BI 695501 Versus Humira in Patients With Active Crohn's D... | NCT02871635

NCT02871635

ID	Type	Description	Link
2016-000612-14	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
BI 695501	Experimental		Drug: BI 695501
HUMIRA + BI 695501	Active Comparator		Drug: BI 695501 Drug: HUMIRA

Name	Type	Description	Arm Group Labels	Other Names
BI 695501	Drug		BI 695501 HUMIRA + BI 695501
HUMIRA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4	The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).	Week 4

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24	The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Borland-Groover Clinic		Jacksonville	Florida	32256	United States
Hope Clinical Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40498294	Derived	Strand V. Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials. Rheumatol Ther. 2025 Aug;12(4):613-616. doi: 10.1007/s40744-025-00766-6. Epub 2025 Jun 11.
39551590	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 12, 2017	Apr 23, 2020

Arm/Group Information

ID	Title	Description
BG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
BG001	Humira EU	Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46). Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.4± 13.44 BG00133.2± 11.52 BG00235.3± 12.63

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00131 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Crohn's Disease Activity Index score at baseline

Crohn's Disease Activity Index (CDAI) is a valid instrument to measure severity in Crohn's disease. The CDAI is composed of 8 factors (Number of liquid stools, abdominal pain, general well being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit, body weight) the score is calculated by adding up the scores after adjustment with a weighting factor. The total score ranges from 0 to approx. 600, higher scores indicates more severe disease. A score of less than or equal to 150 is evaluated as a remission while 220 and 450 indicate moderate to severely active disease.

Mean

Standard Deviation

Scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG000307.3± 76.69 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4

The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.

The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.

Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).

The full analysis set (FAS) contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.

Posted

Number

Percentage of participants

Week 4

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
OG001	Humira EU	Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46). Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.

Units	Counts
Participants	OG00068 OG00172

Title

Denominators

Categories

Title	Measurements
	OG00088.0 OG00193.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)					Risk Ratio (RR)	0.945			2-Sided	90	0.870	1.028			BI 695501 as numerator Humira EU as denominator		Other

Secondary

Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24

The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease.

The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders.

Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.

Posted

Number

Percentage of participants

Week 24

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Secondary

Percentage of Patients in Clinical Remission (CDAI <150) at Week 24

Patients with CDAI <150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.

The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.

Posted

Number

Percentage of participants

at Week 24

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
OG001

Secondary

Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)

Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.

The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.

Posted

Number

Percentage of participants

From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Secondary

Percentage of Patients With Infections

The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.

The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.

Posted

Number

Percentage of participants

From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.
OG001

Secondary

Percentage of Patients With Serious Infections

The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.

The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.

Posted

Number

Percentage of participants

From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Secondary

Percentage of Patients Who Experienced Hypersensitivity Reactions

The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.

The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.

Posted

Number

Percentage of participants

From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Secondary

Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)

The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.

The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.

Posted

Number

Percentage of participants

From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Secondary

Percentage of Patients With Injection Site Reactions

The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.

The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.

Posted

Number

Percentage of participants

From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.

ID	Title	Description
OG000	BI 695501	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BI 695501 (Baseline - Week 24 + 10 Weeks [70 Days])	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.	72	6	72	23	72
EG001	Humira (Baseline - Week 24 + 10 Weeks [70 Days])	Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46). Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.	75	8	75	16	75
EG002	BI 695501 (Week 24 - Week 46 + 10 Weeks [70 Days])	Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (CDAI decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46). Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection.	72	2	72	13	72
EG003	Humira (Week 24 - Week 46 + 10 Weeks [70 Days])	Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46). Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection.	75	9	75	12	75

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute sinusitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG0030 affected75 at risk
Anal abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0011 affected75 at risk EG0020 affected72 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0011 affected75 at risk EG0020 affected72 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Psoas abscess	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0021 affected72 at risk EG003
Rotavirus infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Multiple sclerosis	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0002 affected72 at risk EG0015 affected75 at risk EG0021 affected72 at risk EG003
Anal fistula	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 affected72 at risk EG0011 affected75 at risk EG0020 affected72 at risk EG003
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0011 affected75 at risk EG0020 affected72 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0011 affected75 at risk EG0020 affected72 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Ruptured ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0011 affected75 at risk EG0020 affected72 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Palmoplantar pustulosis	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 affected72 at risk EG0010 affected75 at risk EG0020 affected72 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0005 affected72 at risk EG0013 affected75 at risk EG0020 affected72 at risk EG0033 affected75 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 affected72 at risk EG0015 affected75 at risk EG0022 affected72 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0002 affected72 at risk EG0012 affected75 at risk EG0025 affected72 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0004 affected72 at risk EG0013 affected75 at risk EG0020 affected72 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 affected72 at risk EG0012 affected75 at risk EG0021 affected72 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0006 affected72 at risk EG0010 affected75 at risk EG0022 affected72 at risk EG003
Weight increased	Investigations	MedDRA 22.0	Systematic Assessment	EG0004 affected72 at risk EG0011 affected75 at risk EG0023 affected72 at risk EG003

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins