Trial Outcomes & Findings for Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine (NCT NCT01083680)

Last Updated: 2017-04-04

Results Overview

The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease. Negative changes indicate reductions (improvement) in disease activity.

Recruitment status

COMPLETED

Target enrollment

4107 participants

Primary outcome timeframe

Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Results posted on

2017-04-04

Participant Flow

A total of 4107 participants were enrolled: 1621 in the full analysis set (FAS) population were analyzed for efficacy; 4107 were analyzed for safety.

Participant milestones

Participant milestones
Measure	Participants With Crohn's Disease (CD) Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Overall Study STARTED	4107
Overall Study Full Analysis Set (FAS), Efficacy	1621
Overall Study COMPLETED	263
Overall Study NOT COMPLETED	3844

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Crohn's Disease (CD) Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Overall Study Lost to Follow-up	2758
Overall Study Withdrawal by Subject	1086

Baseline Characteristics

Baseline analysis (age, continuous) accounts for safety analysis set population with available data. This information wasn't available for 31 participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Crohn's Disease (CD) n=4107 Participants Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Age, Continuous	36.6 years STANDARD_DEVIATION 12.7 • n=4076 Participants • Baseline analysis (age, continuous) accounts for safety analysis set population with available data. This information wasn't available for 31 participants.
Sex: Female, Male Female	2500 Participants n=4083 Participants • Baseline analysis (gender) accounts for safety analysis set population with available data. This information wasn't available for 24 participants.
Sex: Female, Male Male	1583 Participants n=4083 Participants • Baseline analysis (gender) accounts for safety analysis set population with available data. This information wasn't available for 24 participants.

PRIMARY outcome

Timeframe: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Effectiveness analyses included all participants with evaluable data.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease (CD) n=1168 Participants Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 3	-117 units on a scale Standard Deviation 117
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 6	-124 units on a scale Standard Deviation 127
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 9	-131 units on a scale Standard Deviation 122
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 12	-137 units on a scale Standard Deviation 125
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 18	-142 units on a scale Standard Deviation 126
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 24	-137 units on a scale Standard Deviation 135
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 30	-145 units on a scale Standard Deviation 119
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 36	-149 units on a scale Standard Deviation 118
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 42	-151 units on a scale Standard Deviation 113
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 48	-153 units on a scale Standard Deviation 109
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 54	-156 units on a scale Standard Deviation 113
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) at Each Visit Month 60	-138 units on a scale Standard Deviation 119

PRIMARY outcome

Timeframe: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Effectiveness analyses included all participants with evaluable data.

The CDAI is a measure of clinical response and remission that was developed for use in clinical trials. The CDAI includes 8 variables encompassing both participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card, and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; there is no set upper limit. The scale for the scores is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease (CD) n=1471 Participants Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 0 (Remission)	12.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 0 (Mild disease)	28.8 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 0 (Moderate disease)	54.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 0 (Severe disease)	4.8 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 3 (Remission)	64.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 3 (Mild disease)	17.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 3 (Moderate Disease)	17.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 3 (Severe Disease)	1.0 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 6 (Remission)	67.0 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 6 (Mild Disease)	15.3 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 6 (Moderate Disease)	16.6 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 6 (Severe Disease)	1.1 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 9 (Remission)	66.7 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 9 (Mild Disease)	18.8 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 9 (Moderate Disease)	14.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 9 (Severe Disease)	0.3 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 12 (Remission)	69.8 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 12 (Mild Disease)	16.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 12 (Moderate Disease)	13.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 12 (Severe Disease)	0.6 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 18 (Remission)	72.8 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 18 (Mild disease)	13.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 18 (Moderate Disease)	13.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 18 (Severe Disease)	0.8 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 24 (Remission)	70.7 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 24 (Mild Disease)	14.9 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 24 (Moderate Disease)	12.9 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 24 (Severe Disease)	1.5 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 30 (Remission)	73.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 30 (Mild Disease)	14.9 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 30 (Moderate Disease)	11.7 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 30 (Severe Diease)	0.3 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 36 (Remission)	75.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 36 (Mild Disease)	11.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 36 (Moderate Disease)	13.0 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 36 (Severe Disease)	0.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 42 (Remission)	74.5 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 42 (Mild Disease)	12.3 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 42 (Moderate Disease)	13.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 42 (Severe Disease)	0.0 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 48 (Remission)	72.7 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 48 (Mild Disease)	16.1 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 48 (Moderate Disease)	10.6 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 48 (Severe Disease)	0.6 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 54 (Remission)	76.3 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 54 (Mild Disease)	12.3 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 54 (Moderate Disease)	11.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 54 (Severe Disease)	0.0 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 60 (Remission)	68.4 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 60 (Mild Disease)	15.2 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 60 (Moderate Disease)	16.5 percentage of participants
Percentage of Full Analysis Set (FAS) Participants in Each CDAI Disease Classification Over Time Month 60 (Severe Disease)	0.0 percentage of participants

PRIMARY outcome

Timeframe: Months 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Effectiveness analyses included all participants with evaluable data.

The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is an abbreviated version of the Inflammatory Bowel Disease (IBD) Questionnaire, a Health-related quality of life (HRQOL) assessment tool for patients with IBD. The SIBDQ utilizes 10 items concerning patient well-being during the last 2 weeks, each of which is scored on a scale of 1 (poor HRQOL) to 7 (optimum HRQOL). The individual sub scores are added to produce the total SIBDQ score. SIBDQ scores range from 10 to 70 with higher values indicating better HRQOL. Positive changes indicate reductions in disease activity.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease (CD) n=947 Participants Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 3	10.8 units on a scale Standard Deviation 12.4
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 6	12.1 units on a scale Standard Deviation 13.2
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 9	12.6 units on a scale Standard Deviation 13.3
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 12	13.7 units on a scale Standard Deviation 13.8
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 18	13.2 units on a scale Standard Deviation 12.9
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 24	14.7 units on a scale Standard Deviation 14.6
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 30	14.8 units on a scale Standard Deviation 14.3
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 36	14.6 units on a scale Standard Deviation 14.8
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 42	15.4 units on a scale Standard Deviation 13.6
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 48	16.9 units on a scale Standard Deviation 14.2
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 54	18.0 units on a scale Standard Deviation 14.4
Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) at Each Visit in FAS Participants Month 60	10.2 units on a scale Standard Deviation 13.3

PRIMARY outcome

Timeframe: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Analysis included safety analysis population with incidence of greater than 1% during the study.

An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. For more details on adverse events please see the AE section below.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease (CD) n=4107 Participants Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Percentage of Participants With Adverse Events (Excluding Serious Adverse Events)	16.7 percentage of participants

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Effectiveness analyses included all participants with evaluable data.

The HBI is a simplified version of the CDAI; HBI scores correlate well with CDAI scores. The HBI consists of 5 items encompassing patient-reported (well-being, symptoms)and objective (presence of abdominal mass or complications) variables. Symptom scores are based on symptom status on the previous day rather than the total of 7 days as for the CDAI. The total HBI score is the sum of the values for each of the five items. Higher HBI scores indicate greater disease activity; 0 would the lower limit with no set upper limit. Scores \< 5 indicate remission, 5 - 7 indicate mild disease, 8 - 16 indicate moderate disease, and 16 indicate severe disease. Each HBI unit is equivalent to approximately 27 CDAI units. Higher scores indicate greater disease activity.

Outcome measures

Outcome measures
Measure	Participants With Crohn's Disease (CD) n=1621 Participants Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 12	4.1 units on a scale Standard Deviation 4.2
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 42	3.9 units on a scale Standard Deviation 3.9
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 0	9.3 units on a scale Standard Deviation 4.6
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 3	4.8 units on a scale Standard Deviation 4.5
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 6	4.5 units on a scale Standard Deviation 4.6
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 9	4.2 units on a scale Standard Deviation 4.2
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 18	3.9 units on a scale Standard Deviation 4.1
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 24	4.1 units on a scale Standard Deviation 4.7
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 30	3.5 units on a scale Standard Deviation 3.9
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 36	3.6 units on a scale Standard Deviation 4.0
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 48	3.4 units on a scale Standard Deviation 3.5
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 54	3.3 units on a scale Standard Deviation 3.6
4.Mean Harvey Bradshaw Index (HBI) in Full Analysis Set (FAS) Participants Over Time Month 60	4.0 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 and 60

Population: Compliance data were not collected.

Adalimumab will be self-administered by participants using Humira®-PEN. Analysis of compliance was not performed as outlined in the protocol.

Outcome measures

Outcome data not reported

Adverse Events

Participants With Crohn's Disease (CD)

Serious events: 548 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants With Crohn's Disease (CD) n=4107 participants at risk Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
Endocrine disorders SECONDARY ADRENOCORTICAL INSUFFICIENCY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Eye disorders GLAUCOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Eye disorders ULCERATIVE KERATITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Eye disorders UVEITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Blood and lymphatic system disorders ANAEMIA	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Blood and lymphatic system disorders IRON DEFICIENCY ANAEMIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Cardiac disorders CARDIAC ARREST	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Cardiac disorders CARDIOVASCULAR DISORDER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Cardiac disorders MYOCARDIAL INFARCTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Cardiac disorders PERICARDIAL EFFUSION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Cardiac disorders TACHYCARDIA	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Congenital, familial and genetic disorders PYLORIC STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Ear and labyrinth disorders INNER EAR DISORDER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Ear and labyrinth disorders SUDDEN HEARING LOSS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Ear and labyrinth disorders TYMPANIC MEMBRANE PERFORATