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Clinical Trial Results:
Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated With CT-P13 in Usual Clinical Practice(CONNECT-IBD)

Summary
EudraCT number	2014-005192-89
Trial protocol	FI
Global end of trial date	31 Oct 2018

Results information
Results version number	v1(current)
This version publication date	06 Feb 2022
First version publication date	06 Feb 2022
Other versions

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

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Trial information

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Sponsor protocol code

C1231001

ISRCTN number

US NCT number

NCT02539368

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

20 Aug 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

31 Oct 2018

Was the trial ended prematurely?

Main objective of the trial

To characterise the population and drug utilisation patterns of patients treated with CT-P13 for CD or UC in the context of SOC Remicade and to explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of SOC Remicade.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Apr 2015

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

2 Years

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 23

Country: Number of subjects enrolled

Czechia: 36

Country: Number of subjects enrolled

Finland: 38

Country: Number of subjects enrolled

France: 622

Country: Number of subjects enrolled

Germany: 623

Country: Number of subjects enrolled

Greece: 87

Country: Number of subjects enrolled

Hungary: 56

Country: Number of subjects enrolled

Italy: 257

Country: Number of subjects enrolled

Netherlands: 54

Country: Number of subjects enrolled

Portugal: 54

Country: Number of subjects enrolled

Slovakia: 60

Country: Number of subjects enrolled

Spain: 451

Country: Number of subjects enrolled

United Kingdom: 182

Worldwide total number of subjects

2543

EEA total number of subjects

2361

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

2387

From 65 to 84 years

152

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 2565 subjects were enrolled in the study, out of which 22 subjects were not eligible to receive treatment for any of the treatment groups. Hence, only those subjects who received treatment during the study observation period were included in the subjects flow section.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

CT-P13

Arm description

Subjects diagnosed with either Crohn’s Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or subjects who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Subjects received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months.

Arm type

Experimental

Investigational medicinal product name

Infliximab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate

Routes of administration

Intravenous use

Dosage and administration details

Infliximab was administered following local standard of care. As per summary of product characteristics: Crohn's disease: 5 mg/kg given as an intravenous infusion followed by an additional 5 mg/kg infusion 2 weeks after the first infusion. Ulcerative colitis: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Remicade

Arm description

Subjects diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or subjects who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Subjects received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.

Arm type

Experimental

Investigational medicinal product name

Remicade

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate

Routes of administration

Intravenous use

Dosage and administration details

Remicade was administered following local standard of care. As per summary of product characteristics: Crohn's disease: 5 mg/kg given as an intravenous infusion followed by an additional 5 mg/kg infusion 2 weeks after the first infusion. Ulcerative colitis: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.

Switched From Remicade to CT-P13

Arm description

Subjects diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.

Arm type

Experimental

Investigational medicinal product name

Infliximab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate

Routes of administration

Intravenous use

Dosage and administration details

Switched From CT-P13 to Remicade

Arm description

Subjects diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.

Arm type

Experimental

Investigational medicinal product name

Remicade

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate

Routes of administration

Intravenous use

Dosage and administration details

Multiple Switchers

Arm description

Subjects with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.

Arm type

Experimental

Investigational medicinal product name

Remicade

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate

Routes of administration

Intravenous use

Dosage and administration details

Investigational medicinal product name

Infliximab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate

Routes of administration

Intravenous use

Dosage and administration details

Number of subjects in period 1	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Started	1522	494	358	67	102
Completed	1117	393	291	60	88
Not completed	405	101	67	7	14
Adverse event, serious fatal	4	2	1	-	-
Consent withdrawn by subject	44	35	9	1	3
Physician decision	49	15	7	-	2
Subject Non-compliant	13	2	1	1	-
Adverse event, non-fatal	44	5	9	-	3
Unspecified	145	18	24	1	3
Lost to follow-up	96	21	16	4	3
Missing	10	3	-	-	-

Baseline characteristics

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Reporting group title

CT-P13

Reporting group description

Reporting group title

Remicade

Reporting group description

Reporting group title

Switched From Remicade to CT-P13

Reporting group description

Reporting group title

Switched From CT-P13 to Remicade

Reporting group description

Reporting group title

Multiple Switchers

Reporting group description

Reporting group values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers	Total
Number of subjects	1522	494	358	67	102	2543
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0
Adults (18-64 years)	1420	474	331	65	97	2387
From 65-84 years	99	20	27	2	4	152
85 years and over	3	0	0	0	1	4
Age Continuous
Units: years
arithmetic mean (standard deviation)	39.8 ± 14.65	38.8 ± 12.74	40.9 ± 14.14	41.1 ± 13.96	38.4 ± 13.23	-
Sex: Female, Male
Units: Subjects
Female	750	233	158	29	48	1218
Male	772	261	200	38	54	1325
Subjects With Medical History of Smoking
Units: Subjects
Subjects With Smoking History	320	94	70	12	17	513
Subjects with no Smoking History	1202	400	288	55	85	2030
Subjects With a History of Cancer
Units: Subjects
Subjects With Cancer History	41	10	6	1	4	62
Subjects with no Cancer History	1481	484	352	66	98	2481
Subjects With Stoma Status
Units: Subjects
Subjects With Stoma Status	33	13	14	3	2	65
Subjects With no Stoma Status	1489	481	344	64	100	2478
Subjects With a History Surgery
Surgery status was a categorical variable defined as yes if the subject had prior surgical treatment related to the treatment of CD or UC.
Units: Subjects
Subjects With Surgery History	395	165	116	23	32	731
Subjects With no Surgery History	1127	329	242	44	70	1812
Subjects With a History of Fistula Disease
Units: Subjects
Subjects With History of Fistula Disease	304	124	86	19	28	561
Subjects With no History of Fistula Disease	1218	370	272	48	74	1982
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	4	1	0	0	0	5
Asian	5	3	5	0	0	13
Native Hawaiian or Other Pacific Islander	1	0	0	0	0	1
Black or African American	7	0	1	0	0	8
White	1080	391	275	55	83	1884
Other	267	60	49	11	14	401
Unknown or Not Reported	158	39	28	1	5	231

End points

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Reporting group title

CT-P13

Reporting group description

Reporting group title

Remicade

Reporting group description

Reporting group title

Switched From Remicade to CT-P13

Reporting group description

Reporting group title

Switched From CT-P13 to Remicade

Reporting group description

Reporting group title

Multiple Switchers

Reporting group description

Primary: Disease Characteristics of Subjects: Disease Duration

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End point title

Disease Characteristics of Subjects: Disease Duration ^[1]

End point description

Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline). Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period. Here, 'Overall number of subjects analysed' signifies number of subjects evaluable for this end point.

End point type

Primary

End point timeframe

Baseline (Day 1)

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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1519	494	358	67	102
Units: months
median (full range (min-max))	63.0 (0 to 579)	112.5 (0 to 632)	120.0 (2 to 593)	86.0 (0 to 519)	101.0 (9 to 457)

No statistical analyses for this end point

Primary: Number of Subjects Who Switched Treatment

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End point title

Number of Subjects Who Switched Treatment ^[2] ^[3]

End point description

Here, number of subjects with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported. Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[2] - 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 analyses was planned for this end point
[3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is reporting data for the arms specified

End point values	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	358	67	102
Units: Subjects
Crohn’s Disease	237	47	72
Ulcerative Colitis	121	20	30

No statistical analyses for this end point

Primary: Reasons for Switching Treatment by Subjects

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End point title

Reasons for Switching Treatment by Subjects ^[4]

End point description

Reasons for switch were not captured in electronic data capture. Hence, due to change in planned analysis, data was not collected and analysed.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[4] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	0 ^[5]	0 ^[6]	0 ^[7]	0 ^[8]	0 ^[9]
Units: Subjects

Notes
[5] - Reasons for switch were not captured in electronic data capture.
[6] - Reasons for switch were not captured in electronic data capture.
[7] - Reasons for switch were not captured in electronic data capture.
[8] - Reasons for switch were not captured in electronic data capture.
[9] - Reasons for switch were not captured in electronic data capture.

No statistical analyses for this end point

Primary: Total Dose of Infusion Received

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End point title

Total Dose of Infusion Received ^[10]

End point description

Total dose of infusion received by the subjects was calculated. Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period. Here, 'Overall number of subjects analysed' signifies number of subjects evaluable for this outcome measure. ''99999'' here signifies data was not available.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[10] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1520	493	358	67	102
Units: milligram
median (full range (min-max))	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)	99999 (-99999 to 99999)

No statistical analyses for this end point

Primary: Number of Subjects by Frequency of Infusion Received

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End point title

Number of Subjects by Frequency of Infusion Received ^[11]

End point description

Number of subjects by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, ‘Others’ category included all the frequencies apart from the mentioned categories. Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period. Here, 'Overall number of subjects analysed' signifies number of subjects evaluable for this end point.

