
• Graded laboratory abnormalities 
• Grade 3 or 4 laboratory abnormalities 
• Marked laboratory abnormalities 


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For all summaries of laboratory abnormalities, the denominator is the number of subjects with 
nonmissing postbaseline values up to 30 days after last dosing date. 
A by-subject listing of treatment-emergent Grade 3 or 4 laboratory abnormalities will be 
provided by subject ID number and time point in chronological order. This listing will include all 
test results that were collected throughout the study for the lab test of interest, with all applicable 
severity grades displayed. 
7.2.3. 
Liver-Related Laboratory Evaluations 
Liver-related abnormalities after initial study drug dosing will be examined and summarized 
using the number and percentage of subjects who were reported to have the following laboratory 
test values for postbaseline measurements: 
• Aspartate aminotransferase (AST): (a) > 3 times of the upper limit of normal (ULN) 
reference range; (b) > 5 × ULN; (c) > 10 × ULN; (d) > 20 × ULN 
• Alanine aminotransferase (ALT): (a) > 3 × ULN; (b) > 5 × ULN; (c) > 10 × ULN; 
(d) > 20 × ULN 
• AST or ALT > 3 × ULN and total bilirubin > 2 × ULN 
The summary will include data from all postbaseline visits up to 30 days after the last dose of 
study drug. For individual laboratory tests, subjects will be counted once based on the most 
severe postbaseline values. For both the composite endpoint of AST or ALT and total bilirubin, 
subjects will be counted once when the criteria are met at the same postbaseline visit date. The 
denominator is the number of subjects in the Safety Analysis Set who have nonmissing 
postbaseline values of all relevant tests at the same postbaseline visit date. A listing of subjects 
who met at least 1 of the above criteria will be provided. 
7.3. 
Body Weight and Vital Signs 
Descriptive statistics will be provided by treatment group for body weight, BMI and vital signs 
(resting blood pressure [systolic blood pressure and diastolic blood pressure], respiratory rate, 
pulse and temperate) as follows: 
• Baseline value 
• Values at each postbaseline time point 
• Change from baseline at each postbaseline time point 
A baseline value will be defined as the last available value collected on or prior to the date/time 
of first dose of study drug. Change from baseline to a postbaseline visit will be defined as the 
postbaseline value minus the baseline value. Body weight and vital signs measured at 
unscheduled visits will be included for the baseline value selection. 


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In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3. No formal statistical testing is planned. 
A by-subject listing of vital signs will be provided by subject ID number and time point in 
chronological order. Body weight, height, and BMI will be included in the vital signs listing, if 
space permits. If not, they will be provided separately. 
Body weight results measured by subjects at home from virtual visits due to COVID-19 impact 
will not be included in the vital signs summary, but will be included in the listing with a flag to 
indicate which records were collected at home. 
7.4. 
Concomitant Medications 
Medications collected during the study will be coded using the current version of the World 
Health Organization (WHO) Drug dictionary. 
Concomitant medications are defined as medications taken while a subject took study drug. Use 
of concomitant medications will be summarized by therapeutic subgroup (ATC level 2) and 
preferred name using the number and percentage of subjects for each treatment group. A subject 
reporting the same medication more than once will be counted only once when calculating the 
number and percentage of subjects who received that medication. The summary will be ordered 
in descending overall frequency, first by ATC class and then by preferred term. For drugs with 
the same frequency, sorting will be done alphabetically. 
For the purposes of analysis, any medications with a start date prior to or on the first dosing date 
of study drug and continued to be taken after the first dosing date, or started after the first dosing 
date but prior to or on the last dosing date of study drug will be considered concomitant 
medications. Medications started and stopped on the same day as the first dosing date or the last 
dosing date of study drug will also be considered concomitant. Medications with a stop date prior 
to the date of first dosing date of study drug or a start date after the last dosing date of study drug 
will be excluded from the concomitant medication summary. If a partial stop date is entered, any 
medication with the month and year (if day is missing) or year (if day and month are missing) 
prior to the date of first study drug administration will be excluded from the concomitant 
medication summary. If a partial start date is entered, any medication with the month and year (if 
day is missing) or year (if day and month are missing) after the study drug stop date will be 
excluded from the concomitant medication summary. Medications with completely missing start 
and stop dates will be included in the concomitant medication summary, unless otherwise 
specified. Summaries will be based on the Safety Analysis Set. No formal statistical testing is 
planned. 
All concomitant medications (other than per-protocol study drugs) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order. 


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7.5. 
Electrocardiogram Results 
A frequency table of the investigators’ assessment of ECG results at each visit will be presented 
by treatment group, using the following categories: normal; abnormal, not clinically significant; 
abnormal, clinically significant. The number and percentage of subjects in each classification 
group will be presented.  
No formal statistical testing is planned. 
A by-subject listing for ECG assessment results will be provided by subject ID number and time 
point in chronological order. 
7.6. 
Other Safety Measures 
A data listing will be provided for subjects who become pregnant during the study. 




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9. 
SOFTWARE 
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA. 
 


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10. 
SAP REVISION 
 
Revision Date 
(DD MMM YYYY) 
Section 
Summary of Revision 
Reason for Revision 
Original Gilead draft 
(11 February 2022) 
 
 
 
Draft 0.3 
(11 July 2022) 
Global 
Editorial changes have been made 
throughout the SAP, where 
appropriate 
To align with GLPG wording / 
template 
4.4 
Added assessment of Ukrainian 
conflict impact 
To better understand the 
Ukrainian conflict impact on 
subject disposition and missing 
data 
6.2 
Added remission by CDAI and 
PRO2 as efficacy endpoints 
To support the secondary 
endpoints. 
6.3, 7.1.8 
Added subgroup analyses for 
efficacy endpoints and adverse 
events 
To assess benefit/risk in 
subjects who completed the 
parent study and subjects who 
met protocol-specified efficacy 
discontinuation criteria 
Draft 0.4 
(1 Augustus 2022) 
Global 
Editorial changes have been made 
throughout the SAP, where 
appropriate 
For clarification, based on team 
feedback  
 
5.2 
Added baseline disease 
characteristics by subgroup 
To complement the 
efficacy/safety subgroup 
analyses 
 
7.1.6 
AEs will be presented ordered by 
total frequency, not alphabetically 
Requested by medical writing 
 
7.5 
Addition of ECG shift table 
Requested by medical leads 
Draft 0.5 
(12 November 2022) 
Global 
Clarifications and corrections 
have been made throughout the 
SAP, where appropriate 
Based on dry-run findings 
3.4 
Update definition subgroups. 
Based on internal discussion 
4.4.5 
Replacing COVID impact 
indicator by listing of AEs related 
to COVID 
The impact indicator is a 
Gilead-defined analysis. Not 
deemed valuable 
7.4 
Addition of ATC level 2 in 
summaries of concomitant 
medications 
Requested by medical leads 
7.5 
ECG shift table replaced by 
frequency table 
Baseline ECG not available in 
this study 
Title page 
Update medical leader 
 


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Final Version 1.0 
(13 January 2023) 
4.4 
Reduction of planned analyses 
related to the impact of the 
Ukrainian conflict 
Data availability 
5.2 
Update prednisone dose 
categories 
Requested by medical leads 
7.1.4 
Added section on the handling of 
“action taken” information in the 
summaries of AEs 
Clarification 
Appendix 5 
Addition of MST lists based on 
the latest MedDRA version  
For transparency on which lists 
were used at the time of 
analysis 
Final Version 2.0 
(1 August 2023) 
3.2, 3.4, 5.1, 
5.2, 6.3 
Extension of analyses of baseline 
characteristics and efficacy 
endpoints in the subset of 
induction non-responders: by 
prior exposure, addition of 
imputation rules 
For better understanding of this 
specific subgroup  
7.1.7 
Removal of specific AE 
summaries 
Considered unnecessary by the 
team 
7.1.8 
Addition of subcategories VTE 
Request medical safety 
7.1.9 
Removal of subgroup analyses for 
AE 
Considered unnecessary by the 
team 
7.2.2 
Removal lab shift tables  
Considered unnecessary by the 
team 


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11. 
APPENDICES 
Appendix 1. 
Schedule of Assessments ........................................................................................................ 44 
Appendix 2. 
CDAI and PRO2 Calculation ................................................................................................. 47 
Appendix 3. 
Data Collection of COVID-19 Data ....................................................................................... 51 
Appendix 4. 
Calculation of Standard Body Weight .................................................................................... 52 
Appendix 5. 
MST Lists for AEs of Interest ................................................................................................ 54 
 
 
 


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Appendix 1. 
Schedule of Assessments 
Study Procedures 
Day 1a 
Week 2 
Week 4 
Every 
4 Weeks 
from 
Day 1 
Week 12 and 
then every 
12 Weeks 
from Day 1 
Clinic Visit 
Every 
24 Weeks 
from 
Day 1 
Clinic 
Visit 
Every 
48 Weeks 
from 
Day 1 
Clinic 
Visit 
Early 
Termination 
(ET) Visit 
Post-Treatment 
(PTx)b 
 
± 3 days 
± 3 days 
± 7 days 
± 7 days 
± 7 days 
± 7 days 
 
± 3 days 
Written Informed Consent 
X 
 
 
 
 
 
 
 
 
Review Inclusion/Exclusion 
Criteria  
X 
 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
 
Symptom-Directed Examination 
(as needed) 
X 
X 
X 
 
X 
 
 
X 
X 
Perianal fistulae assessment 
(for subjects rolling over from 
GS-US-419-4016 only) c 
 
 
 
 
X 
 
 
X 
X 
Vital Signsd 
X 
X 
X 
 
X 
 
 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
Weight  
X 
X 
X 
 
X 
 
 
X 
X 
Hematology 
X 
X 
X 
 
X 
 
 
X 
X 
Chemistry 
X 
X 
X 
 
X 
 
 
X 
X 
Lipid Profile (fasting)e 
 
 
 
 
 
X 
 
 
 
Urinalysis 
X 
 
 
 
 
X 
 
 
 
Pregnancy Testf 
X 
 
X 
X 
 
 
 
X 
X 
HBV DNA monitoring (Japan)g 
X 
 
X 
X 
 
 
 
 
 
HBV DNA monitoring (other 
regions)h 
X 
 
 
 
X 
 
 
 
 
TB Assessmenti 
X 
 
 
 
 
 
X 
 
 






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Appendix 2. 
CDAI and PRO2 Calculation 
The total CDAI score is a weighted sum of all 8 variables as specified in Table 11-1, and the 
PRO2 scores will be assessed according to Table 11-2. Details for the calculations of CDAI and 
PRO2 scores at baseline and post-baseline visits are provided in this appendix. 
Table 11-1. 
Calculation of Total CDAI Score 
Variable no. 
Variable 
Variable description 
Multiplier 
1 
Liquid or very soft stool 
Daily stool count is summed for 7 days 
2 
2 
Abdominal pain 
Sum of 7 days of daily ratings as 
0 = none, 1 = mild, 2 = moderate, 3 = severe 
5 
3 
General wellbeing 
Sum of 7 days of daily ratings as 
0 = generally well, 1 = slightly below par, 
2 = poor, 3 = very poor, 4 = terrible 
7 
4 
Complications 
Number of listed complications: 
- Arthritis or arthralgia 
- Erythema nodosum, pyoderma 
gangrenosum or apthous stomatitis 
- Iritis or uveitis 
- Anal fissures or fistulae or abscess 
- Other fistula 
- Fever over 37.8 C [100 F] during past week 
20 each 
5 
Use of anti-diarrheal 
medications 
Use of diphenoxylate or loperamide or other 
opiate for diarrhea 
0 = No, 1 = Yes 
30 
6 
Abdominal mass 
0 = none, 2 = questionable, 5 = definite 
10 
7 
Hematocrit* 
Males: 47 – Hct [%] 
Females: 42 – Hct [%] 
*Result must be greater than or equal to 0. 
If negative result enter 0 
6 × difference 
8 
Weight* 
Percentage deviation from standard weight 
(1 – weight / standard weight) × 100 
*Limit of -10 (Result must be greater than or 
equal to -10) 
1 
CDAI score 
 
 
TOTAL 
CDAI = Crohn’s Disease Activity Index; Hct = hematocrit 


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Table 11-2. 
Calculation of PRO2 Components 
Variable no. 
Variable 
Variable Description 
1 
Liquid or very soft stool 
Mean of the daily (liquid or very 
soft) stool count for 7 days 
2 
Abdominal pain 
Mean of 7 days of daily ratings as 
0 = none, 1 = mild, 2 = moderate, 3 = 
severe 
 
Each PRO2 subscore will be rounded to the nearest integer (eg, 2) in the determination of subject 
eligibility for the study and calculation of endpoints. 
The 3 patient-reported outcome components for CDAI (and each subscore for PRO2) are 
determined using an electronic daily diary, which collects subject reported components directly. 
Given that the ileocolonoscopy procedure (non-protocol-directed procedures) may impact the 
validity of the diary data, diary data collected 1 day prior to and on the day of the procedure will 
not be used in the calculation of CDAI and PRO2 subscores for all visits. Those days are called 
non-evaluable days.  
Calculation of CDAI and PRO2 Scores for Baseline and Post-baseline Visits 
The calculations of CDAI and PRO2 scores for baseline and post-baseline visits are specified 
below: 
1) The Day 1 visit date will be used as the anchor day for baseline and following visit dates will 
be used as the anchor day for post-baseline visits. The visit date for each analysis visit will be 
selected as the anchor day among all scheduled visits and unscheduled visits where CDAI 
were assessed within the analysis window as defined in Section 3.8.2. Only diary data 
collected on evaluable days within a 10-day window which starts 10 days prior to the 
selected visit date (V-Day 1) and ends on the day prior to V-Day 1 will be used for 
calculation.  
2) If there are 7 or more evaluable records within the 10-day window, take the sum of the 
7 evaluable records closest to V-Day 1 for the corresponding CDAI subject-reported 
component. For the corresponding PRO2 component, take the average of the 7 evaluable 
records within the 10-day window closest to V-Day 1. 
a) If there are 4 or more (but less than 7) evaluable records within this 10-day window, 
the average of the available records will be taken, and then multiplied by 7 for the 
corresponding CDAI patient-reported component. For the corresponding PRO2 
component, the average of the available records will be taken. 
b) If subjects do not have at least 4 evaluable records within this 10-day window, the 
corresponding CDAI patient-reported component, and the corresponding PRO2 
component will not be calculated and will be considered as missing for that visit. 




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If subjects have at least 1 of the 8 CDAI components missing, then their total CDAI score 
will be considered missing. If at least 1 out of the 6 complications under the complication 
component is missing, then the complication component will be considered missing. 
4) The PRO2 subscores for a specific visit are based on the evaluation of liquid or very soft 
stool frequency and abdominal pain subscores individually (rounded to the nearest integer) 
within the analysis window as defined in Section 3.8.2. 
Source of Information Used for CDAI and PRO2 Calculation 
The sources of information used for the calculations of CDAI and PRO2 scores as described 
above are given in Error! Reference source not found. (the calculated scores from ERT data w
ill not be used for data analysis). Hematocrit results collected from local laboratories and body 
weight measured at home due to COVID-19 impact will be used in CDAI calculation. 
Table 11-4. 
Sources of Information for Calculating CDAI and PRO2 Scores 
Variable in Calculation 
Data Source 
Visit Date 
VISITDAT in VISDT dataset from eCRF data 
Stool Frequency Diary Data 
QSSTRESN in DIARY dataset with QSTESTCD=“SOFSTOOL” from 
vendor ERT data 
Abdominal Pain Diary Data 
QSSTRESN in DIARY dataset with QSTESTCD=“ABDPAIN” from vendor 
ERT data 
Subject Standard Weight  
SEX_STD in DM dataset and HEIGHT_STD in VSPERF dataset from eCRF 
data will be used to determine the standard weight based on Appendix 4. 
Subject Actual Weight 
WEIGHT_STD in VSPERF dataset from eCRF data 
Hematocrit Value 
CNVRESN in COVLAB dataset with LBTEST=“Hematocrit” from vendor 
Covance data or LBORRES in LB_HEM dataset with 
LBTEST=“Hematocrit” from eCRF data if collected in local laboratory due 
to COVID-19 impact 
Note: eCRF = electronic case report form(s). ERT is the vendor that electronically collects patient and investigator reported 
outcomes. 
 
 


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Appendix 3. 
Data Collection of COVID-19 Data 
This appendix describes the clinical trial site collection of COVID-19 data pertaining to 
missed/virtual visits and the data processing algorithm that will be used to determine which visits 
are missing and which visits are virtual. 
Data Collection 
A COVID-19 supplement to the eCRF Completion Guidelines (CCG) was provided by Clinical 
Data Management to instruct clinical trial sites with data entry expectations pertaining to 
scenarios related to the COVID-19 pandemic. If a visit was missed, sites were instructed to enter 
“Visit missed due to COVID-19” and if an in-person visit was conducted virtually, sites were 
instructed to enter “Virtual visit due to COVID-19”. 
Determination of Missed and Virtual Visits 
Natural Language Processing (NLP) will be used to search the CRF comment fields to identify 
instances of “COVID-19”, “Virtual”, or synonyms (see Table 11-5).  The search terms will be 
maintained in a global lookup table and can be modified to tune the NLP model. Any comments 
with COVID-19 search terms, “Missed visit” or “Virtual visit will be assigned as follows: 
 
i. 
If COVID-19 terms are identified through NLP and the visit date is missing, then 
result is “Missed Visit” 
ii. 
If COVID-19 and Virtual terms are identified through NLP for a visit, then result 
is “Virtual Visit”. When there are multiple records for the same subject and the 
same visit, if one record could be categorized as “Virtual Visit”, all records 
associated with this subject and this visit will be categorized as “Virtual Visit” 
iii. 
Otherwise result is missing 
 
Table 11-5. 
Example Search Terms for “COVID-19” and “Virtual” Used to 
Identify Missed/Virtual Visits 
Search Terms for “COVID-19” 
Search Terms for “Virtual” 
COVID19 
CORONA 
CORONAVIRUS 
PANDEMIC 
OUTBREAK 
CRISIS 
LOCKDOWN 
QUARANTINE 
SHELTER 
 
VIRTUAL 
TELEMED 
TELEHEALTH 
TELEPHONE 
REMOTE 
TELEMEDICINE  
TELECONSULTATION 
TELEPHONICALLY 
PHONE 
HOME VISIT 
ZOOM 
SKYPE 


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Appendix 4. 
Calculation of Standard Body Weight 
The following table will be used to determine the standard body weight for each subject. Height 
from the eCRF will be used and is assumed to be measured without shoes. 
Women 
Height in cm  
(in shoes)* 
Standard Weight  
in kg 
  
Height in cm  
(in shoes)* 
Standard Weight  
in kg 
127 
41.2 
163 
60.2 
128 
41.7 
164 
60.7 
129 
42.3 
165 
61.3 
130 
42.8 
166 
61.9 
131 
43.3 
167 
62.4 
132 
43.8 
168 
62.9 
133 
44.4 
169 
63.4 
134 
44.9 
170 
63.9 
135 
45.4 
171 
64.5 
136 
45.9 
172 
65.0 
137 
46.4 
173 
65.5 
138 
47.0 
174 
66.0 
139 
47.5 
175 
66.6 
140 
48.0 
176 
67.2 
141 
48.6 
177 
67.7 
142 
49.1 
178 
68.3 
143 
49.6 
179 
68.8 
144 
50.2 
180 
69.3 
145 
50.7 
181 
69.8 
146 
51.2 
182 
70.3 
147 
51.8 
183 
70.8 
148 
52.3 
184 
71.3 
149 
52.8 
185 
71.8 
150 
53.1 
186 
72.3 
151 
54.1 
187 
72.8 
152 
54.5 
188 
73.3 
153 
55.0 
189 
73.8 
154 
55.4 
190 
74.3 
155 
55.9 
191 
74.9 
156 
56.4 
192 
75.4 
157 
57.0 
193 
76.0 
158 
57.5 
194 
76.5 
159 
58.1 
195 
77.0 
160 
58.6 
196 
77.6 
161 
59.1 
197 
78.1 
162 
59.6 
198 
78.6 
* 
add 2.0 cm if shoeless. Please round height to a whole number and select the appropriate standard weight (eg, height 
157.4 cm will be rounded to 157 cm; 157.5 cm will be rounded to 158 cm.) 


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Men 
Height in cm  
(in shoes)* 
Standard Weight  
in kg 
  
Height in cm  
(in shoes)* 
Standard Weight  
in kg 
142 
54.4 
179 
71.9 
143 
54.9 
180 
72.4 
144 
55.4 
181 
73.0 
145 
55.8 
182 
73.6 
146 
56.3 
183 
74.3 
147 
56.8 
184 
74.8 
148 
57.2 
185 
75.5 
149 
57.7 
186 
76.2 
150 
58.2 
187 
76.9 
151 
58.6 
188 
77.6 
152 
59.1 
189 
78.2 
153 
59.6 
190 
78.8 
154 
60.0 
191 
79.6 
155 
60.5 
192 
80.4 
156 
61.0 
193 
81.2 
157 
61.4 
194 
82.1 
158 
61.9 
195 
82.9 
159 
62.2 
196 
83.8 
160 
62.6 
197 
84.7 
161 
62.9 
198 
85.4 
162 
63.3 
199 
86.1 
163 
63.7 
200 
86.7 
164 
64.1 
201 
87.4 
165 
64.6 
202 
88.0 
166 
65.0 
203 
88.8 
167 
65.5 
204 
89.4 
168 
66.0 
205 
90.1 
169 
66.6 
206 
90.7 
170 
67.1 
207 
91.4 
171 
67.6 
208 
92.1 
172 
68.1 
209 
92.7 
173 
68.7 
210 
93.4 
174 
69.2 
211 
94.1 
175 
69.7 
212 
94.8 
176 
70.3 
213 
95.5 
177 
70.8 
214 
96.1 
178 
71.3 
  
  
* 
add 2.0 cm if shoeless. Please round height to a whole number and select the appropriate standard weight (eg, height 157.4 
cm will be rounded to 157 cm; 157.5 cm will be rounded to 158 cm.) 
 
 


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Appendix 5. 
MST Lists for AEs of Interest 
 
 
Herpes Zoster - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10019974 
Herpes zoster 
PT 
10030865 
Ophthalmic herpes zoster 
PT 
10061208 
Herpes zoster infection neurological 
PT 
10063491 
Herpes zoster oticus 
PT 
10065038 
Herpes zoster disseminated 
PT 
10072210 
Genital herpes zoster 
PT 
10074241 
Varicella zoster gastritis 
PT 
10074243 
Varicella zoster oesophagitis 
PT 
10074245 
Herpes zoster pharyngitis 
PT 
10074248 
Herpes zoster meningoencephalitis 
PT 
10074251 
Herpes zoster meningomyelitis 
PT 
10074253 
Herpes zoster necrotising retinopathy 
PT 
10074254 
Varicella zoster pneumonia 
PT 
10074259 
Herpes zoster meningitis 
PT 
10074297 
Herpes zoster cutaneous disseminated 
PT 
10074298 
Varicella zoster sepsis 
PT 
10075611 
Varicella zoster virus infection 
PT 
10076667 
Disseminated varicella zoster vaccine virus infection 
PT 
10079327 
Herpes zoster meningoradiculitis 
PT 
10080516 
Herpes zoster reactivation 
PT 
10082717 
Herpetic radiculopathy 
PT 
10084396 
Disseminated varicella zoster virus infection 
PT 
10086594 
Oral herpes zoster 
PT 
10086746 
Varicella encephalitis 
PT 
10086747 
Varicella meningitis 
PT 
 
  
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Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10000583 
Acral lentiginous melanoma 
PT 
10000585 
Acral lentiginous melanoma stage I 
PT 
10000586 
Acral lentiginous melanoma stage II 
PT 
10000587 
Acral lentiginous melanoma stage III 
PT 
10000588 
Acral lentiginous melanoma stage IV 
PT 
10000739 
Acute erythroid leukaemia 
PT 
10000830 
Acute leukaemia 
PT 
10000846 
Acute lymphocytic leukaemia 
PT 
10000847 
Acute lymphocytic leukaemia (in remission) 
PT 
10000860 
Acute megakaryocytic leukaemia 
PT 
10000871 
Acute monocytic leukaemia 
PT 
10000872 
Acute monocytic leukaemia (in remission) 
PT 
10000880 
Acute myeloid leukaemia 
PT 
10000881 
Acute myeloid leukaemia (in remission) 
PT 
10000890 
Acute myelomonocytic leukaemia 
PT 
10001019 
Acute promyelocytic leukaemia 
PT 
10001141 
Adenocarcinoma 
PT 
10001150 
Adenocarcinoma gastric 
PT 
10001167 
Adenocarcinoma of colon 
PT 
10001197 
Adenocarcinoma of the cervix 
PT 
10001244 
Adenosquamous carcinoma of the cervix 
PT 
10001245 
Adenosquamous cell lung cancer 
PT 
10001247 
Adenosquamous cell lung cancer recurrent 
PT 
10001248 
Adenosquamous cell lung cancer stage 0 
PT 
10001249 
Adenosquamous cell lung cancer stage I 
PT 
10001250 
Adenosquamous cell lung cancer stage II 
PT 
10001251 
Adenosquamous cell lung cancer stage III 
PT 
10001254 
Adenosquamous cell lung cancer stage IV 
PT 
10001388 
Adrenocortical carcinoma 
PT 
10001413 
Adult T-cell lymphoma/leukaemia 
PT 
10001416 
Adult T-cell lymphoma/leukaemia recurrent 
PT 
10001417 
Adult T-cell lymphoma/leukaemia refractory 
PT 
10001418 
Adult T-cell lymphoma/leukaemia stage I 
PT 
10001419 
Adult T-cell lymphoma/leukaemia stage II 
PT 
10001420 
Adult T-cell lymphoma/leukaemia stage III 
PT 
 
  
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Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10001421 
Adult T-cell lymphoma/leukaemia stage IV 
PT 
10001433 
Aesthesioneuroblastoma 
PT 
10001660 
Aleukaemic leukaemia 
PT 
10001882 
Alveolar soft part sarcoma 
PT 
10001884 
Alveolar soft part sarcoma metastatic 
PT 
10001887 
Alveolar soft part sarcoma recurrent 
PT 
10002133 
Anal cancer recurrent 
PT 
10002134 
Anal cancer stage 0 
PT 
10002135 
Anal cancer stage I 
PT 
10002136 
Anal cancer stage II 
PT 
10002137 
Anal cancer stage III 
PT 
10002138 
Anal cancer stage IV 
PT 
10002224 
Anaplastic astrocytoma 
PT 
10002227 
Anaplastic large cell lymphoma T- and null-cell types 
PT 
10002229 
Anaplastic large cell lymphoma T- and null-cell types recurrent 
PT 
10002230 
Anaplastic large cell lymphoma T- and null-cell types refractory 
PT 
10002231 
Anaplastic large cell lymphoma T- and null-cell types stage I 
PT 
10002232 
Anaplastic large cell lymphoma T- and null-cell types stage II 
PT 
10002233 
Anaplastic large cell lymphoma T- and null-cell types stage III 
PT 
10002234 
Anaplastic large cell lymphoma T- and null-cell types stage IV 
PT 
10002240 
Anaplastic thyroid cancer 
PT 
10002411 
Angiocentric lymphoma 
PT 
10002414 
Angiocentric lymphoma recurrent 
PT 
10002415 
Angiocentric lymphoma refractory 
PT 
10002416 
Angiocentric lymphoma stage I 
PT 
10002417 
Angiocentric lymphoma stage II 
PT 
10002418 
Angiocentric lymphoma stage III 
PT 
10002419 
Angiocentric lymphoma stage IV 
PT 
10002449 
Angioimmunoblastic T-cell lymphoma 
PT 
10002452 
Angioimmunoblastic T-cell lymphoma recurrent 
PT 
10002453 
Angioimmunoblastic T-cell lymphoma refractory 
PT 
10002454 
Angioimmunoblastic T-cell lymphoma stage I 
PT 
10002455 
Angioimmunoblastic T-cell lymphoma stage II 
PT 
10002456 
Angioimmunoblastic T-cell lymphoma stage III 
PT 
10002457 
Angioimmunoblastic T-cell lymphoma stage IV 
PT 
 
  
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Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10002476 
Angiosarcoma 
PT 
10002477 
Angiosarcoma metastatic 
PT 
10002480 
Angiosarcoma recurrent 
PT 
10003506 
Aspiration bone marrow abnormal 
PT 
10003571 
Astrocytoma 
PT 
10003890 
B precursor type acute leukaemia 
PT 
10003899 
B-cell lymphoma 
PT 
10003902 
B-cell lymphoma recurrent 
PT 
10003903 
B-cell lymphoma refractory 
PT 
10003904 
B-cell lymphoma stage I 
PT 
10003905 
B-cell lymphoma stage II 
PT 
10003906 
B-cell lymphoma stage III 
PT 
10003907 
B-cell lymphoma stage IV 
PT 
10003908 
B-cell small lymphocytic lymphoma 
PT 
10003911 
B-cell small lymphocytic lymphoma recurrent 
PT 
10003912 
B-cell small lymphocytic lymphoma refractory 
PT 
10003913 
B-cell small lymphocytic lymphoma stage I 
PT 
10003914 
B-cell small lymphocytic lymphoma stage II 
PT 
10003915 
B-cell small lymphocytic lymphoma stage III 
PT 
10003916 
B-cell small lymphocytic lymphoma stage IV 
PT 
10003917 
B-cell type acute leukaemia 
PT 
10003922 
B-cell unclassifiable lymphoma high grade 
PT 
10003923 
B-cell unclassifiable lymphoma low grade 
PT 
10004585 
Bile duct adenocarcinoma 
PT 
10004589 
Bile duct adenosquamous carcinoma 
PT 
10004593 
Bile duct cancer 
PT 
10004596 
Bile duct cancer recurrent 
PT 
10004633 
Bile duct squamous cell carcinoma 
PT 
10004738 
Biopsy bone marrow abnormal 
PT 
10004798 
Biopsy lymph gland abnormal 
PT 
10004986 
Bladder adenocarcinoma recurrent 
PT 
10004987 
Bladder adenocarcinoma stage 0 
PT 
10004988 
Bladder adenocarcinoma stage I 
PT 
10004989 
Bladder adenocarcinoma stage II 
PT 
10004990 
Bladder adenocarcinoma stage III 
PT 
 
  
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Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10004991 
Bladder adenocarcinoma stage IV 
PT 
10004992 
Bladder adenocarcinoma stage unspecified 
PT 
10005003 
Bladder cancer 
PT 
10005005 
Bladder cancer recurrent 
PT 
10005006 
Bladder cancer stage 0, with cancer in situ 
PT 
10005007 
Bladder cancer stage 0, without cancer in situ 
PT 
10005008 
Bladder cancer stage I, with cancer in situ 
PT 
10005009 
Bladder cancer stage I, without cancer in situ 
PT 
10005010 
Bladder cancer stage II 
PT 
10005011 
Bladder cancer stage III 
PT 
10005012 
Bladder cancer stage IV 
PT 
10005075 
Bladder squamous cell carcinoma recurrent 
PT 
10005076 
Bladder squamous cell carcinoma stage 0 
PT 
10005077 
Bladder squamous cell carcinoma stage I 
PT 
10005078 
Bladder squamous cell carcinoma stage II 
PT 
10005079 
Bladder squamous cell carcinoma stage III 
PT 
10005080 
Bladder squamous cell carcinoma stage IV 
PT 
10005081 
Bladder squamous cell carcinoma stage unspecified 
PT 
10005084 
Bladder transitional cell carcinoma 
PT 
10005949 
Bone cancer 
PT 
10006007 
Bone sarcoma 
PT 
10006032 
Borderline ovarian tumour 
PT 
10006131 
Brain neoplasm malignant 
PT 
10006143 
Brain stem glioma 
PT 
10006187 
Breast cancer 
PT 
10006189 
Breast cancer in situ 
PT 
10006198 
Breast cancer recurrent 
PT 
10006199 
Breast cancer stage I 
PT 
10006200 
Breast cancer stage II 
PT 
10006201 
Breast cancer stage III 
PT 
10006202 
Breast cancer stage IV 
PT 
10006417 
Bronchial carcinoma 
PT 
10006595 
Burkitt's lymphoma 
PT 
10006598 
Burkitt's lymphoma recurrent 
PT 
10006599 
Burkitt's lymphoma refractory 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-59- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10006600 
Burkitt's lymphoma stage I 
PT 
10006601 
Burkitt's lymphoma stage II 
PT 
10006602 
Burkitt's lymphoma stage III 
PT 
10006603 
Burkitt's lymphoma stage IV 
PT 
10007275 
Carcinoid tumour 
PT 
10007279 
Carcinoid tumour of the gastrointestinal tract 
PT 
10007280 
Carcinoid tumour of the prostate 
PT 
10007281 
Carcinoid tumour of the stomach 
PT 
10007282 
Carcinoid tumour pulmonary 
PT 
10007368 
Carcinoma in situ of eye 
PT 
10007384 
Carcinoma in situ of penis 
PT 
10007401 
Carcinoma in situ of trachea 
PT 
10007953 
Central nervous system lymphoma 
PT 
10008342 
Cervix carcinoma 
PT 
10008344 
Cervix carcinoma recurrent 
PT 
10008345 
Cervix carcinoma stage I 
PT 
10008346 
Cervix carcinoma stage II 
PT 
10008347 
Cervix carcinoma stage III 
PT 
10008348 
Cervix carcinoma stage IV 
PT 
10008583 
Chloroma 
PT 
10008584 
Chloroma (in remission) 
PT 
10008593 
Cholangiocarcinoma 
PT 
10008734 
Chondrosarcoma 
PT 
10008736 
Chondrosarcoma metastatic 
PT 
10008738 
Chondrosarcoma recurrent 
PT 
10008747 
Chordoma 
PT 
10008757 
Choriocarcinoma 
PT 
10008773 
Choroid melanoma 
PT 
10008943 
Chronic leukaemia 
PT 
10008958 
Chronic lymphocytic leukaemia 
PT 
10008959 
Chronic lymphocytic leukaemia (in remission) 
PT 
10008961 
Chronic lymphocytic leukaemia recurrent 
PT 
10008962 
Chronic lymphocytic leukaemia refractory 
PT 
10008963 
Chronic lymphocytic leukaemia stage 0 
PT 
10008964 
Chronic lymphocytic leukaemia stage 1 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-60- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10008965 
Chronic lymphocytic leukaemia stage 2 
PT 
10008966 
Chronic lymphocytic leukaemia stage 3 
PT 
10008967 
Chronic lymphocytic leukaemia stage 4 
PT 
10009013 
Chronic myeloid leukaemia 
PT 
10009014 
Chronic myeloid leukaemia (in remission) 
PT 
10009018 
Chronic myelomonocytic leukaemia 
PT 
10009019 
Chronic myelomonocytic leukaemia (in remission) 
PT 
10009252 
Clear cell endometrial carcinoma 
PT 
10009253 
Clear cell sarcoma of the kidney 
PT 
10009944 
Colon cancer 
PT 
10009952 
Colon cancer recurrent 
PT 
10009953 
Colon cancer stage I 
PT 
10009954 
Colon cancer stage II 
PT 
10009955 
Colon cancer stage III 
PT 
10009956 
Colon cancer stage IV 
PT 
10010030 
Colorectal cancer recurrent 
PT 
10010032 
Colorectal cancer stage I 
PT 
10010033 
Colorectal cancer stage II 
PT 
10010034 
Colorectal cancer stage III 
PT 
10010035 
Colorectal cancer stage IV 
PT 
10010038 
Colorectal carcinoma stage 0 
PT 
10011548 
CSF lymphocyte count abnormal 
PT 
10011549 
CSF lymphocyte count increased 
PT 
10011683 
Cutaneous T-cell lymphoma stage IV 
PT 
10012818 
Diffuse large B-cell lymphoma 
PT 
10012821 
Diffuse large B-cell lymphoma recurrent 
PT 
10012822 
Diffuse large B-cell lymphoma refractory 
PT 
10012823 
Diffuse large B-cell lymphoma stage I 
PT 
10012824 
Diffuse large B-cell lymphoma stage II 
PT 
10012825 
Diffuse large B-cell lymphoma stage III 
PT 
10012826 
Diffuse large B-cell lymphoma stage IV 
PT 
10014720 
Endometrial adenocarcinoma 
PT 
10014733 
Endometrial cancer 
PT 
10014734 
Endometrial cancer metastatic 
PT 
10014736 
Endometrial cancer recurrent 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-61- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10014737 
Endometrial cancer stage 0 
PT 
10014738 
Endometrial cancer stage I 
PT 
10014739 
Endometrial cancer stage II 
PT 
10014740 
Endometrial cancer stage III 
PT 
10014741 
Endometrial cancer stage IV 
PT 
10014958 
Eosinophilic leukaemia 
PT 
10014968 
Ependymoma malignant 
PT 
10015099 
Epithelioid sarcoma 
PT 
10015101 
Epithelioid sarcoma metastatic 
PT 
10015104 
Epithelioid sarcoma recurrent 
PT 
10015246 
Erythraemic myelosis (in remission) 
PT 
10015493 
Essential thrombocythaemia 
PT 
10015560 
Ewing's sarcoma 
PT 
10015562 
Ewing's sarcoma metastatic 
PT 
10015564 
Ewing's sarcoma recurrent 
PT 
10015759 
Extra-osseous Ewing's sarcoma 
PT 
10015761 
Extra-osseous Ewing's sarcoma metastatic 
PT 
10015764 
Extra-osseous Ewing's sarcoma recurrent 
PT 
10015789 
Extragonadal primary embryonal carcinoma 
PT 
10015800 
Extragonadal primary germ cell tumour mixed stage I 
PT 
10015801 
Extragonadal primary germ cell tumour mixed stage II 
PT 
10015802 
Extragonadal primary germ cell tumour mixed stage III 
PT 
10015805 
Extragonadal primary non-seminoma stage I 
PT 
10015806 
Extragonadal primary non-seminoma stage II 
PT 
10015809 
Extragonadal primary non-seminoma stage III 
PT 
10015810 
Extragonadal primary non-seminoma stage IV 
PT 
10015811 
Extragonadal primary seminoma (pure) stage I 
PT 
10015812 
Extragonadal primary seminoma (pure) stage II 
PT 
10015815 
Extragonadal primary seminoma (pure) stage III 
PT 
10015816 
Extragonadal primary seminoma (pure) stage IV 
PT 
10015823 
Extranodal marginal zone B-cell lymphoma (MALT type) recurrent 
PT 
10015824 
Extranodal marginal zone B-cell lymphoma (MALT type) refractory 
PT 
10015825 
Extranodal marginal zone B-cell lymphoma (MALT type) stage I 
PT 
10015826 
Extranodal marginal zone B-cell lymphoma (MALT type) stage II 
PT 
10015827 
Extranodal marginal zone B-cell lymphoma (MALT type) stage III 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-62- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10015828 
Extranodal marginal zone B-cell lymphoma (MALT type) stage IV 
PT 
10015831 
Extraocular retinoblastoma 
PT 
10015840 
Extraskeletal chondrosarcoma metastatic 
PT 
10015843 
Extraskeletal chondrosarcoma recurrent 
PT 
10015847 
Extraskeletal osteosarcoma 
PT 
10015849 
Extraskeletal osteosarcoma metastatic 
PT 
10015852 
Extraskeletal osteosarcoma recurrent 
PT 
10016180 
Fallopian tube cancer 
PT 
10016182 
Fallopian tube cancer metastatic 
PT 
10016184 
Fallopian tube cancer stage I 
PT 
10016185 
Fallopian tube cancer stage II 
PT 
10016186 
Fallopian tube cancer stage III 
PT 
10016187 
Fallopian tube cancer stage IV 
PT 
10016632 
Fibrosarcoma 
PT 
10016635 
Fibrosarcoma metastatic 
PT 
10016897 
Follicle centre lymphoma diffuse small cell lymphoma recurrent 
PT 
10016898 
Follicle centre lymphoma diffuse small cell lymphoma refractory 
PT 
10016899 
Follicle centre lymphoma diffuse small cell lymphoma stage I 
PT 
10016900 
Follicle centre lymphoma diffuse small cell lymphoma stage II 
PT 
10016901 
Follicle centre lymphoma diffuse small cell lymphoma stage III 
PT 
10016902 
Follicle centre lymphoma diffuse small cell lymphoma stage IV 
PT 
10016905 
Follicle centre lymphoma, follicular grade I, II, III recurrent 
PT 
10016906 
Follicle centre lymphoma, follicular grade I, II, III refractory 
PT 
10016907 
Follicle centre lymphoma, follicular grade I, II, III stage I 
PT 
10016908 
Follicle centre lymphoma, follicular grade I, II, III stage II 
PT 
10016909 
Follicle centre lymphoma, follicular grade I, II, III stage III 
PT 
10016910 
Follicle centre lymphoma, follicular grade I, II, III stage IV 
PT 
10016935 
Follicular thyroid cancer 
PT 
10017614 
Gallbladder cancer 
PT 
10017619 
Gallbladder cancer recurrent 
PT 
10017701 
Ganglioglioma 
PT 
10017708 
Ganglioneuroblastoma 
PT 
10017758 
Gastric cancer 
PT 
10017761 
Gastric cancer recurrent 
PT 
10017762 
Gastric cancer stage 0 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-63- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10017763 
Gastric cancer stage I 
PT 
10017764 
Gastric cancer stage II 
PT 
10017765 
Gastric cancer stage III 
PT 
10017940 
Gastrointestinal carcinoma 
PT 
10017973 
Gastrointestinal lymphoma 
PT 
10018160 
Genital neoplasm malignant female 
PT 
10018336 
Glioblastoma 
PT 
10018337 
Glioblastoma multiforme 
PT 
10018338 
Glioma 
PT 
10018340 
Gliosarcoma 
PT 
10018395 
Glottis carcinoma 
PT 
10018404 
Glucagonoma 
PT 
10018825 
Haemangiopericytoma 
PT 
10018826 
Haemangiopericytoma of meninges 
PT 
10019053 
Hairy cell leukaemia 
PT 
10019823 
Hepatoblastoma recurrent 
PT 
10020067 
High grade B-cell lymphoma Burkitt-like lymphoma 
PT 
10020070 
High grade B-cell lymphoma Burkitt-like lymphoma recurrent 
PT 
10020071 
High grade B-cell lymphoma Burkitt-like lymphoma refractory 
PT 
10020072 
High grade B-cell lymphoma Burkitt-like lymphoma stage I 
PT 
10020073 
High grade B-cell lymphoma Burkitt-like lymphoma stage II 
PT 
10020074 
High grade B-cell lymphoma Burkitt-like lymphoma stage III 
PT 
10020075 
High grade B-cell lymphoma Burkitt-like lymphoma stage IV 
PT 
10020206 
Hodgkin's disease 
PT 
10020208 
Hodgkin's disease lymphocyte depletion stage I site unspecified 
PT 
10020209 
Hodgkin's disease lymphocyte depletion stage I subdiaphragm 
PT 
10020210 
Hodgkin's disease lymphocyte depletion stage I supradiaphragm 
PT 
10020211 
Hodgkin's disease lymphocyte depletion stage II site unspecified 
PT 
10020212 
Hodgkin's disease lymphocyte depletion stage II subdiaphragm 
PT 
10020213 
Hodgkin's disease lymphocyte depletion stage II supradiaphragm 
PT 
10020215 
Hodgkin's disease lymphocyte depletion type recurrent 
PT 
10020216 
Hodgkin's disease lymphocyte depletion type refractory 
PT 
10020217 
Hodgkin's disease lymphocyte depletion type stage III 
PT 
10020218 
Hodgkin's disease lymphocyte depletion type stage IV 
PT 
10020219 
Hodgkin's disease lymphocyte depletion type stage unspecified 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-64- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10020220 
Hodgkin's disease lymphocyte predominance stage I site unspec 
PT 
10020221 
Hodgkin's disease lymphocyte predominance stage I subdiaphragm 
PT 
10020222 
Hodgkin's disease lymphocyte predominance stage I supradiaphragm 
PT 
10020223 
Hodgkin's disease lymphocyte predominance stage II site unspec 
PT 
10020224 
Hodgkin's disease lymphocyte predominance stage II subdiaphragm 
PT 
10020225 
Hodgkin's disease lymphocyte predominance stage II supradiaphragm 
PT 
10020227 
Hodgkin's disease lymphocyte predominance type recurrent 
PT 
10020228 
Hodgkin's disease lymphocyte predominance type refractory 
PT 
10020229 
Hodgkin's disease lymphocyte predominance type stage III 
PT 
10020230 
Hodgkin's disease lymphocyte predominance type stage IV 
PT 
10020231 
Hodgkin's disease lymphocyte predominance type stage unspecified 
PT 
10020233 
Hodgkin's disease mixed cellularity recurrent 
PT 
10020234 
Hodgkin's disease mixed cellularity refractory 
PT 
10020235 
Hodgkin's disease mixed cellularity stage I site unspecified 
PT 
10020236 
Hodgkin's disease mixed cellularity stage I subdiaphragmatic 
PT 
10020237 
Hodgkin's disease mixed cellularity stage I supradiaphragmatic 
PT 
10020238 
Hodgkin's disease mixed cellularity stage II subdiaphragmatic 
PT 
10020239 
Hodgkin's disease mixed cellularity stage II supradiaphragmatic 
PT 
10020240 
Hodgkin's disease mixed cellularity stage III 
PT 
10020241 
Hodgkin's disease mixed cellularity stage IV 
PT 
10020242 
Hodgkin's disease mixed cellularity stage unspecified 
PT 
10020244 
Hodgkin's disease nodular sclerosis 
PT 
10020245 
Hodgkin's disease nodular sclerosis recurrent 
PT 
10020246 
Hodgkin's disease nodular sclerosis refractory 
PT 
10020252 
Hodgkin's disease nodular sclerosis stage III 
PT 
10020253 
Hodgkin's disease nodular sclerosis stage IV 
PT 
10020266 
Hodgkin's disease recurrent 
PT 
10020267 
Hodgkin's disease refractory 
PT 
10020268 
Hodgkin's disease stage I 
PT 
10020269 
Hodgkin's disease stage II 
PT 
10020270 
Hodgkin's disease stage III 
PT 
10020271 
Hodgkin's disease unclassifiable 
PT 
10020391 
Hormone-secreting ovarian tumour 
PT 
10021042 
Hypopharyngeal cancer 
PT 
10021044 
Hypopharyngeal cancer recurrent 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-65- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10021045 
Hypopharyngeal cancer stage 0 
PT 
10021046 
Hypopharyngeal cancer stage I 
PT 
10021047 
Hypopharyngeal cancer stage II 
PT 
10021048 
Hypopharyngeal cancer stage III 
PT 
10021049 
Hypopharyngeal cancer stage IV 
PT 
10021977 
Inflammatory carcinoma of breast recurrent 
PT 
10021978 
Inflammatory carcinoma of breast stage III 
PT 
10021979 
Inflammatory carcinoma of breast stage IV 
PT 
10021980 
Inflammatory carcinoma of the breast 
PT 
10022498 
Insulinoma 
PT 
10022706 
Intestinal T-cell lymphoma recurrent 
PT 
10022707 
Intestinal T-cell lymphoma refractory 
PT 
10022708 
Intestinal T-cell lymphoma stage I 
PT 
10022709 
Intestinal T-cell lymphoma stage II 
PT 
10022710 
Intestinal T-cell lymphoma stage III 
PT 
10022711 
Intestinal T-cell lymphoma stage IV 
PT 
10022770 
Intracranial meningioma malignant 
PT 
10023249 
Juvenile chronic myelomonocytic leukaemia 
PT 
10023774 
Large cell lung cancer 
PT 
10023775 
Large cell lung cancer recurrent 
PT 
10023776 
Large cell lung cancer stage 0 
PT 
10023777 
Large cell lung cancer stage I 
PT 
10023778 
Large cell lung cancer stage II 
PT 
10023779 
Large cell lung cancer stage III 
PT 
10023780 
Large cell lung cancer stage IV 
PT 
10023791 
Large granular lymphocytosis 
PT 
10023825 
Laryngeal cancer 
PT 
10023828 
Laryngeal cancer recurrent 
PT 
10023829 
Laryngeal cancer stage 0 
PT 
10023830 
Laryngeal cancer stage I 
PT 
10023831 
Laryngeal cancer stage II 
PT 
10023832 
Laryngeal cancer stage III 
PT 
10023833 
Laryngeal cancer stage IV 
PT 
10023841 
Laryngeal neoplasm 
PT 
10023856 
Laryngeal squamous cell carcinoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-66- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10024189 
Leiomyosarcoma 
PT 
10024191 
Leiomyosarcoma metastatic 
PT 
10024194 
Leiomyosarcoma recurrent 
PT 
10024218 
Lentigo maligna 
PT 
10024220 
Lentigo maligna recurrent 
PT 
10024221 
Lentigo maligna stage I 
PT 
10024222 
Lentigo maligna stage II 
PT 
10024223 
Lentigo maligna stage III 
PT 
10024224 
Lentigo maligna stage IV 
PT 
10024288 
Leukaemia 
PT 
10024293 
Leukaemia basophilic 
PT 
10024299 
Leukaemia granulocytic 
PT 
10024305 
Leukaemia monocytic 
PT 
10024325 
Leukaemic lymphoma 
PT 
10024407 
Leydig cell tumour of the testis 
PT 
10024520 
Linitis plastica 
PT 
10024535 
Lip and/or oral cavity cancer recurrent 
PT 
10024536 
Lip and/or oral cavity cancer stage 0 
PT 
10024537 
Lip and/or oral cavity cancer stage I 
PT 
10024538 
Lip and/or oral cavity cancer stage II 
PT 
10024539 
Lip and/or oral cavity cancer stage III 
PT 
10024540 
Lip and/or oral cavity cancer stage IV 
PT 
10024557 
Lip neoplasm malignant stage unspecified 
PT 
10024627 
Liposarcoma 
PT 
10024629 
Liposarcoma metastatic 
PT 
10024632 
Liposarcoma recurrent 
PT 
10025031 
Lung adenocarcinoma 
PT 
10025033 
Lung adenocarcinoma recurrent 
PT 
10025034 
Lung adenocarcinoma stage 0 
PT 
10025035 
Lung adenocarcinoma stage I 
PT 
10025036 
Lung adenocarcinoma stage II 
PT 
10025037 
Lung adenocarcinoma stage III 
PT 
10025038 
Lung adenocarcinoma stage IV 
PT 
10025065 
Lung carcinoma cell type unspecified recurrent 
PT 
10025066 
Lung carcinoma cell type unspecified stage 0 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-67- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10025067 
Lung carcinoma cell type unspecified stage I 
PT 
10025068 
Lung carcinoma cell type unspecified stage II 
PT 
10025069 
Lung carcinoma cell type unspecified stage III 
PT 
10025070 
Lung carcinoma cell type unspecified stage IV 
PT 
10025120 
Lung squamous cell carcinoma recurrent 
PT 
10025121 
Lung squamous cell carcinoma stage 0 
PT 
10025122 
Lung squamous cell carcinoma stage I 
PT 
10025123 
Lung squamous cell carcinoma stage II 
PT 
10025124 
Lung squamous cell carcinoma stage III 
PT 
10025125 
Lung squamous cell carcinoma stage IV 
PT 
10025223 
Lymphangiosarcoma 
PT 
10025270 
Lymphocytic leukaemia 
PT 
10025300 
Lymphoid leukaemia (in remission) 
PT 
10025310 
Lymphoma 
PT 
10025312 
Lymphoma AIDS related 
PT 
10025342 
Lymphoplasmacytoid lymphoma/immunocytoma 
PT 
10025345 
Lymphoplasmacytoid lymphoma/immunocytoma recurrent 
PT 
10025346 
Lymphoplasmacytoid lymphoma/immunocytoma refractory 
PT 
10025347 
Lymphoplasmacytoid lymphoma/immunocytoma stage I 
PT 
10025348 
Lymphoplasmacytoid lymphoma/immunocytoma stage II 
PT 
10025349 
Lymphoplasmacytoid lymphoma/immunocytoma stage III 
PT 
10025350 
Lymphoplasmacytoid lymphoma/immunocytoma stage IV 
PT 
10025552 
Malignant fibrous histiocytoma 
PT 
10025554 
Malignant fibrous histiocytoma metastatic 
PT 
10025557 
Malignant fibrous histiocytoma of bone 
PT 
10025561 
Malignant fibrous histiocytoma recurrent 
PT 
10025566 
Malignant haemangiopericytoma 
PT 
10025567 
Malignant haemangiopericytoma metastatic 
PT 
10025570 
Malignant haemangiopericytoma recurrent 
PT 
10025581 
Malignant histiocytosis 
PT 
10025598 
Malignant hydatidiform mole 
PT 
10025635 
Malignant lymphoma unclassifiable high grade 
PT 
10025636 
Malignant lymphoma unclassifiable low grade 
PT 
10025638 
Malignant mast cell neoplasm 
PT 
10025650 
Malignant melanoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-68- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10025652 
Malignant melanoma in situ 
PT 
10025654 
Malignant melanoma of sites other than skin 
PT 
10025668 
Malignant melanoma stage I 
PT 
10025669 
Malignant melanoma stage II 
PT 
10025670 
Malignant melanoma stage III 
PT 
10025671 
Malignant melanoma stage IV 
PT 
10025674 
Malignant mesenchymoma metastatic 
PT 
10025677 
Malignant mesenchymoma recurrent 
PT 
10025697 
Malignant neoplasm of ampulla of Vater 
PT 
10025839 
Malignant neoplasm of choroid 
PT 
10025861 
Malignant neoplasm of conjunctiva 
PT 
10025871 
Malignant neoplasm of cornea 
PT 
10025910 
Malignant neoplasm of eye 
PT 
10025997 
Malignant neoplasm of islets of Langerhans 
PT 
10026030 
Malignant neoplasm of lacrimal duct 
PT 
10026031 
Malignant neoplasm of lacrimal gland 
PT 
10026183 
Malignant neoplasm of orbit 
PT 
10026326 
Malignant neoplasm of paraurethral glands 
PT 
10026350 
Malignant neoplasm of placenta 
PT 
10026351 
Malignant neoplasm of pleura 
PT 
10026426 
Malignant neoplasm of renal pelvis 
PT 
10026432 
Malignant neoplasm of retina 
PT 
10026470 
Malignant neoplasm of spermatic cord 
PT 
10026472 
Malignant neoplasm of spinal cord 
PT 
10026532 
Malignant neoplasm of thorax 
PT 
10026533 
Malignant neoplasm of thymus 
PT 
10026616 
Malignant neoplasm of uterine adnexa 
PT 
10026659 
Malignant oligodendroglioma 
PT 
10026662 
Malignant ovarian cyst 
PT 
10026663 
Malignant palate neoplasm 
PT 
10026672 
Malignant pituitary tumour 
PT 
10026702 
Malignant splenic neoplasm 
PT 
10026800 
Mantle cell lymphoma recurrent 
PT 
10026801 
Mantle cell lymphoma refractory 
PT 
10026802 
Mantle cell lymphoma stage I 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-69- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10026803 
Mantle cell lymphoma stage II 
PT 
10026804 
Mantle cell lymphoma stage III 
PT 
10026805 
Mantle cell lymphoma stage IV 
PT 
10026945 
Mature B-cell type acute leukaemia 
PT 
10027095 
Medullary carcinoma of breast 
PT 
10027105 
Medullary thyroid cancer 
PT 
10027107 
Medulloblastoma 
PT 
10027193 
Meningioma malignant 
PT 
10027406 
Mesothelioma 
PT 
10027407 
Mesothelioma malignant 
PT 
10027411 
Mesothelioma malignant recurrent 
PT 
10027450 
Metastases to abdominal cavity 
PT 
10027451 
Metastases to adrenals 
PT 
10027452 
Metastases to bone 
PT 
10027454 
Metastases to breast 
PT 
10027455 
Metastases to kidney 
PT 
10027457 
Metastases to liver 
PT 
10027458 
Metastases to lung 
PT 
10027459 
Metastases to lymph nodes 
PT 
10027460 
Metastases to neck 
PT 
10027462 
Metastases to ovary 
PT 
10027463 
Metastases to pleura 
PT 
10027465 
Metastases to skin 
PT 
10027468 
Metastases to spine 
PT 
10027469 
Metastases to the mediastinum 
PT 
10027480 
Metastatic malignant melanoma 
PT 
10027761 
Mixed hepatocellular cholangiocarcinoma 
PT 
10028076 
Mucinous endometrial carcinoma 
PT 
10028533 
Myelodysplastic syndrome 
PT 
10028535 
Myelodysplastic syndrome unclassifiable 
PT 
10028537 
Myelofibrosis 
PT 
10028549 
Myeloid leukaemia 
PT 
10028561 
Myeloid metaplasia 
PT 
10028729 
Nasal cavity cancer 
PT 
10028767 
Nasal sinus cancer 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-70- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10028787 
Nasopharyngeal cancer recurrent 
PT 
10028788 
Nasopharyngeal cancer stage 0 
PT 
10028789 
Nasopharyngeal cancer stage I 
PT 
10028790 
Nasopharyngeal cancer stage II 
PT 
10028791 
Nasopharyngeal cancer stage III 
PT 
10028792 
Nasopharyngeal cancer stage IV 
PT 
10028811 
Natural killer-cell leukaemia 
PT 
10028997 
Neoplasm malignant 
PT 
10029145 
Nephroblastoma 
PT 
10029260 
Neuroblastoma 
PT 
10029274 
Neurofibrosarcoma metastatic 
PT 
10029277 
Neurofibrosarcoma recurrent 
PT 
10029341 
Neurotensinoma 
PT 
10029460 
Nodal marginal zone B-cell lymphoma 
PT 
10029463 
Nodal marginal zone B-cell lymphoma recurrent 
PT 
10029464 
Nodal marginal zone B-cell lymphoma refractory 
PT 
10029465 
Nodal marginal zone B-cell lymphoma stage I 
PT 
10029466 
Nodal marginal zone B-cell lymphoma stage II 
PT 
10029467 
Nodal marginal zone B-cell lymphoma stage III 
PT 
10029468 
Nodal marginal zone B-cell lymphoma stage IV 
PT 
10029488 
Nodular melanoma 
PT 
10029515 
Non-small cell lung cancer recurrent 
PT 
10029516 
Non-small cell lung cancer stage 0 
PT 
10029517 
Non-small cell lung cancer stage I 
PT 
10029518 
Non-small cell lung cancer stage II 
PT 
10029519 
Non-small cell lung cancer stage III 
PT 
10029520 
Non-small cell lung cancer stage IIIA 
PT 
10029521 
Non-small cell lung cancer stage IIIB 
PT 
10029522 
Non-small cell lung cancer stage IV 
PT 
10029547 
Non-Hodgkin's lymphoma 
PT 
10029600 
Non-Hodgkin's lymphoma recurrent 
PT 
10029601 
Non-Hodgkin's lymphoma refractory 
PT 
10029602 
Non-Hodgkin's lymphoma stage I 
PT 
10029603 
Non-Hodgkin's lymphoma stage II 
PT 
10029604 
Non-Hodgkin's lymphoma stage III 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-71- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10029605 
Non-Hodgkin's lymphoma stage IV 
PT 
10029609 
Non-Hodgkin's lymphoma unspecified histology aggressive recurrent 
PT 
10029610 
Non-Hodgkin's lymphoma unspecified histology aggressive refractory 
PT 
10029611 
Non-Hodgkin's lymphoma unspecified histology aggressive stage I 
PT 
10029612 
Non-Hodgkin's lymphoma unspecified histology aggressive stage II 
PT 
10029613 
Non-Hodgkin's lymphoma unspecified histology aggressive stage III 
PT 
10029614 
Non-Hodgkin's lymphoma unspecified histology aggressive stage IV 
PT 
10029622 
Non-Hodgkin's lymphoma unspecified histology indolent stage I 
PT 
10029623 
Non-Hodgkin's lymphoma unspecified histology indolent stage II 
PT 
10029624 
Non-Hodgkin's lymphoma unspecified histology indolent stage III 
PT 
10029625 
Non-Hodgkin's lymphoma unspecified histology indolent stage IV 
PT 
10030137 
Oesophageal adenocarcinoma 
PT 
10030140 
Oesophageal adenocarcinoma recurrent 
PT 
10030141 
Oesophageal adenocarcinoma stage 0 
PT 
10030142 
Oesophageal adenocarcinoma stage I 
PT 
10030143 
Oesophageal adenocarcinoma stage II 
PT 
10030144 
Oesophageal adenocarcinoma stage III 
PT 
10030145 
Oesophageal adenocarcinoma stage IV 
PT 
10030155 
Oesophageal carcinoma 
PT 
10030159 
Oesophageal carcinoma recurrent 
PT 
10030162 
Oesophageal carcinoma stage 0 
PT 
10030187 
Oesophageal squamous cell carcinoma recurrent 
PT 
10030188 
Oesophageal squamous cell carcinoma stage 0 
PT 
10030189 
Oesophageal squamous cell carcinoma stage I 
PT 
10030190 
Oesophageal squamous cell carcinoma stage II 
PT 
10030191 
Oesophageal squamous cell carcinoma stage III 
PT 
10030192 
Oesophageal squamous cell carcinoma stage IV 
PT 
10030286 
Oligodendroglioma 
PT 
10031096 
Oropharyngeal cancer 
PT 
10031098 
Oropharyngeal cancer recurrent 
PT 
10031099 
Oropharyngeal cancer stage 0 
PT 
10031100 
Oropharyngeal cancer stage I 
PT 
10031101 
Oropharyngeal cancer stage II 
PT 
10031102 
Oropharyngeal cancer stage III 
PT 
10031104 
Oropharyngeal lymphoepithelioma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-72- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10031112 
Oropharyngeal squamous cell carcinoma 
PT 
10031291 
Osteosarcoma 
PT 
10031294 
Osteosarcoma metastatic 
PT 
10031296 
Osteosarcoma recurrent 
PT 
10033128 
Ovarian cancer 
PT 
10033144 
Ovarian dysgerminoma stage I 
PT 
10033148 
Ovarian dysgerminoma stage II 
PT 
10033152 
Ovarian dysgerminoma stage III 
PT 
10033156 
Ovarian dysgerminoma stage IV 
PT 
10033158 
Ovarian epithelial cancer metastatic 
PT 
10033160 
Ovarian epithelial cancer recurrent 
PT 
10033161 
Ovarian epithelial cancer stage I 
PT 
10033162 
Ovarian epithelial cancer stage II 
PT 
10033163 
Ovarian epithelial cancer stage III 
PT 
10033164 
Ovarian epithelial cancer stage IV 
PT 
10033183 
Ovarian germ cell choriocarcinoma stage I 
PT 
10033187 
Ovarian germ cell choriocarcinoma stage II 
PT 
10033191 
Ovarian germ cell choriocarcinoma stage III 
PT 
10033195 
Ovarian germ cell choriocarcinoma stage IV 
PT 
10033196 
Ovarian germ cell embryonal carcinoma stage I 
PT 
10033200 
Ovarian germ cell embryonal carcinoma stage II 
PT 
10033204 
Ovarian germ cell embryonal carcinoma stage III 
PT 
10033208 
Ovarian germ cell embryonal carcinoma stage IV 
PT 
10033218 
Ovarian germ cell endodermal sinus tumour stage I 
PT 
10033219 
Ovarian germ cell endodermal sinus tumour stage II 
PT 
10033220 
Ovarian germ cell endodermal sinus tumour stage III 
PT 
10033221 
Ovarian germ cell endodermal sinus tumour stage IV 
PT 
10033223 
Ovarian germ cell polyembryoma stage I 
PT 
10033227 
Ovarian germ cell polyembryoma stage II 
PT 
10033231 
Ovarian germ cell polyembryoma stage III 
PT 
10033235 
Ovarian germ cell polyembryoma stage IV 
PT 
10033237 
Ovarian germ cell teratoma stage I 
PT 
10033241 
Ovarian germ cell teratoma stage II 
PT 
10033245 
Ovarian germ cell teratoma stage III 
PT 
10033249 
Ovarian germ cell teratoma stage IV 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-73- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10033268 
