Clinical trial NCT02914561
Conditions: Crohn's Disease
Sponsor: Galapagos NV
Start date: 2016-10-31; Completion date: 2022-11-11
Enrollment: 1372 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

Detailed description:

Arms: arm 1: Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. arm 2: Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks. arm 3: Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. arm 4: Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. arm 5: Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks. arm 6: Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. arm 7: Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58. arm 8: Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58. arm 9: Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58. arm 10: Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58. arm 11: Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Interventions: intervention 1: Filgotinib intervention 2: Placebo
Intervention descriptions: intervention 1: Filgotinib tablets administered orally once daily. intervention 2: Placebo administered orally once daily.

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled 
Studies Evaluating the Efficacy and Safety of Filgotinib in the 
Induction and Maintenance of Remission in Subjects with 
Moderately to Severely Active Crohn’s Disease
Sponsor:
Galapagos NV
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
129646
2016-001367-36
NCT02914561
Indication:
Crohn’s Disease 
Protocol ID:
GS-US-419-3895
Galapagos Medical 
Leader:
Name:
Protocol 
Version/Date:
Original:
15 July 2016
Amendment 1:
07 September 2016
Amendment 2:
11 November 2016
Amendment 3:
19 January 2017
Amendment 4:
15 June 2017
Amendment 5:
05 March 2018
Amendment 6:
07 February 2019
Amendment 7:
22 August 2019
Amendment 8:
01 May 2020
Amendment 8.1:
04 September 2020 (Germany and Portugal)
Amendment 9:
02 December 2021
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.
PPD






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7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events .................................95
7.1.1.
Adverse Events......................................................................................................................95
7.1.2.
Serious Adverse Events.........................................................................................................95
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................96
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...................................................96
7.2.2.
Assessment of Severity..........................................................................................................97
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to the Sponsor................................................................................................................97
7.3.1.
Adverse Events......................................................................................................................97
7.3.2.
Serious Adverse Events.........................................................................................................98
7.4.
Sponsor Reporting Requirements............................................................................................................99
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................99
7.6.
Toxicity Management............................................................................................................................100
7.6.1.
Grades 1 and 2 Laboratory Abnormality or Clinical Event ................................................100
7.6.2.
Grade 3 Laboratory Abnormality or Clinical Event............................................................100
7.6.3.
Grade 4 Laboratory Abnormality or Clinical Event............................................................100
7.7.
Special Situations Reports.....................................................................................................................101
7.7.1.
Definitions of Special Situations.........................................................................................101
7.7.2.
Instructions for Reporting Special Situations......................................................................102
8.
STATISTICAL CONSIDERATIONS...............................................................................................................104
8.1.
Analysis Objectives and Endpoints.......................................................................................................104
8.1.1.
Analysis Objectives.............................................................................................................104
8.1.2.
Primary Endpoints...............................................................................................................111
8.1.3.
Secondary Endpoints...........................................................................................................112
8.2.
Analysis Conventions............................................................................................................................118
8.2.1.
Analysis Sets .......................................................................................................................118
8.3.
Data Handling Conventions ..................................................................................................................119
8.4.
Demographic Data and Baseline Characteristics ..................................................................................120
8.5.
Efficacy Analysis...................................................................................................................................120
8.5.1.
Primary Analyses.................................................................................................................120
8.5.2.
Secondary Analyses.............................................................................................................121
8.5.3.
Multiplicity Adjustments.....................................................................................................121
8.6.
Safety Analysis......................................................................................................................................131
8.6.1.
Extent of Exposure ..............................................................................................................131
8.6.2.
Adverse Events....................................................................................................................132
8.6.3.
Laboratory Evaluations .......................................................................................................133
8.6.4.
Other Safety Evaluations.....................................................................................................133
8.7.
Pharmacokinetic Analysis .....................................................................................................................133
8.9.
Sample Size ...........................................................................................................................................134
8.9.1.
Induction Studies (Cohorts A and B) ..................................................................................134
8.9.2.
Maintenance Study ..............................................................................................................134
8.10.
Data Monitoring Committee..................................................................................................................135
8.11.
Cardiovascular Safety Endpoint Adjudication Committee ...................................................................136
9.
RESPONSIBILITIES.........................................................................................................................................138
9.1.
Investigator Responsibilities .................................................................................................................138
9.1.1.
Good Clinical Practice.........................................................................................................138
9.1.2.
Institutional Review Board/Independent Ethics Committee Review and 
Approval..............................................................................................................................138
CCI
CCI
CCI


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9.1.3.
Informed Consent ................................................................................................................139
9.1.4.
Confidentiality.....................................................................................................................139
9.1.5.
Study Files and Retention of Records .................................................................................139
9.1.6.
Case Report Forms ..............................................................................................................141
9.1.7.
Investigational Medicinal Product Accountability and Return ...........................................141
9.1.8.
Inspections...........................................................................................................................142
9.1.9.
Protocol Compliance ...........................................................................................................142
9.2.
Sponsor Responsibilities .......................................................................................................................142
9.2.1.
Protocol Modifications ........................................................................................................142
9.2.2.
Study Report and Publications ............................................................................................142
9.3.
Joint Investigator/Sponsor Responsibilities ..........................................................................................143
9.3.1.
Payment Reporting ..............................................................................................................143
9.3.2.
Access to Information for Monitoring.................................................................................143
9.3.3.
Access to Information for Auditing or Inspections .............................................................143
9.3.4.
Study Discontinuation .........................................................................................................143
10.
REFERENCES...................................................................................................................................................144
11.
APPENDICES....................................................................................................................................................146
Appendix 1.
Investigator Signature Page...................................................................................................147
Appendix 2.
Study Procedures Table.........................................................................................................148
Appendix 3.
Management of Clinical and Laboratory Adverse Events.....................................................153
Appendix 4.
Crohn’s Disease Activity Index (CDAI) and Patient Reported Outcomes – 2 items 
(PRO2)...................................................................................................................................154
Appendix 5.
Simple Endoscopic Score for Crohn’s Disease (SES-CD)....................................................155
Appendix 6.
CTCAE Grading Scale for Severity of Adverse Events........................................................156
Appendix 7.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................157
Appendix 8.
Clinical Laboratory Assessment Table..................................................................................161
LIST OF IN-TEXT TABLES
Table 3-1.
Re-Randomization of Induction Cohorts A and B to Maintenance Study ..............................60
Table 5-1.
Prohibited Concomitant Medications ......................................................................................81
Table 7-1.
Grading of Adverse Event Severity.........................................................................................97
LIST OF IN-TEXT FIGURES
Figure 3-1.
Study Design Schematic..........................................................................................................58
Figure 8-1.
Induction Studies (Cohorts A and B): Testing Strategy for the Primary and Key 
Secondary Hypotheses...........................................................................................................124
Figure 8-2.
Maintenance Study: Testing Strategy for the Primary and Key Secondary 
Hypotheses.............................................................................................................................127
Figure 8-3.
Maintenance Study: EU-Specific Testing Strategy for the Primary and Key 
Secondary Hypotheses...........................................................................................................130


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PROTOCOL SYNOPSIS
Galapagos NV
Generaal De Wittelaan L11 A3
2800 Mechelen, Belgium
Study Title: 
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled 
Studies Evaluating the Efficacy and Safety of Filgotinib in the 
Induction and Maintenance of Remission in Subjects with 
Moderately to Severely Active Crohn’s Disease
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
129646
2016-001367-36
NCT02914561
Study Centers 
Planned:
Approximately 500 sites globally
Objectives:
The overall objective of the study is to evaluate the effect of 
treatment with filgotinib on the induction and maintenance of clinical 
remission, as well as, endoscopic response in subjects with 
moderately to severely active Crohn's disease (CD). Subjects who 
are biologic-naïve or biologic-experienced will be enrolled in 
Cohort A and subjects who are biologic-experienced will be enrolled 
in Cohort B, respectively. Treatment assignments will be randomized 
within each Cohort. 
Cohort A: Biologic-Naïve and Biologic-Experienced Subjects, 
Induction Study
The primary objectives of Cohort A Induction Study are:

To evaluate the efficacy of filgotinib as compared to placebo in 
establishing clinical remission by Crohn’s Disease Activity Index 
(CDAI) at Week 10 

To evaluate the efficacy of filgotinib as compared to placebo in 
establishing endoscopic response at Week 10
The key secondary objectives of Cohort A Induction Study are: 

To evaluate the efficacy of filgotinib as compared to placebo in 
establishing clinical remission by Patient Reported Outcomes 
(PRO2) at Week 10 

To evaluate the efficacy of filgotinib as compared to placebo in 
establishing clinical response by CDAI at Week 10


















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
Re-randomization (Week 11) 
Subjects in Cohorts A and B who complete the Induction 
Study and achieve either clinical remission by PRO2 or 
endoscopic response by SES-CD at Week 10 will be 
re-randomized into the Maintenance Study at Week 11
Subjects who do not achieve clinical remission by PRO2 or 
endoscopic response at Week 10 will have the option to enter 
a separate, Long-Term Extension (LTE) study 
(GS-US-419-3896; Galapagos Study ID GLPG0634-CL-310)

Blinded Maintenance Study (Weeks 11 to 58)

Post-Treatment (PTx) safety assessments
Subjects who opt out of the LTE study (GS-US-419-3896) 
will return 30 days after the last dose of study drug for PTx 
safety assessments 
Subjects who complete all procedures per protocol, including 
the endoscopy, of the 58-week study will be offered the 
option to continue into the LTE study (GS-US-419-3896)
Subjects who are eligible and opt to participate in the LTE 
study (GS-US-419-3896) can continue into the study without 
PTx safety assessments.
Treatment Regimen (Cohorts A and B Induction Studies)
Subjects who meet protocol eligibility criteria will be assigned to the 
respective Cohort and subsequently randomized in a blinded fashion 
in a 1:1:1 ratio to 1 of 3 treatments as follows: 
Treatment 1 (n = 220): filgotinib 200 mg and placebo-to-match 
(PTM) filgotinib 100 mg, once daily
Treatment 2 (n = 220): filgotinib 100 mg and PTM filgotinib 
200 mg, once daily
Treatment 3 (n = 220): PTM filgotinib 200 mg and PTM filgotinib 
100 mg, once daily
Note: United States (US) and Korea males who have not failed at 
least two prior biologic therapies (any tumor necrosis factor-alpha 
[TNFα] antagonist and vedolizumab) will be randomized in a 
1:1 ratio to either filgotinib 100 mg or matching placebo.


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Within each Cohort, treatment assignments will be stratified 
according to the following factors in the Induction studies:
Stratification Factors (Cohort A, Biologic-Naïve and 
Biologic-Experienced Induction Study)

History of  exposure to no biologic agent, one biologic agent, or 
more than one biologic agent

Concomitant use of oral, systemically absorbed corticosteroids 
(eg, prednisone) at Day 1, (Yes or No)

Concomitant use of immunomodulators (eg, 6-mercaptopurine 
[6-MP], azathioprine, methotrexate [MTX]) at Day 1, 
(Yes or No)
Stratification Factors (Cohort B, Biologic-Experienced Induction 
Study)

Exposure to one biologic agent versus more than one biologic 
agent

Concomitant use of oral, systemically absorbed corticosteroids 
(eg, prednisone) at Day 1, (Yes or No)

Concomitant use of immunomodulators (eg, 6-MP, azathioprine, 
MTX) at Day 1, (Yes or No)
Subjects from Cohort A or B who are eligible for the Maintenance 
study will be re-randomized to treatment as follows:
Treatment Assignment Induction Studies
Cohorts A and B
Maintenance Study
Re-randomization
Treatment 1, 200 mg 
Treatment 1, filgotinib 200 mg
Treatment 3, Placebo
Treatment 2, 100 mg
Treatment 2, filgotinib100 mg
Treatment 3, Placebo
Treatment 3, Placebo
Continue Treatment 3, Placebo 
Note: Subjects receiving Treatment 1 or 2 in the Induction study will be randomized in a 
2:1 manner to either continue on the assigned filgotinib regimen or to placebo for the 
duration of the Maintenance study
Stratification Factors (Maintenance Study)

History of exposure to a biologic agent (Yes or No)

Concomitant use of oral, systemically absorbed corticosteroids 
(eg, prednisone) at Day 1, (Yes or No)

Concomitant use of immunomodulators (eg, 6-mercaptopurine 
[6-MP], azathioprine, methotrexate [MTX]) at Day 1, 
(Yes or No)




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
Documented diagnosis of CD with a minimum disease duration 
of 3 months with involvement of the ileum and/or colon at a 
minimum, documented by the following:
a) Medical record documentation of, or an ileocolonoscopy 
(full colonoscopy with the intubation of terminal ileum) 
report dated ≥ 3 months before enrollment, which shows 
features consistent with CD, determined by the procedure 
performing physician, AND
b) Medical record documentation of, or a histopathology report 
showing features consistent with CD, determined by the 
pathologist.

Moderately to severely active CD determined by CDAI 220 to 
450 (inclusive), AND PRO2 (abdominal pain score ≥ 2 [on a 
scale of 0 to 3] OR stool frequency ≥ 4), AND centrally read 
SES-CD score ≥ 6 (or ≥ 4 if disease is limited to the ileum and/or 
right colon) 

May be receiving the following drugs (subjects on these therapies 
must be willing to remain on stable doses for the noted time):
a) Oral 5-aminosalicylate (5-ASA) compounds provided the 
dose prescribed has been stable for at least 4 weeks prior to 
randomization; dose must remain stable for the first 10 weeks 
after randomization
b) Azathioprine or 6-MP or MTX provided the dose prescribed 
has been stable for 4 weeks prior to randomization; dose must 
remain stable for the first 10 weeks after randomization
c) Oral corticosteroid therapy (prednisone prescribed at a stable 
dose ≤ 30 mg/day or budesonide prescribed at a stable dose 
of ≤ 9 mg/day) provided the dose prescribed has been stable 
for 2 weeks prior to randomization; dose must remain stable 
for the first 14 weeks after randomization
d) Antibiotics for the treatment of CD (eg, metronidazole, 
ciprofloxacin) provided the dose prescribed has been stable 
for 2 weeks prior to randomization. Dose must remain stable 
for the first 10 weeks after randomization. Subjects who are 
on cyclic therapy must continue their standard low-dose 
regimen without change for the first 10 weeks after 
randomization.


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
Must not have the current following complications of CD:
a) Symptomatic strictures, OR
b) Severe (impassable) rectal/anal stenosis, OR
c) Fistulae other than perianal fistulae, OR
d) Short bowel syndrome, OR
e) Any other manifestation that might require surgery, OR
f)
Any other complications which could preclude the use of the 
CDAI to assess response to therapy, or would possibly 
confound the evaluation of benefit from treatment with 
filgotinib

Must not have ulcerative colitis, indeterminate colitis, ischemic 
colitis, fulminant colitis, or toxic mega-colon 

Must not have active tuberculosis (TB) or history of latent TB 
that has not been treated (see inclusion criterion 7 for further 
information)

Must not use any prohibited concomitant medications as 
described in Section 5.4.2 
Cohort A (Biologic-Naïve and Biologic-Experienced) Induction 
Study 
Main Eligibility Criteria, Cohort A ONLY 
Subjects must meet all of the additional criteria to be eligible for 
participation in Cohort A Induction Study.
Biologic-Naïve Subjects

Previously demonstrated an inadequate clinical response, loss of 
response to, or intolerance of at least one of the following agents 
(depending on current country treatment 
recommendations/guidelines):
a) Corticosteroids
i)
Active disease despite a history of at least an induction 
regimen of a dose equivalent to oral prednisone 30 mg 
daily for 2 weeks or intravenously (IV) for 1 week, OR
ii) Two failed attempts to taper steroids below a dose 
equivalent of 10 mg daily prednisone, OR
iii) History of steroid intolerance including, but not limited 
to, Cushing’s syndrome, osteopenia/osteoporosis, 
hyperglycemia, insomnia, serious infections,  depression, 
allergic reactions, mood disturbances, or any other 
condition that contributed to discontinuation of the agent


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b) Immunomodulators
i)
Active disease despite a history of at least a 12 week 
regimen of oral azathioprine (≥ 2  mg/kg/day) or 6-MP 
(≥ 1 mg/kg/day), or MTX (25 mg subcutaneously [SC] or 
intramuscularly [IM] per week for induction and ≥ 15 mg 
IM per week for maintenance), OR
ii)
History of intolerance to at least one immunomodulator 
including, but not limited to, serious infections, 
hepatotoxicity, cytopenia, pancreatitis, thiopurine 
methyltransferase (TPMT) genetic mutation, allergic 
reactions, or any other condition that contributed to 
discontinuation of the agent

No prior or current use of any TNFα antagonist including 
(but not limited to) infliximab, adalimumab, golimumab, 
certolizumab, or biosimilar agents at any time

No prior or current use of vedolizumab at any time

No prior or current use of ustekinumab at any time
Biologic-Experienced Subjects

Previously demonstrated an inadequate clinical response, loss of 
response to, or intolerance of, at least one of the following agents 
(depending on current country treatment 
recommendations/guidelines) or discontinuation of use of at least 
one of the following agents for reasons other than inadequate 
clinical response, loss of response, or intolerance:
a) TNFα Antagonists
i)
Active disease despite a history of at least one induction 
regimen of infliximab, adalimumab, certolizumab or 
biosimilar as follows: 

Infliximab: A 14-week induction regimen of 5 mg/kg 
IV at Weeks 0, 2, and 6 (6 week induction regimen 
with 2 doses at Weeks 0 and 2 in EU)

Adalimumab: A 4-week induction regimen consisting 
of 160 mg SC (four 40-mg injections in one day or 
two 40-mg injections per day for two consecutive 
days) on Day 1, followed by a second dose 2 weeks 
later (Day 15) of 80 mg

Certolizumab: A 8 week induction regimen of 400 mg 
SC at Weeks 0, 2 and 4


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OR
ii) Recurrence of symptoms during maintenance therapy 
with the above agents, OR
iii) History of intolerance to any TNFα antagonists including, 
but not limited to, serious infections, hepatotoxicity, heart 
failure, allergic reactions, or any other condition that 
contributed to discontinuation of the agent
b) Vedolizumab
i)
Active disease despite a history of at least a 14-week 
induction regimen of vedolizumab consisting of 300 mg 
IV at Weeks 0, 2 and 6, OR
ii) History of intolerance to vedolizumab including, but not 
limited to, serious infections, hepatotoxicity, cytopenia, 
allergic reactions, or any other condition that contributed 
to discontinuation of the agent
c) Ustekinumab
i)
Active disease despite a history of a 8 week induction 
regimen with a single dose of ustekinumab IV per 
weight-based dosing (260mg for up to 55kg; 390mg for 
greater than 55 to 85kg; 520mg for greater than 85kg) at 
Week 0, OR
ii) Recurrence of symptoms during maintenance therapy 
with ustekinumab SC, OR
iii) History of intolerance to ustekinumab including, but not 
limited to, serious infections, allergic reactions, or any 
other condition that contributed to discontinuation of the 
agent

Must not have used any TNFα antagonist or vedolizumab 
≤ 8 weeks prior to screening, ustekinumab IV or SC ≤12 weeks 
prior to screening, or any other biologic agent ≤ 8 weeks prior to 
screening or within 5 times the half-life of the biologic agent 
prior to screening, whichever is longer. Subjects who have an 
undetectable serum level of a biologic agent since its last dose 
using a commercially available assay can undergo study 
screening without the above-mentioned waiting period.


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Cohort B (Biologic-Experienced) Induction Study 
Main Eligibility Criteria, Cohort B ONLY 

Previously demonstrated an inadequate clinical response, loss of 
response to, or intolerance of, at least one of the following agents 
(depending on current country treatment 
recommendations/guidelines):
a) TNFα Antagonists
i)
Active disease despite a history of at least one induction 
regimen of infliximab, adalimumab, certolizumab or 
biosimilar as follows: 

Infliximab: A 14-week induction regimen of 5 mg/kg 
IV at Weeks 0, 2, and 6 (6 week induction regimen 
with 2 doses at Weeks 0 and 2 in EU)

Adalimumab: A 4-week induction regimen consisting 
of 160 mg SC (four 40-mg injections in one day or 
two 40-mg injections per day for two consecutive 
days) on Day 1, followed by a second dose 2 weeks 
later (Day 15) of 80 mg

Certolizumab: A 8 week induction regimen of 400 mg 
SC at Weeks 0, 2 and 4
OR
ii)
Recurrence of symptoms during maintenance therapy 
with the above agents, OR
iii)
History of intolerance to any TNFα antagonists including, 
but not limited to, serious infections, hepatotoxicity, heart 
failure, allergic reactions, or any other condition that 
contributed to discontinuation of the agent
b) Vedolizumab
i)
Active disease despite a history of at least a 14-week 
induction regimen of vedolizumab consisting of 300 mg 
IV at Weeks 0, 2 and 6, OR
ii)
History of intolerance to vedolizumab including, but not 
limited to, serious infections, hepatotoxicity, cytopenia, 
allergic reactions, or any other condition that contributed 
to discontinuation of the agent


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c) Ustekinumab
i)
Active disease despite a history of a 8 week induction 
regimen with a single dose of ustekinumab IV per 
weight-based dosing (260mg for up to 55kg; 390mg for 
greater than 55 to 85kg; 520mg for greater than 85kg) at 
Week 0, OR
ii)
Recurrence of symptoms during maintenance therapy 
with ustekinumab SC, OR
iii)
History of intolerance to ustekinumab including, but not 
limited to, serious infections, allergic reactions, or any 
other condition that contributed to discontinuation of the 
agent

Must not have used any TNFα antagonist or vedolizumab 
≤ 8 weeks prior to screening, ustekinumab IV or SC ≤12 weeks 
prior to screening, or any other biologic agent ≤ 8 weeks prior to 
screening or within 5 times the half-life of the biologic agent 
prior to screening, whichever is longer. Subjects who have an 
undetectable serum level of a biologic agent since its last dose 
using a commercially available assay can undergo study 
screening without the above-mentioned waiting period.
Maintenance Study
Main Eligibility Criteria:

Completion of Cohort A or Cohort B Induction Study with either 
clinical remission by PRO2 or endoscopic response at Week 10
Study Procedures/
Frequency:
Adverse events and concomitant medications will be assessed at each 
visit.
Non-responding subjects completing all Week 10 assessment will be 
eligible to enter the LTE study (GS-US-419-3896). 
Subjects who opt out of the LTE study (GS-US-419-3896) will 
return 30 days after the last dose of study drug for PTx safety 
assessments. 
Subjects who are eligible and opt to participate in the LTE study 
(GS-US-419-3896) can continue into the study without PTx safety 
assessments.
Subjects who complete the Week 58 visit will have the option to 
continue study drug in a blinded fashion in the LTE study 
(GS-US-419-3896)


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Concomitant Crohn’s Disease Medication Management:
Subjects on permitted concomitant medications for CD that are 
described in the inclusion criteria (eg, 5-ASA, and 
immunomodulators) must remain on stable doses until Week 10. 
Steroids must remain stable to Week 14.
Starting at Week 14, subjects who are on concomitant steroids must 
begin tapering steroid therapy. The dose should be reduced at a rate 
starting at 2.5 mg per week up to 5 mg per week (or equivalent taper 
if not prednisone).  Subjects who are on budesonide should have 
their daily dose reduced by 3 mg every 3 weeks until they are 
completely off steroids.  For subjects undergoing taper, steroids may 
be increased or restarted at doses up to and including their baseline 
dose if return of symptoms is apparent. These subjects will not be 
considered treatment failures. Subjects who need to restart or 
increase steroid treatment at a dose that exceeds their baseline dose 
of steroids (dose may not exceed 30 mg prednisone [or equivalent] or 
budesonide 9 mg/day) will be considered treatment failures for all 
clinical end points but will be permitted to remain in the study.

For additional prohibited CD medications, reference Table 5-1.
Test Product, Dose, 
and Mode of 
Administration:

Filgotinib 200 mg oral tablet, once daily

Filgotinib 100 mg oral tablet, once daily
Reference Therapy, 
Dose, and Mode of 
Administration:

PTM filgotinib 200 mg oral tablet, once daily

PTM filgotinib 100 mg oral tablet, once daily
Criteria for 
Evaluation:
Safety:
Assessment of AEs and concomitant medications will continue 
throughout the duration of the study. Safety evaluations include 
documentation of AEs, PE (complete or symptom driven), vital 
signs, and clinical laboratory evaluations (hematology, chemistry, 
urinalysis). An ECG will be performed at screening, Week 10 (or at 
Early Termination (ET) if subject terminates prior to Week 10), 
Week 26 and Week 58.
A data monitoring committee (DMC) will meet to evaluate all 
available safety data accumulated during the study. The initial 
meeting will occur after approximately 100 subjects reach Week 10 
in Cohorts A and B combined. Following this, subsequent meetings 
will occur approximately once every 4 months or at a frequency 
determined by the DMC.




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The Cochran-Mantel-Haenszel (CMH) approach adjusting for 
stratification factors will be used for hypothesis testing of the 
co-primary end points. Subjects who do not have sufficient 
measurements to determine efficacy end points will be considered 
failures (ie, non-responder imputation [NRI]).
The graphical approach {Bretz 2009} of sequentially rejective 
Beonferroni-based iterative multiple test procedures will be used to 
control a family-wise type I error rate (FWER) at 5% (ie, α = 0.05) 
for hypothesis testing on co-primary and key secondary end points. 
See Section 8.5.3 for details and the significance level that will be 
used to declare a statistically significant treatment effect for each 
filgotinib dose group when compared to placebo.
Cohorts A and B End-of-Induction Analysis
Efficacy and safety data will be evaluated by the DMC after all 
subjects in Cohorts A and B complete Week 10 dosing 
(or prematurely discontinue study drug but complete PTx 
assessments). Data from Cohorts A and B (examined independently) 
will be used to evaluate the study overall for possible discontinuation 
(See Section 8.10 for details).
Maintenance Study
The primary analysis set for efficacy analyses is FAS, which 
includes all re-randomized subjects who met the protocol definition 
of clinical remission by PRO2 or endoscopic response at Week 10, 
and received at least 1 dose of study drug in the Maintenance Study 
(Weeks 11 to 58).
The primary analysis will compare each filgotinib dose group to 
placebo on each co-primary end point (the proportion of subjects 
achieving clinical remission by CDAI at Week 58 and the proportion 
of subjects achieving endoscopic response at Week 58). In the EU, 
the primary analysis will compare each filgotinib dose group to 
placebo on each co-primary end point (the proportion of subjects 
achieving clinical remission by PRO2 at Week 58 and the proportion 
of subjects achieving endoscopic response end points at Week 58). 
The CMH approach adjusting for stratification factors will be used 
for hypothesis testing of the co-primary end points. Subjects who do 
not have sufficient measurements to determine efficacy end points 
will be considered failures (ie, NRI).


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The graphical approach {Bretz 2009} of sequentially rejective 
Beonferroni-based iterative multiple test procedures will be used to 
control a FWER at 5% (ie, α = 0.05) for hypothesis testing on 
co-primary and key secondary end points. See Section 8.5.3 for 
details and the significance level that will be used to declare a 
statistically significant treatment effect for each filgotinib dose group 
when compared to placebo.
Pharmacokinetics:
Plasma concentrations of filgotinib and its metabolite GS-829845 
will be listed and summarized using descriptive statistics.
Sample Size:
Induction Studies (Cohorts A and B)
The sample size was chosen to ensure that a clinically meaningful 
difference in both clinical remission rate by CDAI at Week 10 and 
endoscopic response rate at Week 10 could be detected when 
comparing filgotinib 200 mg to placebo within each Induction Study.
A sample size of 220 subjects in each treatment group (n = 660 total) 
will provide an overall power of 97% for filgotinib 200 mg group 
comparison to placebo at a 2-sided 0.05 significance level to detect a 
treatment difference of 20% in clinical remission rate by CDAI at 
Week 10 (45% on filgotinib 200 mg and 25% on placebo) and a 
treatment difference of 15% in endoscopic response rate at Week 10 
(25% on filgotinib 200 mg and 10% on placebo). Since each end 
point needs to achieve statistical significance, the overall power of 
97% is calculated as the product of the two individual powers based 
on each end point. 
For the EU, the sample size was chosen to ensure that a clinically 
meaningful difference in both clinical remission rate by PRO2 at 
Week 10 and endoscopic response rate at Week 10 could be detected 
when comparing filgotinib 200 mg to placebo within each Induction 
Study.
A sample size of 220 subjects in each treatment group (n = 660 total) 
will provide an overall power of 93% for filgotinib 200 mg dose 
group comparison to placebo at a 2-sided 0.05 significance level to 
detect a treatment difference of 15% in clinical remission rate by 
PRO2 at Week 10 (30% on filgotinib 200 mg and 15% on placebo) 
and a treatment difference of 15% in endoscopic response rate at 
Week 10 (25% on filgotinib 200 mg and 10% on placebo). Since 
each end point needs to achieve statistical significance, the overall 
power of 93% is calculated as the product of the two individual 
powers based on each end point.


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Maintenance Study
Assuming an induction response rate (ie, proportion of subjects 
achieving either clinical remission by PRO2 or endoscopic response 
at Week 10) of 40% among subjects receiving filgotinib 200 mg or 
filgotinib 100 mg treatment, approximately 176 subjects from each 
filgotinib dose group from Cohorts A and B Induction Studies 
combined would be eligible to be re-randomized into the 
Maintenance Study.
The sample size was chosen to ensure that a clinically meaningful 
difference in both clinical remission rate by CDAI and endoscopic 
response rate at Week 58 could be detected when comparing 
filgotinib 200 mg to placebo in the Maintenance Study.
A sample size of 60 subjects in the placebo group and 120 subjects in 
the filgotinib group at the same dose level as the induction dose will 
provide an overall 94% power for filgotinib 200 mg comparison to 
placebo at a 2-sided 0.05 significance level to detect a treatment 
difference of 30% in maintenance clinical remission rate by CDAI at 
Week 58 and maintenance endoscopic response rate at Week 58 
(50% on filgotinib 200 mg and 20% on placebo). Since each end 
point needs to achieve statistical significance, the overall power of 
94% is calculated as the product of the two individual powers based 
on each end point.
For the EU, the sample size was chosen to ensure that a clinically 
meaningful difference in both clinical remission rate by PRO2 and 
endoscopic response rate at Week 58 could be detected when 
comparing filgotinib 200 mg to placebo in the Maintenance Study.
A sample size of 60 subjects in the placebo group and 120 subjects in 
the filgotinib group at the same dose level as the induction dose will 
provide an overall 94% power for filgotinib 200 mg comparison to 
placebo at a 2-sided 0.05 significance level to detect a treatment 
difference of 30% in maintenance clinical remission rate by PRO2 at 
Week 58 and maintenance endoscopic response rate at Week 58 
(50% on filgotinib 200 mg and 20% on placebo). Since each 
end point needs to achieve statistical significance, the overall power 
of 94% is calculated as the product of the two individual powers 
based on each end point.
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.


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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
ALT
alanine aminotransferase
ANC
absolute neutrophil count
ANCOVA
analysis of covariance
AP
abdominal pain
AST
aspartate aminotransferase
AUC
area under the plasma/serum/peripheral blood mononuclear cell 
concentration, drug versus time curve
BLQ 
below the limit of quantitation
BMI
body mass index
C. diff
Clostridium difficile
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
CMH
Cochran-Mantel-Haenszel
CMV
cytomegalovirus
CNS
central nervous system
CPK 
creatine phosphokinase
CRF
case report form(s)
CRO
contract (or clinical) research organization 
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
CVEAC
Cardiovascular Safety Endpoint Adjudication Committee
CYP
Cytochrome P450
DAI
disease activity index
DMC
data monitoring committee
DNA
deoxyribonucleic acid
CCI
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DSS
dextran sodium sulfate
E.coli
Escherichia coli
EC
ethics committee
ECG
Electrocardiogram
eCRF
electronic case report form(s)
EDC
Electronic Data Capture 
e-Diary
electronic diary
EMA
European Medicines Agency
eSAE system
electronic SAE system
ET
early termination
EU
European Union
EudraCT
European clinical trials database
FAS
Full Analysis Set
FDA
(United States) Food and Drug Administration
FWER
family-wise type I error rate
GCP
Good Clinical Practice (Guidelines)
 
GI
gastrointestinal
HBcAB
Hepatitis B Virus core antibody
HBsAB
Hepatitis B Virus surface antibody
HBsAG
Hepatitis B Virus surface antigen
HBV
Hepatitis B virus
HCV
Hepatitis C virus
HDL
high-density lipoprotein
HDPE
high density polyethylene
hERG
human ether-a-gogo
HIV
Human Immunodeficiency Virus
HLGT
High-Level Group Term
HLT
High-Level Term
IB
investigator brochure
IBD
inflammatory bowel disease
IC50
concentration of an inhibitor that is required for 50-percent inhibition 
ICF
informed consent form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
IEC
independent ethics committee
CCI
CCI
CCI
CCI
CCI


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IL
Interleukin
IM
intramuscularly
IMP
investigational medicinal product
IND
Investigational new drug
INR
International Normalized Ratio
IRB
institutional review board
IUD
intrauterine device
IV
Intravenous
IWRS
interactive web response system
JAK
Janus Kinase
JAK-STAT
Janus Kinase (JAK)-Signal Transducer and Activator of Transcription 
(STAT)
LAM
lactational amenorrhea method 
LDL
low-density lipoprotein
LLOQ
Lower limit of quantitation
LLT
Lower-Level Term
LOCF
Last Observation Carried Forward
LTE
long-term extension
mAb
monoclonal antibody 
MACE
Major Adverse Cardiovascular Events
MedDRA
Medical Dictionary for Regulatory Activities
MPO
myeloperoxidase 
MTX
Methotrexate
NOEL
no-observed-effect-levels
NRI
non-responder imputation
NSAID
Nonsteroidal Anti-inflammatory Drugs
O&P
ova and parasites test
OAT
organic anion transporters
PBMC
peripheral blood mononuclear cell
PCP
pneumocystis
PD
pharmacodynamics
PE
physical examination
PEG
polyethylene glycol
P-gp
p-glycoprotein
PI
principal investigator
PK
Pharmacokinetic
PRO2
patient reported outcomes consisting of 2 items: abdominal pain severity 
and liquid stool frequency
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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
SC
Subcutaneous
SD
standard deviation
SES-CD
Simple Endoscopic Score for Crohn’s Disease
SF
stool frequency
SI
international system of units 
SOC
system organ class
SOP
standard operating procedure
spp
Species
STAT
signal transducer and activator of transcription
SUSAR
suspected unexpected serious adverse reaction
TB
Tuberculosis
TEAE
treatment-emergent adverse event
TgrasH2
transgenic
TNFα
tumor necrosis factor-alpha
TPMT
thiopurine methyltransferase
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
CCI
CCI
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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 subscore 
cut off values of ≤1 for abdominal pain and ≤3 for stool frequency that define clinical remission. 
As yet, stool frequency and abdominal pain subscores of the CDAI have not been used on their 
own in prospective clinical trials. 
The Simple Endoscopic Score for Crohn’s Disease (SES-CD) was first validated in 2004 and has 
been used extensively in clinical trials to demonstrate endoscopic improvement in disease 
activity following interventions. It measures presence and size of ulcers, proportion of surface 
affected with ulcers, proportion of surface affected by other lesions, and the presence and 
severity of stenotic lesions {Daperno 2004}. The bowel is divided into segments (ileum, right 
colon, transverse colon, left colon, and rectum) and each segment is scored individually, then the 
segment scores are summed for a total score (range: 0 to 60). A 50% or higher reduction in the 
overall SES-CD score is generally used as a sign of treatment response {Ferrante 2013}.
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 
α4β7 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 include 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).
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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.
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, and is currently under 
regulatory review for the treatment of UC in 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.  


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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.
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 DSS 
dextran 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-gogo [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).


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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.
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. 


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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.
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. 


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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. 
This is a double-blind, placebo controlled trial (GS-US-419-3895; Galapagos Study ID 
GLPG0634-CL-309) comparing the efficacy of filgotinib versus placebo in the induction and 
maintenance of clinical remission and endoscopic response in subjects with moderately to 
severely active CD. A previous Phase 2 study with filgotinib demonstrated the efficacy of 
filgotinib 200 mg in inducing clinical remission in 10 weeks. Thus the onset of response is 
expected to occur early in the course of treatment. 
The use of placebo in this type of design has an important value, as “placebo response” is widely 
known to occur during clinical studies conducted in CD. The addition of a placebo arm is 
important, as this enables a control for potential influences derived from the natural course of CD 
and other effects that are inherent to overall medical care. Therefore the inclusion of a placebo 
arm in this study is necessary to prove efficacy of filgotinib. However, exposure to placebo has 
been kept as minimal as possible.
1.3.1.
Rationale for Endpoint and Timing
The co-primary end points for this study are assessed by the CDAI and SES-CD. In the EU, 
based on the Committee for Medicinal Products for Human Use Guideline on the Development 
of New Medicinal Products for the Treatment of Crohn’s Disease, the co-primary end points are 
assessed by PRO2 and SES-CD. 
Part 1 of Study GLPG0634-CL-211 supports the efficacy of filgotinib in CD at Week 10. The 
study assessed for clinical remission, defined by CDAI < 150 as the primary end point.  
Week 10 CDAI and un-weighted stool frequency (SF) and abdominal pain (AP) data from 
Study GLPG0634-CL-211 in the subset of subjects with available data was evaluated to 
determine a PRO2 responder (clinical remission by PRO2) definition corresponding to achieving 
clinical remission as assessed by a CDAI score < 150. A receiver operating characteristic (ROC) 
curve analysis was conducted to find the optimal cutoffs for SF and AP corresponding to CDAI 
score < 150. The optimal cutoffs (specificity, sensitivity) for SF and AP are 3.071 (0.803, 0.755) 
and 0.929 (0.902, 0.755), respectively. A responder definition of 3 or less daily stools 
(SF score ≤ 3) AND mild or no abdominal pain (AP score ≤ 1) is well reflective of the state of 
minimal to mild disease activity equivalent to clinical remission. Based on the Phase 2 CDAI 
data, a clinical remission by PRO2 response definition of achieving 3 or less liquid stools and a 
maximum abdominal pain score of 1 (based upon CDAI scale of 0 to 3 in which 1 represents 
mild abdominal pain) will be used to define clinical response as co-primary end points.


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The rationale for the change in the clinical co-primary end point from PRO2 to CDAI is that the 
US Food and Drug Administration (FDA) informed the Sponsor, in 2019, that it had recently 
accepted proposals from other sponsors to define the co-primary end points in CD studies as 
clinical remission using a CDAI score of < 150 and 
 or response using the 
SES-CD score. The rationale provided by the FDA for this recommendation was the paucity of 
available prospective data validating the best cutoffs for PRO-based scoring that define either 
eligibility or clinical remission. Therefore, the Study GS-US-419-3895 protocol was revised in 
Amendment 8 to align with this recommendation. CDAI remission is a well-established clinical 
primary end point that has been evaluated in clinical trials for products approved for the 
treatment of moderate to severely active CD in the US, the EU, and other regions.
Endoscopic response will be another co-primary end point assessed by SES-CD. Use of centrally 
read endoscopy will further reduce bias in assessment of 
. Maintenance and 
durability of response and remission will be explored in the 48-week maintenance phase using a 
traditional model of induction-maintenance design. 
1.3.2.
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 induction portion of the study will evaluate 2 doses of filgotinib. The purpose of the 
maintenance phase is to evaluate the ability of drug to sustain remission in subjects who have 
responded at a given dose. Therefore, the re-randomization will occur into 2 arms for active 
treated subjects: continuation of the induction dose or re-randomization to placebo.  
In conclusion, JAK inhibition represents a promising target in the treatment of moderate to 
severe CD, and filgotinib, a safe and well tolerated oral therapy based on Phase 2 data.  The 
present study is intended to establish the safety and efficacy of JAK-selective inhibition on a life 
threatening disease with presently inadequate treatment options.
CCI
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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. For further details about infections and malignancies, please 
refer to the IB.


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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 
results from FITZROY. A lack of response contingency after Week 10 will enable early access 
to active drug when clinically indicated. In FITZROY, an increase in mean hemoglobin 
concentration was observed, without difference between filgotinib and placebo. No clinically 
significant changes from baseline in mean neutrophil counts or liver function tests were observed 
at 10 weeks. Filgotinib treated subjects showed an increase in HDL and no significant change in 
LDL. Lipid and hemoglobin effects represent potential benefits in this population. 
An independent and experienced data monitoring committee (DMC) appointed to monitor the 
study will provide an additional level of risk mitigation. The DMC may advise to continue the 
study unchanged, to modify the study, or to discontinue the study. The initial meeting will occur 
after approximately 100 subjects reach Week 10 in Cohorts A and B combined. Following this, 
subsequent meetings will occur approximately once every 4 months or at a frequency determined 
by the DMC. 
Taking all of these considerations into account with respect to the filgotinib program, the early 
signals for efficacy demonstrated in the CD clinical trials, as well as the beneficial findings in 
nonclinical models of disease and the overall safety, tolerability, and PK characteristics of 
filgotinib that have been elucidated to date, there is a favorable benefit-risk profile for this agent 
in continued development as a treatment for CD. The overall risk/benefit balance of this study is 
considered favorable. 
For additional information about the risks of filgotinib, reference is made to the filgotinib IB.
1.5.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.
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These studies include:

Screening (Days -30 to -1)

Randomization (Day 1)

Blinded Induction Studies (Day 1 – Week 11)
Cohorts A and B Week 10 efficacy assessments:
■
At Week 10, CDAI and PRO2 to assess clinical remission 
■
At Week 10, SES-CD to assess endoscopic response 
Blinded Bridge Phase (Week 10 to 11): dosing will continue in a blinded fashion through 
the end of Week 10 until re-randomization at Week 11

Re-randomization (Week 11) 
Subjects in Cohort A and B who complete the Induction Study and achieve either clinical 
remission by PRO2 or endoscopic response by SES-CD at Week 10 will be 
re-randomized into the Maintenance Study at Week 11
Subjects who achieve neither clinical remission by PRO2 nor endoscopic response at 
Week 10 will have the option to enter a separate Long-Term Extension (LTE) study 
(GS-US-419-3896 [Galapagos Study ID GLPG0634-CL-310])

Blinded Maintenance Study (Weeks 11 to 58)

Post-Treatment (PTx) safety assessments:
 Subjects who opt out of the LTE study (GS-US-419-3896) will return 30 days after the 
last dose of study drug for PTx safety assessments
Subjects who complete all procedures per protocol, including the endoscopy, of the 
58 week study will be offered the option to continue into the LTE study 
(GS-US-419-3896)
Subjects who are eligible and opt to participate in the LTE study (GS-419-3896) can 
continue into the study without PTx safety assessments
3.3.
Study Treatments
Subjects who meet protocol eligibility criteria will be assigned to the respective Cohort and 
subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments as follows: 
Treatment 1 (n = 220): filgotinib 200 mg and placebo-to-match (PTM) filgotinib 100 mg, 
once daily
Treatment 2 (n = 220): filgotinib 100 mg and PTM filgotinib 200 mg, once daily
Treatment 3 (n = 220): PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily


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Note: US and Korea males who have not failed at least two biologic therapies (any TNFα 
antagonist and vedolizumab) will be randomized in a 1:1 ratio to either filgotinib 100 mg or 
matching placebo.
Within each Cohort, treatment assignments will be stratified according to the following factors in 
the Induction studies:
Stratification Factors (Cohort A, Biologic-Naïve and Biologic-Experienced Induction 
Study)

History of exposure to no biologic agent, one biologic agent, or more than one biologic agent

Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No)

Concomitant use of immunomodulators (eg, 6-mercaptopurine [6-MP], azathioprine, MTX) 
at Day 1, (Yes or No)
Stratification Factors (Cohort B, Biologic-Experienced Induction Study)

Exposure to one biologic agent versus more than one biologic agent

Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No)

Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
(Yes or No)
Subjects from Cohorts A and B who are eligible for the Maintenance Study will be 
re-randomized to treatment as follows:
Table 3-1.
Re-Randomization of Induction Cohorts A and B to Maintenance 
Study
Treatment Assignment Induction Studies
Cohorts A and B
Maintenance Study
Re-randomization
Treatment 1, 200 mg
Treatment 1, filgotinib 200 mg
Treatment 3, Placebo
Treatment 2, 100 mg
Treatment 2, filgotinib 100 mg
Treatment 3, Placebo
Treatment 3, Placebo
Continue Treatment 3, Placebo
Note:
Subjects receiving Treatment 1 or 2 in the Induction study will be randomized in a 2:1 manner to either continue on the 
assigned filgotinib regimen or to placebo for the duration of the Maintenance study


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Stratification Factors (Maintenance Study)

History of exposure to a biologic agent (Yes or No)

Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No)

Concomitant use of immunomodulators (eg, 6-mercaptopurine [6-MP], azathioprine, 
methotrexate [MTX]) at Day 1, (Yes or No)
3.4.
Duration of Treatment
Randomized subjects will receive a maximum of 58 weeks of study drug. Subjects who are 
non-responders based on the results of the Week 10 assessments will be offered the option to 
receive open-label filgotinib by entering into the LTE study (GS-US-419-3896).
Subjects meeting disease worsening criteria at Week 11 or later must be discontinued from 
blinded treatment and will be offered the option to receive open-label filgotinib in the LTE study 
(See Section 3.6, Disease Worsening Criteria).
Subjects who complete all procedures per protocol, including the endoscopy of the Week 58 
visit, will have the option to continue study drug in a blinded fashion in the LTE study.
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. 
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.


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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

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]: 
< 0.75x109 cells/L)
2 sequential platelet counts < 75,000 platelets/mm3(SI: < 75.0x109 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 > 2x 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 > 3x the upper limit of normal 
(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 > 5x ULN
2 sequential values for estimated creatinine clearance (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 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 physician. 

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.

Subjects withdrawing from the study should complete Early Termination (ET), followed by 
Post-Treatment  (PTx) assessments 30 days  after the last dose of study drug.


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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 disease worsening criteria evaluated after Week 11 must be 
discontinued from blinded treatment and will be offered the option to receive open-label 
filgotinib by entering into the separate LTE study (GS-US-419-3896).

Increase in CDAI score ≥ 100 points from the Week 10 value and CDAI score ≥ 220 points 
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 anytime subsequent to the 
Week 11 visit).

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); these subjects do not 
qualify for LTE study.    
3.7.
End of Study 
End of Study is defined as when the last subject has completed 58 weeks of treatment plus 
30 days follow-up. 
3.8.
Post Study Care 
All subjects completing all study related procedures, including endoscopy at Week 58, will be 
offered an opportunity to participate in the LTE study (GS-US-419-3896). For those subjects 
who do not participate in the LTE study, after the subject has completed their study participation, 
the long-term care of the participant will remain the responsibility of their primary treating 
physicians. 






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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
Cohort A Induction Study
Approximately 660 subjects who meet the eligibility criteria at screening will be randomized in a 
blinded fashion in a 1:1:1 ratio to filgotinib 200 mg, filgotinib 100 mg, or matching placebo.
Cohort B Induction Study
Approximately 660 subjects who meet the eligibility criteria at screening will be randomized in a 
blinded fashion in a 1:1:1 ratio to filgotinib 200 mg, filgotinib 100 mg, or matching placebo.
Maintenance Study
Subjects from Cohorts A and B who achieve either clinical remission by PRO2 or endoscopic 
response at Week 10 will be re-randomized at Week 11 in a blinded fashion in a 2:1 ratio to 
either the same dose of filgotinib or placebo. Refer to Section 3.3, Table 3-1.
In order to manage the total study enrollment, the Sponsor, at its sole discretion, may suspend 
screening and/or enrollment at any site or study-wide at any time.
4.2.
Induction Study (Cohorts A and B) 
4.2.1.
Inclusion Criteria 
Subjects must meet all of the following inclusion criteria to be eligible for participation in either 
the Cohort A or B Induction Study.
1) Must have the ability to understand and sign a written ICF, which must be obtained prior to 
initiation of study procedures
2) Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the 
date of the screening visit
3) Females of childbearing potential (as defined in Appendix 7) must have a negative serum 
pregnancy test at screening and a negative urine pregnancy test at baseline
4) Male subjects and female subjects of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol specified method(s) of contraception as described in 
Appendix 7


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5) Documented diagnosis of CD with a minimum disease duration of 3 months with 
involvement of the ileum and/or colon at a minimum, documented by the following:
a) Medical record documentation of, or an ileocolonoscopy (full colonoscopy with the 
intubation of terminal ileum) report dated ≥ 3 months before enrollment, which shows 
features consistent with CD, determined by the procedure performing physician AND
b) Medical record documentation of or a histopathology report showing features consistent 
with CD, determined by the pathologist. 
6) Moderately or severely active CD as defined by: 
a) CDAI total score between 220 and 450 inclusive (refer to Appendix 4), AND
b) PRO2 score consisting of abdominal pain ≥ 2 (on CDAI scale of 0 to 3) OR daily stool 
frequency ≥ 4 (refer to Appendix 4), AND
c) Evidence of active disease as measured by SES-CD (refer to Appendix 5) based on 
central reading:
i)
Total score ≥ 6, OR
ii) If disease is limited to the ileum and/or right colon, a combined score ≥ 4 in these 
two segments
7) Meet one of the following TB screening criteria: 
a) No evidence of active or latent TB ie,
i)
A negative QuantiFERON® TB-Gold In-Tube test (or centrally reported equivalent 
assay) at screening, AND 
ii) A chest radiograph (views as per local guidelines) taken at screening or within the 
3 months prior to screening (with the report or films available for investigator review) 
without evidence of active or latent TB infection, AND
iii) No history of either untreated or inadequately treated latent or active TB infection
b) Previously treated for TB: ie, if a subject has previously received an adequate course of 
therapy as per local standard of care for either latent TB (eg, 9 months of isoniazid in a 
location where rates of primary multi-drug resistant TB infections are < 5% or an 
acceptable alternative regimen) or active TB (acceptable multi-drug regimen). In these 
cases, no QuantiFERON® TB-Gold In-Tube test (or centrally reported equivalent assay) 
need be obtained, but a chest radiograph must be obtained if not done so within 3 months 
prior to screening (with the report or films available for investigator review). It is the 
responsibility of the investigator to verify the adequacy of previous anti-TB treatment and 
provide appropriate documentation.


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c) Newly identified latent TB during screening: ie, a subject who has a newly identified 
positive diagnostic TB test result (defined as a positive QuantiFERON® TB Gold in Tube 
test [or centrally reported equivalent assay]) in which active TB has been ruled out and 
for which appropriate, ongoing, prophylactic treatment for latent TB has been initiated 
for a minimum of 4 weeks prior to the first administration of study medication. Adequate 
treatment for latent TB is defined according to local country guidelines for 
immunocompromised subjects. Quantiferon testing may not be repeated except in the 
case of a single repeat for indeterminate results.
Cases falling under category “b” and “c” need to be approved by the Sponsor prior to enrollment 
in the study. No subject with currently ACTIVE TB may be enrolled in the study, regardless of 
past or present anti-TB medication use.
8) Laboratory parameters (subjects who fail to meet below reference laboratory tests may be 
re-tested once at discretion of investigator prior to being considered a screen failure): 
a) Hepatic panel (AST, ALT, total bilirubin) ≤ 2 times ULN
b) Estimated CrCl ≥ 40 ml/min as calculated by the CC&G equation
c) Hemoglobin ≥ 8 g/dL (both males and females)
d) Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1,500/mm3)
e) Platelets ≥ 100 × 109/L
f)
White blood cells (WBC) ≥ 3.0 x 109/L
g) Absolute lymphocyte count >750/mm3
9) May be receiving the following drugs (subjects on these therapies must be willing to remain 
on stable doses for the noted times):
a) Oral 5-aminosalicylate (5-ASA) compounds provided the dose prescribed has been stable 
for at least 4 weeks prior to randomization; dose must remain stable for the first 10 weeks 
after randomization
b) Azathioprine or 6-MP or MTX provided the dose prescribed has been stable for 4 weeks 
prior to randomization; dose must remain stable for the first 10 weeks after 
randomization
c) Oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or 
budesonide prescribed at a stable dose of ≤ 9 mg/day) provided the dose prescribed has 
been stable for 2 weeks prior to randomization; dose must remain stable for the 
first 14 weeks after randomization
d) Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) provided the dose 
prescribed has been stable for 2 weeks prior to randomization. Dose must remain stable 
for the first 10 weeks after randomization. Subjects who are on cyclic therapy must 
continue their standard low-dose regimen without change for the first 10 weeks after 
randomization. 


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10) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks 
after last dose.
11) Must be up to date on colorectal cancer screening and surveillance as standard of care 
according to local guidelines.
4.2.2.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in either the 
Cohort A or B induction study.
1) Pregnant or lactating females
2) Males and females of reproductive potential who are unwilling to abide by protocol-specified 
contraceptive methods as defined by Appendix 7
3) 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 
up to 35 days after the last dose of the study drug
4) Male subjects unwilling to refrain from sperm donation during the study and for at least 
90 days after the last dose of study drug
5) Known hypersensitivity to filgotinib, its metabolites, or formulation excipients
6) Currently have any of the following complications of CD:
a) Symptomatic strictures, OR
b) Severe (impassable) rectal/anal stenosis, OR
c) Fistulae other than perianal fistulae, OR 
d) Short bowel syndrome, OR
e) Any other complications which could preclude the use of the CDAI to assess response to 
therapy, or would possibly confound the evaluation of benefit from treatment with 
filgotinib
7) Have any current or prior abscesses, unless they have been drained and treated at least 
6 weeks prior to Day 1 and are not anticipated to require surgery
8) History of major surgery or trauma within 30 days prior to screening 
9) Presence of UC, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon 
10) History of total colectomy, subtotal colectomy, presence of ileostomy or colostomy, or likely 
requirement for surgery during the study
11) Dependence on parenteral nutrition
12) History or evidence of incompletely resected colonic mucosal dysplasia 


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13) Stool sample positive for Clostridium difficile (C. diff) toxin, pathogenic Escherichia coli 
(E. coli), Salmonella species (spp), Shigella spp, Campylobacter spp, or Yersinia spp
14) Stool sample positive for ova and parasites test (O&P) unless approved by the medical 
monitor
15) Active clinically significant infection or any infection requiring hospitalization or treatment 
with intravenous anti-infectives within 30 days of screening (or 8 weeks of Day 1); or any 
infection requiring oral anti-infective therapy within 2 weeks of screening (or 6 weeks of 
Day 1)
16) Infection with HIV, hepatitis B, or hepatitis C
17) Presence of Child-Pugh Class C hepatic impairment
18) Active TB or history of latent TB that has not been treated (See inclusion criterion 7 for 
further information)
19) History of malignancy within the last 5 years except for subjects who have been treated or 
resected for non-melanoma skin cancer or cervical carcinoma in situ
20) History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder, 
or multiple myeloma
21) History of treatment with lymphocyte-depleting therapies, including but not limited to 
alemtuzumab, cyclophosphamide, total lymphoid irradiation, and rituximab
22) History of cytapheresis ≤ 2 months prior to screening
23) Use of any prohibited concomitant medications as described in Section 5.4.2 
24) Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease) 
or psychiatric problem (including, but not limited to 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
25) Administration of a live or attenuated vaccine within 30 days of randomization
26) History of opportunistic infection or immunodeficiency syndrome
27) Currently on any chronic systemic (oral or intravenous) anti-infective therapy for chronic 
infection (such as pneumocystis (PCP), cytomegalovirus (CMV), herpes zoster, atypical 
mycobacteria)
28) History of disseminated Staphylococcus aureus
29) History of symptomatic herpes zoster or herpes simplex within 12 weeks of screening, or any 
history of disseminated herpes simplex, disseminated herpes zoster, ophthalmic zoster, or 
central nervous system zoster


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4.3.
Cohort A (Biologic-Naïve and Biologic-Experienced) Induction Study
4.3.1.
Inclusion Criteria for Biologic-Naïve Subjects Enrolled in Cohort A
Biologic-Naïve subjects must meet all of the additional inclusion criteria to be eligible for 
Cohort A.
1) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance 
to at least one of the following agents (depending on current country treatment 
recommendations/guidelines):
a) Corticosteroids
i)
Active disease despite a history of at least an induction regimen of a dose equivalent 
to oral prednisone 30 mg daily for 2 weeks or intravenously (IV) for 1 week, OR
ii) Two failed attempts to taper steroids below a dose equivalent of 10 mg daily 
prednisone, OR
iii) History of steroid intolerance including, but not limited to, Cushing’s syndrome, 
osteopenia/osteoporosis, hyperglycemia, insomnia, serious infections, depression, 
allergic reactions, mood disturbances, or any other condition that contributed to 
discontinuation of the agent
b) Immunomodulators
i)
Active disease despite a history of at least a 12 week regimen of oral azathioprine 
(≥ 2 mg/kg/day) or 6-MP (≥ 1 mg/kg/day), or MTX (25 mg subcutaneously [SC] or 
intramuscularly [IM] per week for induction and ≥ 15mg IM per week for 
maintenance), OR
ii) History of intolerance to at least one immunomodulator including, but not limited to, 
serious infections, hepatotoxicity, cytopenia, pancreatitis, thiopurine 
methyltransferase (TPMT) genetic mutation, allergic reactions, or any other condition 
that contributed to discontinuation of the agent
4.3.2.
Exclusion Criteria for Biologic-Naïve Subjects Enrolled in Cohort A 
Biologic-Naïve subjects who meet any of the following exclusion criteria are not eligible for 
Cohort A.
1) Prior or current use of TNFα antagonist, including (but not limited to) infliximab, 
adalimumab, golimumab, certolizumab, or biosimilar agent
2) Prior or current use of vedolizumab at any time
3) Prior or current use of ustekinumab at any time


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4.3.3.
Inclusion Criteria for Biologic-Experienced Subjects Enrolled in Cohort A
Biologic-Experienced subjects must meet all of the additional inclusion criteria to be eligible for 
Cohort A.
1) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance 
to at least one of the following agents (depending on current country treatment 
recommendations/guidelines) or discontinuation of use of at least one of the following agents 
for reasons other than inadequate clinical response, loss of response, or intolerance:
a) TNFα Antagonists
i)
Active disease despite a history of at least one induction regimen of infliximab, 
adalimumab, certolizumab or biosimilar as follows:

Infliximab: A 14 week induction regimen of 5 mg/kg IV at Weeks 0, 2, 
and 6 (6 week induction regimen with 2 doses at Weeks 0 and 2 in EU)

Adalimumab: A 4 week induction regimen consisting of 160 mg SC (four 40-mg 
injections in one day or two 40-mg injections per day for two consecutive days) 
on Day 1, followed by a second dose 2 weeks later (Day 15) of 80 mg

Certolizumab: A 8 week induction regimen of 400 mg SC at Weeks 0, 2, and 4
OR
i)
Recurrence of symptoms during maintenance therapy with the above agents, OR
ii) History of intolerance to any TNFα antagonists including, but not limited to, serious 
infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that 
contributed to discontinuation of the agent 
b) Vedolizumab
i)
Active disease despite a history of at least a 14 week induction regimen of 
vedolizumab consisting of 300 mg IV at Weeks 0, 2, and 6, OR
ii) History of intolerance to vedolizumab including, but not limited to, serious infections, 
hepatotoxicity, cytopenia, allergic reactions, or any other condition that contributed to 
discontinuation of the agent
c) Ustekinumab
i)
Active disease despite a history of a 8 week induction regimen with a single dose of 
ustekinumab IV per weight-based dosing (260 mg for up to 55 kg; 390 mg for greater 
than 55 to 85 kg; 520 mg for greater than 85 kg) at Week 0, OR
ii) Recurrence of symptoms during maintenance therapy with ustekinumab SC, OR
iii) History of intolerance to ustekinumab including, but not limited to, serious infections, 
allergic reactions, or any other condition that contributed to discontinuation of the 
agent


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4.3.4.
Exclusion Criteria for Biologic-Experienced Subjects Enrolled in Cohort A
Biologic-Experienced subjects who meet the following exclusion criterion are not eligible for 
Cohort A.
1) Have used any TNFα antagonist or vedolizumab ≤ 8 weeks prior to screening, ustekinumab 
IV or SC ≤ 12 weeks prior to screening, or any other biologic agent ≤ 8 weeks prior to 
screening or within 5 times the half-life of the biologic agent prior to screening, whichever is 
longer. Subjects who have an undetectable serum level of a biologic agent since its last dose 
using a commercially available assay can undergo study screening without the 
above-mentioned waiting period.
4.4.
Cohort B (Biologic-Experienced) Induction Study
4.4.1.
Inclusion Criteria, Cohort B ONLY
Subjects must meet all of the additional inclusion criteria to be eligible for participation in 
Cohort B induction study.
1) Previously demonstrated an inadequate clinical response, loss of response to, or intolerance 
to at least one of the following agents (depending on current country treatment 
recommendations/guidelines):
a) TNFα Antagonists
i)
Active disease despite a history of at least one induction regimen of infliximab, 
adalimumab, certolizumab or biosimilar as follows:

Infliximab: A 14 week induction regimen of 5 mg/kg IV at Weeks 0, 2, 
and 6 (6 week induction regimen with 2 doses at Weeks 0 and 2 in EU)

Adalimumab: A 4 week induction regimen consisting of 160 mg SC (four 40-mg 
injections in one day or two 40-mg injections per day for two consecutive days) 
on Day 1, followed by a second dose 2 weeks later (Day 15) of 80 mg 

Certolizumab: A 8 week induction regimen of 400 mg SC at Weeks 0, 2, and 4
OR
i)
Recurrence of symptoms during maintenance therapy with the above agents, OR
ii) History of intolerance to any TNFα antagonists including, but not limited to, serious 
infections, hepatotoxicity, heart failure, allergic reactions, or any other condition that 
contributed to discontinuation of the agent


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b) Vedolizumab
i)
Active disease despite a history of at least a 14 week induction regimen of 
vedolizumab consisting of 300 mg IV at Weeks 0, 2, and 6, OR
ii) History of intolerance to vedolizumab including, but not limited to, serious infections, 
hepatotoxicity, cytopenia, allergic reactions, or any other condition that contributed to 
discontinuation of the agent
c) Ustekinumab
i)
Active disease despite a history of a 8 week induction regimen with a single dose of 
ustekinumab IV per weight-based dosing (260mg for up to 55kg; 390mg for greater 
than 55 to 85kg; 520mg for greater than 85kg) at Week 0, OR
ii) Recurrence of symptoms during maintenance therapy with ustekinumab SC, OR
iii) History of intolerance to ustekinumab including, but not limited to, serious infections, 
allergic reactions, or any other condition that contributed to discontinuation of the 
agent
4.4.2.
Exclusion Criteria, Cohort B ONLY
Subjects who meet the following exclusion criterion are not to be enrolled in Cohort B induction 
study.
1) Have used any TNFα antagonist or vedolizumab ≤ 8 weeks prior to screening, ustekinumab 
IV or SC ≤12 weeks prior to screening, or any other biologic agent ≤ 8 weeks prior to 
screening or within 5 times the half-life of the biologic agent prior to screening, whichever is 
longer. Subjects who have an undetectable serum level of a biologic agent since its last dose 
using a commercially available assay can undergo study screening without the 
above-mentioned waiting period.
4.5.
Maintenance Study 
4.5.1.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in the 
Maintenance Study.
1) Completion of Cohort A or B induction study with either clinical remission by PRO2 or 
endoscopic response at Week 10
2) Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks 
after last dose
3) May be on oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or 
budesonide at a dose of ≤ 9 mg/day); dose must remain stable to Week 14


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4.5.2.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in the 
maintenance study.
1) Males and females of reproductive potential who are unwilling to abide by protocol-specified 
contraceptive methods as defined by Appendix 7
2) 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 
up to 35 days after the last dose of the study drug
3) Male subjects unwilling to refrain from sperm donation during the study and for at least 
90 days after the last dose of study drug
4) Use of any prohibited concomitant medications as described in Section 5.4.2 


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
5.1.1.
Procedures for Breaking 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. 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).
5.1.2.
Blinding
During the randomized 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. The pharmacokinetics file administrator, or designee, in Bioanalytical 
Operations and/or Clinical Data Management, who facilitates the data transfer of PK files 
between the Sponsor and vendors, will remain unblinded. Individuals in Clinical Packaging and 
Labeling or Clinical Supply Management who have an unblinded inventory manager role in the 
interactive voice/web response  system 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 support data monitoring committee data review and PK/PD 
data merge. 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.


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5.2.
Description and Handling of Filgotinib and Placebo to Match (PTM) 
Filgotinib
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 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.
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. 


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5.3.
Dosage and Administration 
The study medication will consist of 200 mg and 100 mg filgotinib tablets for oral 
administration, and PTM 200 mg and 100 mg filgotinib tablets for oral administration.
The following treatments will be evaluated:

Treatment 1: filgotinib 200 mg and PTM filgotinib 100 mg, once daily

Treatment 2: filgotinib 100 mg and PTM filgotinib 200 mg, once daily

Treatment 3: PTM filgotinib 200 mg  and PTM filgotinib 100 mg, once daily
Subjects who are non-responders based on the results of the Week 10 assessments will be offered 
the option to receive open-label filgotinib by entering into the LTE study (GS-US-419-3896). 
Subjects meeting disease worsening criteria after Week 11 must be discontinued from blinded 
treatment and will be offered the option to receive open-label filgotinib 200 mg (See Section 3.6, 
Disease Worsening Criteria), except for US and Korea males who will be offered filgotinib 
100 mg unless they have failed at least 2 other biologic therapies (any TNFα antagonist and 
vedolizumab). Subjects who complete the Week 58 visit will have the option to continue study 
drug in a blinded fashion in the LTE study.
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
All medications taken up to 30 days prior to the screening visit through the end of study 
(30 days after the last dose of study drug) need to be recorded in the source documents and on 
the eCRF. 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.


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5.4.1.
Allowed Concomitant Medications 
The allowed concomitant medication(s) for CD must be maintained at a stable dose for the noted 
time without dosing alteration or discontinuation.
The allowed medications for CD are as follows:

Oral 5-ASA compounds provided the dose prescribed has been stable for at least 4 weeks 
prior to randomization; dose must be stable for the first 10 weeks after randomization

Azathioprine, 6-MP, or MTX provided the dose prescribed has been stable for 4 weeks prior 
to randomization; dose must be stable for the first 10 weeks after randomization

Oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 30 mg/day or 
budesonide prescribed at a stable dose of ≤ 9 mg/day) provided the dose prescribed has been 
stable for 2 weeks prior to randomization; dose must be stable for the first 14 weeks after 
randomization 

Antibiotics for the treatment of CD (eg, metronidazole, ciprofloxacin) provided the dose 
prescribed has been stable for 2 weeks prior to randomization.  Dose must remain stable for 
the first 10 weeks after randomization. Subjects who are on cyclic therapy must continue 
their standard low-dose regimen without change for the first 10 weeks after randomization.

Antidiarrheals for chronic diarrhea are allowed throughout the study as necessary for control 
of chronic diarrhea; stable doses are encouraged


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5.4.2.
Prohibited Concomitant Medications 
The prohibited medications are as follows:
Table 5-1.
Prohibited Concomitant Medications
Drug Class
Agents Disallowed
Prohibited Period
Strong P-gp Inducersa
Anticonvulsants
Phenobarbital, phenytoin, carbamazepine,
Antimycobacterials
Rifabutin, rifapentine, rifampin
Herbal/Natural 
Supplements
St. John’s wort, danshen 
(Salvia Miltiorrhiza)
30 days prior to screening through the 
end of the study
Prohibited IBD Medications
Corticosteroids
Dose equivalent to > 30 mg/day of 
prednisone
30 days prior to screening through the 
end of the study
TNFα antagonist
Infliximab, adalimumab, golimumab, 
certolizumab, or biosimilar agent
8 weeks prior to screeningd through the 
end of the study
Integrin antagonist
Vedolizumab and natalizumab
8 weeks prior to screeningd through the 
end of the study
Interleukin antagonist
Ustekinumab
12 weeks prior to screeningd through 
the end of the study
Cyclosporine, thalidomide, tacrolimus, 
leflunomide, and any investigational agent
30 days prior to screening through the 
end of the study
Other (non-biologic)
Any JAK inhibitor
Any time before and through the end of 
the study
Investigational biologics
Any investigational biologic agent
8 weeks prior to screening through the 
end of the study (or at least 5 half lives)
Lymphocyte-depleting 
therapies
Alemtuzumab, cyclophosphamide, total 
lymphoid irradiation, rituximab, and any 
other lymphocyte depleting therapy
Any time before and through the end of 
the study
Other Prohibited Medications
Chronic Nonsteroidal 
Anti-inflammatory 
Drugs (NSAIDs)b 
Aspirin, ibuprofen, naproxen, diclofenac, 
indomethacin, COX-2 inhibitors
From screening through the end of the 
study
Other biologicsc
Antibody based or other systemic 
biologics, eg, denosumab, trastuzumab
Requires medical monitor consultation
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. 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
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.
c
Other biologics may be allowed with the approval of the medical monitor.
d
Subjects who have an undetectable serum level of a biologic agent since its last dose using a commercially available assay 
can undergo study screening without the above-mentioned waiting period.


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5.4.3.
Corticosteroid Tapering
Starting at Week 14, subjects who are on concomitant steroids must begin tapering  steroid 
therapy. The dose should be reduced at a rate starting at 2.5 mg per week up to 5 mg per week 
(or equivalent taper if not prednisone) until subject is no longer on steroids. Subjects who are on 
budesonide should have their daily dose reduced by 3 mg every 3 weeks until they are 
completely off steroids. For subjects undergoing taper, steroids may be increased or restarted at 
doses up to and including their baseline dose if return of symptoms is apparent. These subjects 
will not be considered treatment failures. Subjects who need to restart or increase steroid 
treatment at a dose that exceeds their baseline dose of steroids (dose may not exceed 30 mg 
prednisone [or equivalent] or budesonide 9 mg/day) will be considered treatment failures for all 
clinical end points but will be permitted to remain in the study.
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.


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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 protocol criteria will be assigned to the respective cohort and 
subsequently randomized in a blinded fashion in a 1:1:1 ratio to filgotinib, or matching placebo.

Treatment 1 (n = 220) : filgotinib 200 mg and  PTM filgotinib 100 mg, once daily 

Treatment 2 (n = 220) : filgotinib100 mg and PTM filgotinib 200 mg, once daily

Treatment 3 (n = 220): PTM filgotinib 200 mg and PTM filgotinib100 mg, once daily
Note: US and Korea males who have not failed at least two biologic therapies (any TNFα 
antagonist and vedolizumab) will be randomized in a 1:1 ratio to either filgotinib 100 mg or 
matching placebo.
Within each Cohort, treatment assignments will be stratified according to the following factors in 
the Induction and Maintenance studies:
Stratification Factors (Cohort A, Biologic-Naïve and Biologic-Experienced Induction 
Study)

History of  exposure to no biologic agent, one biologic agent, or more than one biologic 
agent

Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No)

Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
(Yes or No)
Stratification Factors (Cohort B, Biologic-Experienced Induction Study)

Exposure to one biologic agent versus more than one biologic agent

Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No)

Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
(Yes or No)


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Stratification Factors (Maintenance Study)

History of exposure to a biologic agent, (Yes or No)

Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No)

Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
(Yes or No)
Refer to Section 3.3, Table 3-1 for re-randomization in the Maintenance Study.
6.2.
Pretreatment Assessments
6.2.1.
Screening Visit
Subjects will be screened within 30 days before randomization to determine eligibility for 
participation in the study. The following will be performed and documented during the screening 
period:

Obtain written informed consent
Additional consent will be required from subjects participating in the PK substudy , 
 and left-over samples for future research 

Review inclusion/exclusion criteria and other protocol restrictions (Section 4)

Obtain medical history and concomitant medications, including CD history and treatment


Ask Anchor Questions for abdominal pain and stool frequency

Complete physical examination (PE) including, vital signs, body weight, and height

Perform 12-Lead ECG

Record any SAEs and all AEs related to protocol mandated procedures occurring after 
signing of the informed consent form.

