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Clinical Trial Results:
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease

Summary
EudraCT number	2016-002763-34
Trial protocol	HU BG AT CZ GB IS SE GR PT SK DE ES BE NL HR IT
Global end of trial date	01 Aug 2023

Results information
Results version number	v1(current)
This version publication date	14 Jun 2024
First version publication date	14 Jun 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

GS-US-419-3896

ISRCTN number

-

US NCT number

NCT02914600

WHO universal trial number (UTN)

-

Sponsor organisation name

Galapagos NV

Sponsor organisation address

Generaal De Wittelaan L11 A3, Mechelen, Belgium, 2800

Public contact

Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com

Scientific contact

Galapagos Medical Information, Galapagos NV, medicalinfo@glpg.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

01 Aug 2023

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

01 Aug 2023

Was the trial ended prematurely?

Yes

Main objective of the trial

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

Protection of trial subjects

This study was conducted under a US investigational new drug (IND) application and in accordance with recognized international scientific and ethical standards, including but not limited to the International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP), and the original principles embodied in the Declaration of Helsinki. These standards are consistent with the requirements of the US Code of Federal Regulations (CFR) Title 21, Part 312 (21CFR312), and the EU Clinical Trials Directive 2001/20/EC as well as other local legislation.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

17 Mar 2017

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Netherlands: 30

Country: Number of subjects enrolled

Poland: 108

Country: Number of subjects enrolled

Portugal: 9

Country: Number of subjects enrolled

Slovakia: 13

Country: Number of subjects enrolled

Spain: 24

Country: Number of subjects enrolled

Sweden: 2

Country: Number of subjects enrolled

United Kingdom: 28

Country: Number of subjects enrolled

Croatia: 1

Country: Number of subjects enrolled

Austria: 9

Country: Number of subjects enrolled

Belgium: 58

Country: Number of subjects enrolled

Czechia: 26

Country: Number of subjects enrolled

France: 99

Country: Number of subjects enrolled

Germany: 71

Country: Number of subjects enrolled

Greece: 1

Country: Number of subjects enrolled

Hungary: 18

Country: Number of subjects enrolled

Ireland: 6

Country: Number of subjects enrolled

Italy: 29

Country: Number of subjects enrolled

United States: 274

Country: Number of subjects enrolled

India: 72

Country: Number of subjects enrolled

Ukraine: 52

Country: Number of subjects enrolled

Japan: 48

Country: Number of subjects enrolled

Canada: 43

Country: Number of subjects enrolled

Australia: 40

Country: Number of subjects enrolled

Russian Federation: 22

Country: Number of subjects enrolled

Israel: 19

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 11

Country: Number of subjects enrolled

Sri Lanka: 11

Country: Number of subjects enrolled

Switzerland: 10

Country: Number of subjects enrolled

Taiwan: 10

Country: Number of subjects enrolled

Romania: 9

Country: Number of subjects enrolled

Malaysia: 8

Country: Number of subjects enrolled

South Africa: 8

Country: Number of subjects enrolled

New Zealand: 7

Country: Number of subjects enrolled

Georgia: 4

Country: Number of subjects enrolled

Hong Kong: 3

Country: Number of subjects enrolled

Singapore: 3

Country: Number of subjects enrolled

Serbia: 2

Worldwide total number of subjects

1188

EEA total number of subjects

513

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

1130

From 65 to 84 years

58

85 years and over

0

Subject disposition

Top of page

Recruitment details

Participants were enrolled in 37 countries. Participants with CD, who had completed or met protocol-specified efficacy discontinuation criteria from previous parent studies (GS-US-419-4015 [NCT03046056], GS-US-419-4016 [NCT03077412] or GS-US-419-3895 [GLPG0634-CL-309] [NCT02914561]) were rolled-over to this long-term extension study.

Screening details

Sponsor decided not to pursue extension of filgotinib indication for CD, as GS-US-419-3895 did not meet the co-primary endpoint and decided to prematurely terminate the study.

Period 1 title

Overall study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Blinding implementation details

Participants who completed the parent study blinded, received blinded treatment. After un-blinding of the parent study, participants received open-label treatment.

Are arms mutually exclusive

Yes

Filgotinib 200 mg

Arm description

Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Arm type

Experimental

Investigational medicinal product name

Filgotinib 200 mg

Investigational medicinal product code

Other name

GS-6034, GLPG0634, Jyseleca®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablet administered orally once daily.

Filgotinib 100 mg

Arm description

Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US & Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Arm type

Experimental

Investigational medicinal product name

Filgotinib 100 mg

Investigational medicinal product code

Other name

GS-6034, GLPG0634, Jyseleca®

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Tablet administered orally once daily.

Placebo

Arm description

Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After un-blinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until un-blinding of the parent study (up to 308 weeks).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Drug matching tablet administered orally once daily.

Number of subjects in period 1	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Started	945	119	124
Completed	0	0	0
Not completed	945	119	124
Adverse event, serious fatal	-	1	1
Consent withdrawn by subject	158	20	18
Study Unblinded, participant confirmed on Placebo	-	-	55
Adverse event, non-fatal	298	35	25
Death	3	-	-
Pregnancy	8	-	-
Lost to follow-up	10	4	-
Enrolled but not treated	1	-	-
Investigators discretion	169	14	13
Sponsors decision	287	41	12
Non compliance with study drug	6	1	-
Protocol deviation	5	3	-

Baseline characteristics

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Reporting group title

Filgotinib 200 mg

Reporting group description

Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Reporting group title

Filgotinib 100 mg

Reporting group description

Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US & Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Reporting group title

Placebo

Reporting group description

Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After un-blinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until un-blinding of the parent study (up to 308 weeks).

Reporting group values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo	Total
Number of subjects	945	119	124	1188
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	39.2 ( 13.60 )	46.7 ( 13.28 )	42.3 ( 12.42 )	-
Gender categorical
Units: Subjects
Female	514	33	56	603
Male	431	86	68	585
Ethnicity
Units: Subjects
Hispanic or Latino	18	5	0	23
Not Hispanic or Latino	905	112	123	1140
Not permitted	22	2	1	25
Race
Units: Subjects
American Indian or Alaska Native	1	0	0	1
Asian	137	18	23	178
Native Hawaiian or Other Pacific Islander	2	0	0	2
Black or African American	18	10	3	31
White	740	89	96	925
Other	6	1	0	7
Not permitted	41	1	2	44

End points

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Reporting group title

Filgotinib 200 mg

Reporting group description

Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Reporting group title

Filgotinib 100 mg

Reporting group description

Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US & Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Reporting group title

Placebo

Reporting group description

Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After un-blinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until un-blinding of the parent study (up to 308 weeks).

Primary: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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End point title

Number of Participants with Treatment Emergent Adverse Events (TEAEs) ^[1]

End point description

An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: • Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug • Any AEs leading to premature discontinuation of study drug. The Safety Analysis Set (SAF) included all participants who took at least 1 dose of study drug.

End point type

Primary

End point timeframe

From the First Dose to Week 312

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis was intended to be performed for this endpoint.

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	944	119	124
Units: participants	820	103	96

No statistical analyses for this end point

Secondary: Change from Baseline in Patient Reported Outcomes 2 (PRO2) Scores

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End point title

Change from Baseline in Patient Reported Outcomes 2 (PRO2) Scores

End point description

PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were summed over the 7 days prior to each visit. The remaining predictors were noted and weighted to create the total CDAI score ranging from 0-600 with a higher score indicating a worse outcome. Participants from safety analysis set with available data were analysed. Here "99999"signifies that no participants were evaluable for the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Week (Wk) 12, Wk 24, Wk 48, Wk 96, Wk 156, Wk 216, Wk 264, and Wk 300

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	911	113	113
Units: units on a scale
arithmetic mean (standard deviation)
Baseline: Liquid/ Soft Stool (n= 911,113,113)	5.6 ( 3.26 )	4.0 ( 3.12 )	2.2 ( 1.92 )
Change at Wk 12:Liquid/ Soft Stool(n=787,103,103)	-1.6 ( 2.71 )	-0.7 ( 2.01 )	0.2 ( 1.44 )
Change at Wk 24:Liquid/Soft Stool(n=682,89,89)	-1.8 ( 2.89 )	-0.7 ( 2.59 )	0.1 ( 1.15 )
Change at Wk 48:Liquid/Soft Stool(n=516,74,81)	-2.0 ( 3.14 )	-0.8 ( 2.49 )	0.0 ( 1.21 )
Change at Wk 96:Liquid/Soft Stool(n=305,49,53)	-2.2 ( 3.11 )	-0.7 ( 2.70 )	0.4 ( 2.79 )
Change at Wk 156:Liquid/Soft Stool(n=177,30,26)	-2.4 ( 3.14 )	-0.7 ( 3.19 )	-0.2 ( 1.63 )
Change at Wk 216:Liquid/Soft Stool(n=82,13,6)	-2.8 ( 3.17 )	-1.2 ( 4.10 )	1.0 ( 1.41 )
Change at Wk 264:Liquid/Soft Stool(n=20,4,0)	-2.0 ( 2.86 )	-4.8 ( 6.18 )	99999 ( 99999 )
Change at Wk 300:Liquid/Soft Stool(n=4,0,0)	0.0 ( 2.71 )	99999 ( 99999 )	99999 ( 99999 )
Baseline: Abdominal Pain(n= 911,113,113)	1.6 ( 0.91 )	1.0 ( 0.89 )	0.7 ( 0.75 )
Change at Wk 12: Abdominal Pain(n=787,103,103)	-0.6 ( 0.91 )	-0.2 ( 0.65 )	0.0 ( 0.52 )
Change at Wk 24: Abdominal Pain(n=682,89,89)	-0.7 ( 0.92 )	-0.2 ( 0.75 )	0.0 ( 0.51 )
Change at Wk 48: Abdominal Pain (n=516,74,81)	-0.8 ( 0.97 )	-0.3 ( 0.70 )	-0.1 ( 0.54 )
Change at Wk 96: Abdominal Pain (n=305,49,53)	-0.8 ( 1.00 )	-0.2 ( 0.73 )	-0.1 ( 0.55 )
Change at Wk 156: Abdominal Pain (n=177,30,26)	-0.8 ( 0.98 )	-0.2 ( 0.77 )	0.0 ( 0.57 )
Change at Wk 216: Abdominal Pain (n=82,13,6)	-0.9 ( 1.05 )	-0.5 ( 0.88 )	0.0 ( 0.00 )
Change at Wk 264: Abdominal Pain (n=20,4,0)	-0.8 ( 0.64 )	-1.3 ( 0.50 )	99999 ( 99999 )
Change at Wk 300: Abdominal Pain (n=4,0,0)	-0.3 ( 0.50 )	99999 ( 99999 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Change from Baseline in CDAI Scores

Top of page

End point title

Change from Baseline in CDAI Scores

End point description

The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and haematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Participants from safety analysis set with available data were analyzed. Here "99999"signifies that no participants were evaluable for the specified timepoint.

