Trial Outcomes & Findings for Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis (NCT NCT00573794)

Last Updated: 2021-07-07

Results Overview

The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

592 participants

Primary outcome timeframe

Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Results posted on

2021-07-07

Participant Flow

A total of 592 subjects were randomized and received at least 1 dose of study drug (safety population); 7 subjects enrolled at 3 noncompliant sites were excluded from the analyses (Intent-to-treat 1 \[ITT-1\] population; N=585).

Participant milestones

Participant milestones
Measure	Adalimumab 40 mg EOW/EW Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Overall Study STARTED	585
Overall Study COMPLETED	255
Overall Study NOT COMPLETED	330

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab 40 mg EOW/EW Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Overall Study Adverse Event	81
Overall Study Withdrew Consent	90
Overall Study Lost to Follow-up	13
Overall Study Protocol Violation	6
Overall Study Lack of Efficacy	94
Overall Study Other	46

Baseline Characteristics

Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab 40 mg EOW/EW n=585 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Age, Continuous	41.6 years STANDARD_DEVIATION 12.85 • n=93 Participants
Sex: Female, Male Female	214 Participants n=93 Participants
Sex: Female, Male Male	371 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=584 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Partial Mayo Score: Change From Baseline Over Time Baseline	2.5 units on a scale Standard Deviation 2.02
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 192	-0.6 units on a scale Standard Deviation 1.84
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 240	-0.8 units on a scale Standard Deviation 1.79
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 292	-0.7 units on a scale Standard Deviation 2.05
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 340	-1.0 units on a scale Standard Deviation 1.97
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 48	-0.2 units on a scale Standard Deviation 2.04
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 96	-0.4 units on a scale Standard Deviation 1.78
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 144	-0.5 units on a scale Standard Deviation 2.06
Partial Mayo Score: Change From Baseline Over Time Change from Baseline to Week 388	-2.0 units on a scale Standard Deviation 1.00

PRIMARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=583 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 144	-0.8 units on a scale Standard Deviation 2.73
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 192	-0.8 units on a scale Standard Deviation 2.52
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 240	-1.0 units on a scale Standard Deviation 2.40
Mayo Score: Change From Baseline Over Time Baseline	3.5 units on a scale Standard Deviation 2.72
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 48	-0.3 units on a scale Standard Deviation 2.64
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 96	-0.5 units on a scale Standard Deviation 2.49
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 292	-0.9 units on a scale Standard Deviation 2.84
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 340	-1.3 units on a scale Standard Deviation 2.87
Mayo Score: Change From Baseline Over Time Change from Baseline to Week 388	-2.0 units on a scale Standard Deviation 1.73

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with evaluable data at given timepoint.

