Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis (NCT NCT02065622)

NCT ID: NCT02065622

Last Updated: 2020-11-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

952 participants

Primary outcome timeframe

Week 8

Results posted on

2020-11-23

Participant Flow

This study included a Main Study (120 sites in 19 countries) and a Japan Sub-Study (22 sites in Japan). After a 3-week screening period, participants were randomized 3:2 to an 8-week double-blind (DB) Induction Period with 2 adalimumab dosing regimens (Induction Standard Dose \[I-SD\] or Induction Higher Dose \[I-HD\]).

At Week 8, participants in Main Study were re-randomized (2:2:1) into 44-week DB Maintenance Period with 3 adalimumab dosing regimens (M-SD, M-HD, or an exploratory Therapeutic Drug Monitoring \[TDM\] Regimen). Participants in Japan Sub-study were re-randomized (1:1) into 44-week DB Maintenance Period with 2 adalimumab dosing regimens (M-SD, M-HD).

Participant milestones

Participant milestones
Measure	Induction (Main Study + Japan Sub-study): I-SD Induction Standard Dose (I-SD): Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD Induction Higher Dose (I-HD): Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Maintenance (Main Study + Japan Sub-study): M-SD Maintenance Standard Dose (M-SD): Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance (Main Study + Japan Sub-study): M-HD Maintenance Higher Dose (M-HD): Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance (Main Study): TDM Regimen Exploratory Therapeutic Drug Monitoring (TDM) Regimen: Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore assessments.
Induction Study STARTED	379	573	0	0	0
Induction Study Enrolled in Main Study	340	512	0	0	0
Induction Study Enrolled in Japan Sub-Study	39	61	0	0	0
Induction Study COMPLETED	332	514	0	0	0
Induction Study NOT COMPLETED	47	59	0	0	0
Maintenance Study STARTED	0	0	345	350	151
Maintenance Study COMPLETED	0	0	221	246	105
Maintenance Study NOT COMPLETED	0	0	124	104	46

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction (Main Study + Japan Sub-study): I-SD Induction Standard Dose (I-SD): Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD Induction Higher Dose (I-HD): Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Maintenance (Main Study + Japan Sub-study): M-SD Maintenance Standard Dose (M-SD): Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance (Main Study + Japan Sub-study): M-HD Maintenance Higher Dose (M-HD): Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance (Main Study): TDM Regimen Exploratory Therapeutic Drug Monitoring (TDM) Regimen: Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore assessments.
Induction Study Adverse Event	13	19	0	0	0
Induction Study Withdrawal by Subject	3	5	0	0	0
Induction Study Lost to Follow-up	1	0	0	0	0
Induction Study Lack of Efficacy	22	27	0	0	0
Induction Study Requires Alternative/Prohibited Therapy	4	5	0	0	0
Induction Study Subject Noncompliance	1	1	0	0	0
Induction Study Other, Not Specified	3	2	0	0	0
Maintenance Study Adverse Event	0	0	25	22	11
Maintenance Study Withdrawal by Subject	0	0	11	5	7
Maintenance Study Lost to Follow-up	0	0	4	1	1
Maintenance Study Lack of Efficacy	0	0	70	55	19
Maintenance Study Requires Alternative/Prohibited Therapy	0	0	7	3	4
Maintenance Study Subject Non-Compliance	0	0	1	3	2
Maintenance Study Other, Not Specified	0	0	6	14	2
Maintenance Study Unknown Reason	0	0	0	1	0