End point type

Secondary

End point timeframe

Baseline, Wk 12, Wk 24, Wk 48, Wk 96, Wk 156, Wk 216, Wk 264, and Wk 300

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	897	110	110
Units: units on a scale
arithmetic mean (standard deviation)
Baseline (n= 897,110,110)	280.5 ( 116.58 )	189.9 ( 112.73 )	120.4 ( 81.33 )
Change at Wk 12 (n=710,94,92)	-86.8 ( 114.02 )	-29.1 ( 79.84 )	4.2 ( 53.42 )
Change at Wk 24(n=608,84,82)	-98.5 ( 122.68 )	-30.8 ( 92.92 )	5.7 ( 51.30 )
Change at Wk 48 (n=461,69,71)	-110.2 ( 125.08 )	-40.9 ( 91.47 )	0.6 ( 49.32 )
Change at Wk 96(n=261,46,45)	-118.6 ( 131.49 )	-23.3 ( 91.94 )	11.0 ( 69.29 )
Change at Wk 156 (n=154,28,24)	-121.4 ( 132.33 )	-33.5 ( 99.15 )	0.3 ( 59.27 )
Change at Wk 216 (n=65,13,4)	-137.0 ( 147.14 )	-57.5 ( 121.12 )	2.5 ( 37.76 )
Change at Wk 264 (n=16,4,0)	-134.8 ( 128.86 )	-171.5 ( 141.81 )	99999 ( 99999 )
Change at Wk 300 (n=4,0,0)	-32.5 ( 92.99 )	99999 ( 99999 )	99999 ( 99999 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From the First Dose to Week 312

Adverse event reporting additional description

Safety Analysis Set

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

Filgotinib 100 mg

Reporting group description

Participants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US & Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Reporting group title

Placebo

Reporting group description

Participants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until unblinding of the parent study.

Reporting group title

Filgotinib 200 mg

Reporting group description

Participants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).