The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \[PGA\]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore \> 1.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=585 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 292	76.7 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Baseline	52.4 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 48	61.2 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 96	69.3 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 144	75.0 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 192	74.7 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 240	77.2 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 340	73.9 percentage of participants
Percentage of Participants With Remission Per Partial Mayo Score Over Time Week 388	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=583 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Mayo Endoscopy Subscore: Change From Baseline Over Time Baseline	1.1 units on a scale Standard Deviation 0.94
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 388	0.0 units on a scale Standard Deviation 1.00
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 48	-0.1 units on a scale Standard Deviation 0.95
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 96	-0.1 units on a scale Standard Deviation 1.02
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 144	-0.2 units on a scale Standard Deviation 0.93
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 192	-0.3 units on a scale Standard Deviation 0.98
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 240	-0.3 units on a scale Standard Deviation 0.97
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 292	-0.3 units on a scale Standard Deviation 1.03
Mayo Endoscopy Subscore: Change From Baseline Over Time Change from Baseline to Week 340	-0.3 units on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=584 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Baseline	0.4 units on a scale Standard Deviation 0.68
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 48	-0.1 units on a scale Standard Deviation 0.73
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 96	-0.0 units on a scale Standard Deviation 0.63
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 340	-0.2 units on a scale Standard Deviation 0.80
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 388	-1.0 units on a scale Standard Deviation 1.00
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 144	-0.1 units on a scale Standard Deviation 0.74
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 192	-0.1 units on a scale Standard Deviation 0.69
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 240	-0.2 units on a scale Standard Deviation 0.63
Mayo Rectal Bleeding Subscore: Change From Baseline Over Time Change from Baseline to Week 292	-0.2 units on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=584 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Baseline	0.8 units on a scale Standard Deviation 0.81
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 48	-0.1 units on a scale Standard Deviation 0.89
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 96	-0.2 units on a scale Standard Deviation 0.84
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 144	-0.2 units on a scale Standard Deviation 0.89
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 192	-0.2 units on a scale Standard Deviation 0.82
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 240	-0.3 units on a scale Standard Deviation 0.82
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 292	-0.2 units on a scale Standard Deviation 0.79
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 340	-0.3 units on a scale Standard Deviation 0.88
Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time Change from Baseline to Week 388	-0.7 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=584 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Mayo Stool Frequency Subscore: Change From Baseline Over Time Baseline	1.3 units on a scale Standard Deviation 1.01
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 48	-0.1 units on a scale Standard Deviation 0.89
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 96	-0.2 units on a scale Standard Deviation 0.84
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 144	-0.2 units on a scale Standard Deviation 0.89
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 192	-0.2 units on a scale Standard Deviation 0.82
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 240	-0.3 units on a scale Standard Deviation 0.86
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 292	-0.3 units on a scale Standard Deviation 1.00
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 340	-0.5 units on a scale Standard Deviation 0.99
Mayo Stool Frequency Subscore: Change From Baseline Over Time Change from Baseline to Week 388	-0.3 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=572 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 96	4.7 units on a scale Standard Deviation 28.73
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 144	5.2 units on a scale Standard Deviation 30.64
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 192	7.6 units on a scale Standard Deviation 28.66
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Baseline	176.0 units on a scale Standard Deviation 34.45
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 48	2.1 units on a scale Standard Deviation 28.91
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 240	11.2 units on a scale Standard Deviation 25.98
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 292	14.8 units on a scale Standard Deviation 27.36
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 340	14.6 units on a scale Standard Deviation 28.12
Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time Change from Baseline to Week 388	11.0 units on a scale Standard Deviation 12.53

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=575 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 192	0.1 units on a scale Standard Deviation 9.41
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Baseline	47.1 units on a scale Standard Deviation 10.16
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 48	-0.7 units on a scale Standard Deviation 9.61
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 96	0.3 units on a scale Standard Deviation 9.64
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 144	0.0 units on a scale Standard Deviation 9.52
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 240	0.7 units on a scale Standard Deviation 7.86
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 292	1.8 units on a scale Standard Deviation 8.13
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 340	1.8 units on a scale Standard Deviation 6.81
36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time Change from Baseline to Week 388	-7.3 units on a scale Standard Deviation 5.58