Ovarian low malignant potential tumour 
PT 
10033364 
Paget's disease of nipple 
PT 
10033365 
Paget's disease of penis 
PT 
10033369 
Paget's disease of the vulva 
PT 
10033572 
Pancoast's tumour 
PT 
10033609 
Pancreatic carcinoma 
PT 
10033610 
Pancreatic carcinoma metastatic 
PT 
10033613 
Pancreatic carcinoma recurrent 
PT 
10033700 
Papillary serous endometrial carcinoma 
PT 
10033701 
Papillary thyroid cancer 
PT 
10033791 
Paraganglion neoplasm malignant 
PT 
10033855 
Paranasal sinus and nasal cavity malignant neoplasm recurrent 
PT 
10033856 
Paranasal sinus and nasal cavity malignant neoplasm stage 0 
PT 
10033857 
Paranasal sinus and nasal cavity malignant neoplasm stage I 
PT 
10033858 
Paranasal sinus and nasal cavity malignant neoplasm stage II 
PT 
10033859 
Paranasal sinus and nasal cavity malignant neoplasm stage III 
PT 
10033860 
Paranasal sinus and nasal cavity malignant neoplasm stage IV 
PT 
10033965 
Parathyroid tumour malignant 
PT 
10034299 
Penile cancer 
PT 
10034329 
Penis carcinoma metastatic 
PT 
10034331 
Penis carcinoma recurrent 
PT 
10034332 
Penis carcinoma stage I 
PT 
10034333 
Penis carcinoma stage II 
PT 
10034334 
Penis carcinoma stage III 
PT 
10034335 
Penis carcinoma stage IV 
PT 
10034480 
Pericardial mesothelioma malignant recurrent 
PT 
10034603 
Peripheral neuroepithelioma of bone metastatic 
PT 
10034605 
Peripheral neuroepithelioma of bone recurrent 
PT 
10034623 
Peripheral T-cell lymphoma unspecified 
PT 
10034625 
Peripheral T-cell lymphoma unspecified recurrent 
PT 
10034626 
Peripheral T-cell lymphoma unspecified refractory 
PT 
10034627 
Peripheral T-cell lymphoma unspecified stage I 
PT 
10034628 
Peripheral T-cell lymphoma unspecified stage II 
PT 
10034629 
Peripheral T-cell lymphoma unspecified stage III 
PT 
10034630 
Peripheral T-cell lymphoma unspecified stage IV 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-74- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10034671 
Peritoneal mesothelioma malignant recurrent 
PT 
10034811 
Pharyngeal cancer 
PT 
10034813 
Pharyngeal cancer recurrent 
PT 
10034814 
Pharyngeal cancer stage 0 
PT 
10034815 
Pharyngeal cancer stage I 
PT 
10034816 
Pharyngeal cancer stage II 
PT 
10034817 
Pharyngeal cancer stage III 
PT 
10034818 
Pharyngeal cancer stage IV 
PT 
10035052 
Pineal germinoma 
PT 
10035222 
Plasma cell leukaemia 
PT 
10035226 
Plasma cell myeloma 
PT 
10035484 
Plasmacytoma 
PT 
10035603 
Pleural mesothelioma 
PT 
10035607 
Pleural mesothelioma malignant recurrent 
PT 
10036057 
Polycythaemia vera 
PT 
10036334 
Postcricoid cancer 
PT 
10036523 
Precursor B-lymphoblastic lymphoma 
PT 
10036532 
Precursor B-lymphoblastic lymphoma stage I 
PT 
10036533 
Precursor B-lymphoblastic lymphoma stage II 
PT 
10036534 
Precursor B-lymphoblastic lymphoma stage III 
PT 
10036535 
Precursor B-lymphoblastic lymphoma stage IV 
PT 
10036543 
Precursor T-lymphoblastic lymphoma/leukaemia 
PT 
10036546 
Precursor T-lymphoblastic lymphoma/leukaemia recurrent 
PT 
10036547 
Precursor T-lymphoblastic lymphoma/leukaemia refractory 
PT 
10036548 
Precursor T-lymphoblastic lymphoma/leukaemia stage I 
PT 
10036549 
Precursor T-lymphoblastic lymphoma/leukaemia stage II 
PT 
10036550 
Precursor T-lymphoblastic lymphoma/leukaemia stage III 
PT 
10036551 
Precursor T-lymphoblastic lymphoma/leukaemia stage IV 
PT 
10036710 
Primary mediastinal large B-cell lymphoma 
PT 
10036713 
Primary mediastinal large B-cell lymphoma recurrent 
PT 
10036714 
Primary mediastinal large B-cell lymphoma refractory 
PT 
10036715 
Primary mediastinal large B-cell lymphoma stage I 
PT 
10036716 
Primary mediastinal large B-cell lymphoma stage II 
PT 
10036717 
Primary mediastinal large B-cell lymphoma stage III 
PT 
10036718 
Primary mediastinal large B-cell lymphoma stage IV 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-75- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10036888 
Prolymphocytic leukaemia 
PT 
10036909 
Prostate cancer metastatic 
PT 
10036911 
Prostate cancer recurrent 
PT 
10036912 
Prostate cancer stage 0 
PT 
10036917 
Prostate cancer stage I 
PT 
10036918 
Prostate cancer stage II 
PT 
10036919 
Prostate cancer stage III 
PT 
10036920 
Prostate cancer stage IV 
PT 
10038019 
Rectal adenocarcinoma 
PT 
10038038 
Rectal cancer 
PT 
10038046 
Rectal cancer recurrent 
PT 
10038047 
Rectal cancer stage 0 
PT 
10038048 
Rectal cancer stage I 
PT 
10038049 
Rectal cancer stage II 
PT 
10038050 
Rectal cancer stage III 
PT 
10038051 
Rectal cancer stage IV 
PT 
10038086 
Rectosigmoid cancer 
PT 
10038094 
Rectosigmoid cancer recurrent 
PT 
10038095 
Rectosigmoid cancer stage 0 
PT 
10038096 
Rectosigmoid cancer stage I 
PT 
10038097 
Rectosigmoid cancer stage II 
PT 
10038098 
Rectosigmoid cancer stage III 
PT 
10038099 
Rectosigmoid cancer stage IV 
PT 
10038111 
Recurrent cancer 
PT 
10038270 
Refractory anaemia with an excess of blasts 
PT 
10038272 
Refractory anaemia with ringed sideroblasts 
PT 
10038389 
Renal cancer 
PT 
10038390 
Renal cancer recurrent 
PT 
10038391 
Renal cancer stage I 
PT 
10038392 
Renal cancer stage II 
PT 
10038393 
Renal cancer stage III 
PT 
10038394 
Renal cancer stage IV 
PT 
10038410 
Renal cell carcinoma recurrent 
PT 
10038411 
Renal cell carcinoma stage I 
PT 
10038412 
Renal cell carcinoma stage II 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-76- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10038413 
Renal cell carcinoma stage III 
PT 
10038414 
Renal cell carcinoma stage IV 
PT 
10038724 
Respiratory tract carcinoma in situ 
PT 
10038878 
Retinal melanoma 
PT 
10038916 
Retinoblastoma 
PT 
10038977 
Retroperitoneal cancer 
PT 
10039019 
Rhabdoid tumour of the kidney 
PT 
10039022 
Rhabdomyosarcoma 
PT 
10039027 
Rhabdomyosarcoma recurrent 
PT 
10039398 
Salivary gland cancer recurrent 
PT 
10039399 
Salivary gland cancer stage 0 
PT 
10039400 
Salivary gland cancer stage I 
PT 
10039401 
Salivary gland cancer stage II 
PT 
10039402 
Salivary gland cancer stage III 
PT 
10039403 
Salivary gland cancer stage IV 
PT 
10039491 
Sarcoma 
PT 
10039497 
Sarcoma uterus 
PT 
10039500 
Sarcomatosis 
PT 
10039744 
Scrotal cancer 
PT 
10039801 
Second primary malignancy 
PT 
10039956 
Seminoma 
PT 
10041056 
Small cell carcinoma 
PT 
10041057 
Small cell carcinoma of the cervix 
PT 
10041067 
Small cell lung cancer 
PT 
10041068 
Small cell lung cancer extensive stage 
PT 
10041069 
Small cell lung cancer limited stage 
PT 
10041070 
Small cell lung cancer recurrent 
PT 
10041121 
Small intestine carcinoma metastatic 
PT 
10041124 
Small intestine carcinoma recurrent 
PT 
10041127 
Small intestine leiomyosarcoma 
PT 
10041329 
Somatostatinoma 
PT 
10041580 
Spinal meningioma malignant 
PT 
10041652 
Splenic marginal zone lymphoma recurrent 
PT 
10041653 
Splenic marginal zone lymphoma refractory 
PT 
10041654 
Splenic marginal zone lymphoma stage I 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-77- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10041655 
Splenic marginal zone lymphoma stage II 
PT 
10041656 
Splenic marginal zone lymphoma stage III 
PT 
10041657 
Splenic marginal zone lymphoma stage IV 
PT 
10041826 
Squamous cell carcinoma of lung 
PT 
10041848 
Squamous cell carcinoma of the cervix 
PT 
10041849 
Squamous cell carcinoma of the hypopharynx 
PT 
10041857 
Squamous cell carcinoma of the oral cavity 
PT 
10041865 
Squamous cell carcinoma of the tongue 
PT 
10041866 
Squamous cell carcinoma of the vagina 
PT 
10041875 
Squamous cell carcinoma of the vulva 
PT 
10041883 
Squamous endometrial carcinoma 
PT 
10042549 
Superficial spreading melanoma stage I 
PT 
10042550 
Superficial spreading melanoma stage II 
PT 
10042551 
Superficial spreading melanoma stage III 
PT 
10042552 
Superficial spreading melanoma stage IV 
PT 
10042553 
Superficial spreading melanoma stage unspecified 
PT 
10042863 
Synovial sarcoma 
PT 
10042864 
Synovial sarcoma metastatic 
PT 
10042867 
Synovial sarcoma recurrent 
PT 
10042970 
T-cell chronic lymphocytic leukaemia 
PT 
10042971 
T-cell lymphoma 
PT 
10042979 
T-cell lymphoma recurrent 
PT 
10042980 
T-cell lymphoma refractory 
PT 
10042981 
T-cell lymphoma stage I 
PT 
10042982 
T-cell lymphoma stage II 
PT 
10042983 
T-cell lymphoma stage III 
PT 
10042984 
T-cell lymphoma stage IV 
PT 
10042985 
T-cell prolymphocytic leukaemia 
PT 
10042987 
T-cell type acute leukaemia 
PT 
10042989 
T-cell unclassifiable lymphoma high grade 
PT 
10042990 
T-cell unclassifiable lymphoma low grade 
PT 
10043303 
Testicular choriocarcinoma stage I 
PT 
10043304 
Testicular choriocarcinoma stage II 
PT 
10043305 
Testicular choriocarcinoma stage III 
PT 
10043309 
Testicular embryonal carcinoma stage I 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-78- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10043310 
Testicular embryonal carcinoma stage II 
PT 
10043311 
Testicular embryonal carcinoma stage III 
PT 
10043331 
Testicular germ cell tumour mixed stage I 
PT 
10043332 
Testicular germ cell tumour mixed stage II 
PT 
10043333 
Testicular germ cell tumour mixed stage III 
PT 
10043339 
Testicular malignant teratoma stage I 
PT 
10043340 
Testicular malignant teratoma stage II 
PT 
10043341 
Testicular malignant teratoma stage III 
PT 
10043350 
Testicular seminoma (pure) stage I 
PT 
10043351 
Testicular seminoma (pure) stage II 
PT 
10043352 
Testicular seminoma (pure) stage III 
PT 
10043357 
Testicular yolk sac tumour stage I 
PT 
10043358 
Testicular yolk sac tumour stage II 
PT 
10043359 
Testicular yolk sac tumour stage III 
PT 
10043515 
Throat cancer 
PT 
10043581 
Thrombophlebitis migrans 
PT 
10043674 
Thymoma malignant recurrent 
PT 
10043966 
Tongue neoplasm malignant stage unspecified 
PT 
10044002 
Tonsil cancer 
PT 
10044285 
Tracheal cancer 
PT 
10044406 
Transitional cell cancer of renal pelvis and ureter metastatic 
PT 
10044407 
Transitional cell cancer of the renal pelvis and ureter 
PT 
10044408 
Transitional cell cancer of the renal pelvis and ureter localised 
PT 
10044410 
Transitional cell cancer of the renal pelvis and ureter recurrent 
PT 
10044411 
Transitional cell cancer of the renal pelvis and ureter regional 
PT 
10044412 
Transitional cell carcinoma 
PT 
10044426 
Transitional cell carcinoma urethra 
PT 
10045515 
Undifferentiated sarcoma 
PT 
10046392 
Ureteric cancer 
PT 
10046393 
Ureteric cancer local 
PT 
10046394 
Ureteric cancer metastatic 
PT 
10046396 
Ureteric cancer recurrent 
PT 
10046397 
Ureteric cancer regional 
PT 
10046431 
Urethral cancer 
PT 
10046433 
Urethral cancer metastatic 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-79- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10046435 
Urethral cancer recurrent 
PT 
10046766 
Uterine cancer 
PT 
10046770 
Uterine carcinoma in situ 
PT 
10046799 
Uterine leiomyosarcoma 
PT 
10046885 
Vaginal cancer 
PT 
10046887 
Vaginal cancer metastatic 
PT 
10046889 
Vaginal cancer recurrent 
PT 
10046890 
Vaginal cancer stage 0 
PT 
10046891 
Vaginal cancer stage I 
PT 
10046892 
Vaginal cancer stage II 
PT 
10046893 
Vaginal cancer stage III 
PT 
10046894 
Vaginal cancer stage IVA 
PT 
10046895 
Vaginal cancer stage IVB 
PT 
10047430 
Vipoma 
PT 
10047741 
Vulval cancer 
PT 
10047742 
Vulval cancer metastatic 
PT 
10047744 
Vulval cancer recurrent 
PT 
10047745 
Vulval cancer stage 0 
PT 
10047746 
Vulval cancer stage I 
PT 
10047747 
Vulval cancer stage II 
PT 
10047748 
Vulval cancer stage III 
PT 
10047749 
Vulval cancer stage IV 
PT 
10047801 
Waldenstrom's macroglobulinaemia 
PT 
10047804 
Waldenstrom's macroglobulinaemia recurrent 
PT 
10047805 
Waldenstrom's macroglobulinaemia refractory 
PT 
10047806 
Waldenstrom's macroglobulinaemia stage I 
PT 
10047807 
Waldenstrom's macroglobulinaemia stage II 
PT 
10047808 
Waldenstrom's macroglobulinaemia stage III 
PT 
10047809 
Waldenstrom's macroglobulinaemia stage IV 
PT 
10048251 
Yolk sac tumour site unspecified 
PT 
10048397 
Endometrial stromal sarcoma 
PT 
10049067 
Spindle cell sarcoma 
PT 
10049556 
Bone marrow tumour cell infiltration 
PT 
10049557 
Bone marrow leukaemic cell infiltration 
PT 
10049717 
Metastases to heart 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-80- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10049718 
Metastases to stomach 
PT 
10049721 
Metastases to pancreas 
PT 
10049722 
Metastases to bladder 
PT 
10049723 
Metastases to thyroid 
PT 
10049724 
Metastases to eye 
PT 
10049725 
Metastases to placenta 
PT 
10049726 
Metastases to uterus 
PT 
10049727 
Metastases to fallopian tube 
PT 
10049728 
Metastases to pituitary gland 
PT 
10049730 
Metastases to muscle 
PT 
10050017 
Lung cancer metastatic 
PT 
10050018 
Renal cancer metastatic 
PT 
10050282 
Blast crisis in myelogenous leukaemia 
PT 
10050487 
Pinealoblastoma 
PT 
10050513 
Metastatic renal cell carcinoma 
PT 
10051066 
Gastrointestinal stromal tumour 
PT 
10051141 
Myeloblastoma 
PT 
10051358 
Post transplant lymphoproliferative disorder 
PT 
10051398 
Malignant neoplasm progression 
PT 
10051662 
Metastases to bone marrow 
PT 
10051663 
Metastases to chest wall 
PT 
10051664 
Metastases to abdominal wall 
PT 
10051665 
Metastases to diaphragm 
PT 
10051666 
Metastases to Eustachian tube 
PT 
10051667 
Metastases to gallbladder 
PT 
10051668 
Metastases to larynx 
PT 
10051669 
Metastases to mouth 
PT 
10051670 
Metastases to nasal sinuses 
PT 
10051671 
Metastases to oesophagus 
PT 
10051672 
Metastases to penis 
PT 
10051673 
Metastases to perineum 
PT 
10051674 
Metastases to peripheral nervous system 
PT 
10051676 
Metastases to peritoneum 
PT 
10051677 
Metastases to pharynx 
PT 
10051678 
Metastases to prostate 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-81- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10051679 
Metastases to rectum 
PT 
10051680 
Metastases to retroperitoneum 
PT 
10051681 
Metastases to salivary gland 
PT 
10051682 
Metastases to spleen 
PT 
10051683 
Metastases to testicle 
PT 
10051684 
Metastases to thorax 
PT 
10051685 
Metastases to trachea 
PT 
10051690 
Urinary bladder sarcoma 
PT 
10051696 
Metastases to meninges 
PT 
10051709 
Gastrinoma malignant 
PT 
10051710 
Phaeochromocytoma malignant 
PT 
10051807 
Pseudosarcoma 
PT 
10051925 
Intestinal adenocarcinoma 
PT 
10051949 
Peritoneal sarcoma 
PT 
10051950 
Pleural sarcoma 
PT 
10052178 
Lymphocytic lymphoma 
PT 
10052358 
Colorectal cancer metastatic 
PT 
10052360 
Colorectal adenocarcinoma 
PT 
10052368 
Leukaemic infiltration pulmonary 
PT 
10052399 
Neuroendocrine tumour 
PT 
10052747 
Adenocarcinoma pancreas 
PT 
10052759 
Ovarian dysgerminoma stage unspecified 
PT 
10052819 
Carcinoid tumour of the small bowel 
PT 
10052903 
Neoplasm of cornea unspecified malignancy 
PT 
10052974 
Lymphoma operation 
PT 
10052975 
Lymphoid tissue operation 
PT 
10053128 
Malignant nipple neoplasm male 
PT 
10053129 
Malignant nipple neoplasm female 
PT 
10053132 
Lymphangiosis carcinomatosa 
PT 
10053180 
Leukaemia cutis 
PT 
10053190 
Splenic neoplasm malignancy unspecified 
PT 
10053231 
Adenoid cystic carcinoma 
PT 
10053504 
Scan bone marrow abnormal 
PT 
10053548 
Gastrointestinal cancer metastatic 
PT 
10053574 
Immunoblastic lymphoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-82- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10053747 
Blast cell crisis 
PT 
10054184 
Small intestine carcinoma 
PT 
10054912 
Cystadenocarcinoma ovary 
PT 
10054913 
Serous cystadenocarcinoma ovary 
PT 
10054914 
Mucinous cystadenocarcinoma ovary 
PT 
10054946 
Malignant pericardial neoplasm 
PT 
10054951 
Disseminated large cell lymphoma 
PT 
10055006 
Pancreatic sarcoma 
PT 
10055007 
Carcinoid tumour of the pancreas 
PT 
10055008 
Gastric sarcoma 
PT 
10055017 
Ear neoplasm malignant 
PT 
10055093 
Brain cancer metastatic 
PT 
10055094 
Cervix cancer metastatic 
PT 
10055095 
Adrenal gland cancer metastatic 
PT 
10055096 
Anal cancer metastatic 
PT 
10055097 
Rectal cancer metastatic 
PT 
10055098 
Oral cavity cancer metastatic 
PT 
10055099 
Ocular cancer metastatic 
PT 
10055100 
Otic cancer metastatic 
PT 
10055101 
Bone cancer metastatic 
PT 
10055102 
Oesophageal cancer metastatic 
PT 
10055103 
Testicular cancer metastatic 
PT 
10055104 
Pharyngeal cancer metastatic 
PT 
10055105 
Sinus cancer metastatic 
PT 
10055106 
Pituitary cancer metastatic 
PT 
10055107 
Thyroid cancer metastatic 
PT 
10055108 
Thymic cancer metastatic 
PT 
10055109 
Tongue cancer metastatic 
PT 
10055110 
Hepatic cancer metastatic 
PT 
10055111 
Biliary cancer metastatic 
PT 
10055113 
Breast cancer metastatic 
PT 
10055114 
Colon cancer metastatic 
PT 
10055115 
Skin cancer metastatic 
PT 
10056251 
Metastases to urinary tract 
PT 
10056266 
Ovarian embryonal carcinoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-83- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10056450 
Mastocytic leukaemia 
PT 
10056558 
Peritoneal mesothelioma malignant 
PT 
10056672 
Neuroectodermal neoplasm 
PT 
10057194 
Acute megakaryocytic leukaemia (in remission) 
PT 
10057266 
Signet-ring cell carcinoma 
PT 
10057269 
Mucoepidermoid carcinoma 
PT 
10057270 
Neuroendocrine carcinoma 
PT 
10057340 
Testicular leiomyosarcoma 
PT 
10057352 
Metastatic carcinoma of the bladder 
PT 
10057376 
Ovarian granulosa-theca cell tumour 
PT 
10057416 
Ocular haemangiopericytoma 
PT 
10057529 
Ovarian cancer metastatic 
PT 
10057644 
Testis cancer 
PT 
10057646 
Peripheral neuroepithelioma of soft tissue 
PT 
10057649 
Endometrial sarcoma 
PT 
10057654 
Breast cancer female 
PT 
10057700 
Angiosarcoma non-metastatic 
PT 
10057838 
Pituitary neoplasm malignant recurrent 
PT 
10057846 
Primitive neuroectodermal tumour 
PT 
10058281 
Gallbladder cancer stage II 
PT 
10058282 
Gallbladder cancer stage III 
PT 
10058283 
Gallbladder cancer stage IV 
PT 
10058286 
Gallbladder adenocarcinoma 
PT 
10058306 
Metastatic bronchial carcinoma 
PT 
10058307 
Metastases to peripheral vascular system 
PT 
10058354 
Bronchioloalveolar carcinoma 
PT 
10058429 
Tongue carcinoma stage 0 
PT 
10058430 
Tongue carcinoma stage I 
PT 
10058431 
Tongue carcinoma stage II 
PT 
10058432 
Tongue carcinoma stage III 
PT 
10058433 
Tongue carcinoma stage IV 
PT 
10058467 
Lung neoplasm malignant 
PT 
10058527 
Oesophageal squamous cell carcinoma metastatic 
PT 
10058671 
Leukaemic infiltration hepatic 
PT 
10058717 
Chronic lymphocytic leukaemia transformation 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-84- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10058728 
Richter's syndrome 
PT 
10058975 
Natural killer-cell lymphoblastic lymphoma 
PT 
10059034 
Acute myeloid leukaemia recurrent 
PT 
10059227 
Biopsy spleen abnormal 
PT 
10059239 
Leukaemic retinopathy 
PT 
10059282 
Metastases to central nervous system 
PT 
10059316 
Gallbladder cancer stage 0 
PT 
10059317 
Gallbladder cancer stage I 
PT 
10059318 
Hepatic cancer stage I 
PT 
10059319 
Hepatic cancer stage II 
PT 
10059320 
Pancreatic carcinoma stage 0 
PT 
10059321 
Pancreatic carcinoma stage I 
PT 
10059322 
Pancreatic carcinoma stage II 
PT 
10059323 
Pancreatic carcinoma stage III 
PT 
10059324 
Hepatic cancer stage III 
PT 
10059325 
Hepatic cancer stage IV 
PT 
10059326 
Pancreatic carcinoma stage IV 
PT 
10059368 
Small intestine carcinoma stage 0 
PT 
10059369 
Small intestine carcinoma stage I 
PT 
10059370 
Small intestine carcinoma stage II 
PT 
10059371 
Small intestine carcinoma stage III 
PT 
10059372 
Small intestine carcinoma stage IV 
PT 
10059373 
Bile duct cancer stage I 
PT 
10059374 
Bile duct cancer stage II 
PT 
10059375 
Bile duct cancer stage III 
PT 
10059376 
Bile duct cancer stage IV 
PT 
10059384 
Bile duct cancer stage 0 
PT 
10059427 
Buschke-Lowenstein's tumour 
PT 
10059498 
Stewart-Treves syndrome 
PT 
10059514 
Small cell lung cancer metastatic 
PT 
10059515 
Non-small cell lung cancer metastatic 
PT 
10059518 
Pleural mesothelioma malignant 
PT 
10059631 
Penile squamous cell carcinoma 
PT 
10060121 
Squamous cell carcinoma of head and neck 
PT 
10060406 
Plasma cell leukaemia in remission 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-85- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10060862 
Prostate cancer 
PT 
10060910 
Precursor B-lymphoblastic lymphoma recurrent 
PT 
10060911 
Precursor B-lymphoblastic lymphoma refractory 
PT 
10060930 
Acute leukaemia in remission 
PT 
10060971 
Astrocytoma malignant 
PT 
10061020 
Breast cancer male 
PT 
10061025 
Cardiac neoplasm malignant 
PT 
10061031 
Thymoma malignant 
PT 
10061042 
Chronic leukaemia in remission 
PT 
10061122 
Endocrine neoplasm malignant 
PT 
10061154 
Female reproductive tract carcinoma in situ 
PT 
10061168 
Gastrointestinal carcinoma in situ 
PT 
10061170 
Follicle centre lymphoma, follicular grade I, II, III 
PT 
10061184 
Germ cell cancer 
PT 
10061220 
Leukaemia in remission 
PT 
10061232 
Lymphoproliferative disorder 
PT 
10061233 
Lymphoproliferative disorder in remission 
PT 
10061237 
Malignant anorectal neoplasm 
PT 
10061238 
Malignant cranial nerve neoplasm 
PT 
10061240 
Malignant lymphoid neoplasm 
PT 
10061241 
Malignant mediastinal neoplasm 
PT 
10061267 
Malignant middle ear neoplasm 
PT 
10061268 
Malignant nervous system neoplasm 
PT 
10061269 
Malignant peritoneal neoplasm 
PT 
10061270 
Malignant respiratory tract neoplasm 
PT 
10061272 
Malignant urinary tract neoplasm 
PT 
10061275 
Mantle cell lymphoma 
PT 
10061287 
Metastases to nervous system 
PT 
10061288 
Metastases to reproductive organ 
PT 
10061289 
Metastatic neoplasm 
PT 
10061295 
Monocytic leukaemia in remission 
PT 
10061301 
Myeloid leukaemia in remission 
PT 
10061306 
Nasopharyngeal cancer 
PT 
10061328 
Ovarian epithelial cancer 
PT 
10061342 
Peripheral neuroepithelioma of bone 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-86- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10061378 
Testicular germ cell cancer 
PT 
10061396 
Urinary tract carcinoma in situ 
PT 
10061424 
Anal cancer 
PT 
10061450 
Carcinoma in situ 
PT 
10061451 
Colorectal cancer 
PT 
10061523 
Lip and/or oral cavity cancer 
PT 
10061526 
Malignant mesenchymoma 
PT 
10061527 
Neurofibrosarcoma 
PT 
10061534 
Oesophageal squamous cell carcinoma 
PT 
10061537 
Pineal parenchymal neoplasm malignant 
PT 
10061597 
Hodgkin's disease stage IV 
PT 
10061600 
Metastases to the respiratory system 
PT 
10061809 
Cervix carcinoma stage 0 
PT 
10061848 
Extragonadal primary malignant teratoma 
PT 
10061849 
Extragonadal primary non-seminoma 
PT 
10061850 
Extranodal marginal zone B-cell lymphoma (MALT type) 
PT 
10061871 
Non-Hodgkin's lymphoma transformed recurrent 
PT 
10061872 
Non-renal cell carcinoma of kidney 
PT 
10061873 
Non-small cell lung cancer 
PT 
10061893 
Ovarian germ cell cancer 
PT 
10061894 
Ovarian germ cell cancer stage I 
PT 
10061895 
Ovarian germ cell cancer stage II 
PT 
10061896 
Ovarian germ cell cancer stage III 
PT 
10061897 
Ovarian germ cell cancer stage IV 
PT 
10061909 
Paranasal sinus and nasal cavity malignant neoplasm 
PT 
10061934 
Salivary gland cancer 
PT 
10061957 
Follicle centre lymphoma diffuse small cell lymphoma 
PT 
10061967 
Gastric cancer stage IV 
PT 
10061988 
Gestational trophoblastic tumour 
PT 
10062001 
Hepatoblastoma 
PT 
10062041 
Lung infiltration malignant 
PT 
10062047 
Lymphocyte morphology abnormal 
PT 
10062050 
Malignant muscle neoplasm 
PT 
10062051 
Malignant nipple neoplasm 
PT 
10062113 
Splenic marginal zone lymphoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-87- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10062122 
Testicular choriocarcinoma 
PT 
10062123 
Testicular embryonal carcinoma 
PT 
10062124 
Testicular seminoma (pure) 
PT 
10062142 
Spleen scan abnormal 
PT 
10062194 
Metastasis 
PT 
10062195 
Metastases to biliary tract 
PT 
10062196 
Metastases to gastrointestinal tract 
PT 
10062197 
Metastases to soft tissue 
PT 
10062485 
Retroperitoneal neoplasm metastatic 
PT 
10062489 
Leukaemia recurrent 
PT 
10062878 
Gastrooesophageal cancer 
PT 
10062904 
Hormone-refractory prostate cancer 
PT 
10063157 
Metastatic glioma 
PT 
10063523 
Colon cancer stage 0 
PT 
10063536 
Vulvar adenocarcinoma 
PT 
10063569 
Metastatic squamous cell carcinoma 
PT 
10063609 
Porocarcinoma 
PT 
10063616 
Radiotherapy to lymph nodes 
PT 
10063620 
Acute lymphocytic leukaemia recurrent 
PT 
10063693 
Malignant neoplasm of eyelid 
PT 
10063706 
Malignant melanoma of eyelid 
PT 
10063908 
Non-Hodgkin's lymphoma unspecified histology aggressive 
PT 
10063916 
Metastatic gastric cancer 
PT 
10064055 
Lip squamous cell carcinoma 
PT 
10064099 
Oropharyngeal cancer stage IV 
PT 
10064344 
Lymphoma transformation 
PT 
10064581 
Desmoplastic small round cell tumour 
PT 
10064605 
Sezary cells increased 
PT 
10064912 
Malignant transformation 
PT 
10065039 
Plasmablastic lymphoma 
PT 
10065305 
Cancer in remission 
PT 
10065349 
Vaginal adenocarcinoma 
PT 
10065430 
HER2 positive breast cancer 
PT 
10065443 
Malignant glioma 
PT 
10065852 
CNS germinoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-88- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10065854 
Chronic eosinophilic leukaemia 
PT 
10065856 
Non-Hodgkin's lymphoma unspecified histology indolent 
PT 
10065857 
Primary effusion lymphoma 
PT 
10065858 
Ovarian stromal cancer 
PT 
10065867 
Alveolar rhabdomyosarcoma 
PT 
10065868 
Embryonal rhabdomyosarcoma 
PT 
10065871 
Nongerminomatous germ cell tumour of the CNS 
PT 
10065907 
Atypical teratoid/rhabdoid tumour of CNS 
PT 
10065908 
Cystadenocarcinoma pancreas 
PT 
10066057 
Mueller's mixed tumour 
PT 
10066136 
Huerthle cell carcinoma 
PT 
10066206 
Apocrine breast carcinoma 
PT 
10066231 
Central nervous system leukaemia 
PT 
10066254 
Gliomatosis cerebri 
PT 
10066384 
Conjunctival melanoma 
PT 
10066471 
Squamous cell carcinoma of pharynx 
PT 
10066474 
Thyroid cancer 
PT 
10066476 
Haematological malignancy 
PT 
10066594 
Medulloblastoma recurrent 
PT 
10066595 
Neuroblastoma recurrent 
PT 
10066600 
Melanoma recurrent 
PT 
10066697 
Ovarian cancer recurrent 
PT 
10066749 
Bladder transitional cell carcinoma stage 0 
PT 
10066750 
Bladder transitional cell carcinoma recurrent 
PT 
10066751 
Bladder transitional cell carcinoma stage I 
PT 
10066752 
Bladder transitional cell carcinoma stage IV 
PT 
10066753 
Bladder transitional cell carcinoma stage II 
PT 
10066754 
Bladder transitional cell carcinoma stage III 
PT 
10066879 
Gallbladder cancer metastatic 
PT 
10066882 
Metastatic salivary gland cancer 
PT 
10066896 
HER2 positive gastric cancer 
PT 
10066948 
Myxofibrosarcoma 
PT 
10066957 
Hepatosplenic T-cell lymphoma 
PT 
10067064 
Endometrial sarcoma recurrent 
PT 
10067065 
Endometrial sarcoma metastatic 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-89- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10067117 
Leukaemic infiltration extramedullary 
PT 
10067184 
Burkitt's leukaemia 
PT 
10067369 
Malignant mesenteric neoplasm 
PT 
10067387 
Myelodysplastic syndrome transformation 
PT 
10067388 
Hepatic angiosarcoma 
PT 
10067399 
Acute biphenotypic leukaemia 
PT 
10067431 
Leukaemic infiltration gingiva 
PT 
10067478 
Choroid plexus carcinoma 
PT 
10067517 
Pancreatic neuroendocrine tumour 
PT 
10067807 
Gingival cancer 
PT 
10067821 
Head and neck cancer 
PT 
10067917 
Inflammatory myofibroblastic tumour 
PT 
10067943 
Hereditary papillary renal carcinoma 
PT 
10067944 
Hereditary leiomyomatosis renal cell carcinoma 
PT 
10067946 
Renal cell carcinoma 
PT 
10067959 
Refractory cytopenia with multilineage dysplasia 
PT 
10068068 
Adenocarcinoma of salivary gland 
PT 
10068115 
Metastatic carcinoid tumour 
PT 
10068116 
Metastatic uterine cancer 
PT 
10068117 
Metastatic ocular melanoma 
PT 
10068124 
Malignant neoplasm of seminal vesicle 
PT 
10068223 
Extramammary Paget's disease 
PT 
10068232 
Chronic myeloid leukaemia transformation 
PT 
10068349 
Epstein-Barr virus associated lymphoproliferative disorder 
PT 
10068532 
5q minus syndrome 
PT 
10068582 
Breast sarcoma 
PT 
10068583 
Breast sarcoma metastatic 
PT 
10068584 
Breast sarcoma recurrent 
PT 
10068595 
Sarcoma metastatic 
PT 
10068601 
Glioneuronal tumour 
PT 
10068694 
Testicular germ cell cancer metastatic 
PT 
10068785 
Histiocytic medullary reticulosis 
PT 
10068873 
Adenosquamous cell carcinoma 
PT 
10068909 
Pancreatic neuroendocrine tumour metastatic 
PT 
10068910 
Primitive neuroectodermal tumour metastatic 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-90- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10068971 
Germ cell cancer metastatic 
PT 
10068974 
Peritoneal carcinoma metastatic 
PT 
10069345 
Solid pseudopapillary tumour of the pancreas 
PT 
10069359 
Leukaemic infiltration renal 
PT 
10069360 
Leukaemic infiltration 
PT 
10069698 
Langerhans' cell histiocytosis 
PT 
10069728 
Rectosigmoid cancer metastatic 
PT 
10069730 
Large cell lung cancer metastatic 
PT 
10069812 
Testicular choriocarcinoma recurrent 
PT 
10069813 
Testis cancer recurrent 
PT 
10070308 
Refractory cancer 
PT 
10070567 
Thyroid cancer stage 0 
PT 
10070902 
Laryngeal cancer metastatic 
PT 
10070905 
Ovarian cancer stage I 
PT 
10070906 
Ovarian cancer stage II 
PT 
10070907 
Ovarian cancer stage III 
PT 
10070908 
Ovarian cancer stage IV 
PT 
10070913 
Metastases to pelvis 
PT 
10071023 
Abdominal wall neoplasm malignant 
PT 
10071027 
Thyroid cancer stage I 
PT 
10071028 
Thyroid cancer stage II 
PT 
10071029 
Thyroid cancer stage III 
PT 
10071030 
Thyroid cancer stage IV 
PT 
10071080 
Transitional cell carcinoma metastatic 
PT 
10071119 
Hormone-dependent prostate cancer 
PT 
10071251 
Tongue cancer recurrent 
PT 
10071441 
Epstein-Barr virus associated lymphoma 
PT 
10071532 
Metastatic choriocarcinoma 
PT 
10071533 
Lung squamous cell carcinoma metastatic 
PT 
10071535 
Non-Hodgkin's lymphoma metastatic 
PT 
10071536 
Head and neck cancer stage IV 
PT 
10071537 
Head and neck cancer stage III 
PT 
10071538 
Head and neck cancer stage II 
PT 
10071539 
Head and neck cancer stage I 
PT 
10071540 
Head and neck cancer metastatic 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-91- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10071541 
Metastatic lymphoma 
PT 
10071542 
Neuroendocrine carcinoma metastatic 
PT 
10071664 
Bladder transitional cell carcinoma metastatic 
PT 
10071776 
Phyllodes tumour 
PT 
10071978 
Anaplastic lymphoma kinase gene and nucleophosmin gene fusion overexpression 
PT 
10072162 
Thyroid cancer recurrent 
PT 
10072432 
Malignant neoplasm of pleura metastatic 
PT 
10072448 
Malignant blue naevus 
PT 
10072449 
Desmoplastic melanoma 
PT 
10072613 
Thyroid B-cell lymphoma 
PT 
10072684 
Refractory cytopenia with unilineage dysplasia 
PT 
10072792 
Tonsil cancer metastatic 
PT 
10072793 
Urethral melanoma metastatic 
PT 
10072813 
Breast angiosarcoma 
PT 
10072814 
Breast angiosarcoma metastatic 
PT 
10073055 
Extragonadal primary germ cell tumour 
PT 
10073056 
Extragonadal primary germ cell tumour mixed 
PT 
10073057 
Extragonadal primary seminoma (pure) 
PT 
10073059 
Malignant neoplasm of unknown primary site 
PT 
10073062 
Biphasic mesothelioma 
PT 
10073063 
Desmoplastic mesothelioma 
PT 
10073064 
Epithelioid mesothelioma 
PT 
10073065 
Sarcomatoid mesothelioma 
PT 
10073066 
Pericardial mesothelioma malignant 
PT 
10073067 
Gallbladder adenosquamous carcinoma 
PT 
10073068 
Gallbladder squamous cell carcinoma 
PT 
10073069 
Hepatic cancer 
PT 
10073070 
Hepatic cancer recurrent 
PT 
10073071 
Hepatocellular carcinoma 
PT 
10073073 
Hepatobiliary cancer 
PT 
10073074 
Hepatobiliary cancer in situ 
PT 
10073086 
Iris melanoma 
PT 
10073094 
Intraductal proliferative breast lesion 
PT 
10073095 
Invasive ductal breast carcinoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-92- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10073096 
Invasive lobular breast carcinoma 
PT 
10073098 
Invasive papillary breast carcinoma 
PT 
10073099 
Lobular breast carcinoma in situ 
PT 
10073100 
Metaplastic breast carcinoma 
PT 
10073101 
Mucinous breast carcinoma 
PT 
10073103 
Neuroendocrine breast tumour 
PT 
10073104 
Tubular breast carcinoma 
PT 
10073106 
Bone giant cell tumour malignant 
PT 
10073107 
Peripheral primitive neuroectodermal bone tumour 
PT 
10073115 
Epididymal cancer 
PT 
10073116 
Genital cancer male 
PT 
10073117 
Sertoli cell testicular tumour 
PT 
10073118 
Spermatocytic seminoma 
PT 
10073119 
Testicular germ cell tumour mixed 
PT 
10073120 
Testicular malignant teratoma 
PT 
10073121 
Testicular yolk sac tumour 
PT 
10073124 
Genital cancer male in situ 
PT 
10073127 
Anaplastic meningioma 
PT 
10073128 
Anaplastic oligodendroglioma 
PT 
10073129 
Angiocentric glioma 
PT 
10073130 
Central nervous system neuroblastoma 
PT 
10073131 
Oligoastrocytoma 
PT 
10073132 
Plasma cell myeloma in remission 
PT 
10073133 
Plasma cell myeloma recurrent 
PT 
10073134 
Extraskeletal myxoid chondrosarcoma 
PT 
10073135 
Dedifferentiated liposarcoma 
PT 
10073136 
Mixed-type liposarcoma 
PT 
10073137 
Myxoid liposarcoma 
PT 
10073138 
Pleomorphic liposarcoma 
PT 
10073139 
Round cell liposarcoma 
PT 
10073140 
Clear cell sarcoma of soft tissue 
PT 
10073141 
Malignant giant cell fibrous histiocytoma 
PT 
10073142 
Inflammatory malignant fibrous histiocytoma 
PT 
10073143 
Pleomorphic malignant fibrous histiocytoma 
PT 
10073144 
Peripheral primitive neuroectodermal tumour of soft tissue 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-93- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10073152 
Adrenal gland cancer 
PT 
10073153 
Familial medullary thyroid cancer 
PT 
10073251 
Clear cell renal cell carcinoma 
PT 
10073259 
Ovarian germ cell tumour mixed 
PT 
10073260 
Ovarian granulosa cell tumour 
PT 
10073261 
Ovarian theca cell tumour 
PT 
10073262 
Ovarian germ cell choriocarcinoma 
PT 
10073263 
Ovarian germ cell endodermal sinus tumour 
PT 
10073264 
Ovarian germ cell polyembryoma 
PT 
10073265 
Ovarian germ cell teratoma 
PT 
10073266 
Borderline mucinous tumour of ovary 
PT 
10073267 
Borderline serous tumour of ovary 
PT 
10073268 
Ovarian clear cell carcinoma 
PT 
10073269 
Ovarian endometrioid carcinoma 
PT 
10073270 
Ovarian Sertoli-Leydig cell tumour 
PT 
10073324 
Keratinising squamous cell carcinoma of nasopharynx 
PT 
10073325 
Nonkeratinising carcinoma of nasopharynx 
PT 
10073328 
Undifferentiated nasopharyngeal carcinoma 
PT 
10073334 
Rhabdoid tumour 
PT 
10073338 
Optic glioma 
PT 
10073358 
Anal squamous cell carcinoma 
PT 
10073359 
Adenocarcinoma of appendix 
PT 
10073360 
Appendix cancer 
PT 
10073361 
Mucinous adenocarcinoma of appendix 
PT 
10073362 
Undifferentiated carcinoma of colon 
PT 
10073363 
Acinar cell carcinoma of pancreas 
PT 
10073364 
Ductal adenocarcinoma of pancreas 
PT 
10073365 
Intraductal papillary-mucinous carcinoma of pancreas 
PT 
10073367 
Pancreatoblastoma 
PT 
10073369 
Acinic cell carcinoma of salivary gland 
PT 
10073370 
Adenoid cystic carcinoma of salivary gland 
PT 
10073371 
Mucoepidermoid carcinoma of salivary gland 
PT 
10073373 
Small intestine adenocarcinoma 
PT 
10073478 
Anaplastic large-cell lymphoma 
PT 
10073479 
Acute undifferentiated leukaemia 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-94- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10073480 
B-cell prolymphocytic leukaemia 
PT 
10073481 
Enteropathy-associated T-cell lymphoma 
PT 
10073534 
Hodgkin's disease nodular sclerosis stage II 
PT 
10073535 
Hodgkin's disease nodular sclerosis stage I 
PT 
10073540 
Intraductal papillary breast neoplasm 
PT 
10073574 
Dermatofibrosarcoma protuberans metastatic 
PT 
10073751 
Intracranial germ cell tumour 
PT 
10073851 
Tumour of ampulla of Vater 
PT 
10073857 
Brain sarcoma 
PT 
10073957 
Composite lymphoma 
PT 
10073978 
Adenosquamous carcinoma of vagina 
PT 
10074340 
Malignant connective tissue neoplasm 
PT 
10074419 
Malignant genitourinary tract neoplasm 
PT 
10074909 
Clear cell carcinoma of cervix 
PT 
10075081 
Chronic myeloid leukaemia recurrent 
PT 
10075173 
Bone marrow infiltration 
PT 
10075245 
Metastatic glucagonoma 
PT 
10075324 
Ocular lymphoma 
PT 
10075332 
Follicular dendritic cell sarcoma 
PT 
10075333 
Soft tissue sarcoma 
PT 
10075460 
Blastic plasmacytoid dendritic cell neoplasia 
PT 
10075555 
Metastases to vagina 
PT 
10075566 
Triple negative breast cancer 
PT 
10075713 
Invasive breast carcinoma 
PT 
10075811 
Testicular germ cell tumour 
PT 
10075812 
Ovarian germ cell tumour 
PT 
10075853 
Leukaemic infiltration ovary 
PT 
10075993 
Primary cardiac lymphoma 
PT 
10076596 
Marginal zone lymphoma 
PT 
10076603 
Poorly differentiated thyroid carcinoma 
PT 
10076748 
Mixed adenoneuroendocrine carcinoma 
PT 
10076866 
Acute lymphocytic leukaemia refractory 
PT 
10076868 
Endotheliomatosis 
PT 
10076876 
Histiocytic sarcoma 
PT 
10076935 
Hormone refractory breast cancer 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-95- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10076969 
Tumour budding 
PT 
10077051 
Transitional cell carcinoma recurrent 
PT 
10077160 
Central nervous system melanoma 
PT 
10077161 
Primary myelofibrosis 
PT 
10077166 
Genitourinary melanoma 
PT 
10077167 
Gastrointestinal melanoma 
PT 
10077303 
Malignant neoplasm papilla of Vater 
PT 
10077314 
Skin squamous cell carcinoma metastatic 
PT 
10077403 
Hairy cell leukaemia recurrent 
PT 
10077435 
Carcinoma ex-pleomorphic adenoma 
PT 
10077465 
Myeloproliferative neoplasm 
PT 
10077476 
Metastases to tonsils 
PT 
10077529 
Marginal zone lymphoma stage I 
PT 
10077530 
Marginal zone lymphoma stage II 
PT 
10077531 
Marginal zone lymphoma stage III 
PT 
10077532 
Marginal zone lymphoma stage IV 
PT 
10077533 
Marginal zone lymphoma recurrent 
PT 
10077534 
Marginal zone lymphoma refractory 
PT 
10077559 
Gastroenteropancreatic neuroendocrine tumour disease 
PT 
10077563 
Leukaemic cardiac infiltration 
PT 
10077675 
Musculoskeletal cancer 
PT 
10077703 
Metastatic nervous system neoplasm 
PT 
10077758 
Malignant meningioma metastatic 
PT 
10077861 
Cholangiosarcoma 
PT 
10077888 
Mismatch repair cancer syndrome 
PT 
10078145 
Malignant joint neoplasm 
PT 
10078174 
Neuroendocrine tumour of the lung 
PT 
10078175 
Neuroendocrine tumour of the lung metastatic 
PT 
10078267 
Metastases to spinal cord 
PT 
10078279 
Myeloblast present 
PT 
10078282 
Leptomeningeal myelomatosis 
PT 
10078295 
NUT midline carcinoma 
PT 
10078341 
Neuroendocrine carcinoma of the bladder 
PT 
10078493 
Papillary renal cell carcinoma 
PT 
10078695 
Malignant polyp 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-96- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10078782 
Langerhans cell sarcoma 
PT 
10078934 
Recurrent N-ras mutation-positive colorectal carcinoma 
PT 
10078972 
Primary gastrointestinal follicular lymphoma 
PT 
10079054 
Naevoid melanoma 
PT 
10079104 
Nasopharyngeal cancer metastatic 
PT 
10079107 
Transformation to acute myeloid leukaemia 
PT 
10079307 
Squamous cell breast carcinoma 
PT 
10079386 
Epstein Barr virus positive mucocutaneous ulcer 
PT 
10079618 
Microsatellite instability cancer 
PT 
10079694 
Chronic myelomonocytic leukaemia with N-ras gene mutation 
PT 
10079877 
Maternal cancer in pregnancy 
PT 
10079987 
Minimal residual disease 
PT 
10080017 
Philadelphia positive acute lymphocytic leukaemia 
PT 
10080200 
Triple hit lymphoma 
PT 
10080201 
Nodular lymphocyte predominant Hodgkin lymphoma 
PT 
10080202 
Double hit lymphoma 
PT 
10080215 
High-grade B-cell lymphoma 
PT 
10080311 
Intestinal metastasis 
PT 
10080323 
Acute bilineal leukaemia 
PT 
10080324 
Sarcomatoid carcinoma 
PT 
10080544 
Chromophobe renal cell carcinoma 
PT 
10080682 
Pleuropulmonary blastoma 
PT 
10080717 
Primary pulmonary melanoma 
PT 
10081003 
Gastrointestinal adenocarcinoma 
PT 
10081036 
Primary breast lymphoma 
PT 
10081037 
Tumour hyperprogression 
PT 
10081119 
Carcinoid tumour of the liver 
PT 
10081189 
Transdifferentiation of neoplasm 
PT 
10081367 
Extranodal marginal zone B-cell lymphoma (BALT type) 
PT 
10081398 
Gastrooesophageal cancer recurrent 
PT 
10081400 
Sarcomatoid carcinoma of the lung 
PT 
10081421 
Carcinoid tumour of the ovary 
PT 
10081428 
Ciliary body melanoma 
PT 
10081431 
Uveal melanoma 
PT 
10081437 
Ewing-like sarcoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-97- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10081513 
Acute myeloid leukaemia refractory 
PT 
10081590 
Malignant biliary obstruction 
PT 
10081592 
Malignant gastrointestinal obstruction 
PT 
10081653 
Bing-Neel syndrome 
PT 
10081847 
Plasma cell myeloma refractory 
PT 
10082075 
Iatrogenic metastasis 
PT 
10082079 
Ovarian melanoma 
PT 
10082180 
Philadelphia positive chronic myeloid leukaemia 
PT 
10082230 
Squamous cell carcinoma of the parotid gland 
PT 
10082277 
External ear neoplasm malignant 
PT 
10082373 
Precursor T-lymphoblastic leukaemia acute 
PT 
10082419 
Pleomorphic leiomyosarcoma 
PT 
10082449 
Ocular surface squamous neoplasia 
PT 
10082495 
Breast implant-associated anaplastic large cell lymphoma 
PT 
10082804 
Solitary fibrous tumour 
PT 
10082915 
Neuroendocrine carcinoma of prostate 
PT 
10082968 
Oesophageal adenosquamous carcinoma 
PT 
10083232 
HER2 negative breast cancer 
PT 
10083233 
Triple positive breast cancer 
PT 
10083234 
Hormone receptor positive breast cancer 
PT 
10083253 
Nasopharyngeal tumour 
PT 
10083456 
Adenocarcinoma metastatic 
PT 
10083708 
Basal cell carcinoma metastatic 
PT 
10083863 
Ameloblastic carcinoma 
PT 
10084056 
Epiglottic cancer 
PT 
10084088 
Lacrimal gland neoplasm 
PT 
10084177 
Intratumoural haematoma 
PT 
10084377 
Grey zone lymphoma 
PT 
10084430 
Malignant airway obstruction 
PT 
10084570 
Pulmonary atypical adenomatous hyperplasia 
PT 
10084787 
HER2 mutant non-small cell lung cancer 
PT 
10084789 
Homologous recombination deficiency positive advanced ovarian cancer 
PT 
10084814 
Craniopharyngioma malignant 
PT 
10085067 
Perivascular epithelioid cell tumour 
PT 
10085091 
Cancer with a high tumour mutational burden 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-98- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10085123 
Follicular lymphoma stage I 
PT 
10085125 
Follicular lymphoma stage II 
PT 
10085126 
Follicular lymphoma stage IV 
PT 
10085127 
Follicular lymphoma stage III 
PT 
10085128 
Follicular lymphoma 
PT 
10085146 
Appendix cancer metastatic 
PT 
10085254 
Cancer cells urine present 
PT 
10085315 
Malignant spinal cord compression 
PT 
10085431 
HER2 positive salivary gland cancer 
PT 
10085443 
Lineage switch leukaemia 
PT 
10085481 
Hormone receptor positive HER2 negative breast cancer 
PT 
10085561 
Hormone receptor negative HER2 positive breast cancer 
PT 
10085663 
Clear cell papillary renal cell carcinoma 
PT 
10085759 
Growing teratoma syndrome 
PT 
10085767 
Neuroendocrine tumour of the rectum 
PT 
10085796 
Meckel's cave tumour 
PT 
10085864 
Hepatic neuroendocrine tumour 
PT 
10085940 
Small intestine neuroendocrine tumour 
PT 
10086077 
Malignant gastric ulcer 
PT 
10086455 
Cholecystic intraepithelial neoplasia 
PT 
10086456 
Intracholecystic papillary neoplasm 
PT 
10086585 
Neuroendocrine carcinoma of the oesophagus 
PT 
10086686 
Malignant central nervous system neoplasm 
PT 
10086693 
Ocular melanoma 
PT 
10086698 
Haematological neoplasm 
PT 
10086714 
B-cell lymphoma unclassifiable 
PT 
10086715 
Malignant unclassifiable lymphoma 
PT 
10086716 
T-cell lymphoma unclassifiable 
PT 
10086769 
Neuroendocrine carcinoma of the cervix 
PT 
10086779 
Carcinoid tumour in the large intestine 
PT 
10086817 
Malignant urinary tract neoplasm metastatic 
PT 
10086958 
Hepatic sarcoma 
PT 
10086987 
Skull base tumour 
PT 
10087104 
Infected metastasis 
PT 
10087220 
Thymic carcinoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-99- 
Malignancies, Excluding Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10087266 
Epiglottic neoplasm 
PT 
10087311 
Adenocarcinoid tumour of the appendix 
PT 
10087324 
Primary cutaneous adenoid cystic carcinoma 
PT 
10087362 
Gastric neuroendocrine carcinoma 
PT 
10087363 
Carcinoid tumour of the mesentery 
PT 
10087364 
Gastrointestinal neuroendocrine carcinoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-100- 
Nonmelanoma Skin Cancers - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10004146 
Basal cell carcinoma 
PT 
10004178 
Basosquamous carcinoma 
PT 
10004179 
Basosquamous carcinoma of skin 
PT 
10006059 
Bowen's disease 
PT 
10007390 
Carcinoma in situ of skin 
PT 
10011677 
Cutaneous T-cell lymphoma 
PT 
10011678 
Cutaneous T-cell lymphoma recurrent 
PT 
10011679 
Cutaneous T-cell lymphoma refractory 
PT 
10011680 
Cutaneous T-cell lymphoma stage I 
PT 
10011681 
Cutaneous T-cell lymphoma stage II 
PT 
10011682 
Cutaneous T-cell lymphoma stage III 
PT 
10023284 
Kaposi's sarcoma 
PT 
10023286 
Kaposi's sarcoma AIDS related 
PT 
10023288 
Kaposi's sarcoma classical type 
PT 
10023347 
Keratoacanthoma 
PT 
10029266 
Neuroendocrine carcinoma of the skin 
PT 
10037732 
Queyrat erythroplasia 
PT 
10039495 
Sarcoma of skin 
PT 
10040808 
Skin cancer 
PT 
10041823 
Squamous cell carcinoma 
PT 
10041834 
Squamous cell carcinoma of skin 
PT 
10057070 
Dermatofibrosarcoma protuberans 
PT 
10063609 
Porocarcinoma 
PT 
10064755 
Atypical fibroxanthoma 
PT 
10068784 
Sebaceous carcinoma 
PT 
10069680 
Eccrine carcinoma 
PT 
10072891 
Skin angiosarcoma 
PT 
10073087 
Malignant sweat gland neoplasm 
PT 
10073088 
Hidradenocarcinoma 
PT 
10075614 
Pilomatrix carcinoma 
PT 
10076248 
Marjolin's ulcer 
PT 
10079945 
Cutaneous lymphoma 
PT 
10080660 
Trichoblastic carcinoma 
PT 
10081136 
Skin squamous cell carcinoma recurrent 
PT 
10085518 
Cutaneous B-cell lymphoma 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-101- 
Gastrointestinal Perforations - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10002248 
Anastomotic ulcer perforation 
PT 
10003012 
Appendicitis perforated 
PT 
10013832 
Duodenal perforation 
PT 
10013849 
Duodenal ulcer perforation 
PT 
10013850 
Duodenal ulcer perforation, obstructive 
PT 
10017815 
Gastric perforation 
PT 
10017835 
Gastric ulcer perforation 
PT 
10017836 
Gastric ulcer perforation, obstructive 
PT 
10018001 
Gastrointestinal perforation 
PT 
10021305 
Ileal perforation 
PT 
10021310 
Ileal ulcer perforation 
PT 
10022694 
Intestinal perforation 
PT 
10023174 
Jejunal perforation 
PT 
10023178 
Jejunal ulcer perforation 
PT 
10023804 
Large intestine perforation 
PT 
10030181 
Oesophageal perforation 
PT 
10034354 
Peptic ulcer perforation 
PT 
10034358 
Peptic ulcer perforation, obstructive 
PT 
10038073 
Rectal perforation 
PT 
10041103 
Small intestinal perforation 
PT 
10052211 
Oesophageal rupture 
PT 
10052488 
Oesophageal ulcer perforation 
PT 
10052497 
Large intestinal ulcer perforation 
PT 
10052498 
Small intestinal ulcer perforation 
PT 
10061248 
Intestinal ulcer perforation 
PT 
10061820 
Diverticular perforation 
PT 
10061975 
Gastrointestinal ulcer perforation 
PT 
10062065 
Perforated ulcer 
PT 
10066993 
Umbilical hernia perforation 
PT 
10074065 
Procedural intestinal perforation 
PT 
10074442 
Abdominal hernia perforation 
PT 
10075254 
Inguinal hernia perforation 
PT 
10078413 
Upper gastrointestinal perforation 
PT 
10078414 
Lower gastrointestinal perforation 
PT 
10085627 
Duodenal rupture 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-102- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10000358 
Accelerated hypertension 
PT 
10000533 
Acquired cardiac septal defect 
PT 
10000891 
Acute myocardial infarction 
PT 
10001029 
Acute pulmonary oedema 
PT 
10001053 
Acute respiratory failure 
PT 
10001115 
Adams-Stokes syndrome 
PT 
10001903 
Amaurosis fugax 
PT 
10002329 
Aneurysm 
PT 
10002331 
Aneurysm arteriovenous 
PT 
10002383 
Angina pectoris 
PT 
10002388 
Angina unstable 
PT 
10002611 
Anomalous atrioventricular excitation 
PT 
10002703 
Anterior spinal artery syndrome 
PT 
10002847 
Anuria 
PT 
10002882 
Aortic aneurysm 
PT 
10002886 
Aortic aneurysm rupture 
PT 
10002895 
Aortic dissection 
PT 
10002897 
Aortic embolus 
PT 
10002899 
Aortic injury 
PT 
10002900 
Aortic necrosis 
PT 
10002906 
Aortic stenosis 
PT 
10002910 
Aortic thrombosis 
PT 
10002912 
Aortic valve disease mixed 
PT 
10002915 
Aortic valve incompetence 
PT 
10002917 
Aortic valve sclerosis 
PT 
10002918 
Aortic valve stenosis 
PT 
10003119 
Arrhythmia 
PT 
10003130 
Arrhythmia supraventricular 
PT 
10003162 
Arterial injury 
PT 
10003173 
Arterial rupture 
PT 
10003175 
Arterial spasm 
PT 
10003178 
Arterial thrombosis 
PT 
10003192 
Arteriovenous fistula thrombosis 
PT 
10003201 
Arteriogram coronary abnormal 
PT 
10003210 
Arteriosclerosis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-103- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10003211 
Arteriosclerosis coronary artery 
PT 
10003212 
Arteriosclerosis Moenckeberg-type 
PT 
10003222 
Arteriosclerotic gangrene 
PT 
10003225 
Arteriospasm coronary 
PT 
10003226 
Arteriovenous fistula 
PT 
10003232 
Arteritis coronary 
PT 
10003445 
Ascites 
PT 
10003658 
Atrial fibrillation 
PT 
10003662 
Atrial flutter 
PT 
10003664 
Atrial septal defect 
PT 
10003665 
Atrial septal defect acquired 
PT 
10003668 
Atrial tachycardia 
PT 
10003671 
Atrioventricular block 
PT 
10003673 
Atrioventricular block complete 
PT 
10003674 
Atrioventricular block first degree 
PT 
10003677 
Atrioventricular block second degree 
PT 
10003880 
Axillary vein thrombosis 
PT 
10004163 
Basilar artery stenosis 
PT 
10004780 
Biopsy heart abnormal 
PT 
10005144 
Bleeding varicose vein 
PT 
10005468 
Blood creatine phosphokinase abnormal 
PT 
10005470 
Blood creatine phosphokinase increased 
PT 
10005472 
Blood creatine phosphokinase MB abnormal 
PT 
10005474 
Blood creatine phosphokinase MB increased 
PT 
10005736 
Blood pressure diastolic abnormal 
PT 
10005737 
Blood pressure diastolic decreased 
PT 
10005739 
Blood pressure diastolic increased 
PT 
10005746 
Blood pressure fluctuation 
PT 
10005748 
Blood pressure immeasurable 
PT 
10005757 
Blood pressure systolic abnormal 
PT 
10005758 
Blood pressure systolic decreased 
PT 
10005760 
Blood pressure systolic increased 
PT 
10006093 
Bradycardia 
PT 
10006127 
Brain hypoxia 
PT 
10006145 
Brain stem haemorrhage 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-104- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10006147 
Brain stem infarction 
PT 
10006148 
Brain stem ischaemia 
PT 
10006578 
Bundle branch block 
PT 
10006579 
Bundle branch block bilateral 
PT 
10006580 
Bundle branch block left 
PT 
10006582 
Bundle branch block right 
PT 
10007509 
Cardiac amyloidosis 
PT 
10007513 
Cardiac aneurysm 
PT 
10007515 
Cardiac arrest 
PT 
10007516 
Cardiac arrest neonatal 
PT 
10007522 
Cardiac asthma 
PT 
10007554 
Cardiac failure 
PT 
10007556 
Cardiac failure acute 
PT 
10007558 
Cardiac failure chronic 
PT 
10007559 
Cardiac failure congestive 
PT 
10007560 
Cardiac failure high output 
PT 
10007567 
Cardiac function disturbance postoperative 
PT 
10007572 
Cardiac hypertrophy 
PT 
10007576 
Cardiac index abnormal 
PT 
10007577 
Cardiac index decreased 
PT 
10007578 
Cardiac index increased 
PT 
10007595 
Cardiac output decreased 
PT 
10007604 
Cardiac sarcoidosis 
PT 
10007617 
Cardio-respiratory arrest 
PT 
10007618 
Cardio-respiratory arrest neonatal 
PT 
10007625 
Cardiogenic shock 
PT 
10007632 
Cardiomegaly 
PT 
10007636 
Cardiomyopathy 
PT 
10007637 
Cardiomyopathy alcoholic 
PT 
10007646 
Cardiothoracic ratio increased 
PT 
10007649 
Cardiovascular disorder 
PT 
10007651 
Cardiovascular function test abnormal 
PT 
10007684 
Carotid arterial embolus 
PT 
10007686 
Carotid artery aneurysm 
PT 
10007687 
Carotid artery stenosis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-105- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10007688 
Carotid artery thrombosis 
PT 
10007830 
Cavernous sinus thrombosis 
PT 
10007980 
Central venous pressure increased 
PT 
10008023 
Cerebellar artery thrombosis 
PT 
10008030 
Cerebellar haemorrhage 
PT 
10008034 
Cerebellar infarction 
PT 
10008088 
Cerebral artery embolism 
PT 
10008089 
Cerebral artery occlusion 
PT 
10008092 
Cerebral artery thrombosis 
PT 
10008097 
Cerebral circulatory failure 
PT 
10008111 
Cerebral haemorrhage 
PT 
10008118 
Cerebral infarction 
PT 
10008120 
Cerebral ischaemia 
PT 
10008132 
Cerebral thrombosis 
PT 
10008138 
Cerebral venous thrombosis 
PT 
10008190 
Cerebrovascular accident 
PT 
10008196 
Cerebrovascular disorder 
PT 
10008479 
Chest pain 
PT 
10008499 
Chest X-ray abnormal 
PT 
10008745 
Chordae tendinae rupture 
PT 
10009192 
Circulatory collapse 
PT 
10009243 
Claudication of jaw muscles 
PT 
10009691 
Clubbing 
PT 
10009838 
Coeliac artery compression syndrome 
PT 
10010276 
Conduction disorder 
PT 
10010967 
Cor biloculare 
PT 
10010968 
Cor pulmonale 
PT 
10010969 
Cor pulmonale acute 
PT 
10010970 
Cor pulmonale chronic 
PT 
10010972 
Cor triatriatum 
PT 
10011071 
Coronary artery aneurysm 
PT 
10011077 
Coronary artery bypass 
PT 
10011078 
Coronary artery disease 
PT 
10011084 
Coronary artery embolism 
PT 
10011086 
Coronary artery occlusion 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-106- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10011089 
Coronary artery stenosis 
PT 
10011090 
Coronary artery surgery 
PT 
10011091 
Coronary artery thrombosis 
PT 
10011101 
Coronary endarterectomy 
PT 
10011105 
Coronary ostial stenosis 
PT 
10011254 
Coxsackie carditis 
PT 
10011258 
Coxsackie myocarditis 
PT 
10011703 
Cyanosis 
PT 
10012118 
Defect conduction intraventricular 
PT 
10012647 
Diabetic cardiomyopathy 
PT 
10012758 
Diastolic hypertension 
PT 
10012979 
DiGeorge's syndrome 
PT 
10013002 
Dilatation atrial 
PT 
10013012 
Dilatation ventricular 
PT 
10013048 
Directional Doppler flow tests abnormal 
PT 
10013573 
Dizziness 
PT 
10013576 
Dizziness exertional 
PT 
10013578 
Dizziness postural 
PT 
10013968 
Dyspnoea 
PT 
10013969 
Dyspnoea at rest 
PT 
10013971 
Dyspnoea exertional 
PT 
10013974 
Dyspnoea paroxysmal nocturnal 
PT 
10014331 
Ejection fraction abnormal 
PT 
10014363 
Electrocardiogram abnormal 
PT 
10014369 
Electrocardiogram ambulatory abnormal 
PT 
10014372 
Electrocardiogram delta waves abnormal 
PT 
10014374 
Electrocardiogram PR shortened 
PT 
10014380 
Electrocardiogram QRS complex prolonged 
PT 
10014387 
Electrocardiogram QT prolonged 
PT 
10014390 
Electrocardiogram ST segment abnormal 
PT 
10014391 
Electrocardiogram ST segment depression 
PT 
10014392 
Electrocardiogram ST segment elevation 
PT 
10014395 
Electrocardiogram T wave inversion 
PT 
10014498 
Embolic stroke 
PT 
10014513 
Embolism arterial 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-107- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10014522 
Embolism venous 
PT 
10014663 
Endocardial fibroelastosis 
PT 
10014961 
Eosinophilic myocarditis 
PT 
10015488 
Essential hypertension 
PT 
10015645 
Exercise electrocardiogram abnormal 
PT 
10015653 
Exercise test abnormal 
PT 
10015856 
Extrasystoles 
PT 
10016427 
Femoral artery aneurysm 
PT 
10018723 
Grey syndrome neonatal 
PT 
10018964 
Haemoptysis 
PT 
10018985 
Haemorrhage intracranial 
PT 
10019005 
Haemorrhagic cerebral infarction 
PT 
10019013 
Haemorrhagic infarction 
PT 
10019016 
Haemorrhagic stroke 
PT 
10019300 
Heart rate abnormal 
PT 
10019301 
Heart rate decreased 
PT 
10019303 
Heart rate increased 
PT 
10019314 
Heart transplant 
PT 
10019634 
Hepatic artery aneurysm 
PT 
10019635 
Hepatic artery embolism 
PT 
10019636 
Hepatic artery thrombosis 
PT 
10019680 
Hepatic infarction 
PT 
10019713 
Hepatic vein thrombosis 
PT 
10019842 
Hepatomegaly 
PT 
10019845 
Hepatorenal failure 
PT 
10020772 
Hypertension 
PT 
10020801 
Hypertensive cardiomegaly 
PT 
10020802 
Hypertensive crisis 
PT 
10020803 
Hypertensive encephalopathy 
PT 
10020823 
Hypertensive heart disease 
PT 
10020871 
Hypertrophic cardiomyopathy 
PT 
10020919 
Hypervolaemia 
PT 
10021076 
Hypoplastic left heart syndrome 
PT 
10021097 
Hypotension 
PT 
10021338 
Iliac artery embolism 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-108- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10022562 
Intermittent claudication 
PT 
10022626 
Interventricular septum rupture 
PT 
10022640 
Intestinal angina 
PT 
10022657 
Intestinal infarction 
PT 
10022680 
Intestinal ischaemia 
PT 
10022758 
Intracranial aneurysm 
PT 
10023025 
Ischaemic hepatitis 
PT 
10023237 
Jugular vein thrombosis 
PT 
10023533 
Labile blood pressure 
PT 
10024119 
Left ventricular failure 
PT 
10024242 
Leriche syndrome 
PT 
10024803 
Long QT syndrome 
PT 
10024855 
Loss of consciousness 
PT 
10024899 
Low cardiac output syndrome 
PT 
10024984 
Lown-Ganong-Levine syndrome 
PT 
10025600 
Malignant hypertension 
PT 
10025603 
Malignant hypertensive heart disease 
PT 
10026674 
Malignant renal hypertension 
PT 
10027394 
Mesenteric arterial occlusion 
PT 
10027395 
Mesenteric artery embolism 
PT 
10027396 
Mesenteric artery stenosis 
PT 
10027397 
Mesenteric artery thrombosis 
PT 
10027401 
Mesenteric vascular insufficiency 
PT 
10027402 
Mesenteric vein thrombosis 
PT 
10027403 
Mesenteric venous occlusion 
PT 
10028178 
Multiple cardiac defects 
PT 
10028212 
Multiple gated acquisition scan abnormal 
PT 
10028594 
Myocardial fibrosis 
PT 
10028596 
Myocardial infarction 
PT 
10028600 
Myocardial ischaemia 
PT 
10028602 
Myocardial necrosis 
PT 
10028604 
Myocardial rupture 
PT 
10028606 
Myocarditis 
PT 
10028612 
Myocarditis meningococcal 
PT 
10028615 
Myocarditis septic 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-109- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10028616 
Myocarditis syphilitic 
PT 
10028617 
Myocarditis toxoplasmal 
PT 
10028629 
Myoglobinuria 
PT 
10028650 
Myopericarditis 
PT 
10028862 
Necrosis ischaemic 
PT 
10028872 
Necrosis of artery 
PT 
10028975 
Neonatal respiratory failure 
PT 
10029446 
Nocturia 
PT 
10029458 
Nodal arrhythmia 
PT 
10029470 
Nodal rhythm 
PT 
10029538 
Non-cardiogenic pulmonary oedema 
PT 
10029748 
Noonan syndrome 
PT 
10030095 
Oedema 
PT 
10030124 
Oedema peripheral 
PT 
10030936 
Optic nerve infarction 
PT 
10030941 
Optic nerve sheath haemorrhage 
PT 
10031123 
Orthopnoea 
PT 
10031127 
Orthostatic hypotension 
PT 
10031131 
Osler's nodes 
PT 
10033557 
Palpitations 
PT 
10033697 
Papillary muscle infarction 
PT 
10033698 
Papillary muscle rupture 
PT 
10033929 
Parasystole 
PT 
10034323 
Penile vascular disorder 
PT 
10034324 
Penile vein thrombosis 
PT 
10034567 
Peripheral circulatory failure 
PT 
10034576 
Peripheral ischaemia 
PT 
10034636 
Peripheral vascular disorder 
PT 
10035092 
Pituitary infarction 
PT 
10035550 
Platypnoea 
PT 
10036155 
Poor peripheral circulation 
PT 
10036511 
Precerebral artery occlusion 
PT 
10036653 
Presyncope 
PT 
10036759 
Prinzmetal angina 
PT 
10037329 
Pulmonary arterial wedge pressure increased 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-110- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10037338 
Pulmonary artery stenosis 
PT 
10037340 
Pulmonary artery thrombosis 
PT 
10037368 
Pulmonary congestion 
PT 
10037377 
Pulmonary embolism 
PT 
10037400 
Pulmonary hypertension 
PT 
10037410 
Pulmonary infarction 
PT 
10037421 
Pulmonary microemboli 
PT 
10037423 
Pulmonary oedema 
PT 
10037437 
Pulmonary thrombosis 
PT 
10037456 
Pulmonary vascular resistance abnormality 
PT 
10037458 
Pulmonary veno-occlusive disease 
PT 
10037459 
Pulmonary venous thrombosis 
PT 
10037469 
Pulse absent 
PT 
10038372 
Renal arteriosclerosis 
PT 
10038378 
Renal artery stenosis 
PT 
10038380 
Renal artery thrombosis 
PT 
10038435 
Renal failure 
PT 
10038447 
Renal failure neonatal 
PT 
10038464 
Renal hypertension 
PT 
10038470 
Renal infarct 
PT 
10038547 
Renal vein embolism 
PT 
10038548 
Renal vein thrombosis 
PT 
10038553 
Renal vessel disorder 
PT 
10038562 
Renovascular hypertension 
PT 
10038695 
Respiratory failure 
PT 
10038748 
Restrictive cardiomyopathy 
PT 
10038826 
Retinal artery embolism 
PT 
10038827 
Retinal artery occlusion 
PT 
10038830 
Retinal artery stenosis 
PT 
10038831 
Retinal artery thrombosis 
PT 
10038871 
Retinal ischaemia 
PT 
10038901 
Retinal vascular disorder 
PT 
10038903 
Retinal vascular occlusion 
PT 
10038907 
Retinal vein occlusion 
PT 
10038908 
Retinal vein thrombosis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-111- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10039111 
Rhythm idioventricular 
PT 
10039163 
Right ventricular failure 
PT 
10039281 
Rubinstein-Taybi syndrome 
PT 
10039330 
Ruptured cerebral aneurysm 
PT 
10040560 
Shock 
PT 
10040581 
Shock symptom 
PT 
10040736 
Sinoatrial block 
PT 
10040738 
Sinus arrest 
PT 
10040739 
Sinus arrhythmia 
PT 
10040741 
Sinus bradycardia 
PT 
10040752 
Sinus tachycardia 
PT 
10041648 
Splenic infarction 
PT 
10042246 
Stroke volume decreased 
PT 
10042265 
Sturge-Weber syndrome 
PT 
10042316 
Subarachnoid haemorrhage 
PT 
10042332 
Subclavian artery embolism 
PT 
10042334 
Subclavian artery thrombosis 
PT 
10042335 
Subclavian steal syndrome 
PT 
10042431 
Subvalvular aortic stenosis 
PT 
10042434 
Sudden death 
PT 
10042569 
Superior vena cava syndrome 
PT 
10042598 
Supravalvular aortic stenosis 
PT 
10042602 
Supraventricular extrasystoles 
PT 
10042604 
Supraventricular tachycardia 
PT 
10042772 
Syncope 
PT 
10042957 
Systolic hypertension 
PT 
10043071 
Tachycardia 
PT 
10043079 
Tachycardia paroxysmal 
PT 
10043337 
Testicular infarction 
PT 
10043581 
Thrombophlebitis migrans 
PT 
10043607 
Thrombosis 
PT 
10043626 
Thrombosis mesenteric vessel 
PT 
10043645 
Thrombotic microangiopathy 
PT 
10043647 
Thrombotic stroke 
PT 
10043742 
Thyroid infarction 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-112- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10044066 
Torsade de pointes 
PT 
10044390 
Transient ischaemic attack 
PT 
10044590 
Trepopnoea 
PT 
10044640 
Tricuspid valve incompetence 
PT 
10044642 
Tricuspid valve stenosis 
PT 
10044644 
Trifascicular block 
PT 
10045413 
Ultrasound Doppler abnormal 
PT 
10046797 
Uterine ischaemia 
PT 
10047080 
Vascular injury 
PT 
10047193 
Vena cava embolism 
PT 
10047195 
Vena cava thrombosis 
PT 
10047216 
Venoocclusive liver disease 
PT 
10047236 
Venous pressure increased 
PT 
10047238 
Venous pressure jugular abnormal 
PT 
10047240 
Venous pressure jugular increased 
PT 
10047249 
Venous thrombosis 
PT 
10047279 
Ventricle rupture 
PT 
10047281 
Ventricular arrhythmia 
PT 
10047284 
Ventricular asystole 
PT 
10047289 
Ventricular extrasystoles 
PT 
10047290 
Ventricular fibrillation 
PT 
10047294 
Ventricular flutter 
PT 
10047295 
Ventricular hypertrophy 
PT 
10047296 
Ventricular hypoplasia 
PT 
10047298 
Ventricular septal defect 
PT 
10047299 
Ventricular septal defect acquired 
PT 
10047302 
Ventricular tachycardia 
PT 
10047330 
Vertebral artery stenosis 
PT 
10047334 
Vertebrobasilar insufficiency 
PT 
10047470 
Viral myocarditis 
PT 
10047818 
Wandering pacemaker 
PT 
10047847 
Waterhouse-Friderichsen syndrome 
PT 
10047903 
Weil's disease 
PT 
10048007 
Withdrawal hypertension 
PT 
10048015 
Wolff-Parkinson-White syndrome 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-113- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10048294 
Mental status changes 
PT 
10048377 
Cardiomyopathy acute 
PT 
10048380 
Aneurysm ruptured 
PT 
10048554 
Endothelial dysfunction 
PT 
10048610 
Cardiotoxicity 
PT 
10048620 
Intracardiac thrombus 
PT 
10048623 
Atrial hypertrophy 
PT 
10048631 
Coronary artery dissection 
PT 
10048632 
Atrial thrombosis 
PT 
10048661 
Wyburn Mason's syndrome 
PT 
10048761 
Atrial rupture 
PT 
10048804 
Kearns-Sayre syndrome 
PT 
10048849 
Myocardial haemorrhage 
PT 
10048858 
Ischaemic cardiomyopathy 
PT 
10048951 
Uhl's anomaly 
PT 
10048959 
Peripheral swelling 
PT 
10048961 
Localised oedema 
PT 
10048963 
Basilar artery occlusion 
PT 
10048964 
Carotid artery occlusion 
PT 
10048965 
Vertebral artery occlusion 
PT 
10048974 
Cardiac pseudoaneurysm 
PT 
10048975 
Vascular pseudoaneurysm 
PT 
10048988 
Renal artery occlusion 
PT 
10049001 
Acute endocarditis 
PT 
10049003 
Accelerated idioventricular rhythm 
PT 
10049060 
Vascular graft occlusion 
PT 
10049079 
Labile hypertension 
PT 
10049171 
Pulmonary vein stenosis 
PT 
10049209 
Aorta hypoplasia 
PT 
10049224 
Electrocardiogram ST-T segment depression 
PT 
10049225 
Electrocardiogram ST-T segment elevation 
PT 
10049235 
Nocturnal dyspnoea 
PT 
10049251 
Heyde's syndrome 
PT 
10049418 
Sudden cardiac death 
PT 
10049430 
Peripartum cardiomyopathy 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-114- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10049440 
Spinal artery embolism 
PT 
10049446 
Subclavian vein thrombosis 
PT 
10049447 
Tachyarrhythmia 
PT 
10049632 
Oedema due to cardiac disease 
PT 
10049633 
Shoshin beriberi 
PT 
10049644 
Williams syndrome 
PT 
10049671 
Negative cardiac inotropic effect 
PT 
10049694 
Left ventricular dysfunction 
PT 
10049760 
Pituitary haemorrhage 
PT 
10049761 
Ventricular pre-excitation 
PT 
10049765 
Bradyarrhythmia 
PT 
10049768 
Silent myocardial infarction 
PT 
10049773 
Left ventricular hypertrophy 
PT 
10049778 
Neonatal anuria 
PT 
10049779 
Peripheral oedema neonatal 
PT 
10049780 
Neonatal cardiac failure 
PT 
10049785 
Atrial pressure increased 
PT 
10049813 
Non-obstructive cardiomyopathy 
PT 
10049874 
Cardio-respiratory distress 
PT 
10049887 
Coronary revascularisation 
PT 
10049993 
Cardiac death 
PT 
10050043 
Left ventricular dilatation 
PT 
10050106 
Paroxysmal arrhythmia 
PT 
10050111 
Cardiomyopathy neonatal 
PT 
10050180 
Subclavian artery stenosis 
PT 
10050202 
Carotid sinus syndrome 
PT 
10050209 
Spinal cord ischaemia 
PT 
10050257 
Cardiovascular deconditioning 
PT 
10050326 
Right ventricular hypertrophy 
PT 
10050329 
Coronary angioplasty 
PT 
10050380 
Electrocardiogram T wave abnormal 
PT 
10050401 
Neonatal multi-organ failure 
PT 
10050403 
Carotid artery dissection 
PT 
10050459 
Pulmonary oedema neonatal 
PT 
10050496 
Reversible ischaemic neurological deficit 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-115- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10050510 
Ventricular hypokinesia 
PT 
10050528 
Ejection fraction decreased 
PT 
10050559 
Aortic valve calcification 
PT 
10050581 
Left ventricular enlargement 
PT 
10050582 
Right ventricular enlargement 
PT 
10050631 
Postoperative hypertension 
PT 
10050900 
Increased ventricular preload 
PT 
10050905 
Decreased ventricular preload 
PT 
10050998 
ECG signs of ventricular hypertrophy 
PT 
10051055 
Deep vein thrombosis 
PT 
10051078 
Lacunar infarction 
PT 
10051093 
Cardiopulmonary failure 
PT 
10051099 
Catheter site haemorrhage 
PT 
10051113 
Arterial restenosis 
PT 
10051128 
Blood pressure inadequately controlled 
PT 
10051177 
Electrocardiogram Q wave abnormal 
PT 
10051199 
Hepatic artery stenosis 
PT 
10051269 
Graft thrombosis 
PT 
10051307 
Ischaemic neuropathy 
PT 
10051328 
Carotid aneurysm rupture 
PT 
10051448 
Hepatojugular reflux 
PT 
10051550 
Carotidynia 
PT 
10051592 
Acute coronary syndrome 
PT 
10051624 
Myocardial reperfusion injury 
PT 
10051734 
Hepatic vein stenosis 
PT 
10051742 
Retinal infarction 
PT 
10051860 
Left atrial enlargement 
PT 
10051895 
Acute chest syndrome 
PT 
10051951 
Scimitar syndrome 
PT 
10051991 
Hepatic artery occlusion 
PT 
10051994 
Pacemaker syndrome 
PT 
10052076 
Haemodynamic instability 
PT 
10052086 
Coronary arterial stent insertion 
PT 
10052173 
Cerebrospinal thrombotic tamponade 
PT 
10052289 
Myocardial bridging 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-116- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10052313 
Liddle's syndrome 
PT 
10052326 
Femoral artery dissection 
PT 
10052333 
Electrocardiogram ST-T segment abnormal 
PT 
10052337 
Diastolic dysfunction 
PT 
10052348 
Left ventricular heave 
PT 
10052371 
Ventricular assist device insertion 
PT 
10052464 
Electrocardiogram repolarisation abnormality 
PT 
10052840 
Cardiac flutter 
PT 
10052895 
Coronary artery insufficiency 
PT 
10052896 
Ocular vascular disorder 
PT 
10053159 
Organ failure 
PT 
10053182 
Arteriovenous graft thrombosis 
PT 
10053216 
Iliac artery stenosis 
PT 
10053261 
Coronary artery reocclusion 
PT 
10053405 
Brain natriuretic peptide increased 
PT 
10053408 
Brain natriuretic peptide abnormal 
PT 
10053410 
Atrial natriuretic peptide abnormal 
PT 
10053412 
Atrial natriuretic peptide increased 
PT 
10053440 
Cardiac monitoring abnormal 
PT 
10053444 
Cardiac ventriculogram right abnormal 
PT 
10053447 
Cardiac ventriculogram abnormal 
PT 
10053450 
Cardiac telemetry abnormal 
PT 
10053453 
Cardiac imaging procedure abnormal 
PT 
10053486 
Pacemaker generated arrhythmia 
PT 
10053499 
Cardiac ventriculogram left abnormal 
PT 
10053633 
Cerebellar artery occlusion 
PT 
10053648 
Vascular occlusion 
PT 
10053657 
Electrocardiogram PR prolongation 
PT 
10053748 
Cardiac valve replacement complication 
PT 
10053841 
Sneddon's syndrome 
PT 
10053942 
Cerebral haematoma 
PT 
10053949 
Vascular pseudoaneurysm ruptured 
PT 
10053994 
Cardiac ventricular thrombosis 
PT 
10054015 
Agonal rhythm 
PT 
10054044 
Diabetic microangiopathy 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-117- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10054092 
Vessel puncture site haemorrhage 
PT 
10054122 
Myocardial calcification 
PT 
10054123 
Malarial myocarditis 
PT 
10054749 
Charcot-Bouchard microaneurysms 
PT 
10054805 
Macroangiopathy 
PT 
10054880 
Vascular insufficiency 
PT 
10054936 
Cardiac cirrhosis 
PT 
10054946 
Malignant pericardial neoplasm 
PT 
10055009 
Cardiac fibroma 
PT 
10055014 
Cardiac stress test abnormal 
PT 
10055032 
Electrocardiogram U-wave abnormality 
PT 
10055122 
Arteriovenous fistula site complication 
PT 
10055123 
Arteriovenous fistula site haemorrhage 
PT 
10055126 
Arteriovenous graft site haemorrhage 
PT 
10055147 
Arteriovenous graft site stenosis 
PT 
10055150 
Arteriovenous fistula site haematoma 
PT 
10055152 
Arteriovenous graft site haematoma 
PT 
10055171 
Hypertensive nephropathy 
PT 
10055662 
Catheter site haematoma 
PT 
10055677 
Haemorrhagic transformation stroke 
PT 
10055803 
Haemorrhage coronary artery 
PT 
10056237 
Migrainous infarction 
PT 
10056261 
Cytomegalovirus myocarditis 
PT 
10056293 
Renal vein occlusion 
PT 
10056328 
Hepatic ischaemia 
PT 
10056370 
Congestive cardiomyopathy 
PT 
10056371 
Cerebrovascular arteriovenous malformation 
PT 
10056382 
Intraoperative cerebral artery occlusion 
PT 
10056409 
Heart and lung transplant 
PT 
10056472 
Ventricular hyperkinesia 
PT 
10056489 
Coronary artery restenosis 
PT 
10057393 
Bifascicular block 
PT 
10057403 
Choroidal infarction 
PT 
10057453 
Aortic dilatation 
PT 
10057454 
Aortic valve prolapse 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-118- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10057455 
Cardiac ventricular disorder 
PT 
10057461 
Cardiac procedure complication 
PT 
10057462 
Vascular procedure complication 
PT 
10057466 
Tricuspid valve calcification 
PT 
10057467 
Tricuspid valve sclerosis 
PT 
10057469 
Vascular stenosis 
PT 
10057500 
Left atrial hypertrophy 
PT 
10057501 
Right atrial hypertrophy 
PT 
10057520 
Peripheral artery dissection 
PT 
10057521 
Peripheral artery aneurysm 
PT 
10057525 
Peripheral artery occlusion 
PT 
10057576 
Cardiac septal hypertrophy 
PT 
10057615 
Endocrine hypertension 
PT 
10057777 
Vertebral artery thrombosis 
PT 
10057799 
Computerised tomogram thorax abnormal 
PT 
10057913 
Electrocardiogram U wave present 
PT 
10057926 
Long QT syndrome congenital 
PT 
10058039 
Cardiac perforation 
PT 
10058079 
Anomalous pulmonary venous connection 
PT 
10058093 
Arrhythmogenic right ventricular dysplasia 
PT 
10058119 
Neurogenic shock 
PT 
10058144 
Postinfarction angina 
PT 
10058145 
Subendocardial ischaemia 
PT 
10058151 
Pulseless electrical activity 
PT 
10058155 
Heart alternation 
PT 
10058156 
Reperfusion arrhythmia 
PT 
10058177 
Hyperkinetic heart syndrome 
PT 
10058178 
Aortic occlusion 
PT 
10058179 
Hypertensive emergency 
PT 
10058181 
Hypertensive urgency 
PT 
10058184 
Ventricular parasystole 
PT 
10058222 
Hypertensive cardiomyopathy 
PT 
10058227 
Right atrial enlargement 
PT 
10058267 
Troponin increased 
PT 
10058268 
Troponin I increased 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-119- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10058269 
Troponin T increased 
PT 
10058317 
ECG signs of myocardial ischaemia 
PT 
10058440 
Myocardiac abscess 
PT 
10058479 
Cardiac function test abnormal 
PT 
10058558 
Hypoperfusion 
PT 
10058562 
Arteriovenous fistula occlusion 
PT 
10058571 
Spinal cord infarction 
PT 
10058597 
Right ventricular dysfunction 
PT 
10058648 
Aortic disorder 
PT 
10058735 
Myoglobinaemia 
PT 
10058842 
Cerebrovascular insufficiency 
PT 
10058939 
Thalamus haemorrhage 
PT 
10058940 
Putamen haemorrhage 
PT 
10058987 
Inferior vena caval occlusion 
PT 
10058988 
Superior vena cava occlusion 
PT 
10058990 
Venous occlusion 
PT 
10058991 
Hepatic vein occlusion 
PT 
10058992 
Iliac vein occlusion 
PT 
10059025 
Coronary bypass thrombosis 
PT 
10059026 
Myocarditis mycotic 
PT 
10059027 
Brugada syndrome 
PT 
10059028 
Gastrointestinal ischaemia 
PT 
10059056 
Ventricular dysfunction 
PT 
10059099 
Atrophie blanche 
PT 
10059109 
Cerebral vasoconstriction 
PT 
10059162 
Ventricular dyskinesia 
PT 
10059164 
Papillary muscle haemorrhage 
PT 
10059238 
Hypertensive angiopathy 
PT 
10059245 
Angiopathy 
PT 
10059399 
Graft ischaemia 
PT 
10059483 
Postpericardiotomy syndrome 
PT 
10059498 
Stewart-Treves syndrome 
PT 
10059611 
Coronary artery perforation 
PT 
10059613 
Stroke in evolution 
PT 
10059862 
Cardiac resynchronisation therapy 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-120- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10059865 
Jugular vein distension 
PT 
10060089 
Left ventricular end-diastolic pressure decreased 
PT 
10060237 
Right ventricular systolic pressure decreased 
PT 
10060806 
Computerised tomogram coronary artery abnormal 
PT 
10060839 
Embolic cerebral infarction 
PT 
10060840 
Ischaemic cerebral infarction 
PT 
10060874 
Aortic rupture 
PT 
10060953 
Ventricular failure 
PT 
10060963 
Arterial disorder 
PT 
10060964 
Arterial haemorrhage 
PT 
10060965 
Arterial stenosis 
PT 
10061024 
Cardiac disorder 
PT 
10061026 
Cardiac operation 
PT 
10061038 
Cerebellar haematoma 
PT 
10061116 
Electrocardiogram change 
PT 
10061169 
Embolism 
PT 
10061216 
Infarction 
PT 
10061255 
Ischaemia 
PT 
10061256 
Ischaemic stroke 
PT 
10061317 
Oedema neonatal 
PT 
10061330 
Papillary muscle disorder 
PT 
10061340 
Peripheral embolism 
PT 
10061369 
Spinal vascular disorder 
PT 
10061389 
Tricuspid valve disease 
PT 
10061406 
Cardiac valve disease 
PT 
10061474 
Pulmonary vascular disorder 
PT 
10061501 
Scan myocardial perfusion abnormal 
PT 
10061589 
Aortic valve disease 
PT 
10061592 
Cardiac fibrillation 
PT 
10061593 
Echocardiogram abnormal 
PT 
10061660 
Artery dissection 
PT 
10061744 
Carotid artery disease 
PT 
10061751 
Cerebrovascular stenosis 
PT 
10061808 
Cardiac electrophysiologic study abnormal 
PT 
10061815 
Diabetic vascular disorder 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-121- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10062108 
Retinal vascular thrombosis 
PT 
10062169 
Vascular access complication 
PT 
10062170 
Vascular bypass dysfunction 
PT 
10062173 
Venoocclusive disease 
PT 
10062198 
Microangiopathy 
PT 
10062314 
Electrocardiogram U wave inversion 
PT 
10062542 
Arterial insufficiency 
PT 
10062546 
Thrombosis in device 
PT 
10062573 
Brain stem thrombosis 
PT 
10062585 
Peripheral arterial occlusive disease 
PT 
10062599 
Arterial occlusive disease 
PT 
10062610 
Ischaemic limb pain 
PT 
10062901 
Multiple lentigines syndrome 
PT 
10062991 
Positive cardiac inotropic effect 
PT 
10063079 
Vascular anastomosis aneurysm 
PT 
10063080 
Postural orthostatic tachycardia syndrome 
PT 
10063081 
Acute left ventricular failure 
PT 
10063082 
Acute right ventricular failure 
PT 
10063083 
Chronic left ventricular failure 
PT 
10063084 
Chronic right ventricular failure 
PT 
10063093 
Basilar artery thrombosis 
PT 
10063164 
Vestibular ischaemia 
PT 
10063176 
Prosthetic cardiac valve thrombosis 
PT 
10063181 
Propofol infusion syndrome 
PT 
10063363 
Brachiocephalic vein thrombosis 
PT 
10063381 
Polypoidal choroidal vasculopathy 
PT 
10063428 
Athletic heart syndrome 
PT 
10063544 
Renal embolism 
PT 
10063547 
Diabetic macroangiopathy 
PT 
10063561 
Pulmonary artery wall hypertrophy 
PT 
10063577 
Graft haemorrhage 
PT 
10063587 
Catheter site bruise 
PT 
10063588 
Ortner's syndrome 
PT 
10063648 
Cerebral artery stenosis 
PT 
10063732 
Aorticopulmonary septal defect 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-122- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10063748 
Electrocardiogram QT interval abnormal 
PT 
10063829 
Device malfunction 
PT 
10063836 
Atrioventricular septal defect 
PT 
10063837 
Reperfusion injury 
PT 
10063868 
Implant site thrombosis 
PT 
10063881 
Vessel puncture site bruise 
PT 
10063897 
Renal ischaemia 
PT 
10063927 
Orthostatic intolerance 
PT 
10063934 
Vascular stent thrombosis 
PT 
10063935 
Kabuki make-up syndrome 
PT 
10064021 
Cardiac septal defect 
PT 
10064063 
CHARGE syndrome 
PT 
10064191 
Atrial conduction time prolongation 
PT 
10064192 
Parachute mitral valve 
PT 
10064195 
Right ventricle outflow tract obstruction 
PT 
10064252 
Vascular graft complication 
PT 
10064408 
Cardiac vein dissection 
PT 
10064409 
Cardiac vein perforation 
PT 
10064539 
Autoimmune myocarditis 
PT 
10064550 
Myocarditis post infection 
PT 
10064595 
Haemorrhagic arteriovenous malformation 
PT 
10064601 
Iliac artery occlusion 
PT 
10064730 
Cerebral hyperperfusion syndrome 
PT 
10064771 
Superior vena cava stenosis 
PT 
10064775 
Arteriovenous graft aneurysm 
PT 
10064911 
Pulmonary arterial hypertension 
PT 
10064939 
Cardiovascular event prophylaxis 
PT 
10064949 
Carotid artery insufficiency 
PT 
10064961 
Thalamic infarction 
PT 
10064962 
Hypoplastic right heart syndrome 
PT 
10064966 
Myocardial oedema 
PT 
10064994 
Subclavian coronary steal syndrome 
PT 
10065218 
Myocarditis bacterial 
PT 
10065219 
Myocarditis helminthic 
PT 
10065341 
Ventricular tachyarrhythmia 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-123- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10065342 
Supraventricular tachyarrhythmia 
PT 
10065384 
Cerebral hypoperfusion 
PT 
10065420 
Coronary artery dilatation 
PT 
10065508 
Orthostatic hypertension 
PT 
10065510 
Aortic elongation 
PT 
10065534 
Macular ischaemia 
PT 
10065558 
Aortic arteriosclerosis 
PT 
10065559 
Cerebral arteriosclerosis 
PT 
10065560 
Mesenteric arteriosclerosis 
PT 
10065561 
Renal artery arteriosclerosis 
PT 
10065608 
Percutaneous coronary intervention 
PT 
10065680 
Embolic pneumonia 
PT 
10065902 
Vessel puncture site haematoma 
PT 
10065918 
Prehypertension 
PT 
10065929 
Cardiovascular insufficiency 
PT 
10065930 
Left ventricle outflow tract obstruction 
PT 
10066001 
Cardiac autonomic neuropathy 
PT 
10066022 
VACTERL syndrome 
PT 
10066059 
Paradoxical embolism 
PT 
10066077 
Diastolic hypotension 
PT 
10066111 
Shunt blood flow excessive 
PT 
10066127 
Ischaemic pancreatitis 
PT 
10066174 
Transfusion-related circulatory overload 
PT 
10066243 
Aortic wall hypertrophy 
PT 
10066286 
Stress cardiomyopathy 
PT 
10066363 
Haemodynamic rebound 
PT 
10066391 
Lupus myocarditis 
PT 
10066591 
Post procedural stroke 
PT 
10066592 
Post procedural myocardial infarction 
PT 
10066801 
Aortic valve atresia 
PT 
10066802 
Shone complex 
PT 
10066857 
Myocarditis infectious 
PT 
10066862 
Tricuspid valve prolapse 
PT 
10066870 
Aorto-oesophageal fistula 
PT 
10066881 
Deep vein thrombosis postoperative 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-124- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10066907 
Vertebral artery hypoplasia 
PT 
10066916 
Arteriovenous fistula aneurysm 
PT 
10067057 
Basal ganglia haemorrhage 
PT 
10067116 
Carotid arteriosclerosis 
PT 
10067167 
Cerebellar embolism 
PT 
10067207 
Rebound tachycardia 
PT 
10067270 
Thrombosis corpora cavernosa 
PT 
10067277 
Cerebral microhaemorrhage 
PT 
10067282 
Right atrial dilatation 
PT 
10067283 
Right atrial pressure increased 
PT 
10067284 
Pulmonary arteriopathy 
PT 
10067285 
Vascular resistance pulmonary increased 
PT 
10067286 
Left atrial dilatation 
PT 
10067325 
Coeliac artery stenosis 
PT 
10067339 
Arrhythmic storm 
PT 
10067347 
Thrombotic cerebral infarction 
PT 
10067466 
Cerebral microangiopathy 
PT 
10067598 
Neurogenic hypertension 
PT 
10067618 
Accessory cardiac pathway 
PT 
10067652 
Electrocardiogram RR interval prolonged 
PT 
10067876 
External counterpulsation 
PT 
10067975 
Aortic intramural haematoma 
PT 
10068044 
Cerebral amyloid angiopathy 
PT 
10068119 
Aortic dissection rupture 
PT 
10068149 
Vessel perforation 
PT 
10068165 
Cardiac valve rupture 
PT 
10068180 
Atrioventricular conduction time shortened 
PT 
10068230 
Cardiorenal syndrome 
PT 
10068239 
Pancreatic infarction 
PT 
10068359 
Hyperdynamic left ventricle 
PT 
10068365 
Femoral artery embolism 
PT 
10068534 
Coronary no-reflow phenomenon 
PT 
10068605 
Venous recanalisation 
PT 
10068621 
Cerebellar ischaemia 
PT 
10068627 
Chronotropic incompetence 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-125- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10068644 
Brain stem stroke 
PT 
10068677 
Splenic embolism 
PT 
10068690 
Pulmonary vein occlusion 
PT 
10068726 
Pulmonary hypertensive crisis 
PT 
10068767 
Viral cardiomyopathy 
PT 
10068776 
Post embolisation syndrome 
PT 
10068841 
Cobb syndrome 
PT 
10069018 
Brachiocephalic vein stenosis 
PT 
10069020 
Basal ganglia infarction 
PT 
10069111 
Inferior vena cava dilatation 
PT 
10069112 
Hepatic vein dilatation 
PT 
10069121 
Cardiac septal defect residual shunt 
PT 
10069140 
Myocardial depression 
PT 
10069167 
Kounis syndrome 
PT 
10069339 
Acute kidney injury 
PT 
10069379 
Peripheral arterial reocclusion 
PT 
10069384 
Ischaemic nephropathy 
PT 
10069385 
Ocular ischaemic syndrome 
PT 
10069469 
Postimplantation syndrome 
PT 
10069550 
Intrapericardial thrombosis 
PT 
10069571 
Atrioventricular dissociation 
PT 
10069658 
HIV cardiomyopathy 
PT 
10069694 
Brachiocephalic artery occlusion 
PT 
10069695 
Subclavian artery occlusion 
PT 
10069696 
Coeliac artery occlusion 
PT 
10069713 
Primary ciliary dyskinesia 
PT 
10069727 
May-Thurner syndrome 
PT 
10069801 
Cardiac complication associated with device 
PT 
10069886 
Omental infarction 