End point type

Primary

End point timeframe

Baseline (Day 1)

Notes
[11] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1283	433	317	60	85
Units: Subjects
Once a week	5	0	0	0	0
Once every 2 weeks	140	5	11	3	3
Once every 3 weeks	1	0	0	0	1
Once every 4 weeks	109	47	32	9	7
Once every 5 weeks	7	8	5	0	4
Once every 6 weeks	84	67	43	3	15
Once every 7 weeks	9	27	14	2	4
Once every 8 weeks	804	247	198	42	47
Other	124	32	14	1	4

No statistical analyses for this end point

Primary: Number of Subjects who had Change in Infusion Dose

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End point title

Number of Subjects who had Change in Infusion Dose ^[12]

End point description

Subjects who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported. Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[12] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1522	494	358	67	102
Units: Subjects	479	110	89	28	31

No statistical analyses for this end point

Primary: Number of Subjects who had Change in Infusion Dose Categorized Based on Reasons of Change

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End point title

Number of Subjects who had Change in Infusion Dose Categorized Based on Reasons of Change ^[13]

End point description

Subjects who had change in infusion dose due to various reasons such as principal investigator's decision, subject's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest [AESI]/ serious adverse event [SAE]), positive for antibodies and other were reported. Here, ‘Others’ category included all reasons apart from the mentioned categories. A subject could have different reasons of dose change across visits, hence could be counted in more than one category. Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period. Here, 'Overall number of subjects analysed' signifies number of subjects evaluable for this end point.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[13] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	479	110	89	28	31
Units: Subjects
Principal Investigator's Decision	213	61	31	26	16
Participant's Decision	5	2	0	0	0
Loss of response	142	27	17	3	12
Lack of compliance	3	1	0	0	0
Hypersensitivity	4	1	1	0	0
Occurrence of Adverse Event (including AESI/SAE)	23	3	3	0	2
Positive for antibodies	5	2	2	0	0
Other	142	26	42	2	9

No statistical analyses for this end point

Primary: Number of Subjects Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)

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End point title

Number of Subjects Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC) ^[14]

End point description

Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[14] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1522	494	358	67	102
Units: Subjects	1025	262	187	39	67

No statistical analyses for this end point

Primary: Number of Subjects With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)

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End point title

Number of Subjects With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs) ^[15]

End point description

An AE was any untoward medical occurrence in a subject who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events. Safety analysis population included all subjects who received at least 1 dose of study drug during the observation period.

End point type

Primary

End point timeframe

From baseline to follow-up period (up to a maximum duration of 2 years)

Notes
[15] - 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 analyses was planned for this end point

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1522	494	358	67	102
Units: Subjects
TEAEs	621	133	130	15	30
SAEs	256	43	57	10	15
TEAEs of Special Interest	189	49	37	8	11

No statistical analyses for this end point

Secondary: Number of Subjects Remaining in Clinical Remission or Relapse

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End point title

Number of Subjects Remaining in Clinical Remission or Relapse

End point description

Clinical remission: total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. An instrument designed to measure disease activity, consists of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician’s global assessment, each sub score graded from 0 to 3: higher scores indicate more severe disease. The scores were added to give a total score range of 0 to 12: higher scores indicate more severe disease. The relapse of clinical remission was defined as the time from date of first attaining CR to date of relapse or death from any cause, whichever occurred first. Full analysis set (FAS)=all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to assessment of CD or UC). Number analysed =subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1516	492	358	67	102
Units: Subjects
Month 6: Remission (n=1036,335,280,54,74)	870	312	261	51	70
Month 12: Remission (n= 914,306,240,47,64)	802	288	224	45	58
Month 18: Remission (n= 703,268,203,32,66)	633	257	192	31	61
Month 24: Remission (n= 424,191,157,24,43)	386	184	148	23	39
Month 6: Relapse (n=1036,335,280,54,74)	166	23	19	3	4
Month 12: Relapse (n= 914,306,240,47,64)	112	18	16	2	6
Month 18: Relapse (n= 703,268,203,32,66)	70	11	11	1	5
Month 24: Relapse (n= 424,191,157,24,43)	38	7	9	1	4

No statistical analyses for this end point

Secondary: Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission

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End point title

Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission

End point description

HBI: simple index of CD activity, measures 5 criteria; the general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0=none to 3= definite and tender), and whether any complications 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula 8=abscess. Total HBI score: sum of all 5 individual criteria. Minimum score: 0, no pre-specified maximum score as it depends on the number of liquid stools. Higher HBI scores=greater disease activity. Level of disease activity: CR (score less than [<] 5), MD (score equal to [=] 5-7), Mod D (score=8-16) and SD (score more than [>] 16). FAS was analyzed. “Number of Subjects Analyzed” = number of subjects evaluable for this end point; “number analysed” = subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	969	348	237	47	72
Units: Subjects
At Baseline (n=969,348,237,47,72)	606	246	150	29	49
Baseline-CR; Month 6-CR (n=606,246,150,29,49)	485	211	125	24	43
Baseline-CR; Month 6-MD (n=606,246,150,29,49)	42	11	11	2	4
Baseline-CR; Month 6-Mod D (n=606,246,150,29,49)	23	8	2	1	0
Baseline-CR; Month 6-SD (n=606,246,150,29,49)	1	1	0	0	0
Baseline-CR; Month 6-Missing (n=606,246,150,29,49)	55	15	12	2	2
Baseline-CR; Month 12-CR (n=606,246,150,29,49)	429	182	109	22	42
Baseline-CR; Month 12-MD (n=606,246,150,29,49)	36	14	8	3	1
Baseline-CR; Month 12-Mod D (n=606,246,150,29,49)	20	4	5	1	0
Baseline-CR; Month 12-SD (n=606,246,150,29,49)	0	0	0	0	0
Baseline-CR;Month 12-Missing (n=606,246,150,29,49)	121	46	28	3	6
Baseline-CR; Month 18-CR (n=606,246,150,29,49)	326	143	96	17	37
Baseline-CR; Month 18-MD (n=606,246,150,29,49)	25	11	4	0	1
Baseline-CR; Month 18-Mod D (n=606,246,150,29,49)	8	4	2	0	1
Baseline-CR; Month 18-SD (n=606,246,150,29,49)	0	0	0	0	0
Baseline-CR; Month18-Missing (n=606,246,150,29,49)	247	88	48	12	10
Baseline-CR; Month 24-CR (n=606,246,150,29,49)	194	98	68	11	28
Baseline-CR; Month 24-MD (n=606,246,150,29,49)	16	7	3	1	2
Baseline-CR; Month 24-Mod D (n=606,246,150,29,49)	5	1	3	0	0
Baseline-CR; Month 24-SD (n=606,246,150,29,49)	0	0	1	0	0
Baseline-CR; Month24-Missing (n=606,246,150,29,49)	391	140	75	17	19

No statistical analyses for this end point

Secondary: Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Disease Activity

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End point title

Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Disease Activity

End point description

HBI: simple index of CD activity, measures 5 criteria; the general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0=none to 3= definite and tender), and whether any complications 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula 8=abscess. Total HBI score: sum of all 5 individual criteria. Minimum score: 0, no pre-specified maximum score as it depends on the number of liquid stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score < 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score >16). Number analysed =subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	969	348	237	47	72
Units: Subjects
At Baseline: MD (n=969,348,237,47,72)	137	45	24	10	7
At Baseline: Mod D (n=969,348,237,47,72)	91	22	15	4	3
At Baseline: SD (n=969,348,237,47,72)	6	2	0	0	0
Baseline-MD; Month 6-CR (n=137,45,24,10,7)	82	21	9	5	3
Baseline-MD; Month 6-MD (n=137,45,24,10,7)	30	13	11	4	1
Baseline-MD; Month 6-Mod D (n=137,45,24,10,7)	12	8	3	0	2
Baseline-MD; Month 6-SD (n=137,45,24,10,7)	0	0	1	0	1
Baseline-MD; Month 6-Missing (n=137,45,24,10,7)	13	3	0	1	0
Baseline-Mod D; Month 6-CR (n=91,22,15,4,3)	39	4	6	3	2
Baseline-Mod D; Month 6-MD (n=91,22,15,4,3)	19	6	2	1	0
Baseline-Mod D; Month 6-Mod D (n=91,22,15,4,3)	25	8	6	0	0
Baseline-Mod D; Month 6-SD (n=91,22,15,4,3)	1	0	0	0	0
Baseline-Mod D; Month 6-Missing (n=91,22,15,4,3)	7	4	1	0	1
Baseline-SD; Month 6-CR (n=6,2,0,0,0)	1	1	0	0	0
Baseline-SD; Month 6-MD (n=6,2,0,0,0)	2	0	0	0	0
Baseline-SD; Month 6-Mod D (n=6,2,0,0,0)	2	0	0	0	0
Baseline-SD; Month 6-SD (n=6,2,0,0,0)	0	1	0	0	0
Baseline-SD; Month 6-Missing (n=6,2,0,0,0)	1	0	0	0	0
Baseline-MD; Month 12-CR (n=137,45,24,10,7)	81	24	14	6	4
Baseline-MD; Month 12-MD (n=137,45,24,10,7)	16	6	3	2	1
Baseline-MD; Month 12-Mod D (n=137,45,24,10,7)	7	6	3	0	1
Baseline-MD; Month 12-SD (n=137,45,24,10,7)	1	0	0	0	1
Baseline-MD; Month 12-Missing (n=137,45,24,10,7)	32	9	4	2	0
Baseline-Mod D; Month 12-CR (n=91,22,15,4,3)	39	6	4	3	3
Baseline-Mod D; Month 12-MD (n=91,22,15,4,3)	15	9	0	1	0
Baseline-Mod D; Month 12-Mod D (n=91,22,15,4,3)	16	2	6	0	0
Baseline-Mod D; Month 12-SD (n=91,22,15,4,3)	0	0	0	0	0
Baseline-Mod D; Month 12-Missing (n=91,22,15,4,3)	21	5	5	0	0
Baseline-SD; Month 12-CR (n=6,2,0,0,0)	1	1	0	0	0
Baseline-SD; Month 12-MD (n=6,2,0,0,0)	2	0	0	0	0
Baseline-SD; Month 12-Mod D (n=6,2,0,0,0)	1	0	0	0	0
Baseline-SD; Month 12-SD (n=6,2,0,0,0)	0	1	0	0	0
Baseline-SD; Month 12-Missing (n=6,2,0,0,0)	2	0	0	0	0
Baseline-MD; Month 18-CR (n=137,45,24,10,7)	60	24	12	2	2
Baseline-MD; Month 18-MD (n=137,45,24,10,7)	10	6	1	4	3
Baseline-MD; Month 18-Mod D (n=137,45,24,10,7)	4	2	1	0	2
Baseline-MD; Month 18-SD (n=137,45,24,10,7)	2	0	0	0	0
Baseline-MD; Month 18-Missing (n=137,45,24,10,7)	61	13	10	4	0
Baseline-Mod D; Month 18-CR (n=91,22,15,4,3)	30	4	2	3	2
Baseline-Mod D; Month 18-MD (n=91,22,15,4,3)	13	7	2	1	1
Baseline-Mod D; Month 18-Mod D (n=91,22,15,4,3)	14	3	3	0	0
Baseline-Mod D; Month 18-SD (n=91,22,15,4,3)	0	0	0	0	0
Baseline-Mod D; Month 18-Missing (n=91,22,15,4,3)	34	8	8	0	0
Baseline-SD; Month 18-CR (n=6,2,0,0,0)	1	1	0	0	0
Baseline-SD; Month 18-MD (n=6,2,0,0,0)	2	1	0	0	0
Baseline-SD; Month 18-Mod D (n=6,2,0,0,0)	1	0	0	0	0
Baseline-SD; Month 18-SD (n=6,2,0,0,0)	0	0	0	0	0
Baseline-SD; Month 18-Missing (n=6,2,0,0,0)	2	0	0	0	0
Baseline-MD; Month 24-CR (n=137,45,24,10,7)	34	13	8	5	2
Baseline-MD; Month 24-MD (n=137,45,24,10,7)	15	6	2	1	2
Baseline-MD; Month 24-Mod D (n=137,45,24,10,7)	2	1	1	0	2
Baseline-MD; Month 24-SD (n=137,45,24,10,7)	1	0	0	0	0
Baseline-MD; Month 24-Missing (n=137,45,24,10,7)	85	25	13	4	1
Baseline-Mod D; Month 24-CR (n=91,22,15,4,3)	23	3	4	3	1
Baseline-Mod D; Month 24-MD (n=91,22,15,4,3)	5	2	1	0	1
Baseline-Mod D; Month 24-Mod D (n=91,22,15,4,3)	10	9	3	1	0
Baseline-Mod D; Month 24-SD (n=91,22,15,4,3)	1	0	0	0	0
Baseline-Mod D; Month 24-Missing (n=91,22,15,4,3)	52	8	7	0	1
Baseline-SD; Month 24-CR (n=6,2,0,0,0)	0	1	0	0	0
Baseline-SD; Month 24-MD (n=6,2,0,0,0)	2	0	0	0	0
Baseline-SD; Month 24-Mod D (n=6,2,0,0,0)	0	0	0	0	0
Baseline-SD; Month 24-SD (n=6,2,0,0,0)	0	1	0	0	0
Baseline-SD; Month 24-Missing (n=6,2,0,0,0)	4	0	0	0	0

No statistical analyses for this end point

Secondary: Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission

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End point title

Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission

End point description

Mayo Score: instrument to measure disease activity of UC. Score ranges: 0-12 points. There are 4 sub scores: graded from 0-3. Higher scores: more severe disease. Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding (0=no blood seen to 3=blood alone passes), and physician’s global assessment (0=normal to 3=severe disease). Total PMS: sum of all parameters, score from 0 (normal or inactive disease) to 9 (severe disease). Score was calculated if data was available for at least 1 of 3 sub scores. Level of disease activity: clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2-4), moderate disease (Mod D) (PMS=5-6) and severe disease (SD) (PMS >6). FAS was analysed. “Number of Subjects Analysed” = number of subjects evaluable for this end point; “number analysed” = subjects evaluable at specific time points.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	547	144	121	20	30
Units: Subjects
At Baseline (n=547,144,121,20,30)	169	83	55	9	13
Baseline-CR; Month 6-CR (n=169,83,55,9,13)	117	65	40	7	9
Baseline-CR; Month 6-MD (n=169,83,55,9,13)	27	9	7	2	2
Baseline-CR; Month 6-Mod D (n=169,83,55,9,13)	7	0	1	0	1
Baseline-CR; Month 6-SD (n=169,83,55,9,13)	1	0	1	0	0
Baseline-CR; Month 6-Missing (n=169,83,55,9,13)	17	9	6	0	1
Baseline-CR; Month 12-CR (n=169,83,55,9,13)	107	65	30	8	8
Baseline-CR; Month 12-MD (n=169,83,55,9,13)	24	4	10	0	4
Baseline-CR; Month 12-Mod D (n=169,83,55,9,13)	5	0	1	0	1
Baseline-CR; Month 12-SD (n=169,83,55,9,13)	1	0	0	0	0
Baseline-CR; Month 12-Missing (n=169,83,55,9,13)	32	14	14	1	0
Baseline-CR; Month 18-CR (n=169,83,55,9,13)	88	55	25	3	9
Baseline-CR; Month 18-MD (n=169,83,55,9,13)	13	8	4	0	0
Baseline-CR; Month 18-Mod D (n=169,83,55,9,13)	6	0	2	0	3
Baseline-CR; Month 18-SD (n=169,83,55,9,13)	2	0	1	0	0
Baseline-CR; Month 18-Missing (n=169,83,55,9,13)	60	20	23	6	1
Baseline-CR; Month 24-CR (n=169,83,55,9,13)	57	38	22	3	6
Baseline-CR; Month 24-MD (n=169,83,55,9,13)	7	5	3	0	0
Baseline-CR; Month 24-Mod D (n=169,83,55,9,13)	2	1	1	0	0
Baseline-CR; Month 24-SD (n=169,83,55,9,13)	0	0	0	0	0
Baseline-CR; Month 24-Missing (n=169,83,55,9,13)	103	39	29	6	7

No statistical analyses for this end point

Secondary: Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity

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End point title

Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity

End point description

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	547	144	121	20	30
Units: Subjects
At Baseline: MD (n=547,144,121,20,30)	157	30	28	4	9
At Baseline: Mod D (n=547,144,121,20,30)	76	13	9	3	4
At Baseline: SD (n=547,144,121,20,30)	47	5	3	0	1
Baseline-MD; Month 6-CR (n=157,30,28,4,9)	71	12	19	3	3
Baseline-MD; Month 6-MD (n=157,30,28,4,9)	48	12	4	1	6
Baseline-MD; Month 6-Mod D (n=157,30,28,4,9)	18	2	1	0	0
Baseline-MD; Month 6-SD (n=157,30,28,4,9)	7	0	1	0	0
Baseline-MD; Month 6-Missing (n=157,30,28,4,9)	13	4	3	0	0
Baseline-Mod D; Month 6-CR (n=76,13,9,3,4)	18	3	2	3	2
Baseline-Mod D; Month 6-MD (n=76,13,9,3,4)	22	8	5	0	2
Baseline-Mod D; Month 6-Mod D (n=76,13,9,3,4)	21	0	1	0	0
Baseline-Mod D; Month 6-SD (n=76,13,9,3,4)	8	1	0	0	0
Baseline-Mod D; Month 6-Missing (n=76,13,9,3,4)	7	1	1	0	0
Baseline-SD; Month 6-CR (n=47,5,3,0,1)	8	2	0	0	1
Baseline-SD; Month 6-MD (n=47,5,3,0,1)	19	1	1	0	0
Baseline-SD; Month 6-Mod D (n=47,5,3,0,1)	6	0	1	0	0
Baseline-SD; Month 6-SD (n=47,5,3,0,1)	7	0	1	0	0
Baseline-SD; Month 6-Missing (n=47,5,3,0,1)	7	2	0	0	0
Baseline-MD; Month 12-CR (n=157,30,28,4,9)	73	16	14	2	2
Baseline-MD; Month 12-MD (n=157,30,28,4,9)	38	6	7	1	5
Baseline-MD; Month 12-Mod D (n=157,30,28,4,9)	10	3	1	0	1
Baseline-MD; Month 12-SD (n=157,30,28,4,9)	3	0	1	1	0
Baseline-MD; Month 12-Missing (n=157,30,28,4,9)	33	5	5	0	1
Baseline-Mod D; Month 12-CR (n=76,13,9,3,4)	24	2	4	2	1
Baseline-Mod D; Month 12-MD (n=76,13,9,3,4)	17	6	2	0	2
Baseline-Mod D; Month 12-Mod D (n=76,13,9,3,4)	6	1	0	0	0
Baseline-Mod D; Month 12-SD (n=76,13,9,3,4)	2	0	0	0	0
Baseline-Mod D; Month 12-Missing (n=76,13,9,3,4)	27	4	3	1	1
Baseline-SD; Month 12-CR (n=47,5,3,0,1)	15	2	0	0	1
Baseline-SD; Month 12-MD (n=47,5,3,0,1)	8	1	1	0	0
Baseline-SD; Month 12-Mod D (n=47,5,3,0,1)	5	0	2	0	0
Baseline-SD; Month 12-SD (n=47,5,3,0,1)	2	0	0	0	0
Baseline-SD; Month 12-Missing (n=47,5,3,0,1)	17	2	0	0	0
Baseline-MD; Month 18-CR (n=157,30,28,4,9)	57	14	15	3	3
Baseline-MD; Month 18-MD (n=157,30,28,4,9)	22	5	6	0	2
Baseline-MD; Month 18-Mod D (n=157,30,28,4,9)	8	1	1	0	1
Baseline-MD; Month 18-SD (n=157,30,28,4,9)	2	0	0	0	0
Baseline-MD; Month 18-Missing (n=157,30,28,4,9)	68	10	6	1	3
Baseline-Mod D; Month 18-CR (n=76,13,9,3,4)	23	4	2	1	1
Baseline-Mod D; Month 18-MD (n=76,13,9,3,4)	16	2	1	0	2
Baseline-Mod D; Month 18-Mod D (n=76,13,9,3,4)	2	1	1	0	0
Baseline-Mod D; Month 18-SD (n=76,13,9,3,4)	0	0	0	0	0
Baseline-Mod D; Month 18-Missing (n=76,13,9,3,4)	35	6	5	2	1
Baseline-SD; Month 18-CR (n=47,5,3,0,1)	15	2	1	0	1
Baseline-SD; Month 18-MD (n=47,5,3,0,1)	5	1	2	0	0
Baseline-SD; Month 18-Mod D (n=47,5,3,0,1)	3	0	0	0	0
Baseline-SD; Month 18-SD (n=47,5,3,0,1)	0	0	0	0	0
Baseline-SD; Month 18-Missing (n=47,5,3,0,1)	24	2	0	0	0
Baseline-MD; Month 24-CR (n=157,30,28,4,9)	43	13	13	2	5
Baseline-MD; Month 24-MD (n=157,30,28,4,9)	10	4	3	0	1
Baseline-MD; Month 24-Mod D (n=157,30,28,4,9)	5	1	1	0	0
Baseline-MD; Month 24-SD (n=157,30,28,4,9)	0	0	0	0	0
Baseline-MD; Month 24-Missing (n=157,30,28,4,9)	99	12	11	2	3
Baseline-Mod D; Month 24-CR (n=76,13,9,3,4)	15	2	0	0	2
Baseline-Mod D; Month 24-MD (n=76,13,9,3,4)	11	3	0	0	1
Baseline-Mod D; Month 24-Mod D (n=76,13,9,3,4)	1	0	1	0	0
Baseline-Mod D; Month 24-SD (n=76,13,9,3,4)	2	1	1	0	0
Baseline-Mod D; Month 24-Missing (n=76,13,9,3,4)	47	7	7	3	1
Baseline-SD; Month 24-CR (n=47,5,3,0,1)	8	2	0	0	0
Baseline-SD; Month 24-MD (n=47,5,3,0,1)	8	1	1	0	0
Baseline-SD; Month 24-Mod D (n=47,5,3,0,1)	1	0	0	0	0
Baseline-SD; Month 24-SD (n=47,5,3,0,1)	0	0	0	0	0
Baseline-SD; Month 24-Missing (n=47,5,3,0,1)	30	2	2	0	1

No statistical analyses for this end point

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Age at Diagnosis

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End point title

Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Age at Diagnosis

End point description

The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing. FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, ''Overall number of subjects analysed'' =Number of subjects evaluable for this outcome measure and number analysed =subjects evaluable at specified rows for each arm.

End point type

Secondary

End point timeframe

At Baseline

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	777	240	164	37	50
Units: Subjects
16 years or younger	61	33	21	4	6
17-40 years	553	174	115	25	39
Over 40 years	162	33	28	8	5
Missing	1	0	0	0	0

No statistical analyses for this end point

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Location

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End point title

Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Location

End point description

The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum (TI), Location 2 (L2) is colon, Location 3 (L3) is ileocolon (IC) and Location 4 (L4) is upper gastrointestinal (UGI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted. FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, ''Overall number of subjects analysed'' =Number of subjects evaluable for this outcome measure and number analysed= subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	969	348	237	47	72
Units: Subjects
Baseline: Location L1 TI (n=777,240,164,37,50)	257	62	34	6	11
Month 6: Location L1 TI (n=589,202,127,33,44)	202	49	26	7	9
Month 12: Location L1 TI (n=468,160,104,33,40)	150	38	22	7	7
Month 18: Location L1 TI (n=330,124,85,22,36)	99	28	16	2	8
Month 24: Location L1 TI (n=190,75,57,18,27)	60	17	15	0	5
Baseline: Location L2 Colon (n=777,240,164,37,50)	135	54	32	14	8
Month 6: Location L2 Colon (n=589,202,127,33,44)	105	47	25	12	11
Month 12: Location L2 Colon (n=468,160,104,33,40)	84	40	20	14	10
Month 18: Location L2 Colon (n=330,124,85,22,36)	53	31	18	10	9
Month 24: Location L2 Colon (n=190,75,57,18,27)	41	16	14	9	5
Baseline: Location L3 IC (n=777,240,164,37,50)	329	107	80	16	28
Month 6: Location L3 IC (n=589,202,127,33,44)	236	94	65	13	22
Month 12: Location L3 IC (n=468,160,104,33,40)	200	71	55	11	21
Month 18: Location L3 IC (n=330,124,85,22,36)	150	55	40	8	17
Month 24: Location L3 IC (n=190,75,57,18,27)	74	33	22	9	14
Baseline: L4 UGI (n=777,240,164,37,50)	14	4	4	1	0
Month 6: L4 UGI (n=589,202,127,33,44)	12	2	3	1	0
Month 12: L4 UGI (n=468,160,104,33,40)	10	3	2	1	1
Month 18: L4 UGI (n=330,124,85,22,36)	8	5	4	1	1
Month 24: L4 UGI (n=190,75,57,18,27)	7	6	3	0	1
Baseline: L1 TI,L4 UGI (n=777,240,164,37,50)	21	2	1	0	1
Month 6: L1 TI, L4 UGI (n=589,202,127,33,44)	15	2	1	0	0
Month 12: L1 TI,L4 UGI (n=468,160,104,33,40)	11	2	1	0	0
Month 18: L1 TI,L4 UGI (n=330,124,85,22,36)	13	0	0	0	0
Month 24: L1 TI,L4 UGI (n=190,75,57,18,27)	2	0	0	0	0
Baseline: L2 Colon,L4 UGI (n=777,240,164,37,50)	6	2	1	0	1
Month 6: L2 Colon,L4 UGI (n=589,202,127,33,44)	3	3	0	0	0
Month 12: L2 Colon,L4 UGI (n=468,160,104,33,40)	2	1	0	0	0
Month 18: L2 Colon,L4 UGI (n=330,124,85,22,36)	2	1	0	0	0
Month 24: L2 Colon,L4 UGI (n=190,75,57,18,27)	0	1	0	0	0
Baseline: L3 IC, L4 UGI (n=777,240,164,37,50)	14	8	12	0	1
Month 6: L3 IC,L4 UGI (n=589,202,127,33,44)	11	5	7	0	2
Month 12: L3 IC, L4 UGI (n=468,160,104,33,40)	8	5	4	0	1
Month 18: L3 IC,L4 UGI (n=330,124,85,22,36)	5	4	7	1	1
Month 24: L3 IC,L4 UGI (n=190,75,57,18,27)	5	2	3	0	2
Baseline: Location Missing (n=777,240,164,37,50)	1	1	0	0	0
Month 6: Location Missing (n=589,202,127,33,44)	5	0	0	0	0
Month 12: Location Missing (n=468,160,104,33,40)	3	0	0	0	0
Month 18: Location Missing (n=330,124,85,22,36)	0	0	0	0	0
Month 24: Location Missing (n=190,75,57,18,27)	1	0	0	0	0