Baseline Characteristics

participants with an assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Total n=952 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 13.14 • n=379 Participants	40.5 years STANDARD_DEVIATION 12.89 • n=573 Participants	40.4 years STANDARD_DEVIATION 12.98 • n=952 Participants
Sex: Female, Male Female	166 Participants n=379 Participants	239 Participants n=573 Participants	405 Participants n=952 Participants
Sex: Female, Male Male	213 Participants n=379 Participants	334 Participants n=573 Participants	547 Participants n=952 Participants
Race/Ethnicity, Customized White	326 Participants n=379 Participants	484 Participants n=573 Participants	810 Participants n=952 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=379 Participants	16 Participants n=573 Participants	24 Participants n=952 Participants
Race/Ethnicity, Customized Asian	44 Participants n=379 Participants	70 Participants n=573 Participants	114 Participants n=952 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	0 Participants n=379 Participants	1 Participants n=573 Participants	1 Participants n=952 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=379 Participants	1 Participants n=573 Participants	2 Participants n=952 Participants
Race/Ethnicity, Customized Missing	0 Participants n=379 Participants	1 Participants n=573 Participants	1 Participants n=952 Participants
Race/Ethnicity, Customized Hispanic or Latino	19 Participants n=379 Participants	28 Participants n=573 Participants	47 Participants n=952 Participants
Race/Ethnicity, Customized Japanese	39 Participants n=379 Participants	61 Participants n=573 Participants	100 Participants n=952 Participants
Race/Ethnicity, Customized Other, Not Specified	321 Participants n=379 Participants	484 Participants n=573 Participants	805 Participants n=952 Participants
Region United States	65 Participants n=379 Participants	113 Participants n=573 Participants	178 Participants n=952 Participants
Region Non-United States	314 Participants n=379 Participants	460 Participants n=573 Participants	774 Participants n=952 Participants
Full Mayo Score (FMS)	8.69 units on a scale STANDARD_DEVIATION 1.509 • n=379 Participants • participants with an assessment	8.87 units on a scale STANDARD_DEVIATION 1.571 • n=570 Participants • participants with an assessment	8.80 units on a scale STANDARD_DEVIATION 1.548 • n=949 Participants • participants with an assessment
FMS: Rectal Bleeding Subscore	1.68 units on a scale STANDARD_DEVIATION 0.955 • n=379 Participants • participants with an assessment	1.75 units on a scale STANDARD_DEVIATION 0.967 • n=570 Participants • participants with an assessment	1.72 units on a scale STANDARD_DEVIATION 0.962 • n=949 Participants • participants with an assessment

PRIMARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8	10.9 percentage of participants	13.3 percentage of participants	11.6 percentage of participants	13.8 percentage of participants

PRIMARY outcome

Timeframe: Week 52

Population: ITT-Responder population (I-ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=145 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=163 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52	29.0 percentage of participants	39.5 percentage of participants	30.1 percentage of participants	41.1 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8	27.1 percentage of participants	31.1 percentage of participants	26.9 percentage of participants	30.5 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8	27.1 percentage of participants	31.1 percentage of participants	26.9 percentage of participants	30.5 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8	60.9 percentage of participants	67.2 percentage of participants	60.7 percentage of participants	65.3 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8	40.0 percentage of participants	47.1 percentage of participants	38.8 percentage of participants	47.3 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8	10.0 percentage of participants	13.1 percentage of participants	10.0 percentage of participants	12.9 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8	63.2 percentage of participants	71.3 percentage of participants	63.1 percentage of participants	69.8 percentage of participants

SECONDARY outcome

Timeframe: Week 8

Population: Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=340 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=512 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=379 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=573 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8	57.1 percentage of participants	61.1 percentage of participants	57.5 percentage of participants	59.9 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=145 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=163 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52	41.4 percentage of participants	51.3 percentage of participants	41.7 percentage of participants	52.0 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: I-ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=92 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=95 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=103 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=108 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52	53.3 percentage of participants	74.7 percentage of participants	54.4 percentage of participants	74.1 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=92 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=95 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=103 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=108 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52	27.2 percentage of participants	38.9 percentage of participants	28.2 percentage of participants	39.8 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Remitter (ITT-RM) Population included all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=37 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=42 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=45 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=52 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52	40.5 percentage of participants	57.1 percentage of participants	44.4 percentage of participants	55.8 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=37 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=42 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=45 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=52 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52	51.4 percentage of participants	64.3 percentage of participants	55.6 percentage of participants	61.5 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-RM Population: participants in ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=26 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=27 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=32 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=35 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52	53.8 percentage of participants	77.8 percentage of participants	56.3 percentage of participants	71.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-RM Population: all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid usage. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=26 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=27 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=32 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=35 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52	34.6 percentage of participants	55.6 percentage of participants	37.5 percentage of participants	51.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=145 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=163 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52	62.1 percentage of participants	66.4 percentage of participants	62.6 percentage of participants	65.7 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Non-Responder (ITT-NRP) Population: all participants in ITT who did not achieve Week 8 response based on the Full Mayo Score utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore \[RBS\] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore \> 1.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=157 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=182 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52	12.1 percentage of participants	15.8 percentage of participants	12.1 percentage of participants	16.0 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Non-Remitter (ITT-NRM) Population: all participants in ITT who did not achieve Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=265 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=262 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=300 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=298 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52	17.4 percentage of participants	22.9 percentage of participants	17.0 percentage of participants	23.8 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants who were remitters at Week 8. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=145 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=163 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52	27.6 percentage of participants	35.5 percentage of participants	27.0 percentage of participants	35.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Remitter (ITT-RM) Population: all participants in ITT who achieved Week 8 remission based on the Full Mayo Score utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=37 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=42 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=45 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=52 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52	45.9 percentage of participants	47.6 percentage of participants	42.2 percentage of participants	44.2 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore \[RBS\] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=145 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=163 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52	62.1 percentage of participants	69.7 percentage of participants	62.6 percentage of participants	71.4 percentage of participants

SECONDARY outcome

Timeframe: Week 52

Population: ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 \[severe problem\] to 7 \[normal health\]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline.

Outcome measures

Outcome measures
Measure	Induction (Main Study): I-SD n=145 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study): I-HD n=152 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-SD n=163 Participants Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction (Main Study + Japan Sub-study): I-HD n=175 Participants Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52	53.8 percentage of participants	61.2 percentage of participants	55.2 percentage of participants	59.4 percentage of participants

Adverse Events

Induction (Main Study + Japan Sub-study): I-SD

Serious events: 19 serious events

Other events: 74 other events

Deaths: 2 deaths

Induction (Main Study + Japan Sub-study): I-HD

Serious events: 22 serious events

Other events: 112 other events

Deaths: 4 deaths

Maintenance (Main Study + Japan Sub-study): M-SD

Serious events: 44 serious events

Other events: 140 other events

Deaths: 2 deaths

Maintenance (Main Study + Japan Sub-study): M-HD

Serious events: 44 serious events

Other events: 141 other events

Deaths: 2 deaths

Maintenance (Main Study): TDM Regimen

Serious events: 15 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Induction (Main Study + Japan Sub-study): I-SD n=379 participants at risk Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 57.5 days.	Induction (Main Study + Japan Sub-study): I-HD n=573 participants at risk Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.0 days.	Maintenance (Main Study + Japan Sub-study): M-SD n=345 participants at risk Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 251.5 days.	Maintenance (Main Study + Japan Sub-study): M-HD n=350 participants at risk Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 263.1 days.	Maintenance (Main Study): TDM Regimen n=151 participants at risk Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 255.9 days.
Blood and lymphatic system disorders ANAEMIA	0.79% 3/379 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.35% 2/573 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.86% 3/350 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Blood and lymphatic system disorders THROMBOCYTOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Cardiac disorders CARDIAC ARREST	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Eye disorders EYELID PTOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Eye disorders OPTIC ATROPHY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders ABDOMINAL PAIN	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders ANOGENITAL DYSPLASIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders COLITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.58% 2/345 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders COLITIS ULCERATIVE	3.2% 12/379 • Number of events 17 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	2.3% 13/573 • Number of events 13 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	4.6% 16/345 • Number of events 16 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	5.1% 18/350 • Number of events 21 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	4.0% 6/151 • Number of events 6 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders DIARRHOEA	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders DUODENAL ULCER PERFORATION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders LARGE INTESTINAL STENOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders MALLORY-WEISS SYNDROME	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders NAUSEA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders PANCREATITIS ACUTE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations GASTROENTERITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Gastrointestinal disorders VOMITING	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
General disorders GAIT DISTURBANCE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
General disorders PYREXIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Hepatobiliary disorders BILE DUCT STONE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Hepatobiliary disorders HEPATITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Hepatobiliary disorders PORTOSPLENOMESENTERIC VENOUS THROMBOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations APPENDICITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations BRONCHITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.87% 3/345 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations CYTOMEGALOVIRUS COLITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations ERYSIPELAS	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations EXTERNAL EAR CELLULITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations GASTROINTESTINAL INFECTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations HERPES ZOSTER	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations INFECTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations OTITIS EXTERNA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations PELVIC INFLAMMATORY DISEASE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations PERINEAL ABSCESS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations PERITONSILLAR ABSCESS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations PNEUMONIA	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.58% 2/345 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	1.1% 4/350 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations SEPSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations STERNITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations TUBERCULOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations TUBERCULOSIS OF INTRATHORACIC LYMPH NODES	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations VARICELLA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations VIRAL INFECTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications MENISCUS INJURY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications PATELLA FRACTURE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Investigations WEIGHT DECREASED	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.57% 2/350 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FIBROMATOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 4 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA IN SITU	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF THE CERVIX	0.26% 1/379 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Nervous system disorders ALTERED STATE OF CONSCIOUSNESS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Nervous system disorders CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Nervous system disorders HYPOAESTHESIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Nervous system disorders MONONEUROPATHY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Psychiatric disorders BINGE DRINKING	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Psychiatric disorders BIPOLAR DISORDER	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Renal and urinary disorders HAEMATURIA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Renal and urinary disorders NEPHROTIC SYNDROME	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Renal and urinary disorders RENAL FAILURE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Renal and urinary disorders URINARY RETENTION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Reproductive system and breast disorders PROSTATOMEGALY	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Respiratory, thoracic and mediastinal disorders NASAL POLYPS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Respiratory, thoracic and mediastinal disorders NASAL SEPTUM DEVIATION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.57% 2/350 • Number of events 2 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Respiratory, thoracic and mediastinal disorders SINUS POLYP	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders ERYTHEMA NODOSUM	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders EXCESSIVE SKIN	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders LINEAR IGA DISEASE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders PEMPHIGOID	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.66% 1/151 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders SUBCORNEAL PUSTULAR DERMATOSIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Surgical and medical procedures WOUND DRAINAGE	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.17% 1/573 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Vascular disorders HYPERTENSION	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/345 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/350 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Vascular disorders THROMBOPHLEBITIS	0.00% 0/379 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/573 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/345 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.29% 1/350 • Number of events 1 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	0.00% 0/151 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.

Other adverse events

Other adverse events
Measure	Induction (Main Study + Japan Sub-study): I-SD n=379 participants at risk Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 57.5 days.	Induction (Main Study + Japan Sub-study): I-HD n=573 participants at risk Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.0 days.	Maintenance (Main Study + Japan Sub-study): M-SD n=345 participants at risk Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 251.5 days.	Maintenance (Main Study + Japan Sub-study): M-HD n=350 participants at risk Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 263.1 days.	Maintenance (Main Study): TDM Regimen n=151 participants at risk Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 255.9 days.
Gastrointestinal disorders COLITIS ULCERATIVE	5.3% 20/379 • Number of events 22 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	3.1% 18/573 • Number of events 18 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	17.4% 60/345 • Number of events 70 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	13.4% 47/350 • Number of events 58 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	15.2% 23/151 • Number of events 29 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations NASOPHARYNGITIS	4.2% 16/379 • Number of events 18 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	5.1% 29/573 • Number of events 34 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	13.6% 47/345 • Number of events 61 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	13.1% 46/350 • Number of events 57 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	7.3% 11/151 • Number of events 20 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.79% 3/379 • Number of events 3 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	1.0% 6/573 • Number of events 6 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	6.4% 22/345 • Number of events 25 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	5.4% 19/350 • Number of events 20 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	6.0% 9/151 • Number of events 10 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Musculoskeletal and connective tissue disorders ARTHRALGIA	2.9% 11/379 • Number of events 11 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	3.1% 18/573 • Number of events 19 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	6.7% 23/345 • Number of events 27 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	6.6% 23/350 • Number of events 27 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	3.3% 5/151 • Number of events 5 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Nervous system disorders HEADACHE	6.1% 23/379 • Number of events 32 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	8.4% 48/573 • Number of events 62 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	4.9% 17/345 • Number of events 19 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	6.3% 22/350 • Number of events 36 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	5.3% 8/151 • Number of events 9 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.
Skin and subcutaneous tissue disorders RASH	2.9% 11/379 • Number of events 11 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	1.7% 10/573 • Number of events 10 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	3.2% 11/345 • Number of events 13 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	5.7% 20/350 • Number of events 24 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.	2.6% 4/151 • Number of events 6 • See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation. Treatment-emergent adverse events (TEAEs) are presented.

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