PT 
10069922 
Vascular graft thrombosis 
PT 
10070190 
Ischaemic gastritis 
PT 
10070243 
Endocardial varices 
PT 
10070296 
Arterioenteric fistula 
PT 
10070511 
Hypoxic-ischaemic encephalopathy 
PT 
10070589 
Ischaemic contracture of the left ventricle 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-126- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10070649 
Vessel puncture site thrombosis 
PT 
10070671 
Cerebral septic infarct 
PT 
10070689 
Dilatation of sinotubular junction 
PT 
10070746 
Stress echocardiogram abnormal 
PT 
10070878 
Cerebral small vessel ischaemic disease 
PT 
10070909 
Metabolic cardiomyopathy 
PT 
10070911 
Inferior vena cava syndrome 
PT 
10070955 
Right ventricular heave 
PT 
10071010 
Subchorionic haemorrhage 
PT 
10071043 
Basal ganglia stroke 
PT 
10071138 
Malnutrition-inflammation-atherosclerosis syndrome 
PT 
10071186 
Ventricular dyssynchrony 
PT 
10071205 
Brain stem microhaemorrhage 
PT 
10071206 
Cerebellar microhaemorrhage 
PT 
10071316 
Spinal artery thrombosis 
PT 
10071436 
Systolic dysfunction 
PT 
10071505 
Vertebrobasilar dolichoectasia 
PT 
10071573 
Susac's syndrome 
PT 
10071660 
N-terminal prohormone brain natriuretic peptide abnormal 
PT 
10071662 
N-terminal prohormone brain natriuretic peptide increased 
PT 
10071666 
Atrial parasystole 
PT 
10071710 
Lenegre's disease 
PT 
10071716 
Vertebral artery dissection 
PT 
10071747 
Cerebral cavernous malformation 
PT 
10072043 
Central nervous system haemorrhage 
PT 
10072052 
Plaque shift 
PT 
10072066 
Artificial heart implant 
PT 
10072186 
Myocardial stunning 
PT 
10072226 
Renal vascular thrombosis 
PT 
10072252 
ECG electrically inactive area 
PT 
10072370 
Prerenal failure 
PT 
10072557 
Peripheral artery restenosis 
PT 
10072558 
Carotid artery restenosis 
PT 
10072563 
Peripheral artery stenosis 
PT 
10072564 
Peripheral artery thrombosis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-127- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10072629 
Intrahepatic portal hepatic venous fistula 
PT 
10072685 
Microvascular coronary artery disease 
PT 
10072744 
Alcohol septal ablation 
PT 
10072788 
False lumen dilatation of aortic dissection 
PT 
10072789 
Iliac artery rupture 
PT 
10072809 
Arterial wall hypertrophy 
PT 
10073230 
Brain stem haematoma 
PT 
10073356 
Cardiac contusion 
PT 
10073455 
Twin reversed arterial perfusion sequence malformation 
PT 
10073565 
Intracranial artery dissection 
PT 
10073708 
Obstructive shock 
PT 
10073774 
Lenticulostriatal vasculopathy 
PT 
10073856 
Larsen syndrome 
PT 
10074063 
Ischaemic enteritis 
PT 
10074222 
Right ventricular dilatation 
PT 
10074269 
Tachycardia induced cardiomyopathy 
PT 
10074301 
Right ventricular hypertension 
PT 
10074337 
Acute aortic syndrome 
PT 
10074349 
Ophthalmic vein thrombosis 
PT 
10074359 
Cardiopulmonary exercise test abnormal 
PT 
10074387 
Axillary web syndrome 
PT 
10074396 
Penetrating atherosclerotic ulcer 
PT 
10074422 
Brain stem embolism 
PT 
10074494 
Hepatic vascular thrombosis 
PT 
10074525 
Mesenteric phlebosclerosis 
PT 
10074540 
Tongue infarction 
PT 
10074583 
Mesenteric vascular occlusion 
PT 
10074600 
Splenic artery thrombosis 
PT 
10074621 
Vein collapse 
PT 
10074639 
Inferior vena cava stenosis 
PT 
10074640 
Junctional ectopic tachycardia 
PT 
10074717 
Precerebral artery thrombosis 
PT 
10074896 
Device embolisation 
PT 
10074971 
Arterial intramural haematoma 
PT 
10075043 
Thyrotoxic cardiomyopathy 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-128- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10075049 
Peripheral venous disease 
PT 
10075162 
Coronary vascular graft occlusion 
PT 
10075211 
Myocardial necrosis marker increased 
PT 
10075253 
Atrio-oesophageal fistula 
PT 
10075291 
Ventricular remodelling 
PT 
10075299 
ECG signs of myocardial infarction 
PT 
10075337 
Right ventricular ejection fraction decreased 
PT 
10075393 
Positive vessel remodelling 
PT 
10075394 
Cerebral aneurysm perforation 
PT 
10075395 
Aneurysm perforation 
PT 
10075396 
Aneurysm recanalisation 
PT 
10075401 
Cerebral reperfusion injury 
PT 
10075423 
Cerebral artery restenosis 
PT 
10075428 
Mahler sign 
PT 
10075449 
Brachiocephalic arteriosclerosis 
PT 
10075450 
Brachiocephalic artery stenosis 
PT 
10075534 
Cardiovascular symptom 
PT 
10075553 
Enterovirus myocarditis 
PT 
10075565 
Lower respiratory tract congestion 
PT 
10075633 
Cerebral capillary telangiectasia 
PT 
10075728 
Carotid artery perforation 
PT 
10075729 
Aortic perforation 
PT 
10075730 
Lower limb artery perforation 
PT 
10075731 
Iliac artery perforation 
PT 
10075732 
Arterial perforation 
PT 
10075733 
Venous perforation 
PT 
10075734 
Cerebral artery perforation 
PT 
10075735 
Vertebral artery perforation 
PT 
10075736 
Basilar artery perforation 
PT 
10075737 
Renal artery perforation 
PT 
10075738 
Splenic artery perforation 
PT 
10075739 
Femoral artery perforation 
PT 
10075740 
Subclavian artery perforation 
PT 
10075741 
Superior vena cava perforation 
PT 
10075742 
Inferior vena cava perforation 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-129- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10075743 
Subclavian vein perforation 
PT 
10075744 
Iliac vein perforation 
PT 
10075745 
Femoral vein perforation 
PT 
10075851 
Aortic valve thickening 
PT 
10075889 
Sinus node dysfunction 
PT 
10075993 
Primary cardiac lymphoma 
PT 
10076145 
Medical device site thrombosis 
PT 
10076203 
Radiation associated cardiac failure 
PT 
10076213 
Irregular breathing 
PT 
10076389 
Radiation myocarditis 
PT 
10076419 
Anginal equivalent 
PT 
10076604 
Atherosclerotic plaque rupture 
PT 
10076605 
Right-to-left cardiac shunt 
PT 
10076627 
Coronary brachytherapy 
PT 
10076692 
Anterior segment ischaemia 
PT 
10076693 
Arteriovenous fistula maturation failure 
PT 
10076713 
Subclavian vein stenosis 
PT 
10076835 
Jugular vein occlusion 
PT 
10076836 
Aortic restenosis 
PT 
10076837 
Brachiocephalic vein occlusion 
PT 
10076839 
Incision site vessel occlusion 
PT 
10076895 
Cerebral vascular occlusion 
PT 
10076898 
Cardiac ventricular scarring 
PT 
10076916 
Kidney congestion 
PT 
10076929 
Cerebral congestion 
PT 
10076976 
Systolic anterior motion of mitral valve 
PT 
10076981 
Post stroke seizure 
PT 
10076982 
Post stroke epilepsy 
PT 
10076994 
Lacunar stroke 
PT 
10076999 
Bezold-Jarisch reflex 
PT 
10077000 
Hypertensive cerebrovascular disease 
PT 
10077031 
Basal ganglia haematoma 
PT 
10077033 
Precerebral arteriosclerosis 
PT 
10077115 
Iliac artery disease 
PT 
10077143 
Vascular stent occlusion 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-130- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10077144 
Vascular stent stenosis 
PT 
10077146 
Post angioplasty restenosis 
PT 
10077162 
Abnormal precordial movement 
PT 
10077177 
Pulmonary hypoperfusion 
PT 
10077260 
Banti's syndrome 
PT 
10077285 
Intracranial arterial fenestration 
PT 
10077330 
Vascular graft stenosis 
PT 
10077331 
Vascular graft restenosis 
PT 
10077334 
Coronary vascular graft stenosis 
PT 
10077361 
Multiple organ dysfunction syndrome 
PT 
10077454 
Cardiac contractility modulation therapy 
PT 
10077455 
Device related thrombosis 
PT 
10077498 
Vertebral artery aneurysm 
PT 
10077503 
Paroxysmal atrioventricular block 
PT 
10077607 
Basilar artery aneurysm 
PT 
10077643 
Vascular access site haemorrhage 
PT 
10077644 
Vascular access site complication 
PT 
10077645 
Vascular access site oedema 
PT 
10077647 
Vascular access site haematoma 
PT 
10077648 
Vascular access site occlusion 
PT 
10077649 
Vascular access site pseudoaneurysm 
PT 
10077652 
Vascular access site rupture 
PT 
10077721 
Vascular graft haemorrhage 
PT 
10077763 
Vascular access site dissection 
PT 
10077767 
Vascular access site bruising 
PT 
10077781 
Prohormone brain natriuretic peptide increased 
PT 
10077783 
Prohormone brain natriuretic peptide abnormal 
PT 
10077819 
Bendopnoea 
PT 
10077824 
Coronary bypass stenosis 
PT 
10077828 
Omental necrosis 
PT 
10077832 
Vascular access malfunction 
PT 
10077834 
Left-to-right cardiac shunt 
PT 
10077864 
Ischaemic mitral regurgitation 
PT 
10077893 
Atrioventricular node dispersion 
PT 
10077988 
Neurovascular conflict 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-131- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10078046 
Brachial artery entrapment syndrome 
PT 
10078078 
Cardiovascular somatic symptom disorder 
PT 
10078118 
Calcium embolism 
PT 
10078201 
Pulmonary artery occlusion 
PT 
10078202 
Post cardiac arrest syndrome 
PT 
10078218 
Surgical ventricular restoration 
PT 
10078269 
Vascular pseudoaneurysm thrombosis 
PT 
10078310 
Central bradycardia 
PT 
10078311 
Cerebral microembolism 
PT 
10078388 
Delayed ischaemic neurological deficit 
PT 
10078417 
Lyme carditis 
PT 
10078431 
Coronary vein stenosis 
PT 
10078670 
Gonococcal heart disease 
PT 
10078675 
Vascular access site thrombosis 
PT 
10078980 
Myocardial hypoxia 
PT 
10079016 
Wall motion score index abnormal 
PT 
10079115 
Respiratory sinus arrhythmia magnitude increased 
PT 
10079116 
Respiratory sinus arrhythmia magnitude decreased 
PT 
10079117 
Respiratory sinus arrhythmia magnitude abnormal 
PT 
10079253 
Non-compaction cardiomyopathy 
PT 
10079319 
Periprocedural myocardial infarction 
PT 
10079339 
Ventricular enlargement 
PT 
10079340 
Atrial enlargement 
PT 
10079586 
Aortic annulus rupture 
PT 
10079588 
Aortic root compression 
PT 
10079589 
Coronary artery compression 
PT 
10079613 
Right ventricular diastolic collapse 
PT 
10079751 
Cardiac dysfunction 
PT 
10079769 
Cavernous sinus syndrome 
PT 
10079904 
Intracardiac pressure increased 
PT 
10080039 
Oedema blister 
PT 
10080307 
Arterial dolichoectasia 
PT 
10080308 
Carotid artery dolichoectasia 
PT 
10080347 
Extraischaemic cerebral haematoma 
PT 
10080484 
Chagas' cardiomyopathy 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-132- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10080569 
Cardiac iron overload 
PT 
10080787 
Wellens' syndrome 
PT 
10080788 
Diabetic coronary microangiopathy 
PT 
10080894 
Procedural shock 
PT 
10080896 
Perforation of great vessels 
PT 
10080987 
Left ventricular diastolic collapse 
PT 
10080992 
Ventricular compliance decreased 
PT 
10081004 
Hypersensitivity myocarditis 
PT 
10081007 
Obesity cardiomyopathy 
PT 
10081099 
Acute cardiac event 
PT 
10081144 
Ophthalmic artery thrombosis 
PT 
10081493 
Electrocardiogram PR segment depression 
PT 
10081792 
Lung opacity 
PT 
10081850 
Jugular vein embolism 
PT 
10081886 
Cardiac device reprogramming 
PT 
10081980 
Subacute kidney injury 
PT 
10082009 
Implantable cardiac monitor replacement 
PT 
10082160 
Supra-aortic trunk sclerosis 
PT 
10082308 
Internal carotid artery deformity 
PT 
10082367 
Left atrial volume abnormal 
PT 
10082368 
Left atrial volume decreased 
PT 
10082369 
Left atrial volume increased 
PT 
10082459 
Subendocardial haemorrhage 
PT 
10082480 
Cardiohepatic syndrome 
PT 
10082493 
Restenosis 
PT 
10082503 
Venous hypertension 
PT 
10082504 
Elastic vessel recoil complication 
PT 
10082565 
Aorto-bronchial fistula 
PT 
10082580 
Myocardial hypoperfusion 
PT 
10082594 
Foville syndrome 
PT 
10082595 
Arteriovenous graft site necrosis 
PT 
10082606 
Immune-mediated myocarditis 
PT 
10082615 
Coronary sinus dilatation 
PT 
10082739 
Vascular access steal syndrome 
PT 
10082827 
Iliac artery restenosis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-133- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10082853 
Peripheral vein thrombus extension 
PT 
10082919 
Pericardial lipoma 
PT 
10082931 
Vascular access site hypoaesthesia 
PT 
10083006 
Eye infarction 
PT 
10083037 
Cerebral venous sinus thrombosis 
PT 
10083102 
Iliac vein stenosis 
PT 
10083103 
Peripheral vein occlusion 
PT 
10083104 
Peripheral vein stenosis 
PT 
10083109 
Vascular access site erythema 
PT 
10083112 
Vascular access site pruritus 
PT 
10083143 
Magnetic resonance imaging thoracic abnormal 
PT 
10083244 
Spontaneous internal carotid artery recanalisation 
PT 
10083275 
Foix-Chavany-Marie syndrome 
PT 
10083302 
Necrotic angiodermatitis 
PT 
10083408 
Internal capsule infarction 
PT 
10083476 
Reactive angioendotheliomatosis 
PT 
10083602 
Cardiac perfusion defect 
PT 
10083635 
Giant cell myocarditis 
PT 
10083657 
Toxic cardiomyopathy 
PT 
10083659 
Hypotensive crisis 
PT 
10083668 
Cerebral microinfarction 
PT 
10083709 
Holiday heart syndrome 
PT 
10083840 
Hepatic perfusion disorder 
PT 
10084002 
Ischaemic cholecystitis 
PT 
10084013 
Post procedural hypotension 
PT 
10084057 
Vascular graft infection 
PT 
10084058 
Congestive hepatopathy 
PT 
10084072 
Embolic cerebellar infarction 
PT 
10084073 
BRASH syndrome 
PT 
10084081 
Coronary steal syndrome 
PT 
10084085 
Atrioventricular node dysfunction 
PT 
10084087 
Cerebrovascular pseudoaneurysm 
PT 
10084092 
Vascular anastomotic haemorrhage 
PT 
10084238 
Neonatal dyspnoea 
PT 
10084339 
Aorto-atrial fistula 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-134- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10084341 
Subclavian artery dissection 
PT 
10084364 
Mitochondrial cardiomyopathy 
PT 
10084482 
Arterial revascularisation 
PT 
10084745 
Temporary mechanical circulatory support 
PT 
10084750 
Arteriovenous fistula site pseudoaneurysm 
PT 
10084753 
Arteriovenous graft site pseudoaneurysm 
PT 
10084767 
Multisystem inflammatory syndrome in children 
PT 
10084806 
Coronary sinus injury 
PT 
10084862 
Supra-aortic trunk stenosis 
PT 
10085242 
Chronic coronary syndrome 
PT 
10085294 
Acquired left ventricle outflow tract obstruction 
PT 
10085297 
Paravalvular regurgitation 
PT 
10085742 
Subclavian arteriosclerosis 
PT 
10085756 
Atrial escape rhythm 
PT 
10085779 
Pseudo-occlusion of internal carotid artery 
PT 
10085821 
Iliac artery arteriosclerosis 
PT 
10085849 
Superior mesenteric artery dissection 
PT 
10085850 
Multisystem inflammatory syndrome in adults 
PT 
10085879 
Myocardial injury 
PT 
10085935 
Vascular access site necrosis 
PT 
10085944 
Haemorrhagic cerebellar infarction 
PT 
10086091 
Multisystem inflammatory syndrome 
PT 
10086097 
Precerebral artery aneurysm 
PT 
10086098 
Precerebral artery dissection 
PT 
10086099 
Post procedural complication circulatory 
PT 
10086118 
Pulmonary artery arteriosclerosis 
PT 
10086230 
Early repolarisation syndrome 
PT 
10086250 
Acquired coronary artery fistula 
PT 
10086295 
Myocardial strain imaging abnormal 
PT 
10086308 
Acquired right ventricle outflow obstruction 
PT 
10086395 
Ophthalmic artery occlusion 
PT 
10086406 
Ophthalmic artery aneurysm 
PT 
10086448 
Cerebrocardiac syndrome 
PT 
10086546 
Malignant middle cerebral artery syndrome 
PT 
10086552 
Post procedural cardiac valve avulsion 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-135- 
CV Events - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10086558 
Buttock claudication 
PT 
10086560 
Aneurysm thrombosis 
PT 
10086620 
Dynamic cardiomyoplasty 
PT 
10086684 
Diabetic complication cardiovascular 
PT 
10086706 
Cardiac contractility decreased 
PT 
10086740 
Fascicular block 
PT 
10086997 
Pacing induced cardiomyopathy 
PT 
10087101 
Myofibrillar myopathy 
PT 
10087106 
Chronic myocarditis 
PT 
10087136 
Heart transplant failure 
PT 
10087137 
Heart-lung transplant failure 
PT 
10087208 
Sigmoid sinus thrombosis 
PT 
10087221 
Septic cardiomyopathy 
PT 
10087237 
Atrial standstill 
PT 
10087358 
Prosthetic cardiac valve central regurgitation 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-136- 
Unstable Angina - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10000891 
Acute myocardial infarction 
PT 
10002383 
Angina pectoris 
PT 
10002388 
Angina unstable 
PT 
10003225 
Arteriospasm coronary 
PT 
10028596 
Myocardial infarction 
PT 
10028600 
Myocardial ischaemia 
PT 
10033697 
Papillary muscle infarction 
PT 
10036759 
Prinzmetal angina 
PT 
10049768 
Silent myocardial infarction 
PT 
10051592 
Acute coronary syndrome 
PT 
10051624 
Myocardial reperfusion injury 
PT 
10058144 
Postinfarction angina 
PT 
10058145 
Subendocardial ischaemia 
PT 
10066592 
Post procedural myocardial infarction 
PT 
10068534 
Coronary no-reflow phenomenon 
PT 
10069167 
Kounis syndrome 
PT 
10072186 
Myocardial stunning 
PT 
10072685 
Microvascular coronary artery disease 
PT 
10076419 
Anginal equivalent 
PT 
10079319 
Periprocedural myocardial infarction 
PT 
10080787 
Wellens' syndrome 
PT 
10083602 
Cardiac perfusion defect 
PT 
10084081 
Coronary steal syndrome 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-137- 
Transient Ischemic Attack - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10006127 
Brain hypoxia 
PT 
10006147 
Brain stem infarction 
PT 
10006148 
Brain stem ischaemia 
PT 
10008034 
Cerebellar infarction 
PT 
10008118 
Cerebral infarction 
PT 
10008120 
Cerebral ischaemia 
PT 
10008190 
Cerebrovascular accident 
PT 
10014498 
Embolic stroke 
PT 
10019005 
Haemorrhagic cerebral infarction 
PT 
10019016 
Haemorrhagic stroke 
PT 
10028047 
Moyamoya disease 
PT 
10043647 
Thrombotic stroke 
PT 
10044390 
Transient ischaemic attack 
PT 
10050209 
Spinal cord ischaemia 
PT 
10050496 
Reversible ischaemic neurological deficit 
PT 
10051078 
Lacunar infarction 
PT 
10053841 
Sneddon's syndrome 
PT 
10055677 
Haemorrhagic transformation stroke 
PT 
10056237 
Migrainous infarction 
PT 
10057375 
Balint's syndrome 
PT 
10058571 
Spinal cord infarction 
PT 
10058842 
Cerebrovascular insufficiency 
PT 
10059613 
Stroke in evolution 
PT 
10060839 
Embolic cerebral infarction 
PT 
10060840 
Ischaemic cerebral infarction 
PT 
10061256 
Ischaemic stroke 
PT 
10064961 
Thalamic infarction 
PT 
10065528 
NIH stroke scale score increased 
PT 
10065531 
NIH stroke scale abnormal 
PT 
10067347 
Thrombotic cerebral infarction 
PT 
10067744 
Capsular warning syndrome 
PT 
10068621 
Cerebellar ischaemia 
PT 
10068644 
Brain stem stroke 
PT 
10069020 
Basal ganglia infarction 
PT 
10070511 
Hypoxic-ischaemic encephalopathy 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-138- 
Transient Ischemic Attack - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10070671 
Cerebral septic infarct 
PT 
10070878 
Cerebral small vessel ischaemic disease 
PT 
10071043 
Basal ganglia stroke 
PT 
10073945 
Perinatal stroke 
PT 
10075401 
Cerebral reperfusion injury 
PT 
10076994 
Lacunar stroke 
PT 
10078202 
Post cardiac arrest syndrome 
PT 
10078388 
Delayed ischaemic neurological deficit 
PT 
10079062 
Cerebellar stroke 
PT 
10080347 
Extraischaemic cerebral haematoma 
PT 
10080713 
Hemihyperaesthesia 
PT 
10082031 
Spinal stroke 
PT 
10082484 
Vertebrobasilar stroke 
PT 
10082594 
Foville syndrome 
PT 
10083174 
Hemidysaesthesia 
PT 
10083408 
Internal capsule infarction 
PT 
10083668 
Cerebral microinfarction 
PT 
10084072 
Embolic cerebellar infarction 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-139- 
Stroke - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10006145 
Brain stem haemorrhage 
PT 
10006147 
Brain stem infarction 
PT 
10008030 
Cerebellar haemorrhage 
PT 
10008034 
Cerebellar infarction 
PT 
10008111 
Cerebral haemorrhage 
PT 
10008118 
Cerebral infarction 
PT 
10008120 
Cerebral ischaemia 
PT 
10008190 
Cerebrovascular accident 
PT 
10014498 
Embolic stroke 
PT 
10018985 
Haemorrhage intracranial 
PT 
10019005 
Haemorrhagic cerebral infarction 
PT 
10019013 
Haemorrhagic infarction 
PT 
10019016 
Haemorrhagic stroke 
PT 
10022775 
Intracranial tumour haemorrhage 
PT 
10022840 
Intraventricular haemorrhage 
PT 
10030936 
Optic nerve infarction 
PT 
10035092 
Pituitary infarction 
PT 
10042316 
Subarachnoid haemorrhage 
PT 
10043647 
Thrombotic stroke 
PT 
10044390 
Transient ischaemic attack 
PT 
10048992 
Spinal cord haemorrhage 
PT 
10049236 
Spinal epidural haemorrhage 
PT 
10049760 
Pituitary haemorrhage 
PT 
10051078 
Lacunar infarction 
PT 
10055677 
Haemorrhagic transformation stroke 
PT 
10057403 
Choroidal infarction 
PT 
10058571 
Spinal cord infarction 
PT 
10058939 
Thalamus haemorrhage 
PT 
10058940 
Putamen haemorrhage 
PT 
10059613 
Stroke in evolution 
PT 
10060839 
Embolic cerebral infarction 
PT 
10060840 
Ischaemic cerebral infarction 
PT 
10061256 
Ischaemic stroke 
PT 
10063176 
Prosthetic cardiac valve thrombosis 
PT 
10064961 
Thalamic infarction 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-140- 
Stroke - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10067057 
Basal ganglia haemorrhage 
PT 
10067347 
Thrombotic cerebral infarction 
PT 
10067744 
Capsular warning syndrome 
PT 
10068644 
Brain stem stroke 
PT 
10069020 
Basal ganglia infarction 
PT 
10070671 
Cerebral septic infarct 
PT 
10071043 
Basal ganglia stroke 
PT 
10072043 
Central nervous system haemorrhage 
PT 
10073563 
Spinal subdural haemorrhage 
PT 
10073564 
Spinal subarachnoid haemorrhage 
PT 
10077193 
Hemihypoaesthesia 
PT 
10080347 
Extraischaemic cerebral haematoma 
PT 
10082031 
Spinal stroke 
PT 
10082484 
Vertebrobasilar stroke 
PT 
10083006 
Eye infarction 
PT 
10083087 
Fluorescence angiogram abnormal 
PT 
10083408 
Internal capsule infarction 
PT 
10083668 
Cerebral microinfarction 
PT 
10083691 
Lambl's excrescences 
PT 
10084072 
Embolic cerebellar infarction 
PT 
10085447 
Claude's syndrome 
PT 
10085448 
Weber's syndrome 
PT 
10085451 
Benedikt's syndrome 
PT 
10085944 
Haemorrhagic cerebellar infarction 
PT 
10086546 
Malignant middle cerebral artery syndrome 
PT 
10086596 
Metabolic stroke 
PT 
10087275 
Heidelberg classification 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-141- 
Cardiac Failure - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10007554 
Cardiac failure 
PT 
10007556 
Cardiac failure acute 
PT 
10007558 
Cardiac failure chronic 
PT 
10007559 
Cardiac failure congestive 
PT 
10007560 
Cardiac failure high output 
PT 
10007577 
Cardiac index decreased 
PT 
10007595 
Cardiac output decreased 
PT 
10007625 
Cardiogenic shock 
PT 
10010968 
Cor pulmonale 
PT 
10010969 
Cor pulmonale acute 
PT 
10010970 
Cor pulmonale chronic 
PT 
10013012 
Dilatation ventricular 
PT 
10024119 
Left ventricular failure 
PT 
10024899 
Low cardiac output syndrome 
PT 
10031123 
Orthopnoea 
PT 
10039163 
Right ventricular failure 
PT 
10049632 
Oedema due to cardiac disease 
PT 
10049694 
Left ventricular dysfunction 
PT 
10050528 
Ejection fraction decreased 
PT 
10051093 
Cardiopulmonary failure 
PT 
10052337 
Diastolic dysfunction 
PT 
10053405 
Brain natriuretic peptide increased 
PT 
10053408 
Brain natriuretic peptide abnormal 
PT 
10058597 
Right ventricular dysfunction 
PT 
10059056 
Ventricular dysfunction 
PT 
10060953 
Ventricular failure 
PT 
10063081 
Acute left ventricular failure 
PT 
10063082 
Acute right ventricular failure 
PT 
10063083 
Chronic left ventricular failure 
PT 
10063084 
Chronic right ventricular failure 
PT 
10068230 
Cardiorenal syndrome 
PT 
10069140 
Myocardial depression 
PT 
10071436 
Systolic dysfunction 
PT 
10071660 
N-terminal prohormone brain natriuretic peptide abnormal 
PT 
10071662 
N-terminal prohormone brain natriuretic peptide increased 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-142- 
Cardiac Failure - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10075337 
Right ventricular ejection fraction decreased 
PT 
10077781 
Prohormone brain natriuretic peptide increased 
PT 
10077783 
Prohormone brain natriuretic peptide abnormal 
PT 
10079613 
Right ventricular diastolic collapse 
PT 
10079751 
Cardiac dysfunction 
PT 
10080987 
Left ventricular diastolic collapse 
PT 
10080992 
Ventricular compliance decreased 
PT 
10082615 
Coronary sinus dilatation 
PT 
10084058 
Congestive hepatopathy 
PT 
10086295 
Myocardial strain imaging abnormal 
PT 
10086620 
Dynamic cardiomyoplasty 
PT 
10086706 
Cardiac contractility decreased 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-143- 
Percutaneous Coronary Intervention - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10002475 
Angioplasty 
PT 
10003140 
Arterectomy with graft replacement 
PT 
10003144 
Arterial aneurysm repair 
PT 
10003148 
Arterial catheterisation 
PT 
10003190 
Arteriovenous fistula operation 
PT 
10007692 
Carotid endarterectomy 
PT 
10011077 
Coronary artery bypass 
PT 
10011090 
Coronary artery surgery 
PT 
10011101 
Coronary endarterectomy 
PT 
10014648 
Endarterectomy 
PT 
10014649 
Endarterectomy of aorta 
PT 
10022736 
Intra-cerebral aneurysm operation 
PT 
10043530 
Thrombectomy 
PT 
10043568 
Thrombolysis 
PT 
10048932 
Vena cava filter insertion 
PT 
10049071 
Vascular operation 
PT 
10049887 
Coronary revascularisation 
PT 
10050329 
Coronary angioplasty 
PT 
10052086 
Coronary arterial stent insertion 
PT 
10052371 
Ventricular assist device insertion 
PT 
10052681 
Valvuloplasty cardiac 
PT 
10052698 
Catheterisation venous 
PT 
10052928 
Clamping of blood vessel 
PT 
10052949 
Arterial therapeutic procedure 
PT 
10052964 
Venous repair 
PT 
10052989 
Intra-aortic balloon placement 
PT 
10053003 
Carotid artery bypass 
PT 
10053351 
Peripheral revascularisation 
PT 
10053494 
Aneurysmectomy 
PT 
10056418 
Arterial bypass operation 
PT 
10057335 
Therapeutic embolisation 
PT 
10057493 
Renal artery angioplasty 
PT 
10057518 
Peripheral artery angioplasty 
PT 
10057617 
Aortic bypass 
PT 
10058408 
Surgical vascular shunt 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-144- 
Percutaneous Coronary Intervention - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10058794 
Vasodilation procedure 
PT 
10059676 
Arteriovenous graft 
PT 
10061656 
Arterial repair 
PT 
10061657 
Arterial stent insertion 
PT 
10062175 
Venous operation 
PT 
10063025 
Atherectomy 
PT 
10063170 
Pulmonary artery banding 
PT 
10063382 
Vascular stent insertion 
PT 
10063389 
Venous stent insertion 
PT 
10063731 
Pulmonary artery therapeutic procedure 
PT 
10064727 
Renal artery stent placement 
PT 
10064778 
Venous ligation 
PT 
10064958 
Thromboembolectomy 
PT 
10065608 
Percutaneous coronary intervention 
PT 
10066050 
Aneurysm repair 
PT 
10066102 
Carotid artery stent insertion 
PT 
10066129 
Arterial switch operation 
PT 
10067740 
Vascular graft 
PT 
10068628 
Prosthetic vessel implantation 
PT 
10069948 
Renal artery stent removal 
PT 
10069949 
Vascular stent removal 
PT 
10069950 
Arterial stent removal 
PT 
10069952 
Carotid artery stent removal 
PT 
10069953 
Coronary artery stent removal 
PT 
10071026 
Arterectomy 
PT 
10071256 
Aortic stent insertion 
PT 
10071260 
Carotid angioplasty 
PT 
10071261 
Mesenteric artery stent insertion 
PT 
10071508 
Cerebral revascularisation 
PT 
10072559 
Carotid revascularisation 
PT 
10072560 
Peripheral endarterectomy 
PT 
10072561 
Peripheral artery bypass 
PT 
10072562 
Peripheral artery stent insertion 
PT 
10072893 
Pulmonary endarterectomy 
PT 
10073598 
Vascular anastomosis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-145- 
Percutaneous Coronary Intervention - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10074169 
Vascular catheterisation 
PT 
10074397 
Vena cava filter removal 
PT 
10075134 
Prosthetic vessel removal 
PT 
10077079 
Cerebral endovascular aneurysm repair 
PT 
10077826 
Venous angioplasty 
PT 
10078636 
Arteriotomy 
PT 
10081419 
Vessel harvesting 
PT 
10081731 
Arterial angioplasty 
PT 
10083018 
Vascular ligation 
PT 
10084091 
Revascularisation procedure 
PT 
10084482 
Arterial revascularisation 
PT 
10084745 
Temporary mechanical circulatory support 
PT 
10084977 
Cardiac catheter removal 
PT 
10085325 
Catheter directed thrombolysis 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49 
 