Serious adverse events	Filgotinib 100 mg	Placebo	Filgotinib 200 mg
Total subjects affected by serious adverse events
subjects affected / exposed	34 / 119 (28.57%)	20 / 124 (16.13%)	284 / 944 (30.08%)
number of deaths (all causes)	2	1	6
number of deaths resulting from adverse events	2	1	5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervix carcinoma stage 0
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lip and/or oral cavity cancer
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lung neoplasm
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant melanoma stage I
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nasal sinus cancer
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Papillary renal cell carcinoma
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma of skin
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tumour inflammation
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombophlebitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Condition aggravated
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Death
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Inflammation
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oedema
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	4 / 944 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Bartholin's cyst
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endometriosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pelvic fluid collection
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vulvovaginal swelling
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	3 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asthmatic crisis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute psychosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Adjustment disorder
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol abuse
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcoholism
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Completed suicide
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Delusional disorder, unspecified type
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
General physical condition abnormal
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood creatinine increased
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Fractured sacrum
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Alcohol poisoning
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anastomotic leak
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cervix injury
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Facial bones fracture
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Fracture of penis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal anastomosis complication
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Patella fracture
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post-traumatic pain
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Congenital, familial and genetic disorders
Developmental hip dysplasia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hydrocele
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angina pectoris
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mitral valve incompetence
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocardial ischaemia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Myocarditis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery stenosis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Atrial fibrillation
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Aphasia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dizziness
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Superior sagittal sinus thrombosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peripheral sensory neuropathy
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychogenic seizure
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Serotonin syndrome
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysarthria
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 119 (0.84%)	1 / 124 (0.81%)	5 / 944 (0.53%)
occurrences causally related to treatment / all	0 / 1	0 / 1	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vestibular disorder
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Colitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal stenosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	1 / 119 (0.84%)	1 / 124 (0.81%)	7 / 944 (0.74%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 11
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal fissure
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	2 / 119 (1.68%)	0 / 124 (0.00%)	17 / 944 (1.80%)
occurrences causally related to treatment / all	0 / 2	0 / 0	1 / 18
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal inflammation
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Food poisoning
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enterocolitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Enteritis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dental necrosis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dental caries
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	5 / 119 (4.20%)	4 / 124 (3.23%)	101 / 944 (10.70%)
occurrences causally related to treatment / all	0 / 6	0 / 4	5 / 108
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colonic fistula
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colon dysplasia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematochezia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hiatus hernia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ileal stenosis
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	4 / 944 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatic cyst
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mechanical ileus
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestine perforation
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestinal ulcer
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestinal stenosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Large intestinal obstruction