Instruct subjects to maintain concomitant medication at a stable dose

Provide subject with the electronic diary (e-Diary) and instructions for daily documentation 
of stool frequency, abdominal pain and general well-being
Subjects should be instructed that all stools in the same toilet visit should be counted as 
one stool. If they pass more than one stool during a toilet visit, they will still count as one
CCI
CCI


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
Conduct phone call approximately 4 days after screening visit to encourage compliance with 
daily documentation of abdominal pain, stool frequency and general well-being

Collect the variables to calculate baseline CDAI score (reference Appendix 4)
Site enters patient assessments from screening visit
CDAI score calculated centrally after all components have been captured electronically

Baseline PRO2 (Appendix 4) – centrally calculated using the patient reported symptoms of 
stool frequency and abdominal pain captured in the e-Diary

TB Assessment – Must have negative QuantiFERON® test (or centrally reported equivalent 
assay) during  screening, and negative chest x- ray within 3 months of or during screening for 
those with no evidence or history of TB. Positive or negative results must not be repeated. An 
indeterminate result should be repeated once and the second result (if positive or negative) 
will be accepted. Two sequential indeterminate results is considered a positive result for the 
purpose of the study. Subjects with previously treated latent or active TB requires sponsor 
approval (See inclusion criterion 7 for details). Subjects who are diagnosed with latent TB at 
screening must initiate an adequate course of prophylaxis as per local standard of care for a 
minimum of 4 weeks prior to randomization. Subject may initiate study drug dosing only 
after consultation with the medical monitor.

Obtain blood samples (reference Study Procedures Table [Appendix 2])
HCV Screening Guidelines
■
Subjects with positive HCV antibody at Screening require reflex testing for  HCV 
RNA. Subjects with HCV RNA ≥ lower limit of quantification (LLOQ) at Screening 
will be excluded. Subjects with positive HCV antibody but HCV RNA < LLOQ are 
eligible.
HBV Screening and Surveillance Guidelines
■
Subjects with positive HBV surface antigen (HBsAg) at Screening are excluded.
■
Subjects who are positive for HBV surface antibody (HBsAb), but negative for both 
HBsAg and HBV core antibody (HBcAb) at Screening are eligible.
■
Subjects with positive HBcAb require reflex testing for HBV DNA. Subjects with 
HBV DNA ≥ LLOQ at Screening will be excluded. Subjects with positive HBcAb 
and HBV DNA < LLOQ are eligible, but will require ongoing HBV DNA monitoring 
every 3 months during this study. These subjects may require prophylactic treatment 
per investigator discretion in accordance with local guidelines/standard of care.


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■
In Japan and where required by local guidelines, subjects with positive HBcAb and/or 
positive HBsAb will require reflex testing for HBV DNA at Screening. Subjects with 
positive HBcAb and/or HBsAb but with HBV DNA < LLOQ at Screening are 
eligible for the study. These subjects will require ongoing HBV DNA monitoring 
every 4 weeks 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).
HIV Screening Guidelines
■
Subjects who have HIV infection, regardless of virologic status, are excluded from 
the study.  

Obtain blood samples for serum pregnancy test (for females of childbearing potential only)

Obtain stool sample (reference Study Procedures Table [Appendix 2])
A stool sample will be obtained for culture for pathogenic bacteria, ova and parasite 
evaluation, and C. difficile toxin assay during screening for the purposes of determining 
eligibility.

Obtain urine sample (reference Study Procedures Table [Appendix 2])

Obtain urine sample for urine drug screen (reference Study Procedures Table [Appendix 2])

Review subject eligibility criteria (centrally calculated CDAI, PRO2 and labs), prior to 
performing a full video ileocolonoscopy with biopsies within 14 days prior to baseline visit: 
Biopsy samples will be collected and sent to central laboratory for storage and then to 
specialty laboratories for subsequent analysis.
Record local endoscopic assessment

Baseline SES-CD scoring and calculation performed by central reader (Appendix 5). 
A single retest of screening labs is permitted only if there is reason to believe the retest value will 
be within accepted parameters, or if the initial value was either due to a sample processing error 
or due to an extenuating circumstance
Subjects meeting all of the inclusion criteria and none of the exclusion criteria will return to the 
clinic within 30 days after screening for randomization into the study. Subjects may be 
randomized more than 30 days after screening if they receive permission from the medical 
monitor. If the subject does not begin the treatment within this 30-day window, specific 
screening evaluation procedures may need to be repeated at the direction of the medical monitor. 
No more than one repeat screening visit is allowed for each subject, unless prior written approval 
has been provided by the Sponsor. All screening procedures will need to be repeated during the 
repeat screening visit except for the ileocolonoscopy procedures. Ileocolonoscopy procedures 
from the previous screening attempt that fall within the specified timeframe (i.e, ileocolonoscopy 
with biopsies within 14 days prior to Day 1 visit) do not need to be repeated.




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6.3.
Randomization
Please refer to Section 6.1.
6.3.1.
Randomization and Study Drug Administration

Enter subject information in the IWRS to receive treatment assignment

Dispense study drug as directed by the IWRS

Instruct the subject on the packaging, storage, and administration of the study drug

Observe the subject taking the first dose of study drug and record the time of first dose 
6.4.
Study Assessments
Please refer to the Study Procedure Table in Appendix 2 for all procedures and time points to be 
conducted after randomization.
6.4.1.
Priority of Assessments
Subject-reported outcomes are recommended to be completed before any other study procedures. 
Invasive study procedures such as blood draws and biopsies should be done at the end of a study 
visit, as much as possible. Investigator questionnaires/assessments should be performed prior to 
reviewing subject-reported outcomes for that visit, as much as possible. 
6.4.2.
Efficacy
Efficacy assessments will be performed at the time points indicated in the Study Procedures 
Table (Appendix 2). 
6.4.2.1.
Crohn’s Disease Activity Index (CDAI) and Patient Reported Outcomes – 2 items 
(PRO2)
The Crohn's Disease Activity Index or CDAI is a tool used to assess the disease activity of 
Crohn's disease. Refer to Appendix 4.  The PRO2 is 2 patient reported outcomes of liquid or very 
soft stool and abdominal pain which are components of the CDAI.
6.4.2.2.
Patient Global Impression – Severity (PGI-S) and Patient Global Impression 
- Change (PGI-C)
The Patient Global Impression of Severity (PGI-S) is a global index that is used to rate the 
severity of Crohn’s disease by patients (a single-state scale). The Patient Global Impression of 
Change (PGI-C) is a scale that aims at evaluating all aspects of patients' health related to Crohn’s 
disease and determining if there has been an improvement or not. The patient has to select the 
one response from the response options that gives the most accurate description of his/her state 
of health (overall status).




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6.4.3.
Safety
Safety will be assessed via AEs, concomitant medications, physical examinations (complete and 
symptom-driven), vital signs, ECGs, and clinical laboratory results.
6.4.3.1.
Clinical Laboratory Evaluations
The hematology, serum chemistry, coagulation laboratory, and stool analyses will be performed 
at a central laboratory. Reference ranges will be supplied by the central laboratory and will be 
used by the investigator to assess the laboratory data for clinical significance and pathological 
changes.
Blood samples will be collected by venipuncture (or optional indwelling catheter for PK 
sampling days) in the arm at the time points indicated in the Study Procedures Table 
(Appendix 2). In addition, urine samples for the clinical laboratory assessments will be collected. 
An overnight fast (no food or drinks, except water) of at least 8 hours will be required prior to 
collection of blood samples for lipid testing.
A stool sample should also be collected at any time during the study for culture for pathogenic 
bacteria, ova and parasites, and C. diff toxin assay when a subject becomes symptomatic, 
including worsening or return of disease activity.
Refer to Appendix 8 for table of clinical laboratory tests.
Laboratory values outside the normal range will be flagged and clinical relevance will be 
assessed by the investigator. More frequent sampling as well as additional tests may be 
performed as deemed necessary by the investigator.
Note that in the case where clinically significant laboratory test results are a potential reason for 
discontinuation from the study drug and/or withdrawal from the study, retesting of the affected 
parameter(s) should be prompt (within 3 to 7 days [except creatinine, which should be retested 
7-14 days apart] ).
The details of sample handling and shipment instructions will be provided in a separate 
laboratory manual.
6.4.3.2.
Pregnancy Testing (for females of childbearing potential)
All females meeting the childbearing potential criteria (Appendix 7) must have a serum 
pregnancy testing at screening and an in-clinic urine pregnancy test must be completed every 
4 weeks at a minimum. If any pregnancy test is positive, study drug should be immediately 
interrupted and the subject should have a serum pregnancy test in clinic that will be centrally 
reported.


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6.4.3.3.
Vital Signs
Vital signs will be measured at the time points indicated in the Study Procedures Table 
(Appendix 2).
Vital signs should be taken after the subject has been resting in the seated or supine position for 
at least 5 minutes and will include pulse rate, respiratory rate, systolic and diastolic blood 
pressure, and temperature.
6.4.3.4.
Physical Examination
A physical examination should be performed at the time points indicated in the Study Procedures 
Table (Appendix 2). Any changes from screening will be recorded. Weight will be measured at 
all visits. Height will be measured at screening only. Subjects should be instructed to remove 
shoes prior to measurement of height.
At screening, a complete physical examination will be performed. A complete physical 
examination will include source documentation of general appearance and the following body 
systems: head, neck, and thyroid; eyes, ears, nose, throat, mouth and tongue; chest 
(excluding breasts); respiratory; cardiovascular; lymph nodes; abdomen; skin, hair, nails; 
musculoskeletal; and neurological. Symptom-driven physical examinations will be performed at 
all other visits based on reported signs and symptoms.
6.4.3.5.
12-lead Electrocardiogram
A resting 12-lead ECG will be performed at the time points indicated in the Study Procedures 
Table (Appendix 2).
The ECG should be obtained after the subject has been resting in the supine position for at least 
5 minutes and will include heart rate (HR), inter-beat (RR), QRS, uncorrected QT, morphology, 
and rhythm analysis. Electrocardiograms will be interpreted by the investigator (or qualified 
designee) for clinical significance and results will be entered into the eCRF.
6.4.3.6.
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).
6.4.4.
Pharmacokinetics Assessments
The PK sample at Week 4 is collected post-dose (at least 30 minutes and up to 3 hours after 
study drug dosing). For this visit, it is preferred that study drug dosing is done in clinic. The PK 
sample at Weeks 26 can be collected at any time without regard to dosing. The PK sample at 
Weeks 10 and 58 are collected at pre-dose (within 2 hours prior to dosing).




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6.6.
Early Termination Assessments 
The following will be performed and documented:

Symptom-directed PE

Obtain body weight and vital signs (resting blood pressure, respiratory rate, pulse and 
temperature)

Perform 12-Lead ECG (for subjects who terminate prior to Week 10)

Review AEs and concomitant medications

 

Collect the variables to calculate CDAI score (reference Appendix 4)
Site collects patient assessments at each visit
CDAI score calculated centrally after all components have been captured electronically

PRO2 score calculated centrally

Obtain fasting 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)
6.7.
End of Study
Please refer to Section 3.7
6.8.
Post Study Care
Please refer to Section 3.8
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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 
eCRF.
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.)


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
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 subinvestigator 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 subinvestigator is responsible for assessing the relationship to 
investigational medicinal product (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. 
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)


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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 6.
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 study drug initiation:
After informed consent, but prior to initiation of study medication, the following types of events 
should be reported on the eCRF: all SAEs and adverse events related to protocol mandated 
procedures.
7.3.1.
Adverse Events
Following initiation of study medication, all AEs, regardless of cause or relationship, until 
30 days after last administration of study IMP must be reported to the eCRF database as 
instructed.
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.


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7.3.2.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occurs after the subject first consents to 
participate in the study (ie, signing the informed consent) and throughout the duration of the 
study, including the protocol-required post-treatment follow-up period, must be reported to the 
eCRF database and the Sponsor as instructed. This also includes any SAEs resulting from 
protocol-associated procedures performed after informed consent is signed.
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. 

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: 
DIVERSITY_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.


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
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. 
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. 
To minimize the possibility of exposing study subjects to unusual risk, the safety information 
from this study will also be reviewed periodically by an independent DMC (as described 
in Section 8.10). The DMC may have access to partially blinded or unblinded data and will make 
recommendations regarding the study according to the DMC charter
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or 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 6). 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.


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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. 

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.  


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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 of 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 the 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 
by a subject.
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 labelling (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. 


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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 DIVERSITY_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.
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 DIVERSITY_safety@glpg.com.
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to DIVERSITY_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 DIVERSITY_safety@glpg.com. 
Pregnancies of female partners of male study subjects exposed to the Sponsor’s or other study 
drugs must also be reported and relevant information should be submitted to 
DIVERSITY_safety@glpg.com using the pregnancy and pregnancy outcome forms within 24 
hours. Monitoring of the subject should continue until the conclusion of the pregnancy. If the end 
of the pregnancy occurs after the study has been completed, the outcome should be reported 
directly to DIVERSITY_safety@glpg.com. 
Refer to Appendix 7 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.


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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 DIVERSITY_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.


















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8.1.2.2.1.
EU-Specific Primary Endpoints for the Cohort B Induction Study 

The proportion of subjects achieving clinical remission by PRO2 at Week 10

The proportion of subjects achieving endoscopic response at Week 10 
8.1.2.3.
Maintenance Study

The proportion of subjects achieving clinical remission by CDAI at Week 58

The proportion of subjects achieving endoscopic response at Week 58
8.1.2.3.1.
EU-Specific Primary Endpoints for the Maintenance Study

The proportion of subjects achieving clinical remission by PRO2 at Week 58

The proportion of subjects achieving endoscopic response at Week 58
8.1.3.
Secondary Endpoints
8.1.3.1.
Cohort A Induction Study
The key secondary end points of Cohort A are:

The proportion of subjects achieving clinical remission by PRO2 at Week 10

The proportion of subjects achieving clinical response by CDAI at Week 10
The other secondary end point of Cohort A is:

PK characteristics for filgotinib and its metabolite GS-829845 
8.1.3.1.1.
EU-Specific Secondary Endpoints for the Cohort A Induction Study 
The EU-specific key secondary end points of Cohort A are:

The proportion of subjects achieving clinical remission by CDAI at Week 10

The proportion of subjects achieving both clinical remission by PRO2 and endoscopic 
response (combined into a single end point on a patient level) at Week 10
The EU-specific other secondary end point of Cohort A is:

PK characteristics for filgotinib and its metabolite GS-829845 


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8.1.3.2.
Cohort B Induction Study
The key secondary end points of Cohort B are:

The proportion of subjects achieving clinical remission by PRO2 at Week 10

The proportion of subjects achieving clinical response by CDAI at Week 10
The other secondary end point of Cohort B is:

PK characteristics for filgotinib and its metabolite GS-829845 
8.1.3.2.1.
EU-Specific Secondary Endpoints for the Cohort B Induction Study 
The EU-specific key secondary end points of Cohort B are:

The proportion of subjects achieving clinical remission by CDAI at Week 10

The proportion of subjects achieving both clinical remission by PRO2 and endoscopic 
response (combined into a single end point on a patient level) at Week 10
The EU-specific other secondary end point of Cohort B is:

PK characteristics for filgotinib and its metabolite GS-829845 
8.1.3.3.
Maintenance Study
The key secondary end points of the Maintenance Study are:

The proportion of subjects achieving clinical remission by PRO2 at Week 58

The proportion of subjects achieving clinical response by CDAI at Week 58

The proportion of subjects achieving sustained clinical remission by CDAI at Weeks 10 
and 58

The proportion of subjects achieving 6-month corticosteroid-free remission by CDAI at 
Week 58

The proportion of subjects achieving sustained clinical remission by PRO2 at Weeks 10 
and 58

The proportion of subjects achieving 6-month corticosteroid-free remission by PRO2 at 
Week 58
The other secondary end point of the Maintenance Study is:

PK characteristics for filgotinib and its metabolite GS-829845 














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Laboratory data that are continuous in nature but are less than the LLOQ or above the upper limit 
of quantitation will be imputed to the value of the lower or upper limit minus or plus one 
significant digit, respectively (eg, if the result of a continuous laboratory test is < 20, a value of 
19 will be assigned; if the result of a continuous laboratory test is < 20.0, a value of 19.9 will be 
assigned).
Procedures for handling missing data for CDAI, PRO2 and SES-CD (and components) will be 
described in the statistical analysis plan (SAP).
8.4.
Demographic Data and Baseline Characteristics
Demographic and baseline measurements for each individual study (Cohort A Induction Study, 
Cohort B Induction Study, and Maintenance Study) will be summarized separately by treatment 
group using standard descriptive statistics (n, mean, standard deviation [SD], median, 1st quartile 
[Q1], 3rd quartile [Q3], minimum, maximum) for continuous variables and number and 
percentage of subjects for categorical variables. 
Demographic summaries will include age, sex, race and ethnicity. Baseline characteristics may 
include height, weight, body mass index (BMI), SES-CD score, CDAI score, PRO2 score, 
number of years since diagnosis of CD, concomitant use of oral corticosteroids, concomitant use 
of immunomodulators, 
, and other variables of interest.
8.5.
Efficacy Analysis
8.5.1.
Primary Analyses
For each Induction Study (Cohort A and Cohort B), the primary analysis will compare a 
filgotinib dose group to placebo on the proportion of subjects achieving clinical remission by 
CDAI at Week 10 and the proportion of subjects achieving endoscopic response at Week 10. In 
the EU, for each Induction Study (Cohort A and Cohort B), the primary analysis will compare a 
filgotinib dose group to placebo on the proportion of subjects achieving clinical remission by 
PRO2 at Week 10 and the proportion of subjects achieving endoscopic response at Week 10. 
Similarly, for the Maintenance Study, the primary analysis will compare a filgotinib dose group 
to placebo on the proportion of subjects achieving clinical remission by CDAI at Week 58 and 
the proportion of subjects achieving endoscopic response at Week 58. In the EU, for the 
Maintenance Study, the primary analysis will compare a filgotinib dose group to placebo on the 
proportion of subjects achieving clinical remission by PRO2 at Week 58 and the proportion of 
subjects achieving endoscopic response at Week 58. For a dose group to demonstrate significant 
treatment effect over placebo, statistical significance needs to be achieved on both clinical 
remission by CDAI and endoscopic response end points at significance level that is specified in 
Section 8.5.3. In the EU, for a dose group to demonstrate significant treatment effect over 
placebo, statistical significance needs to be achieved on both clinical remission by PRO2 and 
endoscopic response end points at significance level that is specified in Section 8.5.3. 
CCI


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The Cochran-Mantel-Haenszel (CMH) approach adjusting for stratification factors will be used 
for hypothesis testing of each primary end point within each study. For calculation of reduction 
from baseline in SES-CD score in the endoscopic response, SES-CD score at screening will be 
used as baseline value. For calculation of CDAI and PRO2 scores, refer to Appendix 4. 
Subjects who do not have sufficient measurements to determine efficacy end points will be 
considered failures (ie, non-responder imputation [NRI]). Sensitivity analyses will be described 
in the SAP.
8.5.2.
Secondary Analyses
The same statistical methods used for testing the primary end points will be utilized for testing 
the key secondary end points in each study (Cohort A Induction Study, Cohort B Induction 
Study, and Maintenance Study) separately. Subjects who do not have sufficient measurements to 
determine efficacy end points will be considered failures (ie, NRI).
8.5.3.
Multiplicity Adjustments
The graphical approach {Bretz 2009} of sequentially rejective Beonferroni-based iterative 
multiple test procedures will be used to control a family-wise type I error rate (FWER) at 5% 
(ie, α = 0.05) for hypothesis testing on co-primary and key secondary end points for each 
individual study (Cohort A Induction Study, Cohort B Induction Study, and Maintenance Study). 
This procedure strongly protects the FWER on all the primary and key secondary end points.
8.5.3.1.
Induction Studies (Cohorts A and B)
The hypotheses to be tested for the induction studies are outlined below. 
The primary null hypotheses to be tested:

H11: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10

H12: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10

H21: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10

H22: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10


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The key secondary null hypotheses to be tested:

H13: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10

H14: The clinical response by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 10

H23: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10 

H24: The clinical response by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 10
Each co-primary endpoint for filgotinib 200 mg compared with placebo will be tested at 2-sided 
0.05 significance level first. If it fails to reject the null hypothesis for at least one co-primary end 
point, then no further formal testings will be performed. If the null hypotheses for both 
co-primary endpoints are rejected, testing will proceed in two sequences as describe below:

Key secondary end points for filgotinib 200 mg compared with placebo at 2-sided 
0.025 significance level in a sequential order

Each co-primary end point for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level. If the null hypotheses for both co-primary end points are rejected, 
then the key secondary end points for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level will be tested in a sequential order
If all the null hypotheses within the same sequence are rejected, then the respective alpha can be 
passed on to the other sequence. If an end point fails to reach statistical significance within the 
sequence, then formal testing will stop, and only nominal significance will be reported for the 
remaining end points.
A graphical illustration of the testing strategy for the primary and key secondary hypotheses in 
the Induction Studies is shown in Figure 8-1.
8.5.3.1.1.
EU-Specific Multiplicity Adjustments for the Induction Studies 
(Cohorts A and B)
The EU-specific hypotheses to be tested for the induction studies are outlined below. 


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The EU-specific primary null hypotheses to be tested:

H11: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10

H12: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10

H21: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10

H22: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10
The EU-specific key secondary null hypotheses to be tested:

H13: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10

H14: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
end point at patient level) in the filgotinib 200 mg group is equal to the clinical remission by 
PRO2 and endoscopic response rate (combined into a single end point at patient level) in the 
placebo group at Week 10

H23: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10

H24: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
end point at patient level) in the filgotinib 100 mg group is equal to the clinical remission by 
PRO2 and endoscopic response rate (combined into a single end point at patient level) in the 
placebo group at Week 10
Each co-primary end point for filgotinib 200 mg compared with placebo will be tested at 2-sided 
0.05 significance level first. If it fails to reject the null hypothesis for at least one co-primary end 
point, then no further formal testings will be performed. If the null hypotheses for both 
co-primary end points are rejected, testing will proceed in two sequences as describe below:

Key secondary end points for filgotinib 200 mg compared with placebo at 2-sided 
0.025 significance level in a sequential order

Each co-primary end point for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level. If the null hypotheses for both co-primary end points are rejected, 
then the key secondary end points for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level will be tested in a sequential order


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If all the null hypotheses within the same sequence are rejected, then the respective alpha can be 
passed on to the other sequence. If an end point fails to reach statistical significance within the 
sequence, then formal testing will stop, and only nominal significance will be reported for the 
remaining end points.
A graphical illustration of the testing strategy for the primary and key secondary hypotheses in 
the Induction Studies is shown in Figure 8-1.
Figure 8-1.
Induction Studies (Cohorts A and B): Testing Strategy for the 
Primary and Key Secondary Hypotheses
8.5.3.2.
Maintenance Study
The hypotheses to be tested for the Maintenance Study are outlined below. 
The primary null hypotheses to be tested:

H11: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58

H12: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58

H21: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58

H22: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58


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The key secondary null hypotheses to be tested:

H13: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58 

H14: The clinical response by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 58 

H15: The sustained clinical remission by CDAI rate in the filgotinib 200 mg group is equal to 
sustained clinical remission by CDAI rate in the placebo group at Weeks 10 and 58

H16: The 6-month corticosteroid-free remission by CDAI rate in the filgotinib 200 mg group 
is equal to the 6-month corticosteroid-free remission by CDAI rate in the placebo group at 
Week 58

H17: The sustained clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to 
the sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58

H18: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 200 mg group 
is equal to 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58

H23: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58 

H24: The clinical response by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 58 

H25: The sustained clinical remission by CDAI rate in the filgotinib 100 mg group is equal to 
sustained clinical remission by CDAI rate in the placebo group at Weeks 10 and 58

H26: The 6-month corticosteroid-free remission by CDAI rate in the filgotinib 100 mg group 
is equal to the 6-month corticosteroid-free remission by CDAI rate in the placebo group at 
Week 58

H27: The sustained clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to 
the sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58

H28: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 100 mg group 
is equal to 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58


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Each co-primary end point for filgotinib 200 mg compared with placebo will be tested at 2-sided 
0.05 significance level first. If it fails to reject the null hypothesis for at least one co-primary end 
point, then no further formal testings will be performed. If the null hypotheses for both 
co-primary end points are rejected, testing will proceed in two sequences as describe below:

Key secondary end points for filgotinib 200 mg compared with placebo at 2-sided 
0.025 significance level in a sequential order

Each co-primary end point for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level. If the null hypotheses for both co-primary end points are rejected, 
then the key secondary end points for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level will be tested in a sequential order
If all the null hypotheses within the same sequence are rejected, then the respective alpha can be 
passed on to the other sequence. If an end point fails to reach statistical significance within the 
sequence, then formal testing will stop and only nominal significance will be reported for the 
remaining endp oints.
Graphical illustrations for the testing strategies for the primary and key secondary hypotheses in 
the Maintenance Study are shown in Figure 8-2.  


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Figure 8-2.
Maintenance Study: Testing Strategy for the Primary and Key 
Secondary Hypotheses
8.5.3.2.1.
EU-Specific Multiplicity Adjustments for the Maintenance Study
The EU-specific hypotheses to be tested for the Maintenance Study are outlined below. 


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The EU-specific primary null hypotheses to be tested:

H11: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58

H12: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58

H21: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58

H22: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58
The EU-specific key secondary null hypotheses to be tested:

H13: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58

H14: The sustained clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to 
sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58 

H15: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
end point at patient level) in the filgotinib 200 mg group is equal to the clinical remission by 
PRO2 and endoscopic response rate (combined into a single end point at patient level) in the 
placebo group at Week 58

H16: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 200 mg group 
is equal to the 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58

H23: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58

H24: The sustained clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to 
sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58

H25: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
end point at patient level) in the filgotinib 100 mg group is equal to the clinical remission by 
PRO2 and endoscopic response rate (combined into a single end point at patient level) in the 
placebo group at Week 58

H26: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 100 mg group 
is equal to the 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58


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Each co-primary end point for filgotinib 200 mg compared with placebo will be tested at 2-sided 
0.05 significance level first. If it fails to reject the null hypothesis for at least one co-primary end 
point, then no further formal testings will be performed. If the null hypotheses for both 
co-primary end points are rejected, testing will proceed in two sequences as describe below:

Key secondary end points for filgotinib 200 mg compared with placebo at 2-sided 
0.025 significance level in a sequential order

Each co-primary end point for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level. If the null hypotheses for both co-primary end points are rejected, 
then the key secondary end points for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level will be tested in a sequential order
If all the null hypotheses within the same sequence are rejected, then the respective alpha can be 
passed on to the other sequence. If an end point fails to reach statistical significance within the 
sequence, then formal testing will stop and only nominal significance will be reported for the 
remaining end points.
Graphical illustrations for the testing strategies for the EU-specific primary and key secondary 
hypotheses in the Maintenance Study are shown in Figure 8-3.






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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:
Induction Studies (Cohorts A and B)

Any AEs with an onset date of on or after the study drug start date for each Induction study 
(Day 1) and up to:
30 days after last dose date, for subjects who prematurely discontinued study drug prior 
to or at Week 10 OR
Week 10, for subjects who completed Week 10 dosing and continued on study drug

Any AEs leading to premature discontinuation of study drug prior to Week 10.
Maintenance Study

Any AEs with an onset date of on or after the study drug start date for the Maintenance study 
(Week 11) and up to 30 days after permanent discontinuation of study drug.

Any AEs leading to premature discontinuation of study drug after first dose of study drug 
administration for the Maintenance study (Week 11).
Overall (Induction and Maintenance)

Any AEs with an onset date of on or after the study drug start date for the entire study 
(Day 1) and up to 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 by 
treatment group. 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.






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The sample size was chosen to ensure that a clinically meaningful difference in both clinical 
remission rate by CDAI and endoscopic response rate at Week 58 could be detected when 
comparing filgotinib 200 mg to placebo in the Maintenance Study.
A sample size of 60 subjects in the placebo group and 120 subjects in the filgotinib group at the 
same dose level as the induction dose will provide an overall 94% power for a filgotinib 200 mg 
comparison to placebo at a 2-sided 0.05 significance level to detect a treatment difference of 
30% in maintenance clinical remission rate by CDAI at Week 58 and maintenance endoscopic 
response rate at Week 58 (50% on filgotinib 200 mg and 20% on placebo). Since each end point 
needs to achieve statistical significance, the overall power of 94% is calculated as the product of 
the two individual powers based on each end point.
8.9.2.1.
EU-Specific Sample Size for the Maintenance Study
The sample size was chosen to ensure that a clinically meaningful difference in both clinical 
remission rate by PRO2 at Week 58 and endoscopic response rate at Week 58 could be detected 
when comparing filgotinib 200 mg to placebo in the Maintenance Study.
A sample size of 60 subjects in the placebo group and 120 subjects in the filgotinib group at the 
same dose level as the induction dose will provide an overall 94% power for filgotinib 200 mg 
comparison to placebo at a 2-sided 0.05 significance level to detect a treatment difference of 
30% in maintenance clinical remission rate by PRO2 at Week 58 and maintenance endoscopic 
response rate at Week 58 (50% on filgotinib 200 mg and 20% on placebo). Since each end point 
needs to achieve statistical significance, the overall power of 94% is calculated as the product of 
the two individual powers based on each end point.
8.10.
Data Monitoring Committee
An external DMC will review the progress of the study and perform interim reviews of safety 
data and provide recommendation to the Sponsor whether the nature, frequency, and severity of 
adverse effects associated with study treatment warrant the early termination of the study in the 
best interests of the participants, whether the study should continue as planned, or the study 
should continue with modifications. 
The initial meeting will occur after approximately 100 subjects reach Week 10 in Cohorts A and 
B combined. Following this, subsequent meetings will occur approximately once every 4 months 
or at a frequency determined by the DMC. 
The DMC’s specific activities will be defined by a mutually agreed upon charter, which will 
define the DMC’s membership, conduct and meeting schedule.
While the DMC will be asked to advise the Sponsor regarding future conduct of the study, 
including possible early study termination, the Sponsor retains final decision-making authority 
on all aspects of the study. If the DMC recommends stopping the study for lack of efficacy, the 
Sponsor’s Executive team will be unblinded to confirm the DMC recommendation.


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Cohorts A and B End-of-Induction Analysis
Efficacy and safety data will be evaluated by the DMC after all subjects in both cohorts complete 
Week 10 dosing (or prematurely discontinue study drug but complete post-treatment 
assessments).
Both cohorts will be examined independently.
Taking into account data in Cohort A and Cohort B, if ALL the following 4 criteria are met for 
BOTH cohorts, the DMC may recommend overall study discontinuation. 

2-sided p-value for filgotinib 200 mg vs placebo comparison is larger than 0.05 on clinical 
remission by CDAI at Week 10

2-sided p-value for filgotinib 100 mg vs placebo comparison is larger than 0.05 on clinical 
remission by CDAI at Week 10

2-sided p-value for filgotinib 200 mg vs placebo comparison is larger than 0.05 on 
endoscopic response at Week 10

2-sided p-value for filgotinib 100 mg vs placebo comparison is larger than 0.05 on 
endoscopic response at Week 10
If any of the above criteria is not met from either cohort, the DMC may recommend that the 
study continue without modification.
Ad-hoc DMC Meetings
An ad-hoc DMC meeting may be triggered by the following conditions:

≥ 2 subjects develop the same (by preferred term) related, Grade 4, unexpected AE in the 
infections and infestations system organ class

≥ 2 subjects develop any related, Grade 4, thromboembolic event that has been positively 
adjudicated by the adjudication committee (See Section 8.11)

Any subject develops a Grade 5, related, unexpected AE. The definition of an unexpected AE 
will be based on the Reference Safety Information that is on file at the time the event occurs
8.11.
Cardiovascular Safety Endpoint Adjudication Committee 
An independent adjudication committee will be formed to periodically review and adjudicate all 
potential major adverse cardiovascular events (MACE) and thromboembolic events in a blinded 
manner.


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The Cardiovascular Safety End point Adjudication Committee (CVEAC)’s specific activities 
will be governed by a mutually agreed charter, which will define the CVEAC’s membership, 
conduct, and meeting schedule.
The following events will be adjudicated and classified by the CVEAC:

Cardiovascular death

Myocardial infarction

Stroke 

Arterial thromboembolism

Venous thromboembolism (eg, deep venous thrombosis, pulmonary embolism)
Further details will be specified in the CVEAC Charter.


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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 subinvestigators 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 subinvestigator’s) participation in the study. The investigator and 
subinvestigator 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. The consent form will inform subjects about 
 and sample 
retention.
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.
CCI


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The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth, gender);

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.


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9.1.6.
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 
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.


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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.
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.


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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.
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.


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10.
REFERENCES
Baumgart DC, Sandborn WJ. Crohn's disease. Lancet 2012;380 (9853):1590-605.
Bretz F, Maurer W, Brannath W, Posch M. A Graphical Approach to Sequentially Rejective 
Multiple Test Procedures. Stat Med 2009;28:586-604.
Cheifetz AS. Management of active Crohn disease. JAMA 2013;309 (20):2150-8.
Daperno M, D'Haens G, Van Assche G, Baert F, Bulois P, Maunoury V, et al. Development and 
validation of a new, simplified endoscopic activity score for Crohn's disease: the 
SES-CD. Gastrointestinal endoscopy 2004;60 (4):505-12.
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.
Ferrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, et al. 
Validation of endoscopic activity scores in patients with Crohn's disease based on 
a post hoc analysis of data from SONIC. Gastroenterology 2013;145 (5):978-86 
e5.
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.
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.


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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.
Simple Endoscopic Score for Crohn’s Disease (SES-CD)
Appendix 6.
CTCAE Grading Scale for Severity of Adverse Events
Appendix 7.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 8.
Clinical Laboratory Assessment Table




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Appendix 2.
Study Procedures Table
Period
Screen
Treatment
Follow-Up
Visit
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
PTxa
ET
Week
0
2
4
6
10
11
14
17
20
23
26
30
34
38
42
46
50
54
58
Study Day
-30 to -1
1
15
29
43
71
78
99
120
141
162
183
211
239
267
295
323
351
379
407
Visit Window 
(±)
±3
±3
±3
±2
±3
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±3
±3
Written 
Informed 
Consent 
X
Medical History 
& 
Demographics
X
Crohn’s Disease 
& Treatment 
History
X
12-lead ECG
X
X
X
X
Xb
Review of 
Inclusion/
Exclusion 
Criteria
X
X
Complete 
Physical Examc
X
Symptom-
directed Examc 
(as needed)
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Vital Signs
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Concomitant 
Medications 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Randomization 
X
X
CCI


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Period
Screen
Treatment
Follow-Up
Visit
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
PTxa
ET
Week
0
2
4
6
10
11
14
17
20
23
26
30
34
38
42
46
50
54
58
Study Day
-30 to -1
1
15
29
43
71
78
99
120
141
162
183
211
239
267
295
323
351
379
407
Visit Window 
(±)
±3
±3
±3
±2
±3
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±3
±3
Study Drug 
Dispensing
X
X
X
X
X
X
X
X
X
Ileocolonoscopy 
(with Biopsies)d
X
X
X
Local 
Endoscopic 
Assessmente
X
X
X
SES-CD
X
X
X
CDAIf
X
X
X
X
X
X
X
X
X
X
X
X
X
PRO2f
X
X
X
X
X
X
X
X
X
X
X
X
X
Abdominal pain 
assessmentg 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Anchor 
Questions
X
Patient Global 
Impression  
Scalesh
X
X
X
eDiary 
instruction & 
reviewi
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Stool for C. diff 
toxin, 
pathogenic 
E. coli, 
Salmonella spp, 
Shigella  spp, 
Campylobacter 
spp or Yersinia 
spp testing j
X
Stool O&P j 
X


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 150
02 December 2021
Period
Screen
Treatment
Follow-Up
Visit
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
PTxa
ET
Week
0
2
4
6
10
11
14
17
20
23
26
30
34
38
42
46
50
54
58
Study Day
-30 to -1
1
15
29
43
71
78
99
120
141
162
183
211
239
267
295
323
351
379
407
Visit Window 
(±)
±3
±3
±3
±2
±3
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±3
±3
Urine drug 
screenk
X
Urinalysis
X
X
X
X
Pregnancy Testl
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
TBm 
X
Chest x-ray n
X
HBV, HCV, 
HIV screeningo
X
HBV DNA 
monitoring 
(Japan)p
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
HBV DNA 
monitoring 
(other regions)p
X
X
X
X
X
Hematology
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemistry
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Lipid profile 
(fasting)q
X
X
X
X
X
Serum 
immunoglobulin
X
X
X
X
X
X
X
CCI
CCI


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 151
02 December 2021
Period
Screen
Treatment
Follow-Up
Visit
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
PTxa
ET
Week
0
2
4
6
10
11
14
17
20
23
26
30
34
38
42
46
50
54
58
Study Day
-30 to -1
1
15
29
43
71
78
99
120
141
162
183
211
239
267
295
323
351
379
407
Visit Window 
(±)
±3
±3
±3
±2
±3
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±5
±3
±3
Blood 
TCR/BCR 
repertoire 
sampler
X
X
X
X
X
PK collection 
(sparse) s
X
X
X
X
PK substudyu
X
CCI
CCICCI




Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 153
02 December 2021
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 
discretion of the investigator


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 154
02 December 2021
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
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
1
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 (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
{Daperno 2004}
Each PRO2 score will be rounded to the nearest integer for determination of eligibility and calculation of end points.


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 155
02 December 2021
Appendix 5.
Simple Endoscopic Score for Crohn’s Disease (SES-CD)
Score
Variables
0
1
2
3
Size of ulcers (cm)
None
Aphthous ulcers
(diameter 0.1-.05)
Large ulcers
(diameter 0.5-2)
Very large ulcers
(diameter > 2)
Ulcerated Surface (%)
None
< 10
10-30
> 30
Affected surface (%)
Unaffected 
segment
< 50
50-75
> 75
Presence of narrowings
None
Single,
can be passed
Multiple,
can be passed
Cannot be passed
*
Total SES-CD: sum of the values of the 4 variables for the 5 bowel segments. Values are given to each variable and for 
every examined bowel segment (eg, rectum, left colon, transverse colon, right colon, and ileum)
{Daperno 2004}


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 156
02 December 2021
Appendix 6.
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).


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 157
02 December 2021
Appendix 7.
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.
1) Definitions
a. 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.
b. 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.
2) Contraception for Female Subjects
a. 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.  


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 158
02 December 2021
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). For male subjects, male 
condom should be used; for their female partners of childbearing potential, an accepted 
contraceptive method should also be considered. Details are outlined below.
Please refer to the latest version of the filgotinib IB for additional information.
b. 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 serum pregnancy test at screening and a 
negative urine pregnancy test on the Day 1 visit prior to randomization.  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 use one of the following methods from screening until 35 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)


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 159
02 December 2021
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

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 35 days after the last study drug dose.
3) Contraception Requirements for Male Subjects
It is theoretically possible that a relevant concentration of study drug may be achieved in a 
female partner from exposure to the male subject’s seminal fluid. Therefore, male subjects with 
female partners of childbearing potential must use condoms during study participation and for 
90 days after the last study drug dose.  Female partners of male study subjects should consider 
using one of the above methods of contraception as well. Male subjects must also refrain from 
sperm donation during treatment and until at least 90 days after the end of study drug dosing.


Filgotinib
Protocol GS-US-419-3895
Final
Galapagos NV
Amendment 9
CONFIDENTIAL
Page 160
02 December 2021
4) 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.
5) 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. Subjects whose partner 
has become pregnant or suspects she is pregnant during the study are to report the information to 
the investigator.
Instructions for reporting pregnancy, partner 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 (in clinic) 
during their study participation. 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.



SAP_001.pdf: 
 
 
 
 
 
 
 
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: 
GLPG0634-CL-309 
Study Title: 
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled 
Studies Evaluating the Efficacy and Safety of Filgotinib in the 
Induction and Maintenance of Remission in Subjects with Moderately 
to Severely Active Crohn’s Disease 
Development Phase: 
3 
Status: 
Final 
Version: 
2.0 
Date: 
15-Jan-2023 
EudraCT: 
2016-001367-36 
IND: 
02914561 
Sponsor: 
Galapagos NV, Generaal De 
Wittelaan L11 A3, 2800 
Mechelen, Belgium 
 
Biostatistician: 
   
Medical Leader: 
 
PPD
PPD


Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
Version 2.0 
CONFIDENTIAL 
Page 2 
 
15 January 2023 
TABLE OF CONTENTS 
 
TABLE OF CONTENTS .............................................................................................................................................. 2 
LIST OF IN-TEXT TABLES ........................................................................................................................................ 4 
LIST OF IN-TEXT FIGURES ...................................................................................................................................... 5 
LIST OF ABBREVIATIONS ........................................................................................................................................ 6 
PHARMACOKINETIC ABBREVIATIONS ................................................................................................................ 8 
1. 
INTRODUCTION ................................................................................................................................................ 9 
1.1. 
Study Objectives ...................................................................................................................................... 9 
1.1.1. 
Primary Objectives ................................................................................................................. 9 
1.1.2. 
Secondary Objectives ........................................................................................................... 10 
 
 
1.2. 
Study Design .......................................................................................................................................... 14 
1.2.1. 
Induction Studies (Cohort A and B) ..................................................................................... 15 
1.2.2. 
Maintenance Study ............................................................................................................... 16 
1.2.3. 
Pharmacokinetics Substudy .................................................................................................. 17 
1.2.4. 
Schedule of Assessments...................................................................................................... 17 
1.3. 
Sample Size and Power .......................................................................................................................... 18 
2. 
TYPE OF PLANNED ANALYSIS .................................................................................................................... 20 
2.1. 
Data Monitoring Committee (DMC) Analyses ...................................................................................... 20 
2.1.1. 
Safety Analyses .................................................................................................................... 20 
2.1.2. 
Cohorts A and B End-of-Induction Analysis ....................................................................... 20 
2.2. 
Final Analysis ........................................................................................................................................ 20 
3. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES ............................................................................ 21 
3.1. 
Analysis Sets .......................................................................................................................................... 21 
3.1.1. 
All Randomized Analysis Sets ............................................................................................. 21 
3.1.2. 
Full Analysis Sets ................................................................................................................. 22 
3.1.3. 
Safety Analysis Sets ............................................................................................................. 22 
3.1.4. 
Pharmacokinetic Analysis Sets............................................................................................. 22 
3.1.5. 
Pharmacokinetic Substudy Analysis Sets ............................................................................. 22 
 
 
3.2. 
Subject Grouping ................................................................................................................................... 23 
3.3. 
Strata and Covariates .............................................................................................................................. 23 
3.4. 
Examination of Subject Subgroups ........................................................................................................ 23 
3.5. 
Multiple Comparisons ............................................................................................................................ 23 
3.5.1. 
EU-Specific .......................................................................................................................... 24 
3.5.2. 
Other (non-EU) .................................................................................................................... 27 
3.6. 
Missing Data and Outliers ...................................................................................................................... 32 
3.6.1. 
Missing Data ........................................................................................................................ 32 
3.6.2. 
Outliers ................................................................................................................................. 32 
3.7. 
Data Handling Conventions and Transformations ................................................................................. 32 
3.8. 
Analysis Visit Windows ......................................................................................................................... 34 
3.8.1. 
Definitions ............................................................................................................................ 34 
3.8.2. 
Analysis Visit Windows ....................................................................................................... 35 
3.8.3. 
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window ................................................................................................................................ 39 
3.9. 
Assessment of Coronavirus Disease 2019 Impact .................................................................................. 40 
CCI
CCI






Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
Version 2.0 
CONFIDENTIAL 
Page 5 
 
15 January 2023 
Table 13-4. 
Calculation of CDAI Patient-Reported Outcome Components and PRO2 Scores at 
Screening .............................................................................................................................. 110 
Table 13-5. 
Calculation of CDAI Patient-Reported Outcome Components and PRO2 Scores at 
Post-Screening Visits............................................................................................................ 113 
Table 13-6. 
Sources of Information for Calculating CDAI and PRO2 Scores ........................................ 115 
Table 13-6. 
Examples of Search Terms for “COVID-19” and “Virtual” Used to Identify Missed 
and Virtual Visits .................................................................................................................. 123 
 
 
LIST OF IN-TEXT FIGURES 
 
Figure 1-1. 
Study Schema ......................................................................................................................... 14 
Figure 3-1. 
Induction Studies (Cohorts A and B): Testing Strategy for the Primary and Key 
Secondary Hypotheses ............................................................................................................ 25 
Figure 3-2. 
Maintenance Study: Testing Strategy for the Primary and Key Secondary 
Hypotheses ............................................................................................................................. 27 
Figure 3-3. 
Induction Studies (Cohorts A and B): Testing Strategy for the Primary and Key 
Secondary Hypotheses ............................................................................................................ 29 
Figure 3-4. 
Maintenance Study: Testing Strategy for the Primary and Key Secondary 
Hypotheses ............................................................................................................................. 31 
 


Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
Version 2.0 
CONFIDENTIAL 
Page 6 
 
15 January 2023 
LIST OF ABBREVIATIONS 
 
6-MP 
6-mercaptopurine 
AE 
adverse event 
AEI 
adverse event of interest 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
AST 
aspartate aminotransferase 
ASTE 
arterial systemic thromboembolism 
BLQ 
below the limit of quantitation 
BMI 
body mass index 
CD 
Crohn’s disease 
CDAI 
Crohn’s Disease Activity Index 
CI 
confidence interval 
CMH 
Cochran-Mantel-Haenszel 
COVID-19 
coronavirus disease 2019 
 
 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
DMC 
data monitoring committee 
ECG 
electrocardiogram 
eCRF 
electronic case report form(s) 
 
 
 
 
ET 
early termination 
EU 
European Union 
FAS 
Full Analysis Set 
FWER 
family-wise type I error rate 
 
 
Gilead 
Gilead Sciences 
 
 
HDL 
high-density lipoprotein 
HLGT 
high-level group term 
HLT 
high-level term 
 
 
 
 
IBD 
inflammatory bowel disease 
 
 
ID 
identification 
Ig 
immunoglobulin 
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI


Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
Version 2.0 
CONFIDENTIAL 
Page 7 
 
15 January 2023 
IWRS 
interactive web response system 
LDL 
low-density lipoprotein 
LLOQ 
lower limit of quantitation 
LLT 
lower-level term 
LOCF 
last observation carried forward 
LOQ 
limit of quantitation 
LS 
least squares 
LTE 
long-term extension 
MACE 
major adverse cardiovascular events 
M-Day 
maintenance study day 
MedDRA 
Medical Dictionary for Regulatory Activities 
MH 
Mantel-Haenszel 
MI 
myocardial infarction 
MICE 
multivariate imputation by chained equations 
 
 
MST 
MedDRA search term 
MTX 
methotrexate 
NCEP 
National Cholesterol Education Program 
NLP 
natural language processing 
 
 
PGIC 
Patient Global Impression Change 
PGIS 
Patient Global Impression Severity 
PK 
pharmacokinetic 
PKAP 
Pharmacokinetic analysis plan 
PRO2 
patient reported outcome consisting of 2 items: abdominal pain severity and liquid stool 
frequency 
PT 
preferred term 
PTM 
placebo-to-match 
Q1 
first quartile  
Q3 
third quartile 
 
 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SD 
standard deviation 
SE 
standard error 
SES-CD 
Simple Endoscopic Score for Crohn’s Disease 
 
 
SMQ 
Standardised MedDRA Query 
SOC 
system organ class 
T-Day 
subject activation date on the electronic diary device during screening 
CCI
CCI
CCI
CCI


Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
Version 2.0 
CONFIDENTIAL 
Page 8 
 
15 January 2023 
TEAE 
treatment-emergent adverse event 
TFLs 
tables, figures, and listings 
TNF-α 
tumor necrosis factor-alpha 
ULN 
upper limit of normal 
US 
United States 
V-Day 
visit day 
VAS 
visual analogue scale 
VTE 
venous thromboembolism 
WHO 
World Health Organization 
 
  
 
PHARMACOKINETIC ABBREVIATIONS 
 
AUC 
area under the concentration versus time curve 
AUCtau 
area under the concentration versus time curve over the dosing interval 
Cmax 
the maximum observed concentration of drug in plasma 
CLss/F 
apparent oral clearance at steady state 
Ctau 
observed drug concentration at the end of the dosing interval 
Tmax 
the time (observed time point) of Cmax 
 
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1. 
INTRODUCTION 
This statistical analysis plan (SAP) describes all statistical analyses methods required to address 
both the EU and non-EU specific objectives. It also describes all tables, figures, and listings 
(TFLs) to be included in the clinical study report (CSR) for Study Protocol GS-US-419-
3895/GLPG0634-CL-309. 
This SAP is based on the study protocol Amendment 9 dated 02 December 2021 and the 
electronic case report forms (eCRF). The SAP will be approved before database finalization of 
the final analysis. Any changes made after the finalization of the SAP will be documented in the 
CSR. 
1.1. 
Study Objectives 
The overall objective of the study is to evaluate the effect of treatment with filgotinib on the 
induction and maintenance of clinical remission and endoscopic response in subjects with 
moderately to severely active Crohn’s disease (CD). Subjects who are biologic-naive or 
biologic-experienced will be enrolled in Cohort A and subjects who are biologic-experienced 
will be enrolled in Cohort B, respectively. Treatment assignments will be randomized within 
each cohort. 
1.1.1. 
Primary Objectives 
The primary objectives are: 
Induction Studies (Cohorts A and B) (EU-specific) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by Patient Reported Outcome (PRO2) at Week 10 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic 
response at Week 10 
Induction Studies (Cohorts A and B) (other: non-EU) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by Crohn’s Disease Activity Index (CDAI) at Week 10 
To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic response 
at Week 10 
Maintenance Study (EU-specific) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by PRO2 at Week 58 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic 
response at Week 58 


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Maintenance Study (other: non-EU) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by CDAI at Week 58 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing endoscopic 
response at Week 58 
1.1.2. 
Secondary Objectives 
The key secondary objectives are: 
Induction Studies (Cohorts A and B) (EU-specific) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by Crohn’s Disease Activity (CDAI) at Week 10  
• To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical 
remission by PRO2 and endoscopic response (combined into a single endpoint on a patient 
level at Week 10 
Induction Studies (Cohorts A and B) (other: non-EU) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by Patient Reported Outcomes (PRO2) at Week 10  
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical response 
by CDAI at Week 10 
Maintenance Study (EU-specific) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by CDAI at Week 58 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing sustained 
clinical remission by PRO2 at Weeks 10 and 58 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing both clinical 
remission by PRO2 and endoscopic response (combined into a single endpoint on a patient 
level) at Week 58 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing 6-month 
corticosteroid-free remission by PRO2 at Week 58 
Maintenance Study (other non-EU) 
• To evaluate the efficacy of filgotinib as compared to placebo in establishing clinical 
remission by PRO2 at Week 58 










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1.2.1. 
Induction Studies (Cohort A and B) 
Subjects who meet protocol eligibility criteria will be assigned to the respective cohort and 
subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments as follows: 
Treatment Groups (Induction Studies) 
Treatment Group 1 (n = 220): Filgotinib 200 mg and placebo-to-match (PTM) filgotinib 
100 mg, once daily 
Treatment Group 2 (n = 220): Filgotinib 100 mg and PTM filgotinib 200 mg, once daily 
Treatment Group 3 (n = 220): PTM filgotinib 200 mg and PTM filgotinib 100 mg, once daily 
Note: males in the US and Korea who have not failed at least 2 biologic therapies (ie, any tumor 
necrosis factor-alpha [TNF-α] antagonist and vedolizumab) will be randomized in a 1:1 ratio to 
receive either filgotinib 100 mg or matching placebo. 
Based on the interactive web response system (IWRS) design, biologic-experienced subjects will 
not enroll in Cohort A until the enrollment for Cohort B has been closed. For subjects enrolled in 
Cohort A before the closure of Cohort B enrollment, treatment assignments will be stratified 
according to the following factors: 
Stratification Factors (Cohort A, Biologic-Naive and Biologic-Experienced Induction 
Study, before Closure of Cohort B Enrollment) 
• Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No) 
• Concomitant use of immunomodulators (eg, 6-mercaptopurine [6-MP], azathioprine, 
methotrexate [MTX]) at Day 1, (Yes or No) 
For subjects enrolled in Cohort A after the closure of Cohort B enrollment, treatment 
assignments will be stratified according to the following factors: 
Stratification Factors (Cohort A, Biologic-Naive and Biologic-Experienced Induction 
Study, after Closure of Cohort B Enrollment) 
• History of exposure to no biologic agent, one biologic agent, or more than one biologic agent 
• Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No) 
• Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
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For subjects enrolled in Cohort B, treatment assignments will be stratified according to the 
following factors: 
Stratification Factors (Cohort B, Biologic-Experienced Induction Study) 
• Exposure to one biologic agent versus more than one biologic agent 
• Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No) 
• Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
(Yes or No) 
1.2.2. 
Maintenance Study 
Subjects in Cohorts A and B who complete the Induction Study and achieve either clinical 
remission by PRO2 or endoscopic response at Week 10 will be re-randomized into the following 
treatments in the Maintenance Study at Week 11.  
Table 1-1. 
Re-Randomization of Induction Cohorts A and B to Maintenance 
Study 
Treatment Assignment in Induction Studies, Cohorts A and B 
Maintenance Study Re-randomization 
Treatment 1, filgotinib 200 mg 
Treatment 1, 200 mg 
Treatment 3, placebo 
Treatment 2, filgotinib 100 mg 
Treatment 2, 100 mg 
Treatment 3, placebo 
Treatment 3, placebo 
Continue Treatment 3, placebo 
Note: Subjects receiving Treatment 1 or 2 in the Induction study will be randomized in a 2:1 ratio to either continue on the 
assigned filgotinib regimen or to placebo for the duration of the Maintenance Study.   
For subjects enrolled in Maintenance before the closure of Induction Cohort B enrollment, 
treatment assignments will be stratified according to the following factors: 
Stratification Factors (Maintenance Study, before the Closure of Induction Cohort B 
Enrollment) 
• Participation in Cohort A or Cohort B 
• Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No) 
• Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
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For subjects enrolled in Maintenance after the closure of Induction Cohort B enrollment, 
treatment assignments will be stratified according to the following factors: 
Stratification Factors (Maintenance Study, after the Closure of Induction Cohort B 
Enrollment) 
• History of exposure to a biologic agent, (Yes or No) 
• Concomitant use of oral, systemically absorbed corticosteroids (eg, prednisone) at Day 1, 
(Yes or No) 
• Concomitant use of immunomodulators (eg, 6-MP, azathioprine, MTX) at Day 1, 
(Yes or No) 
Subjects who achieve neither clinical remission by PRO2 nor endoscopic response at Week 10 
will have the option to enter a separate, Long-Term Extension (LTE) study 
(GS-US-419-3896/GLPG0634-CL-310). The Maintenance Study will run from Weeks 11 to 58 
with the primary efficacy assessments at Week 58. Subjects who opt out of the LTE study will 
return 30 days after the last dose of study drug for post-treatment safety assessments. Subjects 
who complete all procedures per protocol, including the endoscopy, of the 58-week study will be 
offered the option to continue into the LTE study. Subjects who are eligible and opt to participate 
in the LTE study can continue into the study without post-treatment safety assessments. 
1.2.3. 
Pharmacokinetics Substudy 
An optional PK substudy will be performed in a subset of subjects (approximately 30 subjects 
each in Cohort A and Cohort B) who provide separate informed consent. In the PK substudy, the 
daily dose of study drug should be administered under supervision in the clinic (at any single 
visit between Week 2 and Week 10, inclusive), and PK samples should be collected predose and 
at 0.5, 1, 2, 3, 4, and 6 hours after dosing. If a substudy PK sample is scheduled to be collected at 
the same time as a sparse PK sample, only one sample should be collected. 
1.2.4. 
Schedule of Assessments  
Efficacy will be assessed primarily through CDAI, PRO2, and Simple Endoscopic Score for 
Crohn’s Disease (SES-CD). CDAI and PRO2 will be assessed at Screening, Weeks 2, 4, 6, 10, 
14, 20, 26, 34, 42, 50, and 58, and ET. SES-CD will be assessed at Screening, Week 10, and 
Week 58.  
For additional details, please see the Schedule of Assessments in Appendix 1.  


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1.3. 
Sample Size and Power 
Induction Studies (Cohorts A and B) 
EU-specific: 
The sample size was chosen to ensure that a clinically meaningful difference in both clinical 
remission rate by PRO2 at Week 10 and endoscopic response rate at Week 10 could be detected 
when comparing filgotinib 200 mg to placebo within each Induction Study. 
A sample size of 220 subjects in each treatment group (N = 660 total) will provide an overall 
power of 93% for a filgotinib 200 mg dose group comparison to placebo at a 2-sided 
0.05 significance level to detect a treatment difference of 15% in clinical remission rate by PRO2 
at Week 10 (30% on filgotinib 200 mg and 15% on placebo) and a treatment difference of 
15% in endoscopic response rate at Week 10 (25% on filgotinib 200 mg and 10% on placebo). 
Since each endpoint needs to achieve statistical significance, the overall power of 93% is 
calculated as the product of the two individual powers based on each endpoint. 
Other (non-EU) 
The sample size was chosen to ensure that a clinically meaningful difference in both clinical 
remission rate by CDAI at Week 10 and endoscopic response rate at Week 10 could be detected 
when comparing filgotinib 200 mg to placebo within each Induction Study. 
A sample size of 220 subjects in each treatment group (N = 660 total) will provide an overall 
power of 97% for a filgotinib 200 mg dose group comparison to placebo at a 2-sided 
0.05 significance level to detect a treatment difference of 20% in clinical remission rate by CDAI 
at Week 10 (45% on filgotinib 200 mg and 25% on placebo) and a treatment difference of 
15% in endoscopic response rate at Week 10 (25% on filgotinib 200 mg and 10% on placebo). 
Since each endpoint needs to achieve statistical significance, the overall power of 97% is 
calculated as the product of the two individual powers based on each endpoint. 
Maintenance Study 
Assuming an Induction response rate (ie, proportion of subjects achieving clinical remission by 
PRO2 or endoscopic response at Week 10) of 40% among subjects receiving filgotinib 200 mg 
or filgotinib 100 mg treatment, approximately 176 subjects from each filgotinib dose group from 
Cohorts A and B Induction Studies combined would be eligible to be re-randomized into the 
Maintenance Study.  
The sample size was chosen to ensure that a clinically meaningful difference in both clinical 
remission rate by CDAI and endoscopic response rate at Week 58 could be detected when 
comparing the filgotinib 200 mg dose group to placebo in the Maintenance Study. 
A sample size of 60 subjects in the placebo group and 120 subjects in the filgotinib group at the 
same dose level as the induction dose will provide an overall 94% power for a filgotinib 200 mg 


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comparison to placebo at a 2-sided 0.05 significance level to detect a treatment difference of 
30% in maintenance clinical remission rate by CDAI/PRO2 at Week 58 and maintenance 
endoscopic response rate at Week 58 (50% on filgotinib 200 mg and 20% on placebo). Since 
each endpoint needs to achieve statistical significance, the overall power of 94% is calculated as 
the product of the two individual powers based on each endpoint. 


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2. 
TYPE OF PLANNED ANALYSIS 
2.1. 
Data Monitoring Committee (DMC) Analyses 
The DMC’s role and responsibilities and the scope of analysis to be provided to the DMC are 
described in a mutually agreed upon charter, which defines the DMC membership, meeting 
logistics, and meeting frequency. 
2.1.1. 
Safety Analyses 
An external multidisciplinary DMC will review the progress of the study and perform interim 
reviews of safety data in order to protect subject welfare and preserve study integrity. The DMC 
is to recommend to the sponsor whether the nature, frequency, and severity of adverse events 
(AEs) associated with study treatment warrant the early termination of the study in the best 
interests of study subjects, whether the study should continue as planned, or whether the study 
should continue with modifications.   
The initial meeting will occur after approximately 100 subjects complete Week 10 or discontinue 
from the study in Cohorts A and B combined. Following this, subsequent meetings will occur 
approximately once every 4 months or at a frequency determined by the DMC. Additional 
meetings may be triggered by safety findings, predetermined or otherwise.  
2.1.2. 
Cohorts A and B End-of-Induction Analysis 
Efficacy and safety analyses will be performed after all subjects in both cohorts complete 
Week 10 or prematurely discontinue study drug (and complete post-treatment assessments, if 
applicable). Please refer to Section 6.5 for details. 
2.2. 
Final Analysis 
After all subjects have completed the Maintenance Study, outstanding data queries have been 
resolved or adjudicated as unresolvable, and the data have been cleaned and finalized, the study 
blind will be broken and the final analysis of the data will be performed. 


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3. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES 
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 Randomized Analysis Set. Data 
collected on log forms, such as AEs, will be presented in chronological order within subject. The 
treatment group to which subjects were randomized or initially assigned will be used in the 
listings. 
Unless otherwise specified, for the Maintenance Study, the data will be summarized by the 
Induction dose (ie, filgotinib 200 mg, filgotinib 100 mg, or placebo) and respective Maintenance 
dose, and overall for subject disposition and baseline characteristics described in Section 4 and 
Section 5, respectively. The data will be summarized by the Induction dose (ie, filgotinib 
200 mg, filgotinib 100 mg) and respective Maintenance dose for efficacy and 
 
described in Section 6 and Section 9, respectively. The data will be summarized by the Induction 
dose (ie, filgotinib 200 mg, filgotinib 100 mg or placebo) and respective Maintenance dose for 
safety analyses described in Section 7. The data will be summarized by Maintenance treatment 
group for PK analyses described in Section 8. 
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 
TFL. 
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 will be provided by subject. 
3.1.1. 
All Randomized Analysis Sets 
The All Randomized Analysis Set for each Induction Study (Cohorts A and B) includes all 
subjects who were randomized on Day 1 into each corresponding study.  
The All Randomized Analysis Set for the Maintenance Study includes all subjects who were 
re-randomized into the Maintenance Study (including subjects randomized to the placebo 
treatment group in the Induction Studies who continued on placebo treatment in the Maintenance 
Study). 
The All Randomized Analysis Sets are the primary analysis sets for by-subject listings. 
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3.1.2. 
Full Analysis Sets 
The Full Analysis Set (FAS) for each Induction Study (Cohorts A and B) includes all 
randomized subjects who took at least 1 dose of study drug in the corresponding Induction 
Study. 
The FAS for the Maintenance Study includes all subjects randomized to either the filgotinib 
200 mg or filgotinib 100 mg treatment groups in the Induction Studies who were re-randomized 
in the Maintenance Study and: 
• Took at least 1 dose of study drug in the Maintenance Study, and 
• Achieved clinical remission by PRO2 or endoscopic response at Week 10 as specified in the 
SAP. 
The Full Analysis Sets are the primary analysis sets for efficacy analyses. 
3.1.3. 
Safety Analysis Sets 
The Safety Analysis Set for each Induction Study (Cohorts A and B) includes all subjects who 
took at least 1 dose of study drug in the corresponding Induction Study. 
The Safety Analysis Set for the Maintenance Study includes all subjects who took at least 1 dose 
of study drug in the Maintenance Study.  
The Safety Analysis Sets are the primary analysis sets for safety analyses. 
3.1.4. 
Pharmacokinetic Analysis Sets 
The primary analysis set for general PK analyses will be defined separately for each individual 
study (Cohort A Induction, Cohort B Induction, and Maintenance). For each study, the PK 
Analysis Set includes all randomized subjects who took at least 1 dose of filgotinib and have at 
least 1 nonmissing concentration value for filgotinib and/or its metabolite GS-829845 reported 
by the PK laboratory. 
3.1.5. 
Pharmacokinetic Substudy Analysis Sets 
The primary analysis set for intensive PK analyses will be the PK Substudy Analysis Set for each 
Induction Study (Cohorts A and B), which includes all randomized subjects from the 
corresponding Induction Study who took at least 1 dose of filgotinib, participated in the PK 
substudy, and have at least 1 nonmissing intensive concentration value for filgotinib and/or its 
metabolite GS-829845 reported by the PK laboratory. This is the primary analysis set for 
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individual study (Cohort A Induction Study, Cohort B Induction Study, and Maintenance Study). 
This procedure strongly protects the FWER on all the primary and key secondary endpoints. 
3.5.1. 
EU-Specific 
3.5.1.1. 
Induction Studies (Cohorts A and B) 
The hypotheses to be tested for the Induction Studies are outlined below.  
The primary null hypotheses to be tested: 
• Hଵଵ: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10 
• Hଵଶ: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10 
• Hଶଵ: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10 
• Hଶଶ: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10 
The key secondary null hypotheses to be tested: 
• Hଵଷ: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10 
• Hଵସ: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
endpoint on a patient level) in the filgotinib 200 mg group is equal to the clinical remission 
by PRO2 and endoscopic response rate (combined into a single endpoint on a patient level) 
in the placebo group at Week 10 
• Hଶଷ: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10  
• Hଶସ: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
endpoint on patient level) in the filgotinib 100 mg group is equal to the clinical remission by 
PRO2 and endoscopic response rate (combined into a single endpoint on a patient level) in 
the placebo group at Week 10 


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Each co-primary endpoint for filgotinib 200 mg compared with placebo will be tested at 2-sided 
0.05 significance level first. If it fails to reject the null hypothesis for at least one co-primary 
endpoint, then no further formal testing will be performed. If the null hypotheses for both 
co-primary endpoints are rejected, testing will proceed in two sequences as describe below: 
• Key secondary endpoints for filgotinib 200 mg compared with placebo at 2-sided 
0.025 significance level in a sequential order 
• Each co-primary endpoint for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level. If the null hypotheses for both co-primary endpoints are rejected, 
then the key secondary endpoints for filgotinib 100 mg compared with placebo at 2-sided 
0.025 significance level will be tested in a sequential order 
If all the null hypotheses within the same sequence are rejected, then the respective alpha can be 
passed on to the other sequence. If an endpoint fails to reach statistical significance within the 
sequence, then formal testing will stop, and only nominal significance will be reported for the 
remaining endpoints. 
A graphical illustration of the testing strategy for the primary and key secondary hypotheses in 
the Induction Studies is shown in Figure 3-1. 
Figure 3-1. 
Induction Studies (Cohorts A and B): Testing Strategy for the 
Primary and Key Secondary Hypotheses 
 
 
3.5.1.2. 
Maintenance Study 
The hypotheses to be tested for the Maintenance Study are outlined below.  


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The primary null hypotheses to be tested: 
• Hଵଵ: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58 
• Hଵଶ: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58 
• Hଶଵ: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58 
• Hଶଶ: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58 
The key secondary null hypotheses to be tested: 
• Hଵଷ: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58 
• Hଵସ: The sustained clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to 
sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58  
• Hଵହ: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
endpoint on a patient level) in the filgotinib 200 mg group is equal to the clinical remission 
by PRO2 and endoscopic response rate (combined into a single endpoint on a patient level) 
in the placebo group at Week 58 
• Hଵ଺: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 200 mg group 
is equal to the 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58 
• Hଶଷ: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58 
• Hଶସ: The sustained clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to 
sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58 
• Hଶହ: The clinical remission by PRO2 and endoscopic response rate (combined into a single 
endpoint on a patient level) in the filgotinib 100 mg group is equal to the clinical remission 
by PRO2 and endoscopic response rate (combined into a single endpoint on a patient level) 
in the placebo group at Week 58 
• Hଶ଺: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 100 mg group 
is equal to the 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58 


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A similar approach as in the induction studies will be followed. A graphical illustration for the 
testing strategies for the primary and key secondary hypotheses in the Maintenance Study is 
shown in Figure 3-2. 
Figure 3-2. 
Maintenance Study: Testing Strategy for the Primary and Key 
Secondary Hypotheses 
 
 
3.5.2. 
Other (non-EU) 
3.5.2.1. 
Induction Studies (Cohorts A and B) 
The hypotheses to be tested for the Induction Studies are outlined below.  
The primary null hypotheses to be tested: 
• Hଵଵ: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10 


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• Hଵଶ: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10 
• Hଶଵ: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 10 
• Hଶଶ: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 10 
The key secondary null hypotheses to be tested: 
• Hଵଷ: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10 
• Hଵସ: The clinical response by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 10 
• Hଶଷ: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 10  
• Hଶସ: The clinical response by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 10 
A similar approach as for the EU-specific endpoints will be followed.  A graphical illustration of 
the testing strategy for the primary and key secondary hypotheses in the Induction Studies is 
shown in Figure 3-3. 


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Figure 3-3. 
Induction Studies (Cohorts A and B): Testing Strategy for the 
Primary and Key Secondary Hypotheses 
 
 
3.5.2.2. 
Maintenance Study 
The hypotheses to be tested for the Maintenance Study are outlined below.  
The primary null hypotheses to be tested: 
• Hଵଵ: The clinical remission by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58 
• Hଵଶ: The endoscopic response rate in the filgotinib 200 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58 
• Hଶଵ: The clinical remission by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical remission by CDAI rate in the placebo group at Week 58 
• Hଶଶ: The endoscopic response rate in the filgotinib 100 mg group is equal to the endoscopic 
response rate in the placebo group at Week 58 
The key secondary null hypotheses to be tested: 


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• Hଵଷ: The clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58  
• Hଵସ: The clinical response by CDAI rate in the filgotinib 200 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 58  
• Hଵହ: The sustained clinical remission by CDAI rate in the filgotinib 200 mg group is equal to 
sustained clinical remission by CDAI rate in the placebo group at Weeks 10 and 58 
• Hଵ଺: The 6-month corticosteroid-free remission by CDAI rate in the filgotinib 200 mg group 
is equal to the 6-month corticosteroid-free remission by CDAI rate in the placebo group at 
Week 58 
• Hଵ଻: The sustained clinical remission by PRO2 rate in the filgotinib 200 mg group is equal to 
the sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58 
• Hଵ଼: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 200 mg group 
is equal to 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58 
• Hଶଷ: The clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to the 
clinical remission by PRO2 rate in the placebo group at Week 58  
• Hଶସ: The clinical response by CDAI rate in the filgotinib 100 mg group is equal to the 
clinical response by CDAI rate in the placebo group at Week 58  
• Hଶହ: The sustained clinical remission by CDAI rate in the filgotinib 100 mg group is equal to 
sustained clinical remission by CDAI rate in the placebo group at Weeks 10 and 58 
• Hଶ଺: The 6-month corticosteroid-free remission by CDAI rate in the filgotinib 100 mg group 
is equal to the 6-month corticosteroid-free remission by CDAI rate in the placebo group at 
Week 58 
• Hଶ଻: The sustained clinical remission by PRO2 rate in the filgotinib 100 mg group is equal to 
the sustained clinical remission by PRO2 rate in the placebo group at Weeks 10 and 58 
• Hଶ଼: The 6-month corticosteroid-free remission by PRO2 rate in the filgotinib 100 mg group 
is equal to 6-month corticosteroid-free remission by PRO2 rate in the placebo group at 
Week 58 
A similar approach as for the EU-specific endpoints will be followed. A graphical illustration for 
the testing strategies for the primary and key secondary hypotheses in the Maintenance Study is 
shown in Figure 3-4. 


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Figure 3-4. 
Maintenance Study: Testing Strategy for the Primary and Key 
Secondary Hypotheses 
 
 
 
 


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3.6. 
Missing Data and Outliers 
3.6.1. 
Missing Data 
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this document. 
For missing last dosing date of study drug, imputation rules are described in Section 4.2.1. 
Imputation and calculation rules for missing patient diary data and other CDAI components are 
described in Appendix 3. Imputation and calculation rules for missing SES-CD data are 
described in Section 6.1.2. The handling of missing or incomplete dates for AE onset is 
described in Section 7.1.5.2 and for prior and concomitant medications in Section 7.4. 
3.6.2. 
Outliers 
Outliers will be identified during the data management and data analysis process. 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 
presentation in listings. If an enrolled subject was not dosed with any study drug, the 
randomization date will be used instead of the first dosing date of study drug. For screen failures, 
the date the informed consent was signed will be used for age calculation. If only birth year is 
collected on the eCRF, “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. 
Duration of CD (years) is the number of years between the diagnosis date of CD and date of first 
dose of Induction study drug. The partial diagnosis date of CD (if any) will be imputed for 
calculation as follows: 
• If day and month are missing but year is available, then the imputed day and month will be 
01 Jan. 
• If day is missing but the month and year are available, then the imputed day will be the 
first day of the month. 
• Partial date will not be imputed if the year is missing. 


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Non-PK 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 LOQ will be used for calculation of descriptive statistics if 
the datum is reported in the form of “ x” (where x is considered the LOQ). For example, 
if the values are reported as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used 
for calculation of 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 for calculation of summary statistics. 
• A value that is 1 unit above the LOQ will be used for calculation of descriptive statistics if 
the datum is reported in the form of “> x” (where x is considered the LOQ). Values with 
decimal points will follow the same logic as above. 
• The LOQ will be used for calculation of descriptive statistics if the datum is reported in the 
form of “≤ x” or “≥ x” (where x is considered the LOQ). 
Natural logarithm transformation will be used for plasma concentrations and analysis of PK 
parameters. Plasma concentration values that are below the limit of quantitation (BLQ) will be 
presented as “BLQ” in the concentration data listing. Values that are BLQ will be treated as 0 at 
predose time points, and one-half the value of the LOQ at postbaseline time points. 
The following conventions will be used for the presentation of summary and order statistics:  
• If at least 1 subject has a concentration value of BLQ for the time point, the minimum value 
will be displayed as “BLQ.” 
• If more than 25% of the subjects have a concentration data value of BLQ for a given time 
point, the minimum and Q1 values will be displayed as “BLQ.” 
• If more than 50% of the subjects have a concentration data value of BLQ for a given time 
point, the minimum, Q1, and median values will be displayed as “BLQ.” 
• If more than 75% of the subjects have a concentration data value of BLQ for a given time 
point, the minimum, Q1, median, and Q3 values will be displayed as “BLQ.” 
• If all subjects have concentration data values of BLQ for a given time point, all order 
statistics (minimum, Q1, median, Q3, and maximum) will be displayed as “BLQ.” 
Pharmacokinetic parameters that are BLQ will be imputed as one-half LOQ before log 
transformation or statistical model fitting. 


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3.8. 
Analysis Visit Windows 
3.8.1. 
Definitions 
3.8.1.1. 
Induction Studies (Cohorts A and B) 
The First Dosing Date of each Induction Study is defined as the date when subjects take the first 
dose of Induction study drug, as recorded in the Study Drug Administration eCRF.  
The Last Dosing Date of each Induction Study is defined as the date when subjects take the last 
dose of Induction study drug as recorded in the Study Drug Administration eCRF.  
Study Day will be calculated from the first dosing date of study drug and derived as follows: 
• For days on or after first dosing date: Assessment Date – First Dosing Date + 1 
• For days prior to the first dosing date: Assessment Date – First Dosing Date  
Therefore, Study Day 1 is the day of the first dose of study drug administration. 
Baseline is defined as the last available observation on or prior to the first dosing date, unless 
otherwise specified.  
3.8.1.2. 
Maintenance Study 
The First Dosing Date of Maintenance Study is defined as the date when subjects take the first 
dose of Maintenance Study drug, as recorded in the Study Drug Administration eCRF. 
The Last Dosing Date of Maintenance Study is defined as the date when subjects take the last 
dose of Maintenance Study drug as recorded in the Study Drug Administration eCRF.  
Maintenance Study Day (M-Day) will be calculated from the First Dosing Date of Maintenance 
Study and derived as:  
• For days on or after First Dosing Date of Maintenance Study: 
Assessment Date – First Dosing Date + 1 
• For days prior to First Dosing Date of Maintenance Study: 
Assessment Date – First Dosing Date  
Therefore, M-Day 1 is the first dosing date of the Maintenance Study. 
Re-randomization baseline (henceforth referred to as maintenance baseline) is defined as the last 
available observation on or prior to the first dosing date of the Maintenance Study. Maintenance 
baseline will be considered the baseline of Maintenance Study, unless otherwise specified. 




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Table 3-2. 
Analysis Visit Windows for Induction Study: Weight, Vital Signs, 
ECG, Hematology, Chemistry, Lipid Profile, Serum Immunoglobulin, 
 
Nominal Visit 
Analysis Visit 
Nominal Day 
(Study Day) 
Lower Limit  
(Study Day) 
Upper Limit 
(Study Day) 
Screening/Day 1 
Baseline 
1 
(none) 
1 
Week 2 
Week 2 
15 
2 
22 
Week 4 
Week 4 
29 
23 
36 
Week 6 
Week 6 
43 
37 
57 
Week 10 
Week 10 
71 
58 
For subjects who 
entered Maintenance 
Study: minimum of 
85 and Study Day of 
[Maintenance first 
dose date]; 
For other subjects: 
≥ 71 
ECG = electrocardiogram; 
 
 
 
 
 
 
 
 
 
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Table 3-4. 
Analysis Visit Windows for Maintenance Study: CDAI, PRO2, 
 
SES-CD, PGIS and PGIC 
Nominal Visit 
Analysis Visit 
Nominal Day 
(M-Day) 
Lower Limit  
(M-Day) 
Upper Limit 
(M-Day) 
Week 10/Week 11 
Maintenance -baseline 
1 
(none) 
1 
Week 14 
Maintenance Week 3 
22 
2 
43 
Week 20 
Maintenance Week 9 
64 
44 
85 
Week 26 
Maintenance Week 15 
106 
86 
134 
Week 34 
Maintenance Week 23 
162 
135 
190 
Week 42 
Maintenance Week 31 
218 
191 
246 
Week 50 
Maintenance Week 39 
274 
247 
302 
Week 58 
Maintenance Week 47 
330 
303 
358 
CDAI = Crohn’s Disease Activity Index; 
 M-Day = maintenance study day; 
 PGIC = patient global impression change; PGIS = patient global impression severity; 
PRO2 = patient reported outcome consisting of 2 items: abdominal pain severity and liquid stool frequency; SES-CD = simple 
endoscopic score for Crohn’s disease. 
Note: For analysis purpose, PRO2 from Weeks 10 and 11 will be considered for the derivation of maintenance baseline, which is 
defined as the last available observation on or prior to the first dosing date of the study drug in Maintenance Study. 
Note: PGIC at maintenance baseline will not be created. 
 
 
 
 
 
 M-Day = maintenance study day  
 
 
 
 
 
 
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Table 3-6. 
Analysis Visit Windows for Maintenance Study: Weight, Vital Signs, 
ECG, Hematology, Chemistry, Lipid Profile, Serum Immunoglobulin 
and 
  
Nominal Visit 
Analysis Visit 
Nominal Day 
(M-Day) 
Lower Limit  
(M-Day) 
Upper Limit 
(M-Day) 
Week 10/Week 11 
Maintenance baseline 
1 
(none) 
1 
Week 14 
Maintenance Week 3 
22 
2 
43 
Week 20 
Maintenance Week 9 
64 
44 
85 
Week 26 
Maintenance Week 15 
106 
86 
134 
Week 34 
Maintenance Week 23 
162 
135 
190 
Week 42 
Maintenance Week 31 
218 
191 
246 
Week 50 
Maintenance Week 39 
274 
247 
302 
Week 58 
Maintenance Week 47 
330 
303 
≥ 330 
ECG = electrocardiogram; 
 M-Day = maintenance study day 
Maintenance baseline will be calculated using Week 11 assessment if available. If there is no Week 11 assessment scheduled, the 
Week 10 assessment will be used for calculation. 
 
 
 
 
  
M-Day = maintenance study day 
Maintenance baseline will be calculated using Week 11 assessment if available. If there is no Week 11 assessment scheduled, the 
Week 10 assessment will be used for calculation. 
 
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3.8.3. 
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window 
Depending on the statistical analysis method, single values may be required for each analysis 
window. For example, change from baseline by visit usually requires a single value, whereas a 
time-to-event analysis would not require 1 value per analysis window. 
If multiple, valid, nonmissing, continuous measurements exist in an analysis window, 
records will be chosen based on the following rules if a single value is needed: 
• In general, the baseline/maintenance baseline value will be the last nonmissing value on or 
prior to the first dosing date of study drug for each individual Induction Study, and 
Maintenance Study, respectively, unless otherwise specified. If multiple measurements occur 
on the same day, the last nonmissing value prior to the first dose of study drug will be 
considered as the baseline value. If these multiple measurements occur at the same time or 
the time is not available, the average of these measurements (for continuous data) will be 
considered the baseline/maintenance baseline value.  
• For postbaseline visits: 
⎯ The record closest to the nominal day for that visit will be selected. 
⎯ If there are 2 records that are equidistant from the nominal day, the later record will be 
selected. 
⎯ If there is more than 1 record on the selected day, the average will be taken, 
unless otherwise specified. 
If multiple, valid, nonmissing, categorical measurements exist in an analysis window, 
records will be chosen based on the following rules if a single value is needed: 
• For baseline/maintenance baseline, the last available record on or prior to the date of the first 
dose of study drug for each individual study (Cohort A Induction, Cohort B Induction, and 
Maintenance) will be selected. If there are multiple records with the same time or no time 
recorded on the same day, the value with the lowest severity will be selected (eg, normal will 
be selected over abnormal for safety ECG findings). 
• For postbaseline visits:  
⎯ The record closest to the nominal day for that visit will be selected. 
⎯ If there are 2 records that are equidistant from the nominal day, the later record will be 
selected. 
⎯ If there is more than 1 record on the selected day, the worst severity will be taken 
(eg, abnormal will be selected over normal for safety ECG findings), unless otherwise 
specified. 
⎯ For shift tables for safety endpoints, the worst severity within the analysis window will 
be used. 


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3.9. 
Assessment of Coronavirus Disease 2019 Impact 
This study is ongoing during the coronavirus disease 2019 (COVID-19) pandemic, which has 
had an impact on study conduct. For example, some subjects were unable to attend onsite visits 
due to shelter-in-place guidelines, site closures, or other public health measures in response to 
the COVID-19 pandemic. Due to these restrictions, virtual visits may be conducted and 
alternative assessments (eg, local laboratory tests) may be used to assess subject safety and 
efficacy. 
The assessment on the impact of the COVID-19 pandemic will be provided in the corresponding 
sections (mainly on subject disposition, efficacy analyses and safety analyses in Sections 4, 6, 
and 7, respectively) throughout this SAP.  
Laboratory results from local laboratories (except hematocrit) due to COVID-19 impact will not 
be collected in the eCRF. Vital signs collected at home (except body weight) during virtual visits 
due to COVID-19 impact will not be collected in the eCRF. Hematocrit results collected from 
local laboratories, body weight measured at home due to COVID-19 impact will be used in 
CDAI calculations only, and will not be included in the safety summary (Sections 7.2. and 7.3, 
respectively). All laboratory and vital sign data collected will be included in listings, with a flag 
to indicate which records were collected at a local laboratory or at home, respectively. 


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4. 
SUBJECT DISPOSITION 
4.1. 
Subject Enrollment and Disposition 
For each individual study (Cohort A Induction, Cohort B Induction, and Maintenance), key study 
dates (ie, first subject screened, first subject randomized, last subject randomized, last subject 
last visit for each co-primary endpoint, and last subject last visit for the CSR) will be provided. 
For each individual study (Cohort A Induction, Cohort B Induction, and Maintenance), 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. 
For each individual study (Cohort A Induction, Cohort B Induction, and Maintenance), a similar 
enrollment table will be provided by randomization stratum. The denominator for the percentage 
of subjects in the stratum will be the total number of enrolled subjects. If there are discrepancies 
in the value used for stratification assignment between the IWRS and the clinical database, the 
value collected in the clinical database will be used for the summary. Subjects with discrepancies 
in the value used for stratification assignment between the IWRS and the clinical database at the 
time of data finalization will be summarized by treatment group and overall. A corresponding 
listing will also be provided. 
The randomization schedule used for each individual study (Cohort A Induction, 
Cohort B Induction, and Maintenance) will be provided as an appendix to the CSR. 
Cohort A Induction Study and Cohort B Induction Study 
A summary of subject disposition will be provided by treatment group and overall for each 
individual Induction study. This summary will present the number of subjects screened, the 
number of subjects who met all eligibility criteria but were not randomized with reasons subjects 
were not randomized, the number of subjects randomized, and the number of subjects in each of 
the categories listed below: 
• Full Analysis Set 
• Safety Analysis Set 
• PK Analysis Set 
• PK Substudy Analysis Set 
• 
 
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• Completed study drug dosing through Week 10 (indicated in Induction Study Drug 
Completion eCRF) 
• Continuing study drug (for analysis other than the final analysis) 
• Did not complete study drug up to Week 10 with reasons for premature discontinuation of 
study drug 
• Completed Induction Study through Week 11 
• Continuing Induction Study (for analysis other than the final analysis) 
• Did not complete Induction Study with reasons for premature discontinuation from the study 
Maintenance Study 
A summary of subject disposition will be provided by treatment group and overall. This 
summary will present the number of subjects who completed the Induction Studies, the number 
of subjects re-randomized, and the number of subjects in each of the categories listed below: 
• Full Analysis Set 
• Safety Analysis Set 
• PK Analysis Set 
• 
 
• Completed study drug dosing through Week 58  
• Did not complete study drug with reasons for premature discontinuation of study drug as 
captured in the CRF. 
• Completed Maintenance Study (defined as completion of protocol-planned duration of the 
study through Week 58) 
• Did not complete Maintenance Study with reasons for premature discontinuation from the 
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 in that study.  
A similar summary as described for subject disposition summary will be provided for 
discontinuing study drug or study due to COVID-19. 
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The following by-subject listings will be provided by subject identification (ID) number in 
ascending order to support the above summary tables: 
• Reasons for premature study drug or study discontinuation (a separate listing of reasons for 
premature study drug or study discontinuation due to COVID-19 will be created) 
• Reasons for screen failure (will be provided by screening ID number in ascending order) 
• 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 to the study drug specified in the protocol. 
Summaries of extent of study drug exposure and adherence will be provided for: 
• Cohort A Induction Study 
• Cohort B Induction Study  
• Maintenance Study  
A by-subject listing will be provided to support summaries.  
In addition, a by-subject listing of study drug administration will be created for subjects with 
study drug interruption due to COVID-19 impact. 
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 haves stopped treatment or the study as indicated by a study 
disposition record), the latest date among the treatment (study) disposition, clinical visit date, 
laboratory sample collection date, and vital sign assessment date that occurred during the on-
treatment period (e.g. after exposure start date) will be used. 
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 for the following using 
descriptive statistics and using the number (ie, cumulative counts) and percentage of subjects 
exposed through the following time periods: 
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• Cohort B Induction Study: 1 day, 2 weeks, 4 weeks, 6 weeks, 10 weeks, and 11 weeks 
• Maintenance Study: 1 day, 3 weeks, 9 weeks, 15 weeks, 23 weeks, 31 weeks, 39 weeks, and 
47 weeks 
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 administered will be summarized using descriptive statistics.  
The presumed total number of tablets administered to a subject will be determined by the data 
collected on the drug accountability eCRF using the following formula. 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 purpose. 
The total number of tablets administered =  
 
Total number of tables dispensed – total number of tablets returned 
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 administered relative to the total amount of study drug expected to be 
administered 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: 
Total Amount of Study Drug Administered
On-Treatment Adherence (%) = 
 x 100
Study Drug Expected to be Administered on Treatment






 
 
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 administration and drug accountability will be provided by 
subject ID number (in ascending order) and visit (in chronological order). 


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4.3. 
Protocol Deviations  
Subjects who did not meet the eligibility criteria for study entry, but enrolled in the study will be 
summarized. 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 and overall based on the All Randomized 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 major protocol deviations by deviation 
reason (eg, nonadherence to study drug, violation of key inclusion/exclusion criteria) will be 
summarized by treatment group and overall for the All Randomized Analysis Set for each 
individual study. A by-subject listing will be provided for those subjects with any major protocol 
deviation.  
Similar summary and listing will be provided for major protocol deviations due to COVID-19.  
4.4. 
Missed and Virtual Visits due to COVID-19  
A summary 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 Randomized 
Analysis Set for each individual study. For each visit, the summary 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.  
An overall summary 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 > 3 missed or virtual 
visits) due to the COVID-19 pandemic will be provided by treatment group and overall.  
A by-subject listing 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 was collected as free text in the 
CRF comment fields. The determination of missing or virtual visits due to COVID-19 was done 
using Natural Language Processing (NLP) to search the CRF comment fields. A detailed 
explanation of the algorithm is given in Appendix 7. 


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5. 
BASELINE CHARACTERISTICS 
5.1. 
Demographics and Other Baseline Characteristics 
For the Induction Studies (Cohorts A and B), subject demographic variables and other baseline 
characteristics will be summarized by treatment group and overall using descriptive statistics for 
continuous variables and using the number and percentage of subjects for categorical variables. 
The summary of demographic data will be provided for the Safety Analysis Set. 
• Age (years, on the date of first dose of the study drug) 
• Age group (< 65 years, ≥ 65 years) 
• Sex at birth (female, male) 
• Race 
• Ethnicity (Hispanic or Latino, Not Hispanic or Latino) 
• Geographic region (United States [US], non-US) 
• Weight 
• Height 
• Body mass index (BMI; in kg/m2) 
• Smoking status (former, current, never)  
For the Maintenance Study, the same demographic variables will be summarized by treatment 
group and overall. Baseline age from the Induction Study will be used for the Maintenance 
Study.  
A by-subject demographic listing, including the informed consent date, will be provided by 
subject ID number in ascending order. 
5.2. 
Baseline Disease Characteristics 
For the Induction Studies (Cohorts A and B) and Maintenance Study, the following baseline 
disease characteristics will be summarized for the Safety Analysis Sets using descriptive 
statistics for continuous variables, and using number and percentage of subjects for categorical 
variables: 
• Duration of CD (years) from date of diagnosis to first dosing date of study drug 
• Duration of CD (< 1 year, ≥ 1 to < 3 years, ≥ 3 to < 7 years, ≥ 7 years) 


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• CDAI score (Induction Studies only) 
• PRO2 subscores: liquid or very soft stool subscore and abdominal pain subscore (Induction 
Studies only) 
⎯ Liquid or very soft stool subscore ≥ 4 
⎯ Abdominal pain subscore (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) 
⎯ Abdominal pain subscore ≥ 2  
⎯ Liquid or very soft stool subscore ≥ 4 and abdominal pain subscore ≥ 2 
• Total PRO2 score (Induction Studies only) 
• Total SES-CD score (Induction Studies only)  
• Number of available segments with SES-CD at Induction baseline 
• Location of CD based on SES-CD at Induction baseline: ileum only, colon only, ileum and 
colon 
• Complications of CD: 
⎯ Fistula (yes, no) 
⎯ Stricture (yes, no) 
⎯ Abscess (yes, no) 
• History of surgeries due to CD (yes, no) 
• 
 
 
• 
 
 
• 
 
• 
 
• CD treatment history 
⎯ Prior use of systemic corticosteroids (yes, no) 
⎯ Prior use of immunomodulators (yes, no) 
⎯ Number of prior exposures to biologic agent (0, 1, 2, ≥ 3) as listed in Appendix 2  
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⎯ Prior use of TNF-α antagonist as listed in Appendix 2 (yes, no) and for subjects with 
prior use: 
■ Number of TNF-α antagonists used 
○ 1 
○ 2 
○ ≥ 3 
■ Worst outcome of prior use of TNF-α antagonist  
○ Treatment failure 
○ Intolerance, including both allergic and non-allergic intolerance 
○ Other 
⎯ Prior use of vedolizumab (yes, no) and for subjects with prior use: 
■ Worst outcome of prior use of vedolizumab 
○ Treatment failure 
○ Intolerance, including both allergic and non-allergic intolerance 
○ Other 
⎯ Prior use of both TNF-α antagonist and vedolizumab (yes, no) 
⎯ Prior use of ustekinumab (yes, no) and for subjects with prior use: 
■ Worst outcome of prior use of ustekinumab 
○ Treatment failure 
○ Intolerance, including both allergic and non-allergic intolerance 
○ Other 
Note: The worst outcome of a prior treatment is treatment failure, followed by intolerance, 
and then other outcomes. 
⎯ Prior failure of both TNF-α antagonist and vedolizumab  
■ Yes (dual refractory, defined as those who have failed at least 2 classes of biologic 
therapies [any TNF-α antagonist and vedolizumab]) 
○ United States (US)/Korea Males 
○ Subjects other than US/Korea Males 


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■ No  
○ US/Korea Males 
○ Subjects other than US/Korea Males 
• Concomitant treatment at baseline (or maintenance baseline for Maintenance Study) 
⎯ Concomitant use of systemically absorbed corticosteroid and/or immunomodulator at 
baseline/maintenance baseline, including: a) systemically absorbed corticosteroid only, 
b) immunomodulator only, c) both, and d) neither; 
⎯ Prednisone equivalent dose for subjects who are on systemically absorbed corticosteroid 
at baseline/maintenance baseline (mg/day) 
⎯ Prednisone equivalent dose for subjects who are on systemically absorbed corticosteroid 
at baseline/maintenance baseline (> 0 to 10 mg/day, > 10 to 20 mg/day, > 20 - 
30 mg/day, >30 mg/day) 
⎯ Concomitant use of 5-aminosalicylates (yes, no) at baseline/maintenance baseline 
In addition, another baseline characteristics table for Maintenance Study using the FAS will be 
generated, including the above baseline characteristics except those marked as “Induction 
Studies only” and the following additional variables:  
• CDAI score at maintenance baseline  
• PRO2 subscores at maintenance baseline: abdominal pain and liquid or very soft stool 
subscores 
• Total PRO2 score at Week 10 
• Total SES-CD score at Week 10 
• Clinical remission by CDAI (yes, no) at Week 10 
• Clinical response by CDAI (yes, no) at Week 10 
• Clinical remission by PRO2 (yes, no) at Week 10 
• Endoscopic response (yes, no) at Week 10 
• 
 
 
  
• 
 
  
5.3. 
Medical History 
Medical history (disease-specific and general conditions) and IBD family history data will be 
collected at screening and presented in data listings. 
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General medical history data will be coded using the current version of Medical Dictionary for 
Regulatory Activities (MedDRA). 






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CD = Crohn’s Disease; CDAI = Crohn’s Disease Activity Index; PRO2 = patient reported outcome consisting of 2 items: 
abdominal pain severity and liquid stool frequency; SES-CD = Simple Endoscopic Score for Crohn’s Disease 
Subjects who achieve either clinical remission by PRO2 or endoscopic response at Week 10 will 
be eligible to be re-randomized into the Maintenance Study.  
Summary of Dichotomous Efficacy Endpoints 
For the Cohort A Induction Study, the Cohort B Induction Study, and the Maintenance Study, 
numbers and percentages of subjects achieving each of the dichotomous efficacy endpoints 
defined above, and numbers and percentages of subjects not achieving those endpoints for the 
following reasons will be summarized by treatment, in a hierarchy order with the first reason 
being the highest.  
1) Data censored due to initiation or change of rescue medication 
2) Subjects who do not meet the endpoint based on observed data 
3) Subjects who do not meet the endpoint due to study drug discontinuation led by 
protocol-specified disease worsening (Maintenance Study only) 
4) Subjects who do not have sufficient measurements to determine the endpoint due to study 
drug discontinuation for other reasons  
5) Subjects who do not have sufficient measurements to determine the endpoint for other 
reasons  
Non-Responder Imputation 
For analysis of all the above defined efficacy endpoints in Table 6-1, subjects who do not have 
sufficient measurements due to any reason (eg, study treatment failure, early study 
discontinuation) to determine the endpoint will be considered non-responders (ie, non-responder 
imputation).  
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 clinical remission by CDAI 
endpoint is defined by the total CDAI score, calculated as a weighted sum of all 8 component 
subscores. If subjects have 3 or more of the 8 component subscores missing, then the subjects 
will be considered as having insufficient data to determine response status and their total CDAI 
score will be considered missing. If subjects have 1 or 2 CDAI components missing, then the 
missing component will be imputed by the LOCF method using the previous valid component 
score from the most recent analysis visit (ie, use the component score from Week 6 for missing 






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• Delayed ileocolonoscopy (occurring after the upper limit of the analysis visit window, as 
defined in Section 3.8.2) 
6.2. 
Primary Efficacy Endpoints 
6.2.1. 
Definition of the Primary Efficacy Endpoints 
EU-specific: 
The co-primary efficacy endpoints are the proportion of subjects achieving clinical remission by 
PRO2 at Week 10 and the proportion of subjects achieving endoscopic response at Week 10 for 
each Induction Study (Cohorts A and B), and the proportion of subjects achieving clinical 
remission by PRO2 at Week 58 and the proportion of subjects achieving endoscopic response at 
Week 58 for the Maintenance Study. Refer to Table 6-1 for the endpoint definitions. 
Other (non-EU): 
The co-primary efficacy endpoints are the proportion of subjects achieving clinical remission by 
CDAI at Week 10 and the proportion of subjects achieving endoscopic response at Week 10 for 
each Induction Study (Cohorts A and B), and the proportion of subjects achieving clinical 
remission by CDAI at Week 58 and the proportion of subjects achieving endoscopic response at 
Week 58 for the Maintenance Study. Refer to Table 6-1 for the endpoint definitions. 
6.2.2. 
Statistical Hypotheses for the Primary Efficacy Endpoints 
For each Induction Study (Cohorts A and B), the primary analysis will compare a filgotinib dose 
group to placebo on the proportion of subjects achieving clinical remission by CDAI at Week 10 
and on the proportion of subjects achieving endoscopic response at Week 10. The primary 
statistical hypotheses at Weeks 10 for each Induction Study are listed in Section 3.5.2.1.  
Similarly, for the Maintenance Study, the primary analysis will compare a filgotinib dose group 
to placebo among the subjects from Cohort A and Cohort B Induction Studies combined being 
treated with the same filgotinib dose in Induction Studies on the proportion of subjects achieving 
clinical remission by CDAI at Week 58 and on the proportion of subjects achieving endoscopic 
response at Week 58. The primary statistical hypotheses at Weeks 58 for the Maintenance Study 
are listed in Section 3.5.2.2.  
For EU-specific analyses, for a filgotinib dose group to demonstrate a significant treatment effect 
over placebo, statistical significance needs to be achieved on both clinical remission by PRO2 
and endoscopic response endpoints at the significance level as specified in Section 3.5. For other 
(non-EU) analyses, for a filgotinib dose group to demonstrate a significant treatment effect over 
placebo, statistical significance needs to be achieved on both clinical remission by CDAI and 
endoscopic response endpoints. 
6.2.3. 
Estimands for the Primary Efficacy Endpoints 
The EU-specific co-primary endpoints are: 


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- 
Clinical remission by PRO2 
- 
Endoscopic response 
The other (non- EU) co-primary endpoints are: 
- 
Clinical remission by CDAI 
- 
Endoscopic response 
6.2.3.1. 
Clinical Remission by PRO2 
The ICH E9 (R1) guidance {U. S. Department of Health & Human Services (DHHS) 2021} 
specifies that an estimand is characterized by five attributes (the treatment, the population, the 
subject level endpoint, handling of intercurrent events, and the population level summary).  
Based on the definitions of the different types of estimands in the ICH E9 (R1), our primary 
estimate of clinical remission by PRO2 endpoint will use a composite estimand (Table 6-2). A 
second composite estimand is also proposed as a sensitivity analysis (Table 6-3).  
Table 6-2. 
Composite Estimand 1 (Primary Analysis) for Clinical Remission by 
PRO2 
Attributes 
Composite Estimand 1 
Treatment 
Filgotinib 200 mg, filgotinib 100 mg, or placebo 
Population 
Full Analysis Set as defined in Section 3.1.2 
Subject level endpoint  
PRO2 clinical remission status (Yes/No) at Week 10 for Induction Studies and at 
Week 58 for Maintenance Study 
If abdominal pain score ≤ 1 and liquid or very soft stool frequency ≤ 3, then the 
subject will be defined as achieving clinical remission at Week 10 or at Week 58, 
respectively. If the above remission criterion is not met or the PRO2 (any 
component) is missing, the subject will be considered as not achieving clinical 
remission by PRO2. 
Handling of missing data 
due to intercurrent events  
Subjects who meet treatment failure criteria (ie, take potentially effective 
medications other than study treatment as defined in Appendix 6) or prematurely 
discontinue from the study without available assessment result are considered as not 
achieving clinical remission by PRO2 
Population-level 
summary  
Difference in proportions in clinical remission by PRO2, comparing a filgotinib 
dose group to placebo group 
 
Table 6-3. 
Composite Estimand 2 (Sensitivity Analysis) for Clinical Remission by 
PRO2 
Attributes 
Composite Estimand 2 
Treatment 
Filgotinib 200 mg, filgotinib 100 mg, or placebo 
Population 
Full Analysis Set as defined in Section 3.1.2 
Subject-level endpoint  
PRO2 clinical remission status (Yes/No) at Week 10 for Induction Studies and 
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If abdominal pain score ≤ 1 and liquid or very soft stool frequency  ≤ 3, then 
the subject will be defined as achieving clinical remission at Week 10 or at 
Week 58, respectively. If the above remission criterion is not met, the subject 
will be considered as not achieving clinical remission by PRO2. If PRO2 is 
missing (any subcomponent), then data will be analyzed using MICE as 
outlined in section 6.2.5. 
Handling of missing data due 
to intercurrent events  
Subjects who meet treatment failure criteria (ie, take potentially effective 
medications other than study treatment as defined in Appendix 6) or 
prematurely discontinue from the study without available assessment result are 
considered as not achieving clinical remission by PRO2 
Population-level summary  
Difference in proportions in clinical remission by PRO2, comparing a 
filgotinib dose group to placebo group 
 
6.2.3.2. 
Clinical Remission by CDAI 
The ICH E9 (R1) guidance {U. S. Department of Health & Human Services (DHHS) 2021} 
specifies that an estimand is characterized by five attributes (the treatment, the population, the 
subject level endpoint, handling of intercurrent events, and the population level summary). 
Because the 8 components of CDAI come from different data sources, the CDAI data may have 
missing data at component level (only some components are missing) as well as at subject level 
(all 8 components are missing). Because of this complication, the definition of the estimand is 
expanded to include 2 additional attributes in addition to the 5 delineated above. These 
2 additional attributes are: (1) the component level endpoint; and (2) the handling of missing data 
at component level endpoint.  
Using this expanded definition of an estimand and based on the definitions of the different types 
of estimands in the ICH E9 (R1), our primary estimate of clinical remission by CDAI endpoint 
will use a composite estimand (Table 6-4). For this composite estimand (estimand 1), the 
handling of missing data will be expanded to the component level in addition to the subject level. 
A second composite estimand is also proposed as a sensitivity analysis (Table 6-5).  
 
Table 6-4. 
Composite Estimand 1 (Primary Analysis) for Clinical Remission by 
CDAI 
Attributes 
Composite Estimand 1 
Treatment 
Filgotinib 200 mg, filgotinib 100 mg, or placebo 
Population 
Full Analysis Set as defined in Section 3.1.2 
Component-level endpoint  
CDAI subscore for each component at Week 10 for Induction Studies and at 
Week 58 for Maintenance Study 
Subject-level endpoint  
CDAI clinical remission status (Yes/No) at Week 10 for Induction Studies and at 
Week 58 for Maintenance Study 
If CDAI < 150, then the subject will be defined as achieving clinical remission at 
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or the CDAI is missing, the subject will be considered as not achieving clinical 
remission by CDAI. 
Handling of missing data 
(component-level endpoint) 
If the subscore for 1 or 2 components are missing at Week 10 (or Week 58), then 
the subscore will be imputed using LOCF imputation method (see Section 6.1.1). 
If the subscores for 3 or more components are missing, then missing subscores 
will not be imputed, and the CDAI will be considered missing. 
Handling of missing data 
due to intercurrent events 
(subject-level endpoint)  
Subjects who meet treatment failure criteria (ie, take potentially effective 
medications other than study treatment as defined in Appendix 6) or prematurely 
discontinue from the study without available assessment result are considered as 
not achieving clinical remission by CDAI 
Population-level summary  
Difference in proportions in clinical remission by CDAI, comparing a filgotinib 
dose group to placebo group 
CDAI = Crohn’s Disease Activity Index; LOCF = last observation carried forward 
Table 6-5. 
Composite Estimand 2 (Sensitivity Analysis) for Clinical Remission by 
CDAI 
Attributes 
Composite Estimand 2 
Treatment 
Filgotinib 200 mg, filgotinib 100 mg, or placebo 
Population 
Full Analysis Set as defined in Section 3.1.2 
Subject-level endpoint  
CDAI clinical remission status (Yes/No) at Week 10 for Induction Studies and 
at Week 58 for Maintenance Study  
If CDAI < 150, then the subject will be defined as achieving clinical remission 
at Week 10 or at Week 58, respectively. If the above remission criterion is not 
met, the subject will be considered as not achieving clinical remission by 
CDAI. If the CDAI is missing, then data will be analyzed using MICE as 
outlined in section 6.2.5. 
Handling of missing data due 
to intercurrent events 
(subject-level endpoint)  
Subjects who meet treatment failure criteria (ie, take potentially effective 
medications other than study treatment as defined in Appendix 6) or 
prematurely discontinue from the study without available assessment result are 
considered as not achieving clinical remission by CDAI 
Population-level summary  
Difference in proportions in clinical remission by CDAI, comparing a 
filgotinib dose group to placebo group 
CDAI = Crohn’s Disease Activity Index 
 
6.2.3.3. 
Endoscopic Response 
Intercurrent events can impact subjects at the segment level (eg, stricture) or at the subject level 
(eg, early termination of the study) for SES-CD data. Similar to the estimand for clinical 
remission by CDAI, the definition of the estimand for endoscopic response is expanded to 
include 2 additional attributes. These 2 additional attributes are: (1) the segment level outcome to 
be measured; and (2) the handling of intercurrent events impacting the segment. 
Using this expanded definition of an estimand and based on the definitions of the different types 
of estimands in the ICH E9(R1) guidance, the primary estimate of endoscopic response endpoint 


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will use a composite estimand (Table 6-6). A second composite estimand is also proposed as a 
sensitivity analysis (Table 6-7). For each estimand, the handling of missing data due to the 
intercurrent events will be expanded to the segment level in addition to the subject level. 
Table 6-6. 
Composite Estimand 1 (Primary Analysis) for Endoscopic Response 
Attributes 
Composite Estimand 1 
Treatment 
Filgotinib 200 mg, filgotinib 100 mg, or placebo 
Population 
Full Analysis Set as defined in Section 3.1.2 
Segment-level outcome to be 
measured 
SES-CD subscore for each segment at baseline and Week 10 for Induction 
Studies and at Week 58 for Maintenance Study 
Subject-level outcome to be 
measured 
Endoscopic response status (Yes/No) at Week 10 for Induction Studies and at 
Week 58 for Maintenance Study 
If the percentage reduction of total SES-CD from Induction baseline is ≥ 50%, 
then the subject will be defined as achieving endoscopic response at Week 10 
or at Week 58, respectively. If the above responder criterion is not met or total 
SES-CD is missing, the subject will be considered as not achieving endoscopic 
response. 
Measure of intervention effect 
& handling of missing data due 
to intercurrent events 
(segment-level outcome) 
If the subscore of a segment is missing at baseline, this segment will not be 
included in the calculation of the total SES-CD for all the visits. If the subscore 
of a segment is observed at baseline, but missing at Week 10 or Week 58, it 
will be imputed using a score of 12 (worst subscore from the sum of the 
4 variables in a segment). 
Measure of intervention effect 
& handling of missing data due 
to intercurrent events (subject-
level outcome)  
Subject who met treatment failure criteria (ie, take potentially effective 
medications rather than study treatment as defined in Appendix 6) or 
prematurely discontinued from study without available assessment result is 
considered a non-responder. 
Population-level summary 
measure  
Difference in proportions in endoscopic response, comparing a filgotinib dose 
group to placebo group 
SES-CD = Simple Endoscopic Score for Crohn’s Disease 
Table 6-7. 
Composite Estimand 2 (Sensitivity Analysis) for Endoscopic Response 
Attributes 
Composite Estimand 2 
Treatment 
Filgotinib 200 mg, filgotinib 100 mg, or placebo 
Population 
Full Analysis Set as defined in Section 3.1.2 
Segment-level outcome to be 
measured 
SES-CD subscore for each segment at baseline and Week 10 for Induction 
Studies and at Week 58 for Maintenance Study 
Subject-level outcome to be 
measured 
Endoscopic response status (Yes/No) at Week 10 for Induction Studies and 
at Week 58 for Maintenance Study 
If the percentage reduction of total SES-CD from Induction baseline is 
≥ 50%, then the subject will be defined as achieving endoscopic response at 


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Week 10 or at Week 58, respectively. If the above responder criterion is not 
met, the subject will be considered as not achieving endoscopic response. If 
total SES-CD is missing, then data will be analyzed using MICE as outlined 
in section 6.2.5. 
Measure of intervention effect & 
handling of missing data due to 
intercurrent events 
(segment-level outcome) 
All segments will be included in the total SES-CD calculation regardless of 
being missing or not. 
Measure of intervention effect & 
handling of missing data due to 
intercurrent events (subject-level 
outcome)  
Subject who met treatment failure criteria (ie, take potentially effective 
medications rather than study treatment as defined in Appendix 6) or 
prematurely discontinued from study without available assessment result is 
considered a non-responder. 
Population-level summary 
measure  
Difference in proportions in endoscopic response, comparing a filgotinib 
dose group to placebo group 
SES-CD = Simple Endoscopic Score for Crohn’s Disease 
6.2.4. 
Primary Analysis of the Primary Efficacy Endpoints 
Primary analysis will be conducted according to the composite estimand 1 specified in 
Section 6.2.3.  
For the individual Induction Studies (Cohort A and Cohort B), a stratified 
Cochran-Mantel-Haenszel (CMH) test will be used to compare the treatment effect between a 
filgotinib dose group (eg, 200 mg) and placebo. The CMH tests will be stratified by the 
following factors:  
Cohort A Induction Study: 
• Number of prior exposures to biologic agent (0, 1, > 1) as listed in Appendix 2  
• Concomitant use of oral, systemically absorbed corticosteroids at Day 1 
• Concomitant use of immunomodulators at Day 1 
Cohort B Induction Study: 
• Number of prior exposures to biologic agent (≤ 1, > 1) as listed in Appendix 2  
• Concomitant use of oral, systemically absorbed corticosteroids at Day 1 
• Concomitant use of immunomodulators at Day 1 
For the Maintenance Study, a stratified CMH test will be used to compare the treatment effect 
between a filgotinib dose group and placebo among the subjects from Induction Cohorts A and B 
combined being treated with the same dose of filgotinib. The CMH test will be stratified by the 
following factors: 


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• History of exposure to a biologic agent, (Yes or No) 
• Concomitant use of oral, systemically absorbed corticosteroids at maintenance baseline 
• Concomitant use of immunomodulators at maintenance baseline 
Stratification factors based on the clinical database will be used for the analysis. The stratified 
CMH chi-square p-value for each of the above comparison will be provided. Strata with low 
numbers of subjects might be aggregated for the analysis. The 2-sided 95% CI of clinical 
remission rate by CDAI and endoscopic response rate based on normal approximation method 
with a continuity correction will be provided for each treatment group. In addition, stratified 
proportion difference along with its 95% 2-sided CI using stratum-adjusted Mantel-Haenszel 
(MH) approach {Koch 1989} for each comparison will be provided as follows: 
The stratified point estimates for difference in proportion of subjects achieving an endpoint 
between each filgotinib (F) treatment group and the placebo (P) group will be calculated 
following formula (1). 
 
 
where 𝑑ℎ= 𝑝̂ிℎ−𝑝̂௉ℎ  is the difference in the proportion of subjects who achieved the endpoint 
between the filgotinib group and the placebo group in stratum ℎ (ℎ = 1, 2, …, K), and 𝑊ℎ=
௡ಷℎ௡ುℎ
௡ಷℎା௡ುℎ is the weight based on the harmonic mean of sample size per treatment group for each 
stratum where 𝑛ிℎand 𝑛௉ℎ are the sample sizes of the filgotinib group and the placebo group in 
stratum h, respectively. 
The 95% stratum-adjusted MH CIs will be calculated following formula (2). 
 
 
Where 𝑆𝐸(𝑝̂ி−𝑝̂௉) =
ඨ∑ௐℎ
మ൬
೛ෝಷℎ
∗(భష೛ෝಷℎ
∗)
೙ಷℎషభ
ା
೛ෝುℎ
∗(భష೛ෝುℎ
∗)
೙ುℎషభ
൰
∑ௐℎ
, 𝑝̂ிℎ
∗=
௠ಷℎା଴.ହ
௡ಷℎାଵ, 𝑝̂௉ℎ
∗=
௠ುℎା଴.ହ
௡ುℎାଵ, and 𝑚ிℎ and 
𝑚௉ℎ are the number of subjects who achieved the endpoint from the filgotinib group and the 
placebo group in stratum h, respectively. 𝑍(ଵିఈ/ଶ) is the 97.5% percentile of normal distribution 
with α = 0.05. 
If the computed lower confidence bound is less than −1, the lower bound is defined as −1. If the 
computed upper confidence bound is greater than 1, then the upper bound is defined as 1. 
The significance level specified in Section 3.5 will be used to declare a statistically significant 
treatment effect for a filgotinib dose group.  


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Bar charts of the proportions of subjects achieving clinical remission by PRO2 (EU), CDAI 
(non-EU) and endoscopic response at Week 10 (for the Induction Studies) and Week 58 (for the 
Maintenance Study) will be provided by treatment group with corresponding p-values.  
In addition, the proportion of subjects with percentage reduction of ≥ 25% from Induction 
baseline in total SES-CD score will be summarized for Week 10 (Induction Studies) and 
Week 58 (Maintenance Study), respectively. The number of available segments with SES-CD 
score at baseline and Week 10, and change from baseline at Week 10 for Induction Studies will 
be summarized. Similarly, the number of available segments with SES-CD score at Induction 
baseline and Week 58, and change from Induction baseline at Week 58 for Maintenance Study 
will be summarized. The score for each segment will be displayed in a data listing. If there is a 
missing segment score, the reason of missingness (if available) will be included. 
6.2.5. 
Sensitivity Analyses for the Primary Efficacy Endpoints 
6.2.5.1. 
Clinical Remission by PRO2 (EU-specific) 
Sensitivity analysis will be conducted according to the composite estimand 2 specified in 
Section 6.2.3.  
The multivariate imputation by chained equations (MICE) {Azur 2011} through regression 
model will be used to impute each missing subscore in PRO2. For Induction Studies, each 
subscore in PRO2 at baseline, Weeks 2, 4, 6, and 10, treatment, and stratification factors will be 
included in the imputation model using the Full Analysis Set. For the Maintenance Study, each 
subscore in PRO2 at maintenance baseline, Weeks 14, 20, 26, 34, 42, 50, and 58, treatment, and 
stratification factors will be included in the imputation model using the Full Analysis Set among 
the subjects from Induction Cohorts A and B combined being treated with the same dose of 
filgotinib. 
For each imputed dataset, the clinical remission status by PRO2 will be derived. The subjects 
who met treatment failure criteria or prematurely discontinued from the study without available 
result from the study will be set as not achieving clinical remission in each imputed dataset. The 
parameters of interest for each imputed dataset will be estimated using a similar method as the 
primary approach. The results from multiple imputations will be combined using Rubin’s rule 
{Rubin 1987}. 
In addition, tipping point analysis with delta-adjusting pattern-mixture approach {Ratitch 2013} 
will be conducted to assess the robustness of analysis result under the MNAR (missing not at 
random) assumption. The proposed method will perform a series of analyses after adjusting for 
stratification factors with a range of different values of the shift parameter δ applied to the 
imputed datasets at which the conclusion about the statistical significance of result will be 
altered. Specifically, the analysis is characterized by two-dimensional sequences (one sequence 
associated with missing data in the placebo group and the other associated with missing data in 
the filgotinib group). In the first step for both sequences, the missing data in both treatment 
groups are imputed under the missing at random (MAR) assumption. For each subsequent step of 
the placebo sequence, the missing data are imputed assuming incrementally more favorable than 
in the previous step of that sequence while holding the shift parameter constant in the filgotinib 


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group. Similarly, for each subsequent step of the filgotinib group sequence, the missing data are 
imputed assuming incrementally less favorable than in the previous step of that sequence while 
holding the shift parameter constant in the placebo group.  
Appendix 8 provides sample SAS model statements for the tipping point analysis. Each δ value 
is classified as either “altering the statistical significance conclusion” or “keeping the statistical 
significance conclusion unchanged.” The tipping points that alter the statistical significance 
conclusion will be provided. The same analysis method for the primary analysis as specified in 
Section 0 will be applied when analyzing the adjusted data generated under different δ values. 
6.2.5.2. 
Clinical Remission by CDAI (other: non-EU) 
Sensitivity analysis will be conducted according to the composite estimand 2 specified in 
Section 6.2.3.  
The multivariate imputation by chained equations (MICE) {Azur 2011} through regression 
model will be used to impute the missing CDAI. If the subscore for at least 1 component is 
missing, then the CDAI is considered missing. For Induction Studies, the CDAI at baseline, 
Weeks 2, 4, 6, and 10, treatment, and stratification factors will be included in the imputation 
model using the Full Analysis Set. For the Maintenance Study, the CDAI at maintenance 
baseline, Weeks 14, 20, 26, 34, 42, 50, and 58, treatment, and stratification factors will be 
included in the imputation model using the Full Analysis Set among the subjects from Induction 
Cohorts A and B combined being treated with the same dose of filgotinib. 
For each imputed dataset, the clinical remission status by CDAI will be derived. The subjects 
who met treatment failure criteria or prematurely discontinued from study without available 
result from study will be set as not achieving clinical remission in each imputed dataset. The 
parameters of interest for each imputed dataset will be estimated using a similar method as the 
primary approach. The results from multiple imputations will be combined using Rubin’s rule 
{Rubin 1987}. 
In addition, tipping point analysis with delta-adjusting pattern-mixture approach {Ratitch 2013} 
will be conducted to assess the robustness of analysis result under the MNAR (missing not at 
random) assumption. The proposed method will perform a series of analyses after adjusting for 
stratification factors with a range of different values of the shift parameter δ applied to the 
imputed datasets at which the conclusion about the statistical significance of result will be 
altered. Specifically, the analysis is characterized by two-dimensional sequences (one sequence 
associated with missing data in the placebo group and the other associated with missing data in 
the filgotinib group). In the first step for both sequences, the missing data in both treatment 
groups are imputed under the missing at random (MAR) assumption. For each subsequent step of 
the placebo sequence, the missing data are imputed assuming incrementally more favorable than 
in the previous step of that sequence while holding the shift parameter constant in the filgotinib 
group. Similarly, for each subsequent step of the filgotinib group sequence, the missing data are 
imputed assuming incrementally less favorable than in the previous step of that sequence while 
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Appendix 8 provides sample SAS model statements for the tipping point analysis. Each δ value 
is classified as either “altering the statistical significance conclusion” or “keeping the statistical 
significance conclusion unchanged.” The tipping points that alter the statistical significance 
conclusion will be provided. The same analysis method for the primary analysis as specified in 
Section 6.2.4 will be applied when analyzing the adjusted data generated under different δ 
values.  
6.2.5.3. 
Endoscopic Response 
Sensitivity analysis will be conducted according to the composite estimand 2 specified in 
Section 6.2.3.  
The MICE {Azur 2011} through regression model will be used to impute the missing segmental 
subscores. For Induction Studies, the segmental score at baseline and Week 10, treatment, and 
stratification factors will be included in the imputation model using the FAS. For the 
Maintenance Study, the segmental score at maintenance baseline and Week 58, treatment, and 
stratification factors will be included in the imputation model using the Full Analysis Set among 
the subjects from Induction Cohorts A and B combined being treated with the same dose of 
filgotinib.  
For each imputed dataset, the percentage change from Induction baseline in the total SES-CD 
score will be calculated for each subject and the endoscopic response status will be derived. The 
subjects who met treatment failure criteria or prematurely discontinued from study without 
available result will be set as non-responders in each imputed dataset. The parameters of interest 
for each imputed dataset will be estimated using a similar method as the primary approach. The 
results from multiple imputations will be combined using Rubin’s rule {Rubin 1987}. 
In addition, tipping point analysis with delta-adjusting pattern-mixture approach {Ratitch 2013} 
will be conducted to assess the robustness of analysis result under the MNAR (missing not at 
random) assumption (see Section 6.2.5.1). 
6.2.5.4. 
Clinical remission by PRO2 and Endoscopic Response 
A cross tabulation will be created showing number and proportion of subjects with response at 
Week 58 (clinical remission and endoscopic response, clinical remission by PRO2 only, 
endoscopic response only, and no endoscopic response and no clinical remission by PRO2) by 
outcome at Week 10: clinical remission by PRO2 and endoscopic response, clinical remission by 
PRO2 alone, clinical endoscopic response only, and no endoscopic response and no clinical 
remission by PRO2). This table will be based on the Safety Analysis Set. 
6.2.6. 
Analysis of the Primary Efficacy Endpoints for Japan Submission 
The following analysis will be conducted as the primary analysis for evaluating the co-primary 
endpoints for the filgotinib 200 mg dose group in each Induction Study in order to support a 
Japanese marketing application. 


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Given the restriction in the US/Korea of only allowing dual refractory males to receive filgotinib 
200 mg, there exists an inherent imbalance in each Induction Study between subjects randomized 
to filgotinib 200 mg and the placebo group with respect to US/Korea non-dual refractory males 
who will only be present in the placebo group, but not in the filgotinib 200 mg group. 
Recognizing this imbalance and the theoretical potential for non-dual refractory subjects to have 
better disease prognosis and a higher chance of response, an analysis excluding US/Korea 
non-dual refractory males from the placebo group in the FAS for each Induction Study will be 
conducted. Similar analysis method as specified in Section 6.2.4 will be used for the treatment 
comparison between the filgotinib 200 mg and the placebo group on clinical remission by CDAI 
and endoscopic response at Week 10.  
The primary analysis to support Japanese marketing application to evaluate efficacy of the 
filgotinib 100 mg dose group in each Induction Study will still be based on all the subjects in the 
FAS.  
6.2.7. 
Subgroup Analyses for the Primary and key secondary Efficacy Endpoints 
The following subgroup analyses of the primary efficacy endpoints will be performed for each 
individual study (Cohort A Induction, Cohort B Induction, and Maintenance).  
Subgroups based on study stratification factors include: 
Cohort A Induction Study Stratification Factors: 
• Number of prior exposures to biologic agent as listed in Appendix 2 (0, ≥1) 
• Concomitant use of oral, systemically absorbed corticosteroids at Day 1 (yes, no) 
• Concomitant use of immunomodulators at Day 1 (yes, no) 
Cohort B Induction Study Stratification Factors: 
• Number of prior exposures to biologic agent as listed in Appendix 2 (≤ 1, > 1) 
• Concomitant use of oral, systemically absorbed corticosteroids at Day 1 (yes, no) 
• Concomitant use of immunomodulators at Day 1 (yes, no) 
Cohort A and B Induction Studies Combined for Prior Exposure to Biologic Agent 
• Number of prior exposures to biologic agent as listed in Appendix 2 (0, ≥ 1) 


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Maintenance Study Stratification Factors: 
• History of exposure to a biologic agent (yes, no) 
• Concomitant use of oral, systemically absorbed corticosteroids at maintenance baseline 
(yes, no) 
• Concomitant use of immunomodulators at maintenance baseline (yes, no) 
Other subgroups for each individual study include:   
• Age group on the date of first dose of the study drug (< 65 years, ≥ 65 years) 
• Sex at birth (female, male) 
• Race (Asian, Black or African American, White, and Other) 
• Geographic region (US, non-US) 
• 
 
• 
 
 
 
• Duration of CD (years from date of diagnosed to first dosing date of Induction study drug) 
(< 1 year, ≥ 1 to < 3 years, ≥ 3 to < 7 years, ≥ 7 years) 
• Baseline disease activity (based on Induction baseline CDAI score) (< 300, ≥ 300)  
• Induction baseline SES-CD score (< 16, ≥ 16) 
• Previous exposure to TNF-α antagonist (yes, no)  
• Prior TNF-α antagonist failure (yes, no)  
• Previous exposure to vedolizumab (yes, no)  
• Prior vedolizumab failure (yes, no)  
• Dual refractory (yes, no)  
• The following 4 subgroups: 
⎯ US/Korean males who are dual refractory 
⎯ US/Korean males who are not dual refractory 
⎯ Non-US/Korean males (US/Korea females and subjects from countries other than US and 
Korea) who are dual refractory 
⎯ Non-US/Korean males who are not dual refractory  
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For a subject, if the value of the grouping variable cannot be determined, this subject will be 
excluded from the corresponding subgroup analysis. Non-stratified risk difference between 
treatment groups will be evaluated for each of the subgroups using Fisher’s exact test. A forest 
plot will graphically present the non-stratified risk difference and 95% CI using normal 
approximation with a continuity correction on the treatment differences (filgotinib – placebo) in 
each co-primary endpoint for each of the subgroups.  
Additional subgroup analyses for geographic region may be added based on the distribution of 
study enrollment prior to study unblinding. 
6.3. 
Secondary Efficacy Endpoints 
6.3.1. 
Definition of the Secondary Efficacy Endpoints 
6.3.1.1. 
EU-specific 
The key secondary efficacy endpoints are:  
Induction Studies (Cohorts A and B) 
• The proportion of subjects achieving clinical remission by CDAI at Week 10 
• The proportion of subjects achieving both clinical remission by PRO2 and endoscopic 
response (combined into a single endpoint on a patient level) at Week 10 
Maintenance Study 
• The proportion of subjects achieving clinical remission by CDAI at Week 58 
• The proportion of subjects achieving sustained clinical remission by PRO2 at Weeks 10 
and 58 
• The proportion of subjects achieving both clinical remission by PRO2 and endoscopic 
response (combined into a single endpoint on a patient level) at Week 58 
• The proportion of subjects achieving 6-month corticosteroid-free remission by PRO2 at 
Week 58 
Refer to Table 6-1 for the endpoint definitions. 
6.3.1.2. 
Other (non-EU) 
The key secondary efficacy endpoints are: 
Induction Studies (Cohorts A and B) 
• The proportion of subjects achieving clinical remission by PRO2 at Week 10 




















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7. 
SAFETY ANALYSES 
Unless otherwise specified, summaries of safety data will be provided for the Safety Analysis Set 
for Cohort A Induction Study, Cohort B Induction Study, and Maintenance Study, and will 
include data collected as specified below: 
Induction Studies (Cohorts A and B) 
• No later than 30 days after the last dosing date of Induction Study, for subjects who did not 
take any study treatment from Maintenance Study, or 
• On or before the first dosing date of Maintenance Study, for subjects who took any study 
treatment in Maintenance Study 
Maintenance Study  
• No later than 30 days after the last dosing date of Maintenance Study 
7.1. 
Adverse Events and Deaths 
7.1.1. 
Adverse Event Dictionary 
Clinical and laboratory AEs will be coded using a current 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 grade 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 adverse events are graded by the investigator as Grade 
1, 2, 3, 4, or 5 according to toxicity criteria specified in the protocol. 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 the 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 eCRF to the 
question of “Related to Study Treatment.” Relatedness will always reflect the investigator 
assessment of causality rather than the sponsor’s. 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. 


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7.1.4. 
Serious Adverse Events 
Serious adverse events (SAEs) will be identified and captured as SAEs if AEs met the definitions 
of SAE specified in the study protocol. SAEs captured and stored in the clinical database will be 
reconciled with the safety database before data finalization. 
7.1.5. 
Treatment-Emergent Adverse Events  
7.1.5.1. 
Definition of Treatment-Emergent Adverse Events 
Treatment-emergent adverse events (TEAEs) are defined as 1 or both of the following: 
Induction Studies (Cohorts A and B) 
• Any AEs with an onset date on or after the study drug start date for each Induction Study 
(Day 1) and  
⎯ No later than 30 days after the last dosing date of Induction Study, for subjects who did 
not take any study treatment from Maintenance Study, or 
⎯ Before the first dosing date of Maintenance Study, for subjects who took any study 
treatment in Maintenance Study 
• Any AEs leading to premature discontinuation of Induction Study drug  
Maintenance Study 
• Any AEs with an onset date on or after the study drug start date for the Maintenance Study 
and no later than 30 days after last dosing date of Maintenance Study 
• Any AEs leading to premature discontinuation of Maintenance Study drug  
7.1.5.2. 
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. For first dosing date and last dosing date 
defined for Induction Studies (Cohorts A and B) and Maintenance Study, please refer to 
Section 3.8.1. The event is considered treatment-emergent if both of the following 2 criteria are 
met: 


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Induction Studies (Cohorts A and B) 
• 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 last dosing date of Induction Study, for subjects who did not take any 
study treatment in Maintenance Study, or 
⎯ The day before the first dosing date of Maintenance Study, for subjects who took any 
study treatment in Maintenance Study 
Maintenance Study 
• The AE onset date is the same as or after the month and year (or year) of the first dosing date 
of Maintenance Study, 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 last dosing date of Maintenance Study 
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 an 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. 
7.1.6. 
Summaries of Adverse Events and Deaths 
Treatment-emergent AEs will be summarized based on the Safety Analysis Set for Cohort A 
Induction Study, Cohort B Induction Study, and Maintenance Study. 
No formal statistical testing is planned. 
7.1.6.1. 
Summaries of AE Incidence  
The number and percentage of subjects who experienced at least 1 TEAE will be provided and 
summarized by SOC, HLT, PT, and treatment group. For other AEs described below, summaries 
will be provided by SOC, PT, and treatment group: 
• TEAEs of Grade 3 or higher (by maximum severity) 
• TEAEs of Grade 2 or higher (by maximum severity) 
• All TE treatment-related AEs 
• TE treatment-related AEs of Grade 3 or higher (by maximum severity) 


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• TE treatment-related AEs of Grade 2 or higher (by maximum severity) 
• All TE SAEs 
• All TE treatment-related SAEs  
• All TEAEs leading to premature discontinuation of study drug 
• All TEAEs leading to premature discontinuation of study 
• All TE SAEs leading to death (ie, outcome of death) 
• All TEAEs leading to temporary dose interruption of study drug 
A brief, high-level summary of AEs described above will be provided by treatment group 
presenting the number and percentage of subjects who reported the above AEs. All deaths 
observed in the study will be also included in this summary. 
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and HLT within each SOC (if applicable), 
and then by PT in descending order of total frequency within each SOC. In addition, a summary 
of all AEs occurring at least 2% of subjects will be summarized by SOC and PT in order of 
descending frequency. 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, the following tables will be generated and summarized by PT only, in descending 
order of total frequency: 
• TEAEs 
• TEAEs of Grade 3 or higher 
• TEAEs of Grade 2 or higher 
• TE SAEs 
• TE treatment-related AEs 
• TE treatment-related SAEs   
• TEAEs leading to premature discontinuation of study drug 


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Data listings will be provided for the following: 
• All AEs, indicating whether the event is treatment-emergent 
• All AEs of Grade 3 or higher 
• All AEs of Grade 2 or higher 
• SAEs 
• Deaths 
• All AEs leading to death (ie, outcome of death) 
• AEs leading to premature discontinuation of study drug 
• AEs leading to premature discontinuation of study 
• AEs leading to dose temporary interruption of study drug 
• AEs related to COVID-19, as determined by the COVID-19 Standardised MedDRA Query 
(SMQ) narrow search 
In addition, an XML file will be created to support EUDRACT reporting 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 a system organ class level or at PT level (this XML file will be created 
in-house). 
7.1.7. 
Adverse Events of Interest 
Adverse events of interest (AEI) include infections, malignancies (excluding nonmelanoma skin 
cancers), nonmelanoma skin cancers, gastrointestinal perforations, 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 (SMQ), utilizing a narrow scope PTs 


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• AEs of malignancies, excluding nonmelanoma skin cancers, utilizing an MST list developed 
by the Sponsor 
• AEs of nonmelanoma skin cancers, utilizing an MST list developed by the Sponsor 
• AEs of gastrointestinal perforations, utilizing an MST list developed by the Sponsor 
• AEs of MACE, utilizing a positively adjudicated event list, presented in the following 
subcategories (Section 7.1.7.1): 
⎯ Cardiovascular (CV) death 
⎯ Non-fatal myocardial infarction (MI) 
⎯ Non-fatal stroke 
• AEs of arterial systemic thromboembolism (ASTE), utilizing a positively adjudicated event 
list (Section 7.1.7.1) 
• AEs of venous thromboembolism (VTE), utilizing a positively adjudicated event list 
(Section 7.1.7.1) 
A list of all AE PTs is provided in Appendix 9. 
The number and percentage of subjects with a reported event will be summarized for each 
treatment group by PT for each AEI category. A data listing for each category of AEI will also 
be provided. 
A by-subject listing for subjects with potential events for adjudication. For each AE, it will be 
described if the AE was adjudicated for a specific category (cardiovascular death, myocardial 
infarction, stroke, arterial systemic thromboembolism and venous thromboembolism) and their 
respective adjudication results (NA if not adjudicated for a specific category) 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). 
7.1.7.1. 
Cardiovascular Safety Endpoint Adjudication Committee 
An independent cardiovascular safety endpoint adjudication committee (CVEAC) will be 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 
will be sent for adjudication. Please refer to the Cardiovascular Event Adjudication Charter for 
more details. 
• All AEs leading to death 


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• 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 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. 
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 for Cohort A Induction Study, Cohort B Induction Study, and Maintenance 
Study. 
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. Test results from hemolyzed samples 
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 Common Terminology Criteria for Adverse Events 
(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 


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Descriptive statistics will be provided by treatment group for each laboratory test specified in the 
study protocol within hematology and chemistry panels, and also laboratory tests from lipids 
panel (under fasting status) including total cholesterol, low-density lipoprotein (LDL), 
high-density lipoprotein (HDL), triglycerides, non-HDL cholesterol (total cholesterol minus 
HDL cholesterol), LDL/HDL ratio, and total immunoglobulin (Ig), IgA, IgM, and IgG, as 
follows for each Induction Study: 
• Baseline values  
• Values at each postbaseline time point  
• Change from baseline at each postbaseline time point 
In addition, descriptive statistics for the laboratory tests described from above will be provided 
by treatment group for the Maintenance Study: 
• maintenance baseline values  
• Values at each postbaseline time point after maintenance baseline 
• Change from maintenance baseline at each postbaseline time point after maintenance 
baseline 
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date of first dose of study drug. Change from baseline to a postbaseline visit will be defined as 
the visit value minus the baseline value. A maintenance baseline laboratory value will be defined 
as the last measurement obtained on or prior to the date of first dose of study drug for the 
Maintenance Study, and change from maintenance baseline will be defined as the visit value 
minus the maintenance 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 (or maintenance baseline) values for 
aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, alkaline 
phosphatase, serum creatinine, creatinine clearance, creatine phosphokinase, white blood cell 
count, absolute neutrophils, absolute lymphocytes, hemoglobin, platelets, fasting total 
cholesterol, fasting LDL, fasting HDL, total Ig, IgG, IgA and IgM, will be plotted using a line 
plot by treatment group and visit. 
In the case of multiple values in an analysis window, data will be selected for analysis as 
described in Section 3.8.3. 


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7.2.2. 
Graded Laboratory Values 
Modified CTCAE 4.03 (see Appendix 6 of the protocol) will be used for assigning 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 
Induction Studies (Cohorts A and B) 
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, and  
• No later than 30 days after the last dosing date of Induction Study, for subjects who did not 
take any study treatment from Maintenance Study, or 
• On or before the first dosing date of Maintenance Study, for subjects who took any study 
treatment in Maintenance Study 
Maintenance Study  
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from maintenance baseline at any post maintenance baseline time point after first 
dosing date of Maintenance Study, no later than 30 days after the last dosing date of 
Maintenance Study drug.  
7.2.2.2. 
Treatment-Emergent Marked Laboratory Abnormalities 
Induction Studies (Cohorts A and B) 
Treatment-emergent marked laboratory abnormalities are defined as values that increase at least 
3 toxicity grades from baseline at any postbaseline time point, and 
• No later than 30 days after the last dosing date of Induction Study, for subjects who did not 
take any study treatment from the Maintenance Study, or 
• On or before the first dosing date of Maintenance Study, for subjects who took any study 
treatment in the Maintenance Study 
Maintenance Study  
Treatment-emergent marked laboratory abnormalities are defined as values that increase at least 
3 toxicity grades from maintenance baseline at any post maintenance baseline time point after the 
first dosing date of Maintenance Study, no later than 30 days after the last dosing date of 
Maintenance Study.  


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7.2.2.3. 
Summaries of Laboratory Abnormalities 
Laboratory data that are categorical will be summarized using the number and percentage of 
subjects in the study with the given response at baseline and each scheduled postbaseline time 
point for Cohort A Induction Study, Cohort B Induction Study, and at maintenance baseline and 
each scheduled time point after maintenance baseline for Maintenance Study. 
The following summaries (number and percentage of subjects) for treatment-emergent laboratory 
abnormalities will be provided by laboratory test and treatment group for Cohort A Induction 
Study, Cohort B Induction Study, and Maintenance Study. Subjects will be categorized 
according to the most severe postbaseline abnormality grade for a given laboratory test: 
• Graded laboratory abnormalities 
• Grade 3 or higher laboratory abnormalities 
• Marked laboratory abnormalities 
For all summaries of laboratory abnormalities, the denominator is the number of subjects with 
nonmissing postbaseline values. 
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 laboratory 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 for Cohort A Induction Study, Cohort B Induction 
Study, and Maintenance Study: 
• AST: (a) > 3 times of upper limit of the normal range (ULN); (b) > 5  ULN; 
(c) > 10  ULN; (d) > 20  ULN 
• ALT: (a) > 3  ULN; (b) > 5  ULN; (c) > 10  ULN; (d) > 20  ULN 
• AST or ALT > 3  ULN and total bilirubin > 2  ULN 
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. 


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7.2.4. 
Complete Blood Count-Related Laboratory Evaluations 
Complete blood count-related abnormalities such as anemia, leucopenia, neutropenia, 
lymphopenia, and thrombocytopenia 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 for Cohort A Induction Study, 
Cohort B Induction Study, and Maintenance Study, respectively. 
The list of laboratory tests to be examined is: 
• Hemoglobin 
• White blood cell count 
• Absolute neutrophil count 
• Lymphocyte count 
• Platelet count 
For each of the above laboratory test, the following will be summarized: 
• Postbaseline worsening CTCAE grade from baseline 
• Baseline value of less than Grade 3 and increase to Grade 3 or 4 at worst postbaseline 
• Baseline value of less than Grade 3 and increase to Grade 4 at worst postbaseline 
For Maintenance Study, maintenance baseline will be used in the summaries described above. 
7.2.5. 
Shifts Relative to the Baseline Value 
Shift tables will be presented by showing change in CTCAE grade for hemoglobin, platelet 
count, white blood cell count, absolute lymphocyte count, absolute neutrophils, triglycerides, and 
total cholesterol. 
Shift tables will be presented by showing change in lab normal range (low, normal, and high) for 
hematocrit, absolute monocyte count, absolute eosinophil count, and absolute basophil count. In 
addition, shift tables for fasting LDL and HDL will be presented  using the following National 
Cholesterol Education Program (NCEP) ATP III categories {National Cholesterol Education 
Program (NCEP) 2001}: 
• For LDL (mg/dL): < 100, 100-129, 130-159, 160-189, and ≥ 190  
• For HDL (mg/dL): < 40, ≥ 40 to < 60, and ≥ 60  


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In all shift tables, the number and proportion of subjects for each category of each laboratory 
result will be summarized by its baseline/maintenance baseline category for Cohort A Induction 
Study, Cohort B Induction Study, and Maintenance Study.  
For Induction Studies, shift tables will be presented for Week 10. For Maintenance Study, shift 
tables will be presented for Weeks 26 and 58. 
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 temperature) as follows for each Induction Study: 
• Baseline value 
• Values at each postbaseline time point  
• Change from baseline at each postbaseline time point  
In addition, descriptive statistics will be provided by treatment group for the Maintenance Study 
as follows: 
• Maintenance baseline values  
• Values at each time point after maintenance baseline 
• Change from maintenance baseline at each time point after maintenance baseline 
A baseline value will be defined as the last available value collected on or prior to the date of 
first dose of study drug. Change from baseline to a postbaseline visit will be defined as the 
postbaseline value minus the baseline value. A maintenance baseline value will be defined as the 
last measurement obtained on or prior to the date of first dose of study drug for the Maintenance 
Study, and change from maintenance baseline will be defined as the visit value minus the 
maintenance baseline value. Body weight and vital signs measured at unscheduled visits will be 
included for the baseline/maintenance baseline value selection.  
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. 


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7.4. 
Prior and Concomitant Medications 
Medications reported at screening and during the study will be coded using the current version of 
the World Health Organization (WHO) Drug dictionary. 
7.4.1. 
Prior Medications 
Prior medications are defined as any medication taken before a subject took the first dose of 
Induction Study drug for Induction Studies, and the first dose of Maintenance Study drug for 
Maintenance Study. 
General prior and CD-specific prior medications will be summarized separately by preferred 
name using the number and percentage of subjects for each treatment group and overall. 
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 by 2nd WHO ATC level and PT in descending overall frequency (for both ATC 
level and PT). For drugs with the same frequency, sorting will be done alphabetically. 
For the purposes of analysis, any medication with a start date prior to the first dosing date of 
study drug will be included in the prior medication summary regardless of when the stop date is. 
If a partial start date is entered the medication will be considered prior unless the month and year 
(if day is missing) or year (if day and month are missing) of the start date are after the 
first dosing date. Medications with a completely missing start date will be included in the prior 
medication summary, unless otherwise specified. 
Summaries will be based on the Safety Analysis Set for Cohort A Induction Study, Cohort B 
Induction Study, and Maintenance Study. No formal statistical testing is planned. 
7.4.2. 
Concomitant Medications 
General concomitant and CD-specific concomitant medications are defined as medications taken 
while a subject took study drug. Use of concomitant medications will be summarized by 2nd 
WHO ATC level and preferred name using the number and percentage of subjects in descending 
overall frequency (for both ATC level and PT). For drugs with the same frequency, sorting will 
be done alphabetically. 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 by PT in descending overall frequency. For drugs with the same 
frequency, sorting will be done alphabetically. 
First dosing date and last dosing date for Cohort A Induction Study, Cohort B Induction Study, 
and Maintenance Study are defined in Section 3.8. For the purposes of analysis, any medication 
with a start date prior to or on the first dosing date of study drug and continued to take 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 


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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 prior and 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. 
7.5. 
Electrocardiogram Results 
A shift table of the investigators’ assessment of ECG results at each visit compared with baseline 
(or maintenance baseline) values will be presented by treatment group for each Induction Study 
and Maintenance Study, using the following categories: normal; abnormal, not clinically 
significant; abnormal, clinically significant. The number and percentage of subjects in each 
cross-classification group of the shift table will be presented. Subjects with a missing value at 
baseline (or maintenance baseline) or postbaseline will not be included in the denominator for 
percentage calculation.  
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. 
7.7. 
Changes from Protocol-Specified Safety Analyses 
The following overall (Induction and Maintenance) safety analysis, indicated in the protocol, will 
not be conducted for this study. Details of the pooled analyses will be specified in the analysis 
plan for integrated safety summary. 
Overall (Induction and Maintenance) 
All safety data collected on or after the first dose of study drug administration for the entire study 
(Day 1) up to 30 days after permanent discontinuation of study drug will be summarized by 
treatment group according to the study drug received.  


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8. 
PHARMACOKINETIC ANALYSES 
The pharmacokinetic analyses are detailed in the pharmacokinetic analysis plan (PKAP) (see 
appendix 10). 
Additional PK analysis may be performed and exposure-response relationships may be explored. 
 
 


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CCI


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10. 
REFERENCES 
Azur MJ, Stuart EA, Frangakis C, Leaf PJ. Multiple Imputation by Chained Equations: What is it 
and how does it work? International journal of methods in psychiatric research 
2011;20 (1):9. 
Bretz F, Maurer W, Brannath W, Posch M. A Graphical Approach to Sequentially Rejective 
Multiple Test Procedures. Stat Med 2009;28:586-604. 
Daperno M, D'Haens G, Van Assche G, Baert F, Bulois P, Maunoury V, et al. Development and 
validation of a new, simplified endoscopic activity score for Crohn's disease: the 
SES-CD. Gastrointestinal endoscopy 2004;60 (4):505-12. 
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 
the assessment of Crohn's disease activity. Aliment Pharmacol Ther 2015;41 
(1):77-86. 
Koch GG, Carr GJ, Amara IA, Stokes ME, Uryniak TJ. Categorical Data Analysis. Chapter 13 in 
Berry, D.A. (ed.).  Statistical Methodology in the Pharmaceutical Sciences. New 
York: Marcel Dekker, Inc., 1989:pp. 414-21.  
National Cholesterol Education Program (NCEP). Detection, Evaluation, and Treatment of High 
Blood Cholesterol in Adults (Adult Treatment Panel III) Executive Summary. 
National Institute of Health  May, 2001. 
Ratitch B, O'Kelly M, Tosiello R. Missing data in clinical trials: from clinical assumptions to 
statistical analysis using pattern mixture models. Pharm Stat 2013;12 (6):337-47. 
Rubin DB. Multiple Imputation for Nonresponse in Surveys. New York, NY: John Wiley & 
Sons, Inc; 1987.  
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. 
U. S. Department of Health & Human Services (DHHS), Food and Drug Administration (FDA), 
Center for Drug Evaluation amd Research (CDER), Center for Biologic 
Evaluation and Research (CBER). E9(R1) Statistical Principles for Clinical 
Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. 
Guidance for Industry. Revision 1. May.  2021. 
 
 


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11. 
SOFTWARE 
SAS® Software Version 9.4 (SAS Institute Inc., Cary, NC, USA) is to be used for all 
programming of tables, listings, and figures. 
nQuery + nTerim Version 4.0 (Statistical Solutions, Cork, Ireland) was used for sample size and 
power calculation. 




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Revision Date 
(DD MMM YYYY) 
Section 
Summary of Revision 
Reason for Revision 
Final Draft 0.3  
(01 April 2021) 
1.1, 1.2, 1.3, 
6 
Modified study objectives randomization 
stratification factors for Induction Cohort 
A and Maintenance Study, study power 
and some of the efficacy endpoints 
To be consistent with the most updated 
protocol 
3.1.3, 7.1, 
7.2 
Deleted overall (Induction and 
Maintenance) safety analysis set and 
corresponding analysis for AE and 
laboratory results 
To focus on the purpose of this SAP, 
which is to conduct analyses separately 
for each study (Induction Cohort A, 
Induction Cohort B, and Maintenance). 
Any details about pooled analyses will 
be specified in the analysis plan for the 
integration safety summary. 
3.5 
Modified the alpha control strategy 
To be consistent with the most updated 
protocol 
3.9, 4, 6.1.3, 
7.2, 7.3, 
Appendix 7 
Added assessment of COVID-19 impact 
To better understand the COVID-19 
impact on subject disposition and 
missing data 
4.2, 7 
Deleted extent of study drug exposure 
and safety analysis for Cohorts A and B 
combined 
To better streamline CSR process and 
will conduct these analyses in the 
integrated safety summary when 
appropriate 
6.1.1 
Modified the LOCF method to impute 
the missing CDAI components by using 
only available values from two visits: 
most recent analysis visit or Induction 
baseline 
To use a more conservative approach 
per FDA feedback 
6.1.2 
Modified the imputation method for 
SES-CD by using the worst score 
To use a more conservative and 
reasonable approach per FDA feedback 
6.2.3 
Added estimands 
To clearly state the strategy to handle 
intercurrent events 
6.2.4 
Used stratum-adjusted proportion 
difference estimate and corresponding 
95% CI instead of non-stratified 
proportion difference estimate and 
corresponding 95% CI 
To be consistent with the way how the 
p-value is generated (stratified CMH 
test) 
6.3.3, 6.2.5 
Deleted some imputation methods on 
missing data as sensitivity analyses 
Some of these imputation methods are 
not the best strategies to handle 
intercurrent events in the estimands 
framework for the study 
6.5 
Modified the criteria to stop the study 
based on End of Induction Analysis 
results 
To be consistent with the most updated 
protocol 
6.5 
Deleted the language regarding Gilead 
Executive team to review the End of 
Induction analysis results in parallel with 
DMC review 
To better protect the integrity of the 
study data and reduce potential bias in 
final analysis 
7.1 
Deleted subgroup analysis for adverse 
events 
To better streamline CSR process and 
will conduct these analyses in the 
integrated safety summary when 
appropriate 
7.1.7 
Added adverse event of interest for 
MACE, ASTE, and VTE based on 
positively adjudicated events by the 
cardiovascular safety endpoint 
adjudication committee 
To be consistent with the most updated 
protocol 




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Revision Date 
(DD MMM YYYY) 
Section 
Summary of Revision 
Reason for Revision 
 
3.8.2 
Gaps between analyses visit windows 
were removed by extending the windows 
To make sure all data is included in the 
analyses 
 
4.2.1 
Improved on the calculation of extent of 
exposure 
To cover all possible scenarios of 
(partially) missing data 
 
4.2.2 
Modified the calculation of treatment 
adherence + modified the treatment 
adherence categories 
To be able to summarize overdoses 
 
4.3 
Removed tabulation of minor protocol 
deviations 
Because the database will not allow this 
summary 
 
4.5 
7.1.6 
Remove overall assessment of COVID-
19 pandemic impact 
Added a listing on the COVID-19 related 
AEs 
To avoid duplication in the listings. All 
aspects of the removed listing were 
covered in other more detailed listings, 
except for the COVID-19 AEs, for 
which a listing was added in section 
7.1.6 
 
5.2 
Add additional categories for baseline 
prednisone equivalent dose 
To better characterize baseline 
prednisone equivalent dose 
 
6.2.5.4 
Added a cross-tabulation of CDAI 
remission and SES-CD response at Week 
58 versus Week 10 
Not all subjects entering the 
Maintenance study achieved CDAI 
remission. The cross-tabulation was 
added to explore those subjects 
 
6.2.7 
- Added subgroup for prior exposure to 
biologic agents in Cohorts A and B 
combined 
- subgroup on number of prior exposure 
combined categories with low numbers 
for Cohort A 
 
 
- 
Cohort A includes both 
subjects with and without 
prior experience to biologic 
agents. Cohort B only has 
subjects with prior exposure. 
Therefore, the best 
comparison between those 
with and without treatment 
experience is the comparison 
combining both Cohorts. 
- 
To avoid subgroups with very 
low numbers 
 
6.6 
Updated to include all changes to 
protocol-specific efficacy analyses 
Because the list was incomplete 
 
7.1.6 
- Added a summary of AEs with pre-
specified cut-off 
- added a listing for COVID-19 related 
AEs 
- To streamline CSR writing (table with 
cut-off in the body of the CSR and the 
complete table in the CSR appendices) 
- to describe all aspects of the pandemic 
 
7.4 
Change the sorting order of prior and 
concomitant therapies 
To streamline CSR writing 
 
8 
Appendix 10 
- 
Description of PK analyses 
replaced by the PKAP in 
appendix 10 
- 
Additional PK parameters were 
added 
- 
To allow for a better flow of 
the SAP 
- 
To characterize the 
pharmacokinetics in more 
detail 
 
Appendix 9 
Add the list of preferred terms based on 
the latest MeDRA version 
Even though previously removed to 
reduce the burden of updating the list 
with each MedDRA up-versioning, it 
was decided to put the lists back in 
based on the latest MedDRA version. 
 
Global 
The EU-specific SAP and the SAP for 
non-EU submission were combined into 
1 SAP 
To have 1 SAP covering all submissions 


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Revision Date 
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Section 
Summary of Revision 
Reason for Revision 
 
Global 
Editorial changes or clarification 
languages have been provided 
throughout the SAP, where appropriate 
To improve clarity and consistency 
 


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13. 
APPENDIX 
Appendix 1. 
Schedule of Assessments 
Appendix 2. 
List of Biologics for CD Treatment 
Appendix 3. 
Crohn’s Disease Activity Index (CDAI) and Patient Reported Outcomes – 2 items 
(PRO2) 
Appendix 4. 
Calculation of Standard Body Weight 
Appendix 5. 
Simple Endoscopic Score for Crohn’s Disease (SES-CD) 
Appendix 6. 
Study Treatment Failure Rules 
Appendix 7. 
Determining Missing and Virtual Visits due to COVID-19 
Appendix 8. 
SAS Programming for Tipping Point Analysis for Binary Endpoint 
 


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Appendix 1. 
Schedule of Assessments 
Period 
Screen 
Treatment 
Follow-Up 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
PTxa 
ET 
Week 
 
0 
2 
4 
6 
10 
11 
14 
17 
20 
23 
26 
30 
34 
38 
42 
46 
50 
54 
58 
 
 
Study Day 
-30 to -1 
1 
15 
29 
43 
71 
78 
99 
120 
141 
162 
183 
211 
239 
267 
295 
323 
351 
379 
407 
 
 
Visit Window 
(±) 
 
 
±3 
±3 
±3 
±2 
±3 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±3 
±3 
 
Written 
Informed 
Consent  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
& 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Crohn’s Disease 
& Treatment 
History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-lead ECG 
X 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
Xb 
Review of 
Inclusion/ 
Exclusion 
Criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete 
Physical Examc 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Symptom-
directed Examc 
(as needed) 
 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Concomitant 
Medications  
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Randomization  
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Period 
Screen 
Treatment 
Follow-Up 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
PTxa 
ET 
Week 
 
0 
2 
4 
6 
10 
11 
14 
17 
20 
23 
26 
30 
34 
38 
42 
46 
50 
54 
58 
 
 
Study Day 
-30 to -1 
1 
15 
29 
43 
71 
78 
99 
120 
141 
162 
183 
211 
239 
267 
295 
323 
351 
379 
407 
 
 
Visit Window 
(±) 
 
 
±3 
±3 
±3 
±2 
±3 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±3 
±3 
 
Study Drug 
Dispensing 
 
X 
 
X 
 
 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
 
 
Ileocolonoscopy 
(with Biopsies)d 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Local 
Endoscopic 
Assessmente 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
SES-CD 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
CDAIf 
X 
 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
PRO2f 
X 
 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Abdominal pain 
assessmentg  
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Anchor 
Questions 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient Global 
Impression 
Scalesh 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
eDiary 
instruction & 
reviewi 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Stool for C. diff 
toxin, 
pathogenic 
E. coli, 
Salmonella spp, 
Shigella spp, 
Campylobacter 
spp or Yersinia 
spp testing j 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Period 
Screen 
Treatment 
Follow-Up 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
PTxa 
ET 
Week 
 
0 
2 
4 
6 
10 
11 
14 
17 
20 
23 
26 
30 
34 
38 
42 
46 
50 
54 
58 
 
 
Study Day 
-30 to -1 
1 
15 
29 
43 
71 
78 
99 
120 
141 
162 
183 
211 
239 
267 
295 
323 
351 
379 
407 
 
 
Visit Window 
(±) 
 
 
±3 
±3 
±3 
±2 
±3 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±3 
±3 
 
Stool O&P j  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug 
screenk 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urinalysis 
X 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Pregnancy Testl 
X 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
TBm  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest x-ray n 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HBV, HCV, 
HIV screeningo 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HBV DNA 
monitoring 
(Japan)p 
 
 
 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
HBV DNA 
monitoring 
(other regions)p 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
Hematology 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Chemistry 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
Lipid profile 
(fasting)q 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
X 
CCI
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Period 
Screen 
Treatment 
Follow-Up 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
PTxa 
ET 
Week 
 
0 
2 
4 
6 
10 
11 
14 
17 
20 
23 
26 
30 
34 
38 
42 
46 
50 
54 
58 
 
 
Study Day 
-30 to -1 
1 
15 
29 
43 
71 
78 
99 
120 
141 
162 
183 
211 
239 
267 
295 
323 
351 
379 
407 
 
 
Visit Window 
(±) 
 
 
±3 
±3 
±3 
±2 
±3 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±5 
±3 
±3 
 
Serum 
immunoglobulin 
 
X 
 
X 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
X 
X 
Blood 
TCR/BCR 
repertoire 
samplerp 
 
X 
 
X 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
PK collection 
(sparse) s 
 
 
 
X 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
X 
 
 
PK substudyu 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CCI
CCI
CCI




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Appendix 2. 
List of Biologics for CD Treatment 
The drug names of biologics considered as CD treatment are listed below. 
No. 
Drug Class 
Drug Name 
1 
TNF-α antagonist 
Adalimumab 
2 
TNF-α antagonist 
Certolizumab/Certolizumab Pegol 
3 
TNF-α antagonist 
Infliximab 
4 
TNF-α antagonist 
TNF-α antagonist biosimilar (to adalimumab, 
Certolizumab/Certolizumab Pegol, or infliximab) 
5 
Integrin antagonist 
Natalizumab 
6 
Integrin antagonist 
Vedolizumab 
7 
Interleukin antagonist 
Ustekinumab 
 


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Appendix 3. 
Crohn’s Disease Activity Index (CDAI) and Patient Reported 
Outcomes – 2 items (PRO2) 
The total CDAI score is a weighted sum of all 8 variables as specified in Table 13-1, and the 
PRO2 scores will be assessed according to Table 13-2 and Table 13-3. Details for the 
calculations of CDAI and PRO2 scores at screening and post-screening visits are provided in this 
appendix. 
Table 13-1. 
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 
{Sandborn 2002} 
 
 


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Table 13-2. 
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 
{Khanna 2015} 
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. 
Table 13-3. 
Calculation of Total PRO2 score 
Variable no. 
Variable 
Variable Description 
Multiplier 
1 
Liquid or very soft 
stool 
Mean of the daily (liquid or very 
soft) stool count for 7 days 
2 
2 
Abdominal pain 
Mean of 7 days of daily ratings as 
0 = none, 1 = mild, 2 = moderate, 
3 = severe 
5 
Total PRO2 scoreg 
 
 
TOTAL 
{Khanna 2015} 
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 (including protocol-directed and 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 at Screening  
Ileocolonoscopy is required to be performed during screening. The calculations of CDAI and 
PRO2 at screening are specified below: 
1) Define T-Day 1 = subject activation date on the electronic diary device during screening  
2) Define a 10-day window using T-Day 1 as the anchor date, and the window starts the day 
after T-Day 1 and ends 10 days after T-Day 1.  
3) For each CDAI patient-reported outcome component, if there are 7 or more evaluable records 
within the 10-day window, take the sum of the 7 evaluable records closest to T-Day 1. For 


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each PRO2 component, take the average of the 7 evaluable records within the 10-day 
window closest to T-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 PRO2 component will not be 
calculated and will be considered as missing.  
A schema of this approach and some examples are included below for further illustration: 
Figure 13-1. 
Selection of Diary Data for the Calculation at Screening 
 
 
Table 13-4. 
Calculation of CDAI Patient-Reported Outcome Components and 
PRO2 Scores at Screening 
Example 
Diary Day Looking Forward from subject activation 
date (T-Day) 
Days for 
Calculation 
Sum of 7 Days 
(CDAI 
Patient-Reported 
Component) 
Average 
of 
7 Days 
(PRO2) 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
Diary 
Subscore 1 
1 
2 
M 
1 
2 
2 
M 
0 
1 
2 
2,3,5,6,7,9,10 
9.0 
1.3 
Diary 
Subscore 2 
M 
M 
1 
M 
2 
1 
M 
2 
M 
M 
4,6,7,9 
10.5 
1.5 
Diary 
Subscore 3 
2 
M 
M 
0 
M 
2 
M 
M 
M 
M 
2,5,7 
Missing 
Missing 
Diary 
Subscore 4 
1 
2 
1 
1 
X 
IL 
3 
3 
1 
2 
2,3,4,5,8,9,10 
12.0 
1.7 


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M = Missing. IL = Ileocolonoscopy day; X = non-evaluable (due to preparation for ileocolonoscopy). 
Days are named relative to subject activation date on electronic diary device during screening (T-Day 1). Rounding of subscores 
into one decimal place is for displaying purpose only. When calculating the total CDAI scores, the subscores will not be rounded. 
4) For the non-diary components (ie, complications, use of anti-diarrheal medications, 
abdominal mass, hematocrit, and weight) of the CDAI, in the case of multiple records 
collected during screening, the value collected on the same date as T-Day 1 will be used; 
otherwise, the earliest valid value during screening (for re-screened subjects, most recent 
screening period will be used first before using previous screening period) will be used. If no 
valid value is available during screening, then the value on Day 1 will be used. 
5) The CDAI total score at screening is based on a weighted sum (rounded to the nearest 
integer) of all 8 components (no rounding applied to the subscore for each component when 
calculating the CDAI total score, but the subscore will be displayed with one decimal place 
for displaying purpose). The weight (multiplier) of each component is specified in 
Table 13-1. For example, if the sum of the 7-day scores for abdominal pain is 10, then the 
abdominal pain CDAI subscore is 10 x 5 = 50, where 5 is the multiplier for abdominal pain. 
The CDAI total score will be set to 0 in the case the calculation leads to a CDAI total score of 
< 0. 
6) The PRO2 subscores at screening are based on the calculation of liquid or very soft stool 
frequency and abdominal pain subscores individually (rounded to the nearest integer). 


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Calculation of CDAI and PRO2 Scores at Post-Screening Visits 
The calculations of CDAI and PRO2 scores at post-screening visits are specified below: 
1) CDAI and PRO2 are not assessed on Day 1 and Week 11 by the study sites, but for baseline 
(or maintenance baseline) summary purpose, the PRO2 subscore and Total PRO2 score will 
be calculated for Day 1 and Week 11. Both screening and Day 1 values will be considered for 
the derivation of Induction baseline for PRO2 subscores and total PRO2 score. Similarly, 
both Weeks 10 and 11 values will be considered for the derivation of maintenance baseline 
for PRO2 subscores and total PRO2 score. CDAI at Day 1 and Week 11 will not be 
calculated, and CDAI at screening will be Induction baseline, and at Week 10 will be 
maintenance baseline. 
2) The visit date will be used as the anchor day for post-screening visits. The visit date for each 
analysis visit will be selected among all scheduled visits and unscheduled visits where CDAI 
were assessed within the analysis window as defined in Section 3.8.2. For Day 1, the date of 
visit from the nominal visit Day 1 will be used. Only diary data collected on evaluable days 
within a 10-day window which starts 10 days prior to the visit date (V-Day 1) and ends on the 
day prior to V-Day 1 will be used for calculation.  
3) If there are 7 or more evaluate 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. 
A schema of this approach and some examples are included below for further explanation: 


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Figure 13-2. 
Selection of Diary Data for the Calculation at Post-Screening Visits 
 
 
Table 13-5. 
Calculation of CDAI Patient-Reported Outcome Components and 
PRO2 Scores at Post-Screening Visits 
Example 
Diary Day Looking Backwards from Visit Date (V-
Day) 
Days for 
Calculation 
Sum of 7 Days 
(CDAI 
Patient-Reported 
Component) 
Average 
of 7 Days 
(PRO2) 
-10 
-9 
-8 
-7 
-6 
-5 
-4 
-3 
-2 
-1 
Diary 
Subscore 1 
1 
2 
2 
M 
0 
1 
2 
2 
1 
X 
-2,-3,-4,-5,-6,-
8,-9 
10.0 
1.4 
Diary 
Subscore 2 
M 
M 
1 
M 
X 
IL 
2 
2 
1 
M 
-2,-3,-4, -8 
10.5 
1.5 
Diary 
Subscore 3 
M 
M 
1 
X 
IL 
M 
M 
2 
1 
M 
-2,-3,-8 
Missing 
Missing 
Diary 
Subscore 4 
0 
M 
2 
2 
1 
0 
M 
2 
X 
IL 
-3,-5,-6,-7,-8,-10 
8.2 
1.2 
M = Missing; IL = Ileocolonoscopy day; X = non-evaluable (due to preparation for ileocolonoscopy). 
Days are named relative to visit date (V-Day 1), where V-Day -1 is the day prior to V-Day 1. 
Rounding of subscores into one decimal place is for displaying purpose only. When calculating the total CDAI scores, the 
subscores will not be rounded. 
4) The CDAI total score for a specific visit is based on a weighted sum (rounded to the nearest 
integer) of all 8 components. The CDAI total score will be set to 0 in the case the calculation 
leads to a CDAI total score of < 0. Each component will be selected within the analysis 
window as defined in  
5) If subjects have 3 or more of the 8 CDAI components missing, then the subjects will be 
considered as having insufficient data to determine response status and 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. 


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a) If subjects have 1 or 2 CDAI components missing, then the missing component will be 
imputed by the LOCF method using the previous valid component score calculated from 
the most recent analysis visit (ie, use the component score from Week 6 for missing 
component at Week 10, or use the component score from Week 50 for missing component 
at Week 58. Scores from other post Induction baseline visits will not be used). If the 
component score from the most recent analysis visit is also missing, the missing value 
will be imputed with the corresponding component score at Induction baseline. 
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. If either subscore is 
missing, no imputation will be done and the subject will be considered as having 
insufficient data to determine clinical remission status and treated as not meeting clinical 
remission.  
6) The total PRO2 score for a specific visit is the sum (rounded to the nearest integer) of liquid 
or very soft stool subscore (without rounding)  2 and abdominal pain subscore (without 
rounding)  5 within the analysis window as defined in Section 3.8.2. If either subscore is 
missing, no imputation will be done, and the subject will be considered as having insufficient 
data to determine clinical remission status and treated as not meeting clinical remission by 
total PRO2 score. 
 
 


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Source of Information Used for Calculation 
The sources of information used for the calculations of CDAI and PRO2 subscores and total 
PRO2 score as described above are given in Table 13-6 (the calculated scores from ERT data will 
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 13-6. 
Sources of Information for Calculating CDAI and PRO2 Scores 
Variable in Calculation 
Data Source 
Ileocolonoscopy Procedure Date 
ILEODAT in ILEO dataset from eCRF data for Screening, Week 10 and 
Week 58; QSTEST = “Date of Colonoscopy” in CDAI dataset from vendor 
ERT data for the rest of the visits 
Visit Date 
VISITDAT in VISDT dataset from eCRF data 
Subject Activation Date on 
Electronic Device 
QSORRES in CDAI dataset with QSTEST=“Date of Visit” and 
Visit=“Screening” from vendor ERT 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 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 


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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 


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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. 
Simple Endoscopic Score for Crohn’s Disease (SES-CD) 
Variables 
Score 
0 
1 
2 
3 
Size of ulcers (cm) 
None 
Aphthous ulcers 
(diameter 0.1-0.5) 
Large ulcers 
(diameter 0.5-2) 
Very large ulcers 
(diameter > 2) 
Ulcerated Surface (%) 
None 
< 10 
10-30 
> 30 
Affected surface (%) 
Unaffected 
segment 
< 50 
50-75 
> 75 
Presence of narrowings 
None 
Single, 
can be passed 
Multiple, 
can be passed 
Cannot be passed 
Total SES-CD: sum of the values of the 4 variables for the 5 bowel segments. Values are given to each variable and for every 
examined bowel segment (eg, rectum, left colon, transverse colon, right colon, and ileum) 
{Daperno 2004} 


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Appendix 6. 
Study Treatment Failure Rules 
Study treatment failure rules apply to treatment failure that occurs during the course of the study. 
Study treatment failure rules will be applied to all efficacy endpoints, unless otherwise specified. 
All efficacy data will be censored (set to missing) after treatment failure criteria are met, 
regardless of the observed data. Subjects who do not have sufficient measurements after 
censoring to determine the dichotomized endpoint(s) will be considered non-responder for 
corresponding endpoint(s). Study treatment failure rules override other data handling rules. 
Subjects who have any of the following events will be considered a study treatment failure after 
the earliest event through the end of the Induction Study (if the event occurred during Induction) 
or through the end of the Maintenance Study (if the event occurred during Maintenance), 
regardless of the actual efficacy data collected. Induction baseline will be referenced when 
calculating the potentially effective use for Induction Studies, and Maintenance baseline will be 
referenced when calculating the potentially effective use for Maintenance Study. 
1) Potentially effective corticosteroid use  
Potentially effective corticosteroids, for the purpose of this SAP, are corticosteroids that may 
impact the disease under study. Potentially effective corticosteroids include the following 
corticosteroids when administered for the indication of CD: 
a) Commencement of: 
Any steroid administered intramuscularly (IM), intravenously (IV), orally (PO), or rectally 
(PR) at any dose for 7 or more continuous days  
• This rule applies regardless if a change in drug, dose, or route (from IM to IV to PO or PR 
or vice versa) occurs within the seven continuous days; and it includes oral steroids with 
intended local actions (eg, budesonide) 
b) Escalation of concomitant steroid dose above the baseline dose for 7 or more continuous 
days. The baseline steroid dose is defined as the dose at Day 1 of induction if the 
escalation occurs in the Induction Study, or Day 1 of maintenance (maintenance baseline) 
if the escalation occurs in the Maintenance Study. Prednisone equivalent dose will be 
used to determine escalation of concomitant systemic steroid dose even if there is a 
change in drug or route. For steroids with predominant local effect (eg, budesonide or any 
rectally administered steroid), the dose escalation rule will apply to scenarios where the 
post-baseline dose is above the baseline dose via the same drug and the same route for 
7 or more continuous days.  


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Potentially effective steroid use only includes use of steroids administered via routes that are IM, 
PO, IV, or PR. The below steroids will not be considered potentially effective steroids regardless 
of indication for use: 
A) ocular steroids (ie, eye drops)  
B) topical steroids (eg, cutaneously applied solely to the skin, or topically applied to the nasal 
mucosa)  
C) inhaled steroids (eg, inhalational fluticasone for asthma) 
D) intra-articular steroids (steroids administered directly into a joint) 
E) neuraxial steroids (steroids administered into the epidural or spinal space) 
2) Potentially effective immunomodulator use  
Commencement of a different class of oral, IM, SC, or IV immunomodulator drugs 
(where the subject was not previously taking concomitant immunomodulators of the same class 
on Day 1 of induction or maintenance), including but not limited to 6-MP, azathioprine, MTX, 
6-thioguanine, and prohibited immunomodulators including but not limited to cyclosporine, 
leflunomide, tacrolimus, thalidomide regardless of dose, for 7 continuous days. The use of an 
immunomodulator will be considered potentially effective when it is administered for the 
indication of CD.  
3) Potentially effective biologic agent use 
Commencement of a biologic agent including but not limited to TNF-α antagonists, 
IL-12/23 antagonists, and vedolizumab (or similar agents), regardless of indication for use and 
duration. 


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Appendix 7. 
Determining Missing and Virtual Visits due to COVID-19 
This appendix describes the clinical trial site collection of COVID-19 data pertaining to 
missed/virtual visits and the data processing algorithm used to determine which visits were 
missing and which visits were virtual. 
Data collection 
A COVID-19 supplement to the eCRF Completion Guidelines was provided by data management 
to instruct clinical trial sites with respect to data entry expectations pertaining to scenarios related 
to the COVID-19 pandemic. If a visit was missed, sites should enter “Visit missed due to 
COVID-19.” If an in-person visit was conducted virtually, sites should enter “Virtual visit due to 
COVID-19.” 
Determination of Missed and Virtual visits 
Natural Language Processing (NLP) was used to search the CRF comment fields to identify 
instances of “COVID-19” (or synonyms, see Table 13-7) and “Virtual” (or synonyms, see 
Table 13-7). The search terms are maintained in a global lookup table and can be modified to 
tune the NLP model. For any comments with COVID-19 search terms, assign “Missed visit” or 
“Virtual visit” 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, NLP will be based on multiple records to ensure that only 1 unique visit type 
(either Missing Visit or Virtual Visit) is assigned for all the records belong to the same 
visit for a subject.  
iii) Otherwise the visit type is missing. 
Table 13-7. 
Examples of Search Terms for “COVID-19” and “Virtual” Used to 
Identify Missed and Virtual Visits  
Search terms for “COVID-19” 
Search terms for “Virtual” 
COVID19 
CORONA 
CORONAVIRUS 
PANDEMIC 
OUTBREAK 
CRISIS 
LOCKDOWN 
VIRTUAL 
TELEMED 
TELEHEALTH 
TELEPHONE 
REMOTE 
TELEMEDICINE  
TELECONSULTATION 


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QUARANTINE 
SHELTER 
 
TELEPHONICALLY 
PHONE 
HOME VISIT 
ZOOM 
SKYPE 
 


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Appendix 8. 
SAS Programming for Tipping Point Analysis for Binary Endpoint 
The following %tp_binary macro generates multiple imputed data and a set of the shift 
parameters that adjust the imputed values will be examined. 
/*----------------------------------------------------------------------------------------------------------------------*/ 
/*--- Delta-Adjusting Method for Tipping Point Analysis for Binary Endpoint                              ---*/ 
/*---                                                                                                                                                    ---*/ 
/*--- Generate imputed data set for specified shift parameters                                                          ---*/ 
/*--- data= input data set                                                                                                                    ---*/ 
/*--- smin= min shift parameter for active drug                                                                                ---*/ 
/*--- smax= max shift parameter for active drug                                                                               ---*/ 
/*--- sinc= increment of the shift parameter for active drug                                                             ---*/ 
/*--- pmin= min shift parameter for placebo drug                                                                            ---*/ 
/*--- pmax= max shift parameter for placebo drug                                                                          ---*/ 
/*--- pinc= increment of the shift parameter for placebo drug                                                         ---*/ 
/*--- trt= treatment group indicator                                                                                                  ---*/ 
/*--- out= output imputed data set                                                                                                   ---*/ 
/*--------------------------------------------------------------------------------------------------------------------*/ 
%macro tp_binary( data=, smin=, smax=, sinc=, pmin=, pmax=, pinc=, trt=, out=); 
 
data &out; 
 
set _null_; 
 
run; 
/*------------ # of shift values ------------*/ 
 
%let ncase_pbo = %sysevalf( (&pmax-&pmin)/&pinc, ceil ); 
 
%do pc=0 %to &ncase_pbo; 
 
%let pj= %sysevalf( &pmin + &pc * &pinc); 
 
 
/*------------ # of shift values ------------*/ 
 
 
%let ncase= %sysevalf( (&smax-&smin)/&sinc, ceil ); 
 
 
/*------- Imputed data for each shift -------*/ 
 
 
%do jc=0 %to &ncase; 
 
 
%let sj= %sysevalf( &smin + &jc * &sinc); 
 
 
 
proc mi data=&data seed=14823 nimpute=20 out=outmi; 
 
 
 
 
var trt01pn strat1V strat2V strat3V RESP; 
 
 
 
 
class trt01pn strat1V strat2V strat3V RESP; 
 
 
 
 
monotone logistic (RESP / link=glogit); 
 
 
 
 
mnar adjust(RESP (event='1') / adjustobs=(trt01pn="&trt") shift= &sj) 
 
 
 
 
 
adjust(RESP (event='1') / adjustobs=(trt01pn='3') shift= &pj); 
 
 
 
 
run; 
 
 
data outmi; 


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set outmi; 
 
 
Shift_Trt= &sj; 
 
 
Shift_Pbo= &pj; 
 
 
run; 
 
 
data &out; 
 
 
set &out outmi; 
 
 
run; 
 
 
%end; 
 
%end; 
%mend tp_binary; 
 
 


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Appendix 9. 
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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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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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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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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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 
 
  
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15 January 2023 
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 
 
 


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Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 8 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 9 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 10 
 
15 January 2023 
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 
 
 


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                      Version 2.0 
CONFIDENTIAL 
Page 11 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 12 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 13 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 14 
 
15 January 2023 
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 
 
  
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Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 15 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 16 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 17 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 18 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 19 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 20 
 
15 January 2023 
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 
 
  
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                      Version 2.0 
CONFIDENTIAL 
Page 21 
 
15 January 2023 
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 
 
 
 
 


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                      Version 2.0 
CONFIDENTIAL 
Page 22 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 23 
 
15 January 2023 
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 
 
 
 
 


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                      Version 2.0 
CONFIDENTIAL 
Page 24 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 25 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 26 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 27 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 28 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 29 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 30 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 31 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 32 
 
15 January 2023 
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 
 
 
 
 


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CONFIDENTIAL 
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15 January 2023 
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 
 
 
 
 


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Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 34 
 
15 January 2023 
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 
 
 
 
 


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                      Version 2.0 
CONFIDENTIAL 
Page 35 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 36 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 37 
 
15 January 2023 
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 
 
 
 
 


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Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 38 
 
15 January 2023 
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 
 
 
 
 


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Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 39 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 40 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 41 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 42 
 
15 January 2023 
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 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 43 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 1 
 
15 January 2023 
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 
 
 
 
 
 
 
 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 2 
 
15 January 2023 
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 
 
 
 


Filgotinib 
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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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 4 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 5 
 
15 January 2023 
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 
 
  
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Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 6 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 7 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 8 
 
15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
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15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
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15 January 2023 
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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
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CONFIDENTIAL 
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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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
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CONFIDENTIAL 
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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 
 
  
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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
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Appendix 10. 
PKAP 
 
 
 
PHARMACOKINETIC ANALYSIS PLAN 
 
 
 
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies 
Evaluating the Efficacy and Safety of Filgotinib in the Induction and 
Maintenance of Remission in Subjects with Moderately to Severely Active 
Crohn’s Disease 
 
 
 
 
Sponsor: 
 
Galapagos NV 
Generaal De Wittelaan L11 A3  
2800 Mechelen 
 Belgium 
 
Protocol Identification: GS-US-419-3895 
 
Pharmacokinetic Analysis Plan 
Version: 1.0 
Date: December 20, 2022 
 


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GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
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PHARMACOKINETIC ANALYSIS PLAN 
 
REPORT TITLE: 
Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the 
Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in 
Subjects with Moderately to Severely Active Crohn’s Disease 
 
QPS PROJECT NO. 
2260-2202CRS 
 
CLIENT PROTOCOL NO. 
GS-US-419-3895 
 
CONTRIBUTING SCIENTISTS: 
 
Sr. Principal Clinical Pharmacokineticist II 
Global Data Services 
QPS, LLC 
 
TESTING FACILITY: 
QPS, LLC 
3 Innovation Way, Suite 240 
Newark, DE 19711 
 
SPONSOR: 
Galapagos NV 
Generaal De Wittelaan L11 A3  
2800 Mechelen, Belgium 
 
SPONSOR REPRESENTATIVES: 
 
Sr Director Clinical Pharmacology 
Galapagos NV 
  
PPD
PPD




Filgotinib 
GS-US-419-3895/GLPG0634-CL-309 
Statistical Analysis Plan 
                      Version 2.0 
CONFIDENTIAL 
Page 16 
 
15 January 2023 
TABLE OF CONTENTS 
Page 
 
1. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................ 20 
2. 
INTRODUCTION ......................................................................................................................... 22 
3. 
STUDY BACKGROUND ............................................................................................................. 23 
4. 
PKAP OBJECTIVE ....................................................................................................................... 24 
5. 
SUMMARY OF STUDY DESIGN ............................................................................................... 25 
6. 
PHARMACOKINETIC ANALYSIS PLAN ................................................................................. 26 
6.1. 
PK Substudy Analysis Set ................................................................................................. 26 
6.2. 
Pharmacokinetic Parameters Estimation ........................................................................... 26 
6.3. 
Data Handling Procedures................................................................................................. 27 
6.4. 
Statistical Evaluations of PK Parameters .......................................................................... 28 
7. 
REPORT ........................................................................................................................................ 30 
8. 
TABLES AND LISTINGS ............................................................................................................ 35 
Table 14.4.1. ...... Descriptive Statistics of Plasma Concentrations of Filgotinib and Metabolite GS-
829845 .............................................................................................................................. 36 
Table 14.4.1.1. Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily 
Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease ........................................ 36 
Table 14.4.1.2. Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily 
Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease ........................................ 37 
Table 14.4.1.3. ..... Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 37 
Table 14.4.1.4. ..... Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 37 
Table 14.4.1.5. Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily 
Oral Administration of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely 
Active Crohn’s Disease - Cohort A .................................................................................. 38 
Table 14.4.1.6. Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily 
Oral Administration of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely 
Active Crohn’s Disease - Cohort B ................................................................................... 39 
Table 14.4.1.7. Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily 
Oral Administration of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely 
Active Crohn’s Disease - Maintenance Study ................................................................... 39 
Table 14.4.1.8. ..... Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once 
Daily Oral Administration of 200 or 100 mg Filgotinib in Subjects with Moderately to 
Severely Active Crohn’s Disease - Cohort A .................................................................... 39 
Table 14.4.1.9. ..... Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once 
Daily Oral Administration of 200 or 100 mg Filgotinib in Subjects with Moderately to 
Severely Active Crohn’s Disease - Cohort B .................................................................... 39 
Table 14.4.1.10. ... Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once 
Daily Oral Administration of 200 or 100 mg Filgotinib in Subjects with Moderately to 
Severely Active Crohn’s Disease - Maintenance Study .................................................... 39 


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Table 14.4.2. .....................Descriptive Statistics of Plasma Filgotinib and Metabolite GS-829845 
Pharmacokinetic Parameters ............................................................................................. 40 
Table 14.4.2.1. ............. Descriptive Statistics of Plasma Pharmacokinetic Parameters of Filgotinib 
Following Once Daily Oral Administration of 200 mg Filgotinib at One Visit Between 
Week 2 and Week 10 in Subjects with Moderately to Severely Active Crohn’s Disease . 40 
Table 14.4.2.2. ............. Descriptive Statistics of Plasma Pharmacokinetic Parameters of Filgotinib 
Following Once Daily Oral Administration of 100 mg Filgotinib at One Visit Between 
Week 2 and Week 10 in Subjects with Moderately to Severely Active Crohn’s Disease . 41 
Table 14.4.2.3. .......... Descriptive Statistics of Plasma Pharmacokinetic Parameters of GS-829845 
Following Once Daily Oral Administration of 200 mg Filgotinib at One Visit Between 
Week 2 and Week 10 in Subjects with Moderately to Severely Active Crohn’s Disease . 41 
Table 14.4.2.4. .......... Descriptive Statistics of Plasma Pharmacokinetic Parameters of GS-829845 
Following Once Daily Oral Administration of 100 mg Filgotinib at One Visit Between 
Week 2 and Week 10 in Subjects with Moderately to Severely Active Crohn’s Disease . 42 
Listing 16.4.1. .............................................. Individual Plasma Concentrations of Filgotinib and 
Metabolite GS-829845 ...................................................................................................... 42 
Listing 16.4.1.1. ......... Individual Plasma Concentrations of Filgotinib Following Once Daily Oral 
Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease ........................................ 42 
Listing 16.4.1.2. ......... Individual Plasma Concentrations of Filgotinib Following Once Daily Oral 
Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease ........................................ 43 
Listing 16.4.1.3. ...... Individual Plasma Concentrations of GS-829845 Following Once Daily Oral 
Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease ........................................ 43 
Listing 16.4.1.4. ...... Individual Plasma Concentrations of GS-829845 Following Once Daily Oral 
Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease ........................................ 43 
Listing 16.4.2. ...................................... Individual Plasma Filgotinib and Metabolite GS-829845 
Pharmacokinetic Parameters ............................................................................................. 43 
Listing 16.4.2.1. ...... Individual Plasma Pharmacokinetic Parameters of Filgotinib Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 43 
Listing 16.4.2.2. ...... Individual Plasma Pharmacokinetic Parameters of Filgotinib Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 44 
Listing 16.4.2.3. .... Individual Plasma Pharmacokinetic Parameters of GS-829845 Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 44 
Listing 16.4.2.4. .... Individual Plasma Pharmacokinetic Parameters of GS-829845 Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 44 
Figure 16.4.3.  .................................................................................. Individual Subject Plasma 
Concentration-Time Graphs .............................................................................................. 45 
Figure 16.4.3.1. ........ Individual Plasma Filgotinib Concentration – Time Profiles Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 45 
Figure 16.4.3.2. ........ Individual Plasma Filgotinib Concentration – Time Profiles Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 46 
Figure 16.4.3.3. ........ Individual Plasma Filgotinib Concentration – Time Profiles Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease – 0 to 24 hours ...... 46 


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Figure 16.4.3.4. ........ Individual Plasma Filgotinib Concentration – Time Profiles Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease – 0 to 24 hours ...... 47 
Figure 16.4.3.5. ..... Individual Plasma GS-829845 Concentration – Time Profiles Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 47 
Figure 16.4.3.6. ..... Individual Plasma GS-829845 Concentration – Time Profiles Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease ............................... 47 
Figure 16.4.3.7. ..... Individual Plasma GS-829845 Concentration – Time Profiles Following Once 
Daily Oral Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease – 0 to 24 hours ...... 47 
Figure 16.4.3.8. ..... Individual Plasma GS-829845 Concentration – Time Profiles Following Once 
Daily Oral Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 
10 in Subjects with Moderately to Severely Active Crohn’s Disease – 0 to 24 hours ...... 47 
 
 


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LIST OF TABLES AND FIGURES 
 
Table 14.2.1. 
Subjects Not Included in the Pharmacokinetic Analysis (if Applicable) .......... 30 
 
Figure 14.2.1. 
Mean (± SD) Plasma Filgotinib Concentration – Time Profiles Following Once 
Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit Between 
Week 2 and Week 10 in Subjects with Moderately to Severely Active Crohn’s 
Disease .............................................................................................................. 31 
Figure 14.2.2. 
Mean (± SD) Plasma GS-829845 Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease ................................................................................................ 32 
Figure 14.2.3. 
Mean (± SD) Plasma Filgotinib Concentration – Time Profiles Following Once 
Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit Between 
Week 2 and Week 10 in Subjects with Moderately to Severely Active Crohn’s 
Disease – 0 to 24 hours ..................................................................................... 32 
Figure 14.2.4. 
Mean (± SD) Plasma GS-829845 Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease – 0 to 24 hours ....................................................................... 33 
Figure 14.2.5. 
Median (Q1, Q3) Plasma Filgotinib Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease ................................................................................................ 33 
Figure 14.2.6. 
Median (Q1, Q3) Plasma GS-829845 Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease ................................................................................................ 33 
Figure 14.2.7. 
Median (Q1, Q3) Plasma Filgotinib Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease – 0 to 24 hours ....................................................................... 33 
Figure 14.2.8. 
Median (Q1, Q3) Plasma GS-829845 Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 or 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease – 0 to 24 hours ....................................................................... 33 
 


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1. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
 
 
AM 
Arithmetic mean 
 
 
%AUCextrap 
Percentage of extrapolated AUC (%AUCt-∞), (1-[AUC0-t/AUC0-inf])*100 
 
 
AUC0-tau 
Area under the concentration-time curve within dosing interval, calculated by 
linear up/log down trapezoidal method.  
 
BLQ 
Below the lower limit of quantification  
 
 
Cmax 
Maximum observed plasma concentration 
 
CD 
 
Crohn’s disease 
 
 
CLss/F 
Apparent total body clearance at steady state 
 
Ctau 
 
The concentration in plasma at the end of a dosing interval 
 
 
CV% 
Percentage coefficient of variation 
 
 
GM 
Geometric mean 
 
H 
 
 
Hour 
IBD 
 
Inflammatory bowel disease 
(IL)-6 
 
Interleukin 
JAKs 
 
Janus kinases 
LLOQ 
 
Max 
Lower limit of quantification 
 
Maximum 
 
 
Min 
Minimum 
 
MRcmax 
 
Metabolic ratio of Cmax  
 
MRctau 
 
Metabolic ratio of Ctau  
 
MRauctau 
 
Metabolic ratio of AUC0-tau  
 
PD 
 
Pharmacodynamics 


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Abbreviation 
Definition 
 
 
PK 
Pharmacokinetic(s) 
 
 
Q1 
 
1st quartile 
Q3 
 
3rd quartile 
RA 
Rheumatoid arthritis 
 
SD 
Standard deviation 
 
 
Tmax 
Time of the maximum observed plasma concentration 
TYKs 
Tyrosine kinases 
UC 
Ulcerative colitis 
 
 


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2. 
INTRODUCTION 
This Pharmacokinetic Analysis Plan (PKAP) for GS-US-419-3895 study has been developed 
according to the study design described in the study protocol Amendment 9 dated on 02 
December 2021 with the purpose of establishing a framework for pharmacokinetic (PK) 
analysis in which answers to the protocol objectives may be obtained in a rigorous fashion, 
without bias or analytical deficiency. 
The purpose of this plan is two-fold: 
• To determine the types of analyses and presentations of data that will form 
the basis for conclusions to be reached; 
• To define in detail how the data will be handled and analyzed, adhering to 
commonly accepted standards and practices of PK and biostatistical 
analysis in the pharmaceutical industry and QPS SOPs. 
The PK parameters and statistical results outlined herein will be reported in a PK Section that 
will be included to the Clinical Study Report (CSR).  
. 
 
 
 


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3. 
STUDY 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.  
 
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, and is currently 
under regulatory review for the treatment of UC in 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). 


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4. 
PKAP OBJECTIVE 
• To assess the PK characteristics of filgotinib and its metabolite GS-829845. 
 


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5. 
SUMMARY OF STUDY DESIGN 
These are combined Phase 3 double-blind, randomized, placebo-controlled studies to 
evaluate the efficacy and safety of filgotinib in the induction and maintenance of clinical 
remission, as well as, endoscopic response in subjects with moderately to severely active CD. 
 
Subjects who are biologic-naïve or biologic-experienced will be enrolled in Cohort A and 
subjects who are biologic-experienced will be enrolled in Cohort B, respectively. Treatment 
assignments will be randomized within each Cohort. 
 
Treatment Regimen (Cohorts A and B Induction Studies) 
Subjects who meet protocol eligibility criteria will be assigned to the respective Cohort and 
subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments as follows: 
 
Treatment 1: filgotinib 200 mg oral tablet and placebo-to-match (PTM) filgotinib 100 mg 
oral tablet, once daily 
Treatment 2: filgotinib 100 mg oral tablet and PTM filgotinib 200 mg oral tablet, once daily 
Treatment 3: PTM filgotinib 200 mg oral tablet and PTM filgotinib 100 mg oral tablet, once 
daily 
 
Note: US and Korea males who have not failed at least two biologic therapies (any TNFα 
antagonist and vedolizumab) will be randomized in a 1:1 ratio to either filgotinib 100 mg or 
matching placebo. 
 
The sparse PK samples at Week 4 are collected pre-dose, and post-dose (at least 30 minutes 
and up to 3 hours after study drug dosing). For this visit, it is preferred that study drug dosing 
is done in clinic. The PK sample at Weeks 26 can be collected at any time without regard to 
dosing. The PK sample at Weeks 10 and 58 are collected at pre-dose (within 2 hours prior to 
dosing). 
 
The optional PK substudy will be performed in a subset of subjects (approximately 16 
subjects on 200 mg treatment and 16 subjects on 100 mg treatment in the substudy) who 
provide a separate informed consent. In the PK substudy, the daily dose of study drug should 
be administered under supervision in the clinic (at one visit between Week 2 and Week 10, 
inclusive), and the PK substudy will have additional plasma PK samples at any single visit 
from Week 2 to Week 10, collected pre-dose, and at 0.5, 1, 2, 3, 4 and 6 hours after 
supervised dosing in the clinic.  If a sub-study PK sample is scheduled to be collected at the 
same time as a sparse PK sample, only one sample should be collected. 
 
For all visits with PK sampling, the time of dose taken prior to and on the day of visit will be 
noted in the eCRF. Plasma concentrations of filgotinib and its metabolite (GS-829845) will 
be analyzed. 


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6. 
PHARMACOKINETIC ANALYSIS PLAN 
6.1. 
PK Substudy Analysis Set 
The primary analysis set for intensive PK analyses will be the PK substudy analysis set for 
each Induction Study (Cohorts A and B), which includes all subjects in the Safety Analysis Set 
from the corresponding Induction Study who have enrolled into the PK substudy, and have 
dense concentration data to provide interpretable results for the specific parameters of interest 
for the analyte under evaluation. 
The primary analysis set for general PK analyses will be defined separately for each individual 
study (Cohort A Induction Study, Cohort B Induction Study, and Maintenance Study). For 
each study, the PK analysis set includes all subjects in the corresponding Safety Analysis Set 
who have at least 1 non-missing plasma concentration data for filgotinib and/or its metabolite 
GS-829845. 
 
6.2. 
Pharmacokinetic Parameters Estimation  
The plasma PK parameters for filgotinib and its metabolite (GS-829845) will be derived by 
non-compartmental analysis of the plasma concentration-time profiles based on actual blood 
sampling times [h] (relative to the corresponding administration time) rounded to two decimal 
digits and negative pre-dose times set to zero. The plasma PK parameters will be computed 
using Phoenix WinNonlin 6.3 or higher. The nominal times will be used to present in the 
individual concentration listings or tables and the mean concentration-time figures. 
 
The following plasma PK parameters of filgotinib and its metabolite (GS-829845) will be 
calculated as data allows. The definition for each PK variable is listed in the following tables:  
 
Cmax 
The maximum observed plasma concentration  
Tmax 
The time to reach Cmax 
Ctau 
The concentration in plasma at the end of a dosing interval 
AUC0-tau 
Area under the concentration-time curve within dosing interval, 
calculated by linear up/log down trapezoidal method. A 24 hour data 
point will be based on imputation of the predose value of filgotinib and 
its metabolite (GS-829845). 
CLss/F 
Apparent total body clearance at steady state, calculated as  
Dose/AUC0-tau, on steady state, for parent compound only 
MRcmax 
Metabolic ratio of GS-829845 Cmax / filgotinib Cmax * (425.51/357.43) 
MRctau 
Metabolic ratio of GS-829845 Ctau / filgotinib Ctau * (425.51/357.43) 
MRauctau 
Metabolic ratio of GS-829845 AUC0-tau / filgotinib AUC0-tau * 
(425.51/357.43) 
The substudy PK analysis population will be used for the analyses. Individual subject listings 
will be provided. For substudy PK analysis, mean and individual plasma concentration-time 


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profiles for filgotinib and its metabolite (GS-829845) will be presented graphically for each 
treatment.  
The measured individual plasma concentrations of filgotinib and its metabolite (GS-829845) 
will be used to directly obtain Cmax and Tmax for substudy PK analysis.  
The concentration in plasma at the end of a dosing interval (Ctau), where tau is 24 h, was also 
determined. To estimate AUC0-tau, the concentration observed in the predose sample (collected 
at steady-state) will be assumed as the same 24h post-dose.  
For general PK analysis, descriptive statistics for plasma concentrations of filgotinib and its 
metabolite GS-829845 will be listed and summarized per timepoint and per treatment for 
Cohort A, Cohort B, and maintenance study.  
6.3. 
Data Handling Procedures  
Only subjects included in the PK substudy analysis set and only samples obtained in this 
substudy will be included in the summary statistics for PK parameters. All analyses will be 
performed on data available at the time point considered. In summary tables, the number of 
subjects with missing data will be presented unless otherwise specified. In the calculation of 
percentages, subjects with missing data will not be considered in numerator or denominator 
unless otherwise specified. 
Missing Concentrations: 
Samples will be treated as missing for PK data analysis, if: 
• Blood samples are collected but no bioanalytical data are reported; 
• Missed PK sample collections; 
• Samples are collected but the sampling time and/or dosing time are not recorded; 
• Samples whose identities are uncertain due to possible handing or labelling errors 
conducted in the clinical site or bioanalytical labs; 
• Sample is diluted and below the quantifiable limits. 
Protocol Deviations and/or Violations 
The data for subjects with significant protocol deviations and/or violations will be cautiously 
evaluated. If the deviation or violation has a significant impact on the filgotinib and its 
metabolite (GS-829845) PK profile, the data for those subjects should be excluded from the 
study’s statistical evaluation by the pharmacokineticist and the reason for excluding individual 
data points will be recorded. Filgotinib and its metabolite (GS-829845) concentration data and 
PK parameters derived for those subjects will not be determined and reported. 
Below the Lower Limit of Quantification Limit (BLQ) 
PK concentration values and PK parameter values below the lower limit of quantitation (BLQ) 
will be presented as “BLQ” in the data listings. BLQ values will be treated as 1/2 of the lower 
limit of quantitation (LLOQ) for calculation of geometric mean and CV%, and will be treated 
as 0 for all other summary statistics. Unexpected BLQ samples or samples whose identity is 


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uncertain due to possible handling or labeling errors can be treated as missing at the judgment 
of the pharmacokineticist and noted accordingly.  
Data exclusion due to vomiting: 
In regard to the data from subjects who experience emesis during the PK sampling period (i.e. 
in the period “predose until the last sample (6 hrs post dose), if vomiting occurs at or before 
2 times median Tmax  under the same treatment, the time course of the study for filgotinib and 
its metabolite GS-829845 will be excluded from pharmacokinetic statistical analysis. 
Data Format (significant figures and decimal points) 
PK concentrations and PK parameters will be reported to 3 significant figures for individual 
concentrations and parameters and summary statistics, with the exception of Tmax (2 decimal 
places), coefficient of variation (CV%, 1 decimal place), and the number of subjects (N, 0 
decimal place). 
 
6.4. 
Statistical Evaluations of PK Parameters 
For each individual study (Cohort A Induction Study, Cohort B Induction Study and 
Maintenance Study), plasma concentrations of filgotinib and its metabolite GS-829845 will be 
listed and summarized by treatment using descriptive statistics (eg, sample size, arithmetic 
mean, geometric mean, % coefficient of variation, standard deviation, median, minimum, and 
maximum). 
For the subjects at the substudy, individual concentrations and PK parameters of filgotinib and 
its metabolite GS-829845 will be listed. Mean concentrations and PK parameters of filgotinib 
and its metabolite GS-829845 will be summarized descriptively. Individual and mean 
concentration-time profiles will be presented on semi-logarithmic and linear formats as mean 
± SD and median (Q1, Q3) by treatment.  
For descriptive statistics of pharmacokinetic parameters and concentration data, sample size, 
arithmetic mean, geometric mean, % coefficient of variation, standard deviation, median, 1
st 
quartile [Q1] (for concentration data only), 3rd quartile [Q3] (for concentration data only), 
minimum, and maximum, will be given.  
Plasma concentrations for the subjects at each individual study and substudy will be listed by 
subject and nominal sampling time and summarized by nominal sampling time and treatment 
using descriptive statistics. Similarly, calculated plasma PK parameters for substudy will be 
listed by subject and summarized by treatment using descriptive statistics. 
 
 
 
 
 
 


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7. 
REPORT  
The following tables and figures will be generated. 
Table 14.2.8. 
Subjects Not Included in the Pharmacokinetic Analysis (if 
Applicable) 
Subject 
Treatment 
Dose level 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Figure 14.2.3. 
Mean (± SD) Plasma Filgotinib Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 or 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects 
with Moderately to Severely Active Crohn’s Disease  
Linear Scale (Mock Figure) 
 
Semi-logarithmic Scale (Mock Figure) 
 


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Figure 14.2.4. 
Mean (± SD) Plasma GS-829845 Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 or 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects 
with Moderately to Severely Active Crohn’s Disease 
Figure 14.2.5. 
Mean (± SD) Plasma Filgotinib Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 or 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects 
with Moderately to Severely Active Crohn’s Disease – 0 to 24 
hours 
Linear Scale (Mock Figure) 
 
Semi-logarithmic Scale (Mock Figure) 


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Figure 14.2.6. 
Mean (± SD) Plasma GS-829845 Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 or 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects 
with Moderately to Severely Active Crohn’s Disease – 0 to 24 
hours 
Figure 14.2.7. 
Median (Q1, Q3) Plasma Filgotinib Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 or 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects 
with Moderately to Severely Active Crohn’s Disease  
Figure 14.2.8. 
Median (Q1, Q3) Plasma GS-829845 Concentration – Time 
Profiles Following Once Daily Oral Administration of 100 or 200 
mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease  
Figure 14.2.9. 
Median (Q1, Q3) Plasma Filgotinib Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 or 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects 
with Moderately to Severely Active Crohn’s Disease – 0 to 24 
hours 
Figure 14.2.10. 
Median (Q1, Q3) Plasma GS-829845 Concentration – Time 
Profiles Following Once Daily Oral Administration of 100 or 200 
mg Filgotinib at One Visit Between Week 2 and Week 10 in 
Subjects with Moderately to Severely Active Crohn’s Disease – 0 
to 24 hours 
 


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8. 
TABLES AND LISTINGS 
Descriptive statistics plasma filgotinib and its metabolite GS-829845 concentrations will be 
provided in Tables 14.4.1. Descriptive statistics plasma pharmacokinetic parameters of 
filgotinib and its metabolite GS-829845 will be included in Tables 14.4.2. The individual 
subject filgotinib and its metabolite GS-829845 plasma concentration will be included in in 
Listing 16.4.1. The individual subject filgotinib and its metabolite GS-829845 plasma 
pharmacokinetic parameters will be included in in Listing 16.4.2. The individual subject 
filgotinib and its metabolite GS-829845 plasma concentration time plots will be included in 
in Figures 16.4.3. 
 
 


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Table 14.4.1. 
Descriptive Statistics of Plasma Concentrations of Filgotinib and Metabolite GS-829845 
Table 14.4.1.1. 
Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily Oral Administration 
of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
 
Plasma Concentration (ng/mL) over Nominal Time (h) 
Subject 
Pre-dose 
0.5 
1 
2 
3 
4 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
N 
 
 
 
 
 
 
 
AM 
 
 
 
 
 
 
 
SD 
 
 
 
 
 
 
 
Min 
 
 
 
 
 
 
 
Q1 
 
 
 
 
 
 
 
Median 
 
 
 
 
 
 
 
Q3 
 
 
 
 
 
 
 
Max 
 
 
 
 
 
 
 
CV% 
 
 
 
 
 
 
 
GM 
 
 
 
 
 
 
 
AM: Arithmetic Mean; SD: Standard Deviation; Min: Minimum; Q1: 1st Quartile; Q3: 3rd Quartile; Max: Maximum; GM: Geometric Mean; CV%: 
Arithmetic CV which is equal to SD/AM*100. 


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Table 14.4.1.2. 
Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily Oral Administration 
of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
Table 14.4.1.3. 
Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once Daily Oral Administration 
of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
Table 14.4.1.4. 
Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once Daily Oral Administration 
of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease 
 
 


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Table 14.4.1.5. 
Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily Oral Administration 
of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease - Cohort A 
 
Plasma Concentration (ng/mL) over Nominal Time  
 
200 mg 
100 mg 
Subject 
Week 4 predose 
Week 
4 
0.5-3 
hr 
Week 
10 
predose 
Week 
26 
anytime 
Week 
58 
predose 
Week 4 predose 
Week 4 
0.5-3 hr 
Week 
10 
predose 
Week 
26 
anytime 
Week 
58 
predose 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
N 
 
 
 
 
 
 
 
AM 
 
 
 
 
 
 
 
SD 
 
 
 
 
 
 
 
Min 
 
 
 
 
 
 
 
Q1 
 
 
 
 
 
 
 
Median 
 
 
 
 
 
 
 
Q3 
 
 
 
 
 
 
 
Max 
 
 
 
 
 
 
 
CV% 
 
 
 
 
 
 
 
GM 
 
 
 
 
 
 
 
AM: Arithmetic Mean; SD: Standard Deviation; Min: Minimum; Q1: 1st Quartile; Q3: 3rd Quartile; Max: Maximum; GM: Geometric Mean; CV%: 
Arithmetic CV which is equal to SD/AM*100.  
   Note: if a sub-study PK sample is scheduled to be collected at the same time as a sparse PK sample, only one sample should be collected. 
 


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Table 14.4.1.6. 
Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily Oral Administration 
of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease - Cohort B 
Table 14.4.1.7. 
Descriptive Statistics of Plasma Concentrations of Filgotinib Following Once Daily Oral Administration 
of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease - 
Maintenance Study 
Table 14.4.1.8. 
Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once Daily Oral Administration 
of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease - Cohort A 
Table 14.4.1.9. 
Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once Daily Oral Administration 
of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease - Cohort B 
Table 14.4.1.10. 
Descriptive Statistics of Plasma Concentrations of GS-829845 Following Once Daily Oral Administration 
of 200 or 100 mg Filgotinib in Subjects with Moderately to Severely Active Crohn’s Disease - 
Maintenance Study 
 
 
 
 
 


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Table 14.4.2. 
Descriptive Statistics of Plasma Filgotinib and Metabolite GS-829845 Pharmacokinetic Parameters 
Table 14.4.2.1. 
Descriptive Statistics of Plasma Pharmacokinetic Parameters of Filgotinib Following Once Daily Oral 
Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with 
Moderately to Severely Active Crohn’s Disease  
Subject 
Cmax 
(ng/mL) 
Tmax 
(h) 
Ctau 
(ng/mL) 
AUC0-tau 
(ng*h/mL) 
CLss/F 
(L/h) 
 
 
 
 
 
 
 
 
 
 
 
 
N 
 
 
 
 
 
AM 
 
 
 
 
 
SD 
 
 
 
 
 
Min 
 
 
 
 
 
Median 
 
 
 
 
 
Max 
 
 
 
 
 
CV% 
 
 
 
 
 
GM 
 
 
 
 
 
AM: Arithmetic Mean; SD: Standard Deviation; Min: Minimum; Max: Maximum; GM: Geometric Mean; CV%: Arithmetic CV which is equal to SD/AM*100.  
Note: To estimate AUC0-tau, the concentration of 24h post-dose is based on imputed predose value. 
 


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Table 14.4.2.2. 
Descriptive Statistics of Plasma Pharmacokinetic Parameters of Filgotinib Following Once Daily Oral 
Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with 
Moderately to Severely Active Crohn’s Disease  
Table 14.4.2.3. 
Descriptive Statistics of Plasma Pharmacokinetic Parameters of GS-829845 Following Once Daily Oral 
Administration of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with 
Moderately to Severely Active Crohn’s Disease  
Subject 
Cmax 
(ng/mL) 
Tmax 
(h) 
Ctau 
(ng/mL) 
AUC0-tau 
(ng*h/mL) 
MRcmax 
MRctau 
MRauctau 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
N 
 
 
 
 
 
 
 
AM 
 
 
 
 
 
 
 
SD 
 
 
 
 
 
 
 
Min 
 
 
 
 
 
 
 
Median 
 
 
 
 
 
 
 
Max 
 
 
 
 
 
 
 
CV% 
 
 
 
 
 
 
 
GM 
 
 
 
 
 
 
 
AM: Arithmetic Mean; SD: Standard Deviation; Min: Minimum; Max: Maximum; GM: Geometric Mean; CV%: Arithmetic CV which is equal to  SD/AM*100. 
Note: To estimate AUC0-tau, the concentration of 24h post-dose is based on imputed predose value.  
MRcmax: Metabolic ratio of GS-829845 Cmax / filgotinib Cmax * (425.51/357.43) 
MRctau: Metabolic ratio of GS-829845 Ctau / filgotinib Ctau * (425.51/357.43) 
MRauctau: Metabolic ratio of GS-829845 AUC0-tau / filgotinib AUC0-tau * (425.51/357.43) 


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Table 14.4.2.4. 
Descriptive Statistics of Plasma Pharmacokinetic Parameters of GS-829845 Following Once Daily Oral 
Administration of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with 
Moderately to Severely Active Crohn’s Disease 
 
Listing 16.4.1. 
Individual Plasma Concentrations of Filgotinib and Metabolite GS-829845 
Listing 16.4.1.1. 
Individual Plasma Concentrations of Filgotinib Following Once Daily Oral Administration of 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease  
 
Plasma Concentration (ng/mL) over Nominal Time (h) 
Subject 
Pre-dose 
0.5 
1 
2 
3 
4 
6 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Listing 16.4.1.2. 
Individual Plasma Concentrations of Filgotinib Following Once Daily Oral Administration of 100 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease  
Listing 16.4.1.3. 
Individual Plasma Concentrations of GS-829845 Following Once Daily Oral Administration of 200 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease  
Listing 16.4.1.4. 
Individual Plasma Concentrations of GS-829845 Following Once Daily Oral Administration of 100 mg 
Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely Active 
Crohn’s Disease  
 
Listing 16.4.2. 
Individual Plasma Filgotinib and Metabolite GS-829845 Pharmacokinetic Parameters 
Listing 16.4.2.1. 
Individual Plasma Pharmacokinetic Parameters of Filgotinib Following Once Daily Oral Administration 
of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
Subject 
Cmax 
(ng/mL) 
Tmax 
(h) 
Ctau 
(ng/mL) 
AUC0-tau 
(ng*h/mL) 
CLss/F 
(L/h) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
Note: To estimate AUC0-tau, the concentration of 24h post-dose is based on imputed predose value.  
    


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Listing 16.4.2.2. 
Individual Plasma Pharmacokinetic Parameters of Filgotinib Following Once Daily Oral Administration 
of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
Listing 16.4.2.3. 
Individual Plasma Pharmacokinetic Parameters of GS-829845 Following Once Daily Oral Administration 
of 200 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
Subject 
Cmax 
(ng/mL) 
Tmax 
(h) 
Ctau 
(ng/mL) 
AUC0-tau 
(ng*h/mL) 
MRcmax 
MRctau 
MRauctau 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: To estimate AUC0-tau, the concentration of 24h post-dose is based on imputed predose value.  
   MRcmax: Metabolic ratio of GS-829845 Cmax / filgotinib Cmax * (425.51/357.43) 
   MRctau: Metabolic ratio of GS-829845 Ctau / filgotinib Ctau * (425.51/357.43)  
   MRauctau: Metabolic ratio of GS-829845 AUC0-tau / filgotinib AUC0-tau * (425.51/357.43) 
 
Listing 16.4.2.4. 
Individual Plasma Pharmacokinetic Parameters of GS-829845 Following Once Daily Oral Administration 
of 100 mg Filgotinib at One Visit Between Week 2 and Week 10 in Subjects with Moderately to Severely 
Active Crohn’s Disease  
 
 
 


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Figure 16.4.3.  
Individual Subject Plasma Concentration-Time Graphs 
Figure 16.4.3.1. 
Individual Plasma Filgotinib Concentration – Time Profiles 
Following Once Daily Oral Administration of 200 mg Filgotinib at 
One Visit Between Week 2 and Week 10 in Subjects with 
Moderately to Severely Active Crohn’s Disease  
Linear Scale (Mock Figure) 
 
 
Semi-logarithmic Scale (Mock Figure) 


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Figure 16.4.3.2. 
Individual Plasma Filgotinib Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to 
Severely Active Crohn’s Disease  
Figure 16.4.3.3. 
Individual Plasma Filgotinib Concentration – Time Profiles Following 
Once Daily Oral Administration of 200 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to 
Severely Active Crohn’s Disease – 0 to 24 hours 
Linear Scale (Mock Figure) 
 
 


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Semi-logarithmic Scale (Mock Figure) 
 
Figure 16.4.3.4. 
Individual Plasma Filgotinib Concentration – Time Profiles Following 
Once Daily Oral Administration of 100 mg Filgotinib at One Visit 
Between Week 2 and Week 10 in Subjects with Moderately to 
Severely Active Crohn’s Disease – 0 to 24 hours 
Figure 16.4.3.5. 
Individual Plasma GS-829845 Concentration – Time Profiles 
Following Once Daily Oral Administration of 200 mg Filgotinib at 
One Visit Between Week 2 and Week 10 in Subjects with Moderately 
to Severely Active Crohn’s Disease  
Figure 16.4.3.6. 
Individual Plasma GS-829845 Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 mg Filgotinib at 
One Visit Between Week 2 and Week 10 in Subjects with Moderately 
to Severely Active Crohn’s Disease  
Figure 16.4.3.7. 
Individual Plasma GS-829845 Concentration – Time Profiles 
Following Once Daily Oral Administration of 200 mg Filgotinib at 
One Visit Between Week 2 and Week 10 in Subjects with Moderately 
to Severely Active Crohn’s Disease – 0 to 24 hours 
Figure 16.4.3.8. 
Individual Plasma GS-829845 Concentration – Time Profiles 
Following Once Daily Oral Administration of 100 mg Filgotinib at 


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One Visit Between Week 2 and Week 10 in Subjects with Moderately 
to Severely Active Crohn’s Disease – 0 to 24 hours