No statistical analyses for this end point

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Behavior of the Disease Activity

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End point title

Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Behavior of the Disease Activity

End point description

The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring (s); Behaviour 3 (B3) was penetrating (P) and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae. FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of subjects analysed =Number of subjects evaluable for this end point. Number analysed= subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	969	348	237	47	72
Units: Subjects
At Baseline: B1 NS, NP (n=777,240,164,37,50)	324	92	66	9	17
Month 6: B1 NS, NP (n=589,202,127,33,44)	242	68	46	10	14
Month 12: B1 NS, NP (n=468,160,104,33,40)	191	56	40	10	17
Month 18: B1 NS, NP (n=330,124,85,22,36)	135	44	26	4	13
Month 24: B1 NS, NP (n=190,75,57,18,27)	77	35	20	3	7
At Baseline: B2 Stricturing (n=777,240,164,37,50)	165	40	43	9	13
Month 6:B2 Stricturing (n=589,202,127,33,44)	122	29	36	8	12
Month 12: B2 Stricturing (n=468,160,104,33,40)	94	26	28	6	9
Month 18: B2 Stricturing (n=330,124,85,22,36)	77	24	26	4	10
Month 24: B2 Stricturing (n=190,75,57,18,27)	47	8	15	3	9
At Baseline: B3 Penetrating (n=777,240,164,37,50)	84	32	16	6	6
Month 6: B3 Penetrating (n=589,202,127,33,44)	64	32	14	5	5
Month 12: B3 Penetrating (n=468,160,104,33,40)	48	26	12	5	2
Month 18:B3 Penetrating (n=330,124,85,22,36)	26	16	9	4	2
Month 24: B3 Penetrating (n=190,75,57,18,27)	18	8	4	4	2
Baseline: Behavior p (n=777,240,164,37,50)	34	5	7	2	3
Month 6: Behavior p (n=589,202,127,33,44)	27	5	4	1	1
Month 12: Behavior p (n=468,160,104,33,40)	17	7	1	1	1
Month 18: Behavior p (n=330,124,85,22,36)	10	4	1	1	0
Month 24: Behavior p (n=190,75,57,18,27)	4	3	1	1	0
Baseline:B2 s, B3 Penetrating(n=777,240,164,37,50)	1	0	0	0	0
Month 6:B2 s, B3 Penetrating(n=589,202,127,33,44)	0	0	0	0	0
Month 12:B2 s, B3 Penetrating(n=468,160,104,33,40)	0	0	0	0	0
Month 18:B2 s, B3 Penetrating(n=330,124,85,22,36)	1	0	0	0	0
Month 24: B2 s, B3 Penetrating(n=190,75,57,18,27)	0	0	0	0	0
Baseline: B1 NS,NP, p (n=777,240,164,37,50)	77	33	16	5	5
Month 6: B1 NS,NP, p (n=589,202,127,33,44)	64	34	11	5	6
Month 12: B1 NS,NP, p (n=468,160,104,33,40)	60	20	9	6	6
Month 18: B1 NS,NP, p (n=330,124,85,22,36)	40	15	11	5	6
Month 24: B1 NS,NP, p (n=190,75,57,18,27)	23	8	6	5	5
At Baseline: B2 s, p (n=777,240,164,37,50)	32	8	4	1	1
Month 6: B2 s, p (n=589,202,127,33,44)	22	5	3	1	0
Month 12: B2 s, p (n=468,160,104,33,40)	22	5	3	2	0
Month 18: B2 s, p (n=330,124,85,22,36)	14	1	1	0	0
Month 24: B2 s, p (n=190,75,57,18,27)	5	1	1	0	0
Baseline: B2 s, B3 P, p (n=777,240,164,37,50)	0	0	0	0	0
Month 6: B2 s, B3 P, p (n=589,202,127,33,44)	1	0	0	0	0
Month 12: B2 s, B3 P, p (n=468,160,104,33,40)	0	0	0	0	0
Month 18: B2 s, B3 P, p (n=330,124,85,22,36)	0	0	0	0	0
Month 24: B2 s, B3 P, p (n=190,75,57,18,27)	0	0	0	0	0
At Baseline: B3 P, p (n=777,240,164,37,50)	57	30	12	5	5
Month 6: B3 P, p (n=589,202,127,33,44)	42	29	13	3	6
Month 12: Behavior B3 P, p (n=468,160,104,33,40)	33	20	11	3	5
Month 18: B3 P, p (n=330,124,85,22,36)	27	20	11	4	5
Month 24: B3 P, p (n=190,75,57,18,27)	15	12	10	2	4
Baseline: Behavior Missing (n=777,240,164,37,50)	3	0	0	0	0
Month 6: Behavior Missing (n=589,202,127,33,44)	5	0	0	0	0
Month 12: Behavior Missing (n=468,160,104,33,40)	3	0	0	0	0
Month 18: Behavior Missing (n=330,124,85,22,36)	0	0	0	0	0
Month 24: Behavior Missing (n=190,75,57,18,27)	1	0	0	0	0

No statistical analyses for this end point

Secondary: Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Extent

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End point title

Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Extent

End point description

The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative Proctitis (UP), Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC. FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of subjects analysed =Number of subjects evaluable for this outcome measure. Number analysed= subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	547	144	121	20	30
Units: Subjects
Baseline E1 UP (n=380,86,66,16,22)	41	10	5	0	2
Month 6 E1 UP (n=302,72,50,15,20)	31	9	1	0	1
Month 12 E1 UP (n=224,66,38,14,18)	17	7	4	0	1
Month 18 E1 UP (n=168,53,32,8,17)	15	7	2	0	2
Month 24 E1 UP (n=101,30,25,5,11)	14	5	2	0	0
Baseline E2 Left-sided UC (n=380,86,66,16,22)	151	26	30	3	8
Month 6 E2 Left-sided UC (n=302,72,50,15,20)	109	23	24	3	6
Month 12 E2 Left-sided UC (n=224,66,38,14,18)	76	21	13	3	7
Month 18 E2 Left-sided UC (n=168,53,32,8,17)	55	16	12	1	5
Month 24 E2 Left-sided UC (n=101,30,25,5,11)	26	10	8	1	2
Baseline E3 Extensive UC (n=380,86,66,16,22)	188	50	31	13	12
Month 6 E3 Extensive UC (n=302,72,50,15,20)	159	40	25	12	13
Month 12 E3 Extensive UC (n=224,66,38,14,18)	128	37	21	11	10
Month 18 E3 Extensive UC (n=168,53,32,8,17)	96	29	18	7	10
Month 24 E3 Extensive UC (n=101,30,25,5,11)	59	15	15	4	9
Baseline Missing (n=380,86,66,16,22)	0	0	0	0	0
Month 6 Missing (n=302,72,50,15,20)	3	0	0	0	0
Month 12 Missing (n=224,66,38,14,18)	3	1	0	0	0
Month 18 Missing (n=168,53,32,8,17)	2	1	0	0	0
Month 24 Missing (n=101,30,25,5,11)	2	0	0	0	0

No statistical analyses for this end point

Secondary: Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Severity

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End point title

Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Severity

End point description

The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day [with or without blood], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily). FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of subjects analysed =Number of subjects evaluable for this outcome measure. Number analysed =subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	547	144	121	20	30
Units: Subjects
Baseline S0 (n=380,86,66,16,22)	80	46	24	6	6
Month 6 S0 (n=302,72,50,15,20)	122	40	26	9	7
Month 12 S0 (n=224,66,38,14,18)	110	39	25	10	6
Month 18 S0 (168,53,32,8,17)	81	35	23	6	8
Month 24 S0 (n=101,30,25,5,11)	71	20	17	3	7
Baseline S1 (n=380,86,66,16,22)	75	17	18	6	4
Month 6 S1 (n=302,72,50,15,20)	70	19	15	3	9
Month 12 S1 (n=224,66,38,14,18)	58	16	5	1	8
Month 18 S1 (168,53,32,8,17)	41	11	5	0	4
Month 24 S1 (n=101,30,25,5,11)	12	6	5	1	2
Baseline S2 (n=380,86,66,16,22)	147	14	19	3	9
Month 6 S2 (n=302,72,50,15,20)	74	7	6	3	3
Month 12 S2 (n=224,66,38,14,18)	40	6	5	2	4
Month 18 S2 (168,53,32,8,17)	29	5	2	2	4
Month 24 S2 (n=101,30,25,5,11)	12	3	1	1	2
Baseline S3 (n=380,86,66,16,22)	75	9	5	1	3
Month 6 S3 (n=302,72,50,15,20)	32	5	3	0	1
Month 12 S3 (n=224,66,38,14,18)	11	3	3	1	0
Month 18 S3 (168,53,32,8,17)	15	1	2	0	1
Month 24 S3 (n=101,30,25,5,11)	6	1	2	0	0
Baseline Missing (n=380,86,66,16,22)	3	0	0	0	0
Month 6 Missing (n=302,72,50,15,20)	4	1	0	0	0
Month 12 Missing (n=224,66,38,14,18)	5	2	0	0	0
Month 18 Missing (168,53,32,8,17)	2	1	0	0	0
Month 24 Missing (n=101,30,25,5,11)	0	0	0	0	0