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal stenosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	2 / 119 (1.68%)	0 / 124 (0.00%)	8 / 944 (0.85%)
occurrences causally related to treatment / all	0 / 2	0 / 0	2 / 9
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal mucosal tear
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal mass
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal haemorrhage
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intestinal fistula
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subileus
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	4 / 944 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small intestinal stenosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small intestinal perforation
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	9 / 119 (7.56%)	3 / 124 (2.42%)	11 / 944 (1.17%)
occurrences causally related to treatment / all	1 / 10	0 / 3	0 / 14
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Short-bowel syndrome
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal perforation
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholangitis sclerosing
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bile duct stone
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Biliary obstruction
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Portal vein thrombosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis acute
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Diabetic foot
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Erythema nodosum
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prurigo
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Renal failure
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Stag horn calculus
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrolithiasis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Calculus urinary
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	4 / 944 (0.42%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ureteric obstruction
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocrine disorders
Goitre
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Joint effusion
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Campylobacter infection
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess intestinal
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess limb
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	15 / 944 (1.59%)
occurrences causally related to treatment / all	0 / 0	0 / 0	3 / 18
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Brain abscess
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
COVID-19
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	5 / 944 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
COVID-19 pneumonia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Cellulitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Clostridium difficile colitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Colonic abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes zoster disseminated
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis viral
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal infection
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes ophthalmic
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastroenteritis cryptosporidial
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mastitis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Perirectal abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary tuberculosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	5 / 944 (0.53%)
occurrences causally related to treatment / all	0 / 1	0 / 0	2 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia haemophilus
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psoas abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Salmonellosis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal infection
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Subcutaneous abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	0 / 944 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vulval abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectal abscess
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 119 (0.84%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetes mellitus inadequate control
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	1 / 944 (0.11%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypophosphataemia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	2 / 944 (0.21%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	Filgotinib 100 mg	Placebo	Filgotinib 200 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	89 / 119 (74.79%)	78 / 124 (62.90%)	697 / 944 (73.83%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	14 / 944 (1.48%)
occurrences all number	3	0	16
Vascular disorders
Hypertension
subjects affected / exposed	8 / 119 (6.72%)	3 / 124 (2.42%)	40 / 944 (4.24%)
occurrences all number	8	3	41
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	65 / 944 (6.89%)
occurrences all number	4	0	94
Fatigue
subjects affected / exposed	5 / 119 (4.20%)	4 / 124 (3.23%)	35 / 944 (3.71%)
occurrences all number	6	6	40
Asthenia
subjects affected / exposed	1 / 119 (0.84%)	1 / 124 (0.81%)	20 / 944 (2.12%)
occurrences all number	1	1	24
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	2 / 119 (1.68%)	1 / 124 (0.81%)	21 / 944 (2.22%)
occurrences all number	2	1	23
Dyspnoea
subjects affected / exposed	0 / 119 (0.00%)	1 / 124 (0.81%)	21 / 944 (2.22%)
occurrences all number	0	1	23
Psychiatric disorders
Anxiety
subjects affected / exposed	3 / 119 (2.52%)	3 / 124 (2.42%)	24 / 944 (2.54%)
occurrences all number	3	3	26
Insomnia
subjects affected / exposed	2 / 119 (1.68%)	0 / 124 (0.00%)	23 / 944 (2.44%)
occurrences all number	2	0	24
Depression
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	20 / 944 (2.12%)
occurrences all number	3	1	20
Investigations
Mycobacterium tuberculosis complex test positive
subjects affected / exposed	0 / 119 (0.00%)	5 / 124 (4.03%)	12 / 944 (1.27%)
occurrences all number	0	5	12
Weight decreased
subjects affected / exposed	1 / 119 (0.84%)	2 / 124 (1.61%)	22 / 944 (2.33%)
occurrences all number	1	2	22
Injury, poisoning and procedural complications
Procedural pain
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences all number	3	0	4
Meniscus injury
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	2 / 944 (0.21%)
occurrences all number	3	1	2
Arthropod bite
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	5 / 944 (0.53%)
occurrences all number	3	0	5
Nervous system disorders
Headache
subjects affected / exposed	4 / 119 (3.36%)	11 / 124 (8.87%)	79 / 944 (8.37%)
occurrences all number	5	12	95
Dizziness
subjects affected / exposed	1 / 119 (0.84%)	1 / 124 (0.81%)	26 / 944 (2.75%)
occurrences all number	1	1	28
Blood and lymphatic system disorders
Lymphopenia
subjects affected / exposed	2 / 119 (1.68%)	1 / 124 (0.81%)	27 / 944 (2.86%)
occurrences all number	3	1	34
Iron deficiency anaemia
subjects affected / exposed	0 / 119 (0.00%)	0 / 124 (0.00%)	22 / 944 (2.33%)
occurrences all number	0	0	23
Anaemia
subjects affected / exposed	3 / 119 (2.52%)	5 / 124 (4.03%)	61 / 944 (6.46%)
occurrences all number	3	5	73
Gastrointestinal disorders
Constipation
subjects affected / exposed	5 / 119 (4.20%)	5 / 124 (4.03%)	21 / 944 (2.22%)
occurrences all number	5	6	27
Anal fistula
subjects affected / exposed	3 / 119 (2.52%)	5 / 124 (4.03%)	24 / 944 (2.54%)
occurrences all number	3	5	31
Abdominal pain upper
subjects affected / exposed	2 / 119 (1.68%)	1 / 124 (0.81%)	24 / 944 (2.54%)
occurrences all number	2	1	27
Abdominal pain
subjects affected / exposed	15 / 119 (12.61%)	15 / 124 (12.10%)	93 / 944 (9.85%)
occurrences all number	19	18	126
Abdominal distension
subjects affected / exposed	5 / 119 (4.20%)	0 / 124 (0.00%)	17 / 944 (1.80%)
occurrences all number	5	0	19
Vomiting
subjects affected / exposed	3 / 119 (2.52%)	3 / 124 (2.42%)	67 / 944 (7.10%)
occurrences all number	3	3	86
Rectal haemorrhage
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	10 / 944 (1.06%)
occurrences all number	3	1	12
Nausea
subjects affected / exposed	8 / 119 (6.72%)	4 / 124 (3.23%)	74 / 944 (7.84%)
occurrences all number	8	6	83
Gastrooesophageal reflux disease
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	22 / 944 (2.33%)
occurrences all number	3	1	24
Gastritis
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	16 / 944 (1.69%)
occurrences all number	3	1	16
Dyspepsia
subjects affected / exposed	2 / 119 (1.68%)	3 / 124 (2.42%)	29 / 944 (3.07%)
occurrences all number	2	3	31
Diarrhoea
subjects affected / exposed	10 / 119 (8.40%)	11 / 124 (8.87%)	54 / 944 (5.72%)
occurrences all number	13	12	66
Crohn's disease
subjects affected / exposed	26 / 119 (21.85%)	20 / 124 (16.13%)	210 / 944 (22.25%)
occurrences all number	36	22	269
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	5 / 944 (0.53%)
occurrences all number	3	1	5
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	7 / 119 (5.88%)	2 / 124 (1.61%)	27 / 944 (2.86%)
occurrences all number	7	3	29
Dermatitis contact
subjects affected / exposed	3 / 119 (2.52%)	1 / 124 (0.81%)	2 / 944 (0.21%)
occurrences all number	3	1	2
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	7 / 119 (5.88%)	2 / 124 (1.61%)	11 / 944 (1.17%)
occurrences all number	9	2	11
Musculoskeletal and connective tissue disorders
Muscle spasms
subjects affected / exposed	4 / 119 (3.36%)	1 / 124 (0.81%)	15 / 944 (1.59%)
occurrences all number	4	1	18
Intervertebral disc protrusion
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	4 / 944 (0.42%)
occurrences all number	3	0	4
Back pain
subjects affected / exposed	4 / 119 (3.36%)	1 / 124 (0.81%)	43 / 944 (4.56%)
occurrences all number	5	3	53
Arthralgia
subjects affected / exposed	15 / 119 (12.61%)	1 / 124 (0.81%)	82 / 944 (8.69%)
occurrences all number	24	3	103
Infections and infestations
Urinary tract infection
subjects affected / exposed	8 / 119 (6.72%)	1 / 124 (0.81%)	57 / 944 (6.04%)
occurrences all number	14	1	82
Upper respiratory tract infection
subjects affected / exposed	8 / 119 (6.72%)	3 / 124 (2.42%)	57 / 944 (6.04%)
occurrences all number	9	4	84
Sinusitis
subjects affected / exposed	7 / 119 (5.88%)	0 / 124 (0.00%)	30 / 944 (3.18%)
occurrences all number	9	0	35
Pharyngitis
subjects affected / exposed	1 / 119 (0.84%)	3 / 124 (2.42%)	18 / 944 (1.91%)
occurrences all number	1	3	22
Oral herpes
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	14 / 944 (1.48%)
occurrences all number	4	0	19
Anal abscess
subjects affected / exposed	3 / 119 (2.52%)	2 / 124 (1.61%)	16 / 944 (1.69%)
occurrences all number	3	2	22
Bronchitis
subjects affected / exposed	5 / 119 (4.20%)	2 / 124 (1.61%)	30 / 944 (3.18%)
occurrences all number	5	4	37
COVID-19
subjects affected / exposed	17 / 119 (14.29%)	9 / 124 (7.26%)	127 / 944 (13.45%)
occurrences all number	17	10	139
Gastroenteritis
subjects affected / exposed	4 / 119 (3.36%)	1 / 124 (0.81%)	26 / 944 (2.75%)
occurrences all number	5	1	29
Herpes zoster
subjects affected / exposed	1 / 119 (0.84%)	1 / 124 (0.81%)	22 / 944 (2.33%)
occurrences all number	1	1	22
Influenza
subjects affected / exposed	4 / 119 (3.36%)	4 / 124 (3.23%)	27 / 944 (2.86%)
occurrences all number	5	6	31
Latent tuberculosis
subjects affected / exposed	2 / 119 (1.68%)	4 / 124 (3.23%)	14 / 944 (1.48%)
occurrences all number	2	4	14
Nasopharyngitis
subjects affected / exposed	13 / 119 (10.92%)	6 / 124 (4.84%)	81 / 944 (8.58%)
occurrences all number	21	6	101
Metabolism and nutrition disorders
Folate deficiency
subjects affected / exposed	3 / 119 (2.52%)	0 / 124 (0.00%)	13 / 944 (1.38%)
occurrences all number	5	0	14
Hyperlipidaemia
subjects affected / exposed	4 / 119 (3.36%)	0 / 124 (0.00%)	3 / 944 (0.32%)
occurrences all number	4	0	3
Hypokalaemia
subjects affected / exposed	3 / 119 (2.52%)	2 / 124 (1.61%)	22 / 944 (2.33%)
occurrences all number	4	2	24
Hypophosphataemia
subjects affected / exposed	1 / 119 (0.84%)	1 / 124 (0.81%)	30 / 944 (3.18%)
occurrences all number	1	1	35
Iron deficiency
subjects affected / exposed	1 / 119 (0.84%)	2 / 124 (1.61%)	21 / 944 (2.22%)
occurrences all number	1	2	23

More information

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Were there any global substantial amendments to the protocol? Yes

07 Sep 2016

Amendment 1: Updated Study Procedures Table and footnotes to reflect changes made to weekly visits assessments/procedures in the protocol. Protocol GS-US-419-3896 title changed from Open-Label to Long-Term Extension study.

11 Nov 2016

Amendment 2: Updated Study Procedures Table to reflect changes made to the study visit assessments/procedures in the protocol.

15 Jun 2017

Amendment 3: Updates were made in response to the South Korean Ministry of Food and Drug Safety request for the use of 200 mg in males in Korea to be limited to male subjects who had failed 2 classes of biologic therapies (any tumor necrosis factor-alpha [TNFα] antagonist and vedolizumab). Updated sections with emerging relevant clinical and pipeline data, and ensured consistency with Investigator Brochure (IB) Ed 12. Updated Study Procedures Table to reflect changes made to the study visit assessments/procedures in the protocol.

08 Mar 2018

Amendment 4: Clarification on inclusion/exclusion criteria including those surrounding hepatitis and tuberculosis (TB), clarified Day 1 visit procedures and provided additional flexibility for enhanced safety monitoring (suggested infectious workups for disease worsening). Updated the department name from Drug Safety and Public Health (DSPH) to Pharmacovigilance & Epidemiology (PVE) Updated the Study Procedures Table and footnotes to reflect changes made to the study visit assessments/procedures in the protocol.

09 Nov 2018

Amendment 5: To allow study-wide unblinding of GSUS- 419-3896 after the parent studies (GSUS- 419-4015, GS-US-419-4016 and GSUS- 419-3895) were unblinded. Inclusion criterion # 2 was amended to include a comprehensive list of the Gilead-sponsored Crohn’s disease (CD) parent studies eligible for roll-over into this long-term extension (LTE) study.

17 Apr 2019

Amendment 5.1: Updated to allow for continuation of concomitant vedolizumab use in subjects who were previously enrolled in study GS-US-419-4016.

05 Sep 2019

Amendment 6: Updated duration of treatment to 432 weeks, or until filgotinib becomes commercially available, whichever comes first, to ensure continued access to filgotinib in subjects who have completed the parent study (GS-US-419-3896). Amended study drug interruption or discontinuation criteria to reflect that subjects with newly positive QuantiFERON® TB test (or centrally reported equivalent assay) are now considered for study drug interruption instead of permanent discontinuation.

23 Mar 2020

Amendment 7: Updated study unblinding language to clarify the unblinding process and to allow subject unblinding once the corresponding parent study (GS-US-419-4015, GS-US-419-4016, or GS-US-419-3895) was unblinded. Updated study drug interruption criteria to allow the investigator to make the assessment of active or latent TB infection based on subject’s individual risk factors and further evaluations per standard of care upon seroconversion or sequential indeterminate QuantiFERON® TB tests. Changes were implemented at the request of the United States Food and Drug Administration (US FDA) regarding new safety information of other Janus kinase (JAK) inhibitors on the potential risk of thromboembolic events. A statement was added to clarify the procedures to be followed if the Data Monitoring Committee (DMC) recommended stopping the study due to lack of efficacy.

02 Dec 2021

Amendment 8: Changed sponsorship from Gilead Sciences, Inc. to Galapagos NV. The Galapagos study number (GLPG0634-CL-310) was added.

23 Nov 2022

Amendment 9: The duration of treatment and end of study were adapted due to the limited number of subjects expected to continue after 31 January 2025 and to allow subjects from other filgotinib treatment studies for CD to be enrolled into this study. Dose interruption criteria regarding renal impairment and lymphopenia were added to align with the IB Edition 17, 15 Jul 2022. The length of time women of childbearing potential should use effective contraception after cessation of filgotinib treatment was changed to align with the post-treatment visit. The requirements for male condom use and reporting of pregnancies in female partners were removed to align with the IB Edition 17, 15 Jul 2022. Monthly pregnancy testing in clinic was changed to allow at home testing for subjects outside the US to reduce the burden on subjects.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
06 Apr 2023	After analyzing all available data from the DIVERSITY 1 and DIVERSITY LTE studies, the sponsor decided not to pursue extension of the filgotinib indication for CD and decided to terminate the DIVERSITY LTE study.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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