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=575 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 48	0.7 units on a scale Standard Deviation 6.98
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 240	2.2 units on a scale Standard Deviation 6.23
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Baseline	49.3 units on a scale Standard Deviation 8.06
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 96	1.2 units on a scale Standard Deviation 6.26
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 144	1.1 units on a scale Standard Deviation 7.08
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 192	1.3 units on a scale Standard Deviation 7.46
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 292	2.5 units on a scale Standard Deviation 7.03
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 340	3.0 units on a scale Standard Deviation 8.71
36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time Change from Baseline to Week 388	8.4 units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=375 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 144	0.9 percent of work time missed Standard Deviation 20.19
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Baseline	4.5 percent of work time missed Standard Deviation 15.42
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 48	1.6 percent of work time missed Standard Deviation 24.04
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 96	-0.2 percent of work time missed Standard Deviation 18.41
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 192	0.2 percent of work time missed Standard Deviation 19.05
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 240	-1.1 percent of work time missed Standard Deviation 17.21
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 292	8.2 percent of work time missed Standard Deviation 30.65
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 340	6.4 percent of work time missed Standard Deviation 24.96
Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time Change from Baseline to Week 388	0.0 percent of work time missed Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=388 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 48	1.1 percent of work time impaired Standard Deviation 22.45
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 96	-1.9 percent of work time impaired Standard Deviation 20.86
WPAI:GH Impairment While Working: Change From Baseline Over Time Baseline	16.7 percent of work time impaired Standard Deviation 20.73
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 144	-0.2 percent of work time impaired Standard Deviation 24.11
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 192	-2.9 percent of work time impaired Standard Deviation 24.04
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 240	-4.0 percent of work time impaired Standard Deviation 21.40
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 292	-3.8 percent of work time impaired Standard Deviation 25.45
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 340	-13.8 percent of work time impaired Standard Deviation 26.04
WPAI:GH Impairment While Working: Change From Baseline Over Time Change from Baseline to Week 388	-15.0 percent of work time impaired Standard Deviation 21.21

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=373 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Baseline	20.1 percent of overall work impairment Standard Deviation 24.30
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 96	-2.7 percent of overall work impairment Standard Deviation 24.99
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 340	-7.3 percent of overall work impairment Standard Deviation 12.05
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 48	1.2 percent of overall work impairment Standard Deviation 28.15
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 144	-0.8 percent of overall work impairment Standard Deviation 28.05
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 192	-2.6 percent of overall work impairment Standard Deviation 26.69
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 240	-5.0 percent of overall work impairment Standard Deviation 24.1
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 292	1.4 percent of overall work impairment Standard Deviation 35.53
WPAI:GH Overall Work Impairment: Change From Baseline Over Time Change from Baseline to Week 388	-15.0 percent of overall work impairment Standard Deviation 21.21

SECONDARY outcome

Timeframe: Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388

Population: Participants in ITT-1 population with both Baseline and visit values.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=550 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
WPAI:GH Activity Impairment: Change From Baseline Over Time Baseline	21.4 percent activity impaired Standard Deviation 24.00
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 48	1.1 percent activity impaired Standard Deviation 24.14
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 96	-1.6 percent activity impaired Standard Deviation 21.80
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 144	-0.7 percent activity impaired Standard Deviation 23.65
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 192	-2.1 percent activity impaired Standard Deviation 20.91
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 240	-3.4 percent activity impaired Standard Deviation 18.63
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 292	-1.5 percent activity impaired Standard Deviation 19.79
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 340	-9.6 percent activity impaired Standard Deviation 11.86
WPAI:GH Activity Impairment: Change From Baseline Over Time Change from Baseline to Week 388	-16.7 percent activity impaired Standard Deviation 15.28

SECONDARY outcome

Timeframe: 5 years

Population: ITT-1 population

The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=585 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Colectomy Rate	3.88 percentage of participants

SECONDARY outcome

Timeframe: 5 years

Population: ITT-1 population

The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=585 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations Physician	561 cumulative number of utilizations
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations Emergency Room	43 cumulative number of utilizations
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations Hospital Admission	65 cumulative number of utilizations
Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations Days in Hospital	435 cumulative number of utilizations

SECONDARY outcome

Timeframe: From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks)

Population: Safety analysis set: all participants who received at least 1 dose of study drug.

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=592 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Number of Participants With Adverse Events Any TEAE	496 Participants
Number of Participants With Adverse Events Any TESAE	158 Participants

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=575 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Hematology: Mean Change From Baseline to Final Values in Hemoglobin	-0.1 g/L Standard Deviation 16.02

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=575 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Hematology: Mean Change From Baseline to Final Values in Hematocrit	0.013 Percentage of red blood cells Standard Deviation 0.0472

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=575 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Red blood cell count	0.03 cells * 10^9/L Standard Deviation 0.416
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Platelet count	-10.5 cells * 10^9/L Standard Deviation 96.98
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils White blood cell count	0.41 cells * 10^9/L Standard Deviation 2.704
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Neutrophils	0.164 cells * 10^9/L Standard Deviation 2.4225
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Lymphocytes	0.155 cells * 10^9/L Standard Deviation 0.8270
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Monocytes	0.051 cells * 10^9/L Standard Deviation 0.2203
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Eosinophils	0.002 cells * 10^9/L Standard Deviation 0.1602
Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils Basophils	0.009 cells * 10^9/L Standard Deviation 0.0586

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=581 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase Alanine aminotransferase	3.7 U/L Standard Deviation 22.03
Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase Aspartate aminotransferase	2.6 U/L Standard Deviation 28.13
Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase Alkaline phosphatase	-0.2 U/L Standard Deviation 34.65

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in ITT-1 population with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=581 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid Total bilirubin	-1.0 μmol/L Standard Deviation 5.35
Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid Creatinine	2.4 μmol/L Standard Deviation 13.18
Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid Uric acid	7.6 μmol/L Standard Deviation 65.52

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=581 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Blood urea nitrogen	0.32 mmol/L Standard Deviation 1.409
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Inorganic phosphate	-0.003 mmol/L Standard Deviation 0.2312
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Calcium	-0.012 mmol/L Standard Deviation 0.1185
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Sodium	-0.0 mmol/L Standard Deviation 2.49
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Potassium	0.07 mmol/L Standard Deviation 0.424
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Glucose	0.05 mmol/L Standard Deviation 1.334
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Cholesterol	-0.025 mmol/L Standard Deviation 0.8853
Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides Triglycerides	0.178 mmol/L Standard Deviation 1.2800

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=581 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein Albumin	-0.4 g/L Standard Deviation 3.85
Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein Total protein	0.7 g/L Standard Deviation 18.99

SECONDARY outcome

Timeframe: Baseline (Week 0), final value (up to 5 years)

Population: Participants in the safety analysis set with both Baseline and visit values.

Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg EOW/EW n=575 Participants Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein	0.382 mg/L Standard Deviation 15.1489