No statistical analyses for this end point

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Fistula Drainage Assessment Index

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End point title

Crohn's Disease: Number of Subjects Categorised on the Basis of Fistula Drainage Assessment Index

End point description

The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity. FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of subjects analysed =Number of subjects evaluable for this end point. Number analysed= subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	969	348	237	47	72
Units: Subjects
Baseline: Remission (n=191,58,22,16,12)	64	30	14	3	6
Month 6: Remission (n=169,58,26,16,14)	65	29	17	6	8
Month 12:Remission (n=121,39,17,14,11)	50	23	11	9	9
Month 18: Remission (n=79,26,14,12,10)	36	16	9	6	8
Month 24: Remission (n=38,21,12,11,10)	16	12	4	7	7
Baseline: Improvement (n=191,58,22,16,12)	90	26	5	11	4
Month 6: Improvement (n=169,58,26,16,14)	62	23	3	9	4
Month 12: Improvement (n=121,39,17,14,11)	39	8	3	1	0
Month 18: Improvement (n=79,26,14,12,10)	23	4	1	2	0
Month 24: Improvement (n=38,21,12,11,10)	8	6	3	3	1
Baseline: Worsened (n=191,58,22,16,12)	9	0	0	0	0
Month 6: Worsened (n=169,58,26,16,14)	12	1	3	1	0
Month 12: Worsened (n=121,39,17,14,11)	9	0	0	1	0
Month 18: Worsened (n=79,26,14,12,10)	5	1	0	2	0
Month 24: Worsened (n=38,21,12,11,10)	3	0	2	0	0
Baseline: Unchanged (n=191,58,22,16,12)	19	2	3	2	1
Month 6: Unchanged (n=169,58,26,16,14)	21	5	3	0	2
Month 12: Unchanged (n=121,39,17,14,11)	20	8	3	3	2
Month 18: Unchanged (n=79,26,14,12,10)	15	5	3	2	2
Month 24: Unchanged (n=38,21,12,11,10)	8	3	3	1	2
Baseline: Not accessible (n=191,58,22,16,12)	4	0	0	0	1
Month 6: Not accessible (n=169,58,26,16,14)	4	0	0	0	0
Month 12: Not accessible (n=121,39,17,14,11)	1	0	0	0	0
Month 18: Not accessible (n=79,26,14,12,10)	0	0	1	0	0
Month 24: Not accessible (n=38,21,12,11,10)	1	0	0	0	0
Baseline: Missing (n=191,58,22,16,12)	5	0	0	0	0
Month 6: Missing (n=169,58,26,16,14)	5	0	0	0	0
Month 12: Missing (n=121,39,17,14,11)	2	0	0	0	0
Month 18: Missing (n=79,26,14,12,10)	0	0	0	0	0
Month 24: Missing (n=38,21,12,11,10)	2	0	0	0	0

No statistical analyses for this end point

Secondary: Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24

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End point title

Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24

End point description

C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement. FAS=all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analysed= subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18 and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1516	492	358	67	102
Units: milligram per liter (mg/L)
arithmetic mean (standard deviation)
Baseline (n=1044,330,229,49,67)	13.70 ± 43.8	10.23 ± 22.6	8.79 ± 17.0	7.70 ± 11.8	12.18 ± 30.7
Change at Month 6 (n=933,285,216,45,66)	-1.09 ± 47.4	1.46 ± 40.0	-1.45 ± 14.6	-1.88 ± 12.3	0.94 ± 32.8
Change at Month 12 (n=678,243,166,38,55)	-4.87 ± 38.6	-2.23 ± 17.3	-1.62 ± 12.2	3.88 ± 25.4	-4.84 ± 30.7
Change at Month 18 (n=428,174,122,27,48)	-6.57 ± 45.2	0.63 ± 37.7	-2.45 ± 11.7	1.83 ± 12.6	-0.59 ± 51.8
Change at Month 24 (234,131,94,21,32)	0.33 ± 177.3	-3.51 ± 18.2	3.19 ± 41.7	4.17 ± 24.6	-3.11 ± 19.6

No statistical analyses for this end point

Secondary: Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24

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End point title

Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24

End point description

Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin. FAS=all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analysed= subjects evaluable at specified time points for each arm.

End point type

Secondary

End point timeframe

Baseline, Months 6, 12, 18, and 24

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1516	492	358	67	102
Units: milligram per kilogram (mg/kg)
arithmetic mean (standard deviation)
Baseline (n=202,47,35,8,16)	1066.31 ± 5419.8	556.88 ± 916.2	362.48 ± 642.8	616.03 ± 1023.3	537.58 ± 1471.9
Change at Month 6 (n=107,28,12,5,8)	-283.21 ± 989.0	-296.95 ± 958.1	-164.60 ± 440.8	-648.16 ± 1333.1	224.56 ± 700.1
Change at Month 12 (n=55,22,10,2,7)	-165.32 ± 691.9	361.51 ± 1741.1	-289.57 ± 1004.9	-382.73 ± 503.1	-643.67 ± 2339.3
Change at Month 18 (n=48,12,9,4,5)	-473.07 ± 1394.3	275.48 ± 1518.0	88.44 ± 746.8	-73.94 ± 125.3	109.16 ± 164.4
Change at Month 24 (n=22,5,6,2,2)	-625.69 ± 1684.7	-862.40 ± 958.4	-494.66 ± 1226.4	-13.35 ± 273.4	-450.98 ± 200.2

No statistical analyses for this end point

Secondary: Number of Subjects With Imaging Test Results

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End point title

Number of Subjects With Imaging Test Results

End point description

Number of subjects who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported. FAS =all subjects who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC).

End point type

Secondary

End point timeframe

From baseline up to follow-up period (a maximum of 2 years)

End point values	CT-P13	Remicade	Switched From Remicade to CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers
Number of subjects analysed	1516	492	358	67	102
Units: Subjects	516	134	106	28	50

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From baseline to follow-up period (up to a maximum duration of 2 years)

Adverse event reporting additional description

Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as non-serious in another, or a subject may have experienced both a serious and non-serious event. Safety population was evaluated.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