 
 


Galapagos 
 
GS-US-419-3896 (GLPG0634-CL-310) 
CONFIDENTIAL 
22323 
-146- 
Specific AE directly associated with the pathogen causing COVID-19 - Galapagos Search Term List 
MedDRA Version 25.0 
TERM_CODE 
TERM_NAME 
TERM_TYPE 
 
10051905 
Coronavirus infection 
PT 
10070255 
Coronavirus test positive 
PT 
10084268 
COVID-19 
PT 
10084271 
SARS-CoV-2 test positive 
PT 
10084380 
COVID-19 pneumonia 
PT 
10084381 
Coronavirus pneumonia 
PT 
10084459 
Asymptomatic COVID-19 
PT 
10084460 
COVID-19 treatment 
PT 
10084461 
SARS-CoV-2 carrier 
PT 
10084480 
SARS-CoV-2 test false negative 
PT 
10084639 
SARS-CoV-2 sepsis 
PT 
10084640 
SARS-CoV-2 viraemia 
PT 
10085080 
Congenital COVID-19 
PT 
10085492 
Vaccine derived SARS-CoV-2 infection 
PT 
10085493 
SARS-CoV-2 RNA 
PT 
10085495 
SARS-CoV-2 RNA increased 
PT 
10085496 
SARS-CoV-2 RNA decreased 
PT 
10085497 
SARS-CoV-2 RNA fluctuation 
PT 
10085503 
Post-acute COVID-19 syndrome 
PT 
10085850 
Multisystem inflammatory syndrome in adults 
PT 
10086091 
Multisystem inflammatory syndrome 
PT 
10086158 
Thrombosis with thrombocytopenia syndrome 
PT 
10086861 
Breakthrough COVID-19 
PT 
 
  
GLPG0634-CL-MACE, 20DEC22:15:49