Adverse Events

Adalimumab 40 mg EOW/EW

Serious events: 158 serious events

Other events: 391 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab 40 mg EOW/EW n=592 participants at risk Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Blood and lymphatic system disorders ANAEMIA	1.0% 6/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders LYMPHADENOPATHY MEDIASTINAL	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders AORTIC VALVE STENOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders ATRIAL FIBRILLATION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders CARDIOGENIC SHOCK	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders CORONARY ARTERY DISEASE	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders LEFT VENTRICULAR DYSFUNCTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders RIGHT VENTRICULAR FAILURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders TACHYCARDIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Congenital, familial and genetic disorders HYPERTROPHIC CARDIOMYOPATHY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Endocrine disorders ADRENAL HAEMORRHAGE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Endocrine disorders GOITRE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Eye disorders OPTIC ISCHAEMIC NEUROPATHY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ABDOMINAL PAIN	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ANAL FISTULA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders COLITIS	0.51% 3/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders COLITIS ULCERATIVE	5.7% 34/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders COLON DYSPLASIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders CROHN'S DISEASE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTROINTESTINAL DYSPLASIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ILEUS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders INGUINAL HERNIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders LARGE INTESTINAL STENOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders NAUSEA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders PNEUMOPERITONEUM	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders PSEUDOPOLYPOSIS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders RECTAL PERFORATION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders RECTAL POLYP	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders UMBILICAL HERNIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders DRUG INTOLERANCE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders DYSPLASIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders MULTIMORBIDITY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders NON-CARDIAC CHEST PAIN	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders POLYP	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders PYREXIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders CHOLELITHIASIS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders PORTAL HYPERTENSION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ABDOMINAL ABSCESS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ABSCESS OF SALIVARY GLAND	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ANAL ABSCESS	0.51% 3/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations APPENDICITIS	0.84% 5/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations APPENDICITIS PERFORATED	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CHRONIC SINUSITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations COLONIC ABSCESS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations DEVICE RELATED INFECTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations DIARRHOEA INFECTIOUS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations DIVERTICULITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations HERPES ZOSTER	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations HERPES ZOSTER MENINGITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INFECTION	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INJECTION SITE ABSCESS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INJECTION SITE CELLULITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations LUNG ABSCESS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ORCHITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PERITONITIS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PNEUMONIA	1.9% 11/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PNEUMONIA BACTERIAL	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations POSTOPERATIVE WOUND INFECTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PULMONARY TUBERCULOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PYELONEPHRITIS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PYELONEPHRITIS ACUTE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations RESPIRATORY TRACT INFECTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SUBCUTANEOUS ABSCESS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations URINARY TRACT INFECTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications ANIMAL BITE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications HEAD INJURY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications HIP FRACTURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications JOINT INJURY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications MENISCUS INJURY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications RIB FRACTURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications TENDON RUPTURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications TIBIA FRACTURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations FALSE POSITIVE TUBERCULOSIS TEST	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Investigations WEIGHT DECREASED	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders HYPOKALAEMIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders HYPONATRAEMIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders BACK PAIN	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders BURSITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.51% 3/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders LUPUS-LIKE SYNDROME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.84% 5/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEOPOROTIC FRACTURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders SYMPATHETIC POSTERIOR CERVICAL SYNDROME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.51% 3/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER TRANSITIONAL CELL CARCINOMA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA STAGE 0	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GALLBLADDER ADENOCARCINOMA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC NEOPLASM	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) UTERINE LEIOMYOMA	0.51% 3/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders AUTONOMIC NERVOUS SYSTEM IMBALANCE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders CAROTID ARTERY STENOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders CARPAL TUNNEL SYNDROME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders DEMYELINATION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders GENERALISED TONIC-CLONIC SEIZURE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders ISCHAEMIC STROKE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders MULTIPLE SCLEROSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders NERVE COMPRESSION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders BIPOLAR I DISORDER	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders CONFUSIONAL STATE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders PSYCHOTIC BEHAVIOUR	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders SUICIDE ATTEMPT	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders DYSURIA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders URETEROLITHIASIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Renal and urinary disorders URINARY INCONTINENCE	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders MENORRHAGIA	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders OVARIAN CYST	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders PROSTATISM	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders PROSTATITIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders UTERINE CYST	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders ALLERGIC RESPIRATORY SYMPTOM	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders NASAL OBSTRUCTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders NASAL SEPTUM DEVIATION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders SLEEP APNOEA SYNDROME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ERYTHEMA NODOSUM	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders HENOCH-SCHONLEIN PURPURA	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Surgical and medical procedures ABORTION INDUCED	0.34% 2/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders DEEP VEIN THROMBOSIS	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders HAEMORRHAGIC INFARCTION	0.17% 1/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	Adalimumab 40 mg EOW/EW n=592 participants at risk Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW.
Gastrointestinal disorders ABDOMINAL PAIN	6.4% 38/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders COLITIS ULCERATIVE	30.4% 180/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders DIARRHOEA	7.8% 46/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders NAUSEA	5.7% 34/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
General disorders FATIGUE	5.9% 35/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations BRONCHITIS	6.8% 40/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INFLUENZA	7.1% 42/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS	9.0% 53/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.8% 58/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations URINARY TRACT INFECTION	5.2% 31/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	19.4% 115/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders ARTHRALGIA	10.5% 62/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders BACK PAIN	6.8% 40/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders HEADACHE	7.8% 46/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders COUGH	6.9% 41/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.6% 33/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders RASH	7.1% 42/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Vascular disorders HYPERTENSION	6.2% 37/592 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks). TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.

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