21.1

Reporting group title

Remicade

Reporting group description

Reporting group title

CT-P13

Reporting group description

Reporting group title

Switched From CT-P13 to Remicade

Reporting group description

Reporting group title

Multiple Switchers

Reporting group description

Reporting group title

Switched From Remicade to CT-P13

Reporting group description

Serious adverse events	Remicade	CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers	Switched From Remicade to CT-P13
Total subjects affected by serious adverse events
subjects affected / exposed	43 / 494 (8.70%)	256 / 1522 (16.82%)	10 / 67 (14.93%)	15 / 102 (14.71%)	57 / 358 (15.92%)
number of deaths (all causes)	2	4	0	0	1
number of deaths resulting from adverse events	0	2	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast cancer in situ
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic lymphocytic leukaemia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal stromal tumour
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intraductal proliferative breast lesion
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Invasive ductal breast carcinoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung adenocarcinoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seminoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tongue neoplasm malignant stage unspecified
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Aneurysm
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aortic aneurysm rupture
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Behcet's syndrome
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Femoral artery embolism
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Poor venous access
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Caesarean section
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colectomy
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ventriculo-peritoneal shunt
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	3 / 494 (0.61%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	1 / 102 (0.98%)	2 / 358 (0.56%)
occurrences causally related to treatment / all	0 / 3	0 / 1	0 / 0	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Foetal death
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Adhesion
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Administration site extravasation
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Alcohol withdrawal syndrome
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chest discomfort
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Condition aggravated
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug ineffective
subjects affected / exposed	1 / 494 (0.20%)	11 / 1522 (0.72%)	0 / 67 (0.00%)	0 / 102 (0.00%)	5 / 358 (1.40%)
occurrences causally related to treatment / all	1 / 1	5 / 11	0 / 0	0 / 0	5 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Face oedema
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hernia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperthermia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Impaired healing
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malaise
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Multiple organ dysfunction syndrome
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Paradoxical drug reaction
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Stenosis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sudden death
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug hypersensitivity
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypersensitivity
subjects affected / exposed	0 / 494 (0.00%)	5 / 1522 (0.33%)	2 / 67 (2.99%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	6 / 6	2 / 2	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sarcoidosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Type I hypersensitivity
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Cervix carcinoma
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Female genital tract fistula
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fibrocystic breast disease
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gynaecomastia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian cyst torsion
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Prostatitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Uterine polyp
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthma
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 494 (0.00%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 4	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory symptom
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric decompensation
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychotic disorder
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Schizophrenia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
C-reactive protein increased
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CSF pressure
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug specific antibody present
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Weight decreased
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Anastomotic fistula
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anastomotic ulcer haemorrhage
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal stoma complication
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Incisional hernia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infusion related reaction
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ligament rupture
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Maternal exposure during pregnancy
subjects affected / exposed	3 / 494 (0.61%)	5 / 1522 (0.33%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural complication
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Road traffic accident
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Wound
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiovascular disorder
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral infarction
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Headache
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Memory impairment
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningioma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Migraine with aura
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Presyncope
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sciatica
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bicytopenia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphopenia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Microcytic anaemia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal hernia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal incarcerated hernia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 494 (0.00%)	11 / 1522 (0.72%)	0 / 67 (0.00%)	0 / 102 (0.00%)	3 / 358 (0.84%)
occurrences causally related to treatment / all	0 / 0	1 / 12	0 / 0	0 / 0	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain lower
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal pain upper
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal fistula
subjects affected / exposed	0 / 494 (0.00%)	7 / 1522 (0.46%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 7	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis
subjects affected / exposed	0 / 494 (0.00%)	13 / 1522 (0.85%)	1 / 67 (1.49%)	1 / 102 (0.98%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	4 / 15	1 / 1	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Colitis ulcerative
subjects affected / exposed	3 / 494 (0.61%)	13 / 1522 (0.85%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 3	5 / 14	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Crohn's disease
subjects affected / exposed	5 / 494 (1.01%)	23 / 1522 (1.51%)	2 / 67 (2.99%)	0 / 102 (0.00%)	6 / 358 (1.68%)
occurrences causally related to treatment / all	1 / 5	3 / 27	0 / 2	0 / 0	1 / 7
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 494 (0.00%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 5	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea haemorrhagic
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulum
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal stenosis
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Duodenitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Enterocutaneous fistula
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fistula of small intestine
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal anastomotic stenosis
subjects affected / exposed	1 / 494 (0.20%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileal perforation
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileal stenosis
subjects affected / exposed	1 / 494 (0.20%)	11 / 1522 (0.72%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	2 / 11	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inflammatory bowel disease
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Inguinal hernia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	2 / 494 (0.40%)	5 / 1522 (0.33%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 7	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal stenosis
subjects affected / exposed	2 / 494 (0.40%)	8 / 1522 (0.53%)	0 / 67 (0.00%)	1 / 102 (0.98%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 2	1 / 8	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Large intestinal stenosis
subjects affected / exposed	1 / 494 (0.20%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malabsorption
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis chronic
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peptic ulcer perforation
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	1 / 494 (0.20%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal stenosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subileus
subjects affected / exposed	0 / 494 (0.00%)	8 / 1522 (0.53%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 10	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct stone
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholangitis sclerosing
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholelithiasis
subjects affected / exposed	2 / 494 (0.40%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis cholestatic
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatocellular injury
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lupus hepatitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis psoriasiform
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hidradenitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Palmoplantar pustulosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pruritus
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psoriasis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pustular psoriasis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyoderma gangrenosum
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rash
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin reaction
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bladder disorder
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
IgA nephropathy
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Kidney congestion
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal failure
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tubulointerstitial nephritis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Adrenocorticotropic hormone deficiency
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Steroid withdrawal syndrome
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thyroid mass
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Angiomyolipoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ankylosing spondylitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	1 / 67 (1.49%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis enteropathic
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Fistula
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Groin pain
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Muscle rupture
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sarcopenia
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Spondylitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic lupus erythematosus
subjects affected / exposed	0 / 494 (0.00%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	4 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess intestinal
subjects affected / exposed	1 / 494 (0.20%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 4	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal abscess
subjects affected / exposed	1 / 494 (0.20%)	5 / 1522 (0.33%)	0 / 67 (0.00%)	0 / 102 (0.00%)	3 / 358 (0.84%)
occurrences causally related to treatment / all	1 / 1	0 / 5	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anal fistula infection
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Beta haemolytic streptococcal infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Biliary sepsis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Brain abscess
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Breast abscess
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Chronic tonsillitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Clostridium difficile infection
subjects affected / exposed	0 / 494 (0.00%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 4	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cryptosporidiosis infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cytomegalovirus colitis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Disseminated tuberculosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epididymitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Epstein-Barr virus infection
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
subjects affected / exposed	2 / 494 (0.40%)	1 / 1522 (0.07%)	1 / 67 (1.49%)	1 / 102 (0.98%)	2 / 358 (0.56%)
occurrences causally related to treatment / all	0 / 2	1 / 1	0 / 1	1 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis C
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infected fistula
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Liver abscess
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lung infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Measles
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 494 (0.00%)	9 / 1522 (0.59%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	4 / 9	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia influenzal
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Rotavirus infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	1 / 494 (0.20%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	1 / 1	0 / 0	0 / 0	0 / 0
Skin infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Staphylococcal sepsis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Subdiaphragmatic abscess
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tonsillitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tuberculosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urosepsis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Varicella
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Malnutrition
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Remicade	CT-P13	Switched From CT-P13 to Remicade	Multiple Switchers	Switched From Remicade to CT-P13
Total subjects affected by non serious adverse events
subjects affected / exposed	100 / 494 (20.24%)	442 / 1522 (29.04%)	7 / 67 (10.45%)	21 / 102 (20.59%)	90 / 358 (25.14%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Malignant melanoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Malignant melanoma in situ
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Malignant melanoma stage III
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Skin cancer
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Vascular disorders
Haematoma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Hot flush
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Poor venous access
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Surgical and medical procedures
Abortion induced
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Intestinal resection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	1 / 494 (0.20%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	3	0	0	0
Gestational trophoblastic detachment
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
General disorders and administration site conditions
Drug ineffective
subjects affected / exposed	24 / 494 (4.86%)	187 / 1522 (12.29%)	0 / 67 (0.00%)	9 / 102 (8.82%)	23 / 358 (6.42%)
occurrences all number	24	187	0	9	23
Dysplasia
subjects affected / exposed	2 / 494 (0.40%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	2	0	0	0	0
Fatigue
subjects affected / exposed	1 / 494 (0.20%)	5 / 1522 (0.33%)	0 / 67 (0.00%)	0 / 102 (0.00%)	4 / 358 (1.12%)
occurrences all number	1	5	0	0	5
Feeling abnormal
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Fibrosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
General physical health deterioration
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Influenza like illness
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Oedema peripheral
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Pyrexia
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	1	1	0	0
Unevaluable event
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Immune system disorders
Drug hypersensitivity
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	1	1	0	0	1
Hypersensitivity
subjects affected / exposed	10 / 494 (2.02%)	29 / 1522 (1.91%)	0 / 67 (0.00%)	1 / 102 (0.98%)	4 / 358 (1.12%)
occurrences all number	10	32	0	1	5
Serum sickness
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Type I hypersensitivity
subjects affected / exposed	2 / 494 (0.40%)	9 / 1522 (0.59%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	2	9	0	0	1
Reproductive system and breast disorders
Ovarian cyst
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Cough
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Dyspnoea
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	1	1	0	0	1
Haemoptysis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Lung disorder
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Nasal discomfort
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Oropharyngeal pain
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	1 / 67 (1.49%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	1	0	1
Respiratory distress
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Psychiatric disorders
Abnormal dreams
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Anxiety
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Depressed mood
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Insomnia
subjects affected / exposed	2 / 494 (0.40%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	2	0	0	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	3	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Blood count abnormal
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	1	0	0
C-reactive protein increased
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Colonoscopy
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Drug specific antibody present
subjects affected / exposed	1 / 494 (0.20%)	6 / 1522 (0.39%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	6	0	0	0
Hepatic enzyme increased
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Mean cell volume decreased
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Injury, poisoning and procedural complications
Exposure to communicable disease
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Infusion related reaction
subjects affected / exposed	3 / 494 (0.61%)	24 / 1522 (1.58%)	0 / 67 (0.00%)	0 / 102 (0.00%)	3 / 358 (0.84%)
occurrences all number	4	24	0	0	5
Limb injury
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Maternal exposure during pregnancy
subjects affected / exposed	13 / 494 (2.63%)	34 / 1522 (2.23%)	0 / 67 (0.00%)	1 / 102 (0.98%)	9 / 358 (2.51%)
occurrences all number	14	37	0	1	9
Medication error
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Suture related complication
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Wound
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Wound dehiscence
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Cardiac disorders
Acute coronary syndrome
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Angina pectoris
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Cardiovascular insufficiency
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Nervous system disorders
Demyelination
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Dizziness
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Facial paralysis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Headache
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Meningioma
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Demyelinating polyneuropathy
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	4 / 494 (0.81%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	5	1	0	1	0
Iron deficiency anaemia
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Leukopenia
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Ear and labyrinth disorders
Neurosensory hypoacusis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Eye disorders
Dry eye
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Retinal vein occlusion
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	0	1	0	0
Scleritis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Vision blurred
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 494 (0.20%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences all number	1	3	0	0	2
Abdominal tenderness
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Anal fistula
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Colitis
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	3	0	0	1
Colitis ulcerative
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences all number	0	2	0	0	4
Crohn's disease
subjects affected / exposed	0 / 494 (0.00%)	7 / 1522 (0.46%)	0 / 67 (0.00%)	0 / 102 (0.00%)	3 / 358 (0.84%)
occurrences all number	0	8	0	0	3
Diarrhoea
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	3	0	0	0
Enteritis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Gastrointestinal anastomotic stenosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Gastrointestinal pain
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Haemorrhoids
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Ileal stenosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Hiatus hernia
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Intestinal obstruction
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Intestinal stenosis
subjects affected / exposed	3 / 494 (0.61%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	3	3	0	0	0
Large intestinal stenosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Nausea
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	2	0	0	0	0
Obstruction gastric
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Oesophagitis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Pancreatic failure
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Pancreatitis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Pouchitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Subileus
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Toothache
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	0	1	0	0
Vomiting
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Hepatobiliary disorders
Autoimmune hepatitis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Cholelithiasis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences all number	0	1	0	0	2
Cholestasis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Hepatic steatosis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Hepatitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Hepatocellular injury
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Non-alcoholic steatohepatitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	2	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Actinic keratosis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Alopecia
subjects affected / exposed	1 / 494 (0.20%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	2	0	0	0
Blister
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Dermatitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Dermatitis allergic
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Dermatitis atopic
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Dermatitis psoriasiform
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Drug eruption
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Dry skin
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Dyshidrotic eczema
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Eczema
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	2	0	0	1
Erythema
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	3	0	0	0
Erythema nodosum
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Hidradenitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Ingrowing nail
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Prurigo
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Pruritus
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Pruritus generalised
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Psoriasis
subjects affected / exposed	3 / 494 (0.61%)	11 / 1522 (0.72%)	0 / 67 (0.00%)	0 / 102 (0.00%)	3 / 358 (0.84%)
occurrences all number	3	11	0	0	4
Rash
subjects affected / exposed	1 / 494 (0.20%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	4	0	0	0
Rash erythematous
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	1 / 67 (1.49%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	1	0	0
Rebound psoriasis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Skin lesion
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Skin reaction
subjects affected / exposed	1 / 494 (0.20%)	18 / 1522 (1.18%)	0 / 67 (0.00%)	3 / 102 (2.94%)	4 / 358 (1.12%)
occurrences all number	2	19	0	3	4
Skin ulcer
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Urticaria
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Renal and urinary disorders
Renal failure
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Endocrine disorders
Thyroiditis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	11 / 494 (2.23%)	12 / 1522 (0.79%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	11	12	0	0	0
Arthritis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Arthropathy
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Back pain
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	1	1	0	0	1
Lupus-like syndrome
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences all number	0	3	0	0	2
Musculoskeletal discomfort
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Osteonecrosis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Pain in extremity
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Systemic lupus erythematosus
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Anal abscess
subjects affected / exposed	2 / 494 (0.40%)	5 / 1522 (0.33%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	2	5	0	0	1
Anal fistula infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Bronchitis
subjects affected / exposed	2 / 494 (0.40%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	1 / 102 (0.98%)	2 / 358 (0.56%)
occurrences all number	2	3	0	1	3
Campylobacter gastroenteritis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Candida infection
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Cellulitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Clostridium difficile infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Cystitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Ear infection
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Erysipelas
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Folliculitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Fungal infection
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Gastroenteritis viral
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Gastrointestinal infection
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Genital herpes
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Genital herpes zoster
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Gingivitis
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Groin abscess
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Herpes simplex
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Herpes virus infection
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 494 (0.00%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	3 / 358 (0.84%)
occurrences all number	0	4	0	0	3
Hordeolum
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	1	0	0	0
Impetigo
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Influenza
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	3	0	0	0
Laryngitis
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Latent tuberculosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	1 / 67 (1.49%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	2	1	0	1
Nail infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Nasopharyngitis
subjects affected / exposed	3 / 494 (0.61%)	5 / 1522 (0.33%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences all number	4	5	0	0	2
Onychomycosis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Ophthalmic herpes simplex
subjects affected / exposed	0 / 494 (0.00%)	3 / 1522 (0.20%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	3	0	0	0
Opportunistic infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	2
Oral candidiasis
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	1	0	0	0
Oral fungal infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Oral herpes
subjects affected / exposed	1 / 494 (0.20%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	4	0	0	0
Otitis media acute
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Papilloma viral infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	1	0	1	0
Parvovirus B19 infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Periodontitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Pertussis
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Pneumonia
subjects affected / exposed	0 / 494 (0.00%)	2 / 1522 (0.13%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	2	0	0	0
Pyelonephritis
subjects affected / exposed	0 / 494 (0.00%)	4 / 1522 (0.26%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	4	0	0	0
Respiratory tract infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Rhinitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Sinusitis
subjects affected / exposed	1 / 494 (0.20%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	1	0	0	0
Skin infection
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Subcutaneous abscess
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	1 / 102 (0.98%)	0 / 358 (0.00%)
occurrences all number	0	0	0	1	0
Tinea cruris
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Tinea pedis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Tinea versicolour
subjects affected / exposed	1 / 494 (0.20%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	1	0	0	0	0
Tonsillitis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	1	0	0	1
Tooth abscess
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	2 / 358 (0.56%)
occurrences all number	0	0	0	0	2
Ureteritis
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Urinary tract infection
subjects affected / exposed	1 / 494 (0.20%)	3 / 1522 (0.20%)	1 / 67 (1.49%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	1	3	1	0	1
Varicella zoster virus infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Viral infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Vulval abscess
subjects affected / exposed	0 / 494 (0.00%)	0 / 1522 (0.00%)	0 / 67 (0.00%)	0 / 102 (0.00%)	1 / 358 (0.28%)
occurrences all number	0	0	0	0	1
Vulvovaginal mycotic infection
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Metabolism and nutrition disorders
Cell death
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Iron deficiency
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0
Vitamin B12 deficiency
subjects affected / exposed	0 / 494 (0.00%)	1 / 1522 (0.07%)	0 / 67 (0.00%)	0 / 102 (0.00%)	0 / 358 (0.00%)
occurrences all number	0	1	0	0	0

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated With CT-P13 in Usual Clinical Practice(CONNECT-IBD)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Disease Characteristics of Subjects: Disease Duration

Primary: Disease Characteristics of Subjects: Disease Duration

Primary: Number of Subjects Who Switched Treatment

Primary: Number of Subjects Who Switched Treatment

Primary: Reasons for Switching Treatment by Subjects

Primary: Reasons for Switching Treatment by Subjects

Primary: Total Dose of Infusion Received

Primary: Total Dose of Infusion Received

Primary: Number of Subjects by Frequency of Infusion Received

Primary: Number of Subjects by Frequency of Infusion Received

Primary: Number of Subjects who had Change in Infusion Dose

Primary: Number of Subjects who had Change in Infusion Dose

Primary: Number of Subjects who had Change in Infusion Dose Categorized Based on Reasons of Change

Primary: Number of Subjects who had Change in Infusion Dose Categorized Based on Reasons of Change

Primary: Number of Subjects Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)

Primary: Number of Subjects Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)

Primary: Number of Subjects With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)

Primary: Number of Subjects With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)

Secondary: Number of Subjects Remaining in Clinical Remission or Relapse

Secondary: Number of Subjects Remaining in Clinical Remission or Relapse

Secondary: Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission

Secondary: Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission

Secondary: Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Disease Activity

Secondary: Crohn's Disease: Number of Subjects With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Disease Activity

Secondary: Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission

Secondary: Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission

Secondary: Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity

Secondary: Ulcerative Colitis: Number of Subjects With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Age at Diagnosis

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Age at Diagnosis

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Location

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Location

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Behavior of the Disease Activity

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Montreal Classification Index by Behavior of the Disease Activity

Secondary: Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Extent

Secondary: Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Extent

Secondary: Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Severity

Secondary: Ulcerative Colitis: Number of Subjects Categorised on the Basis of Montreal Classification Index by Severity

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Fistula Drainage Assessment Index

Secondary: Crohn's Disease: Number of Subjects Categorised on the Basis of Fistula Drainage Assessment Index

Secondary: Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24

Secondary: Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24

Secondary: Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24

Secondary: Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24

Secondary: Number of Subjects With Imaging Test Results

Secondary: Number of Subjects With Imaging Test Results

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated With CT-P13 in Usual Clinical Practice(CONNECT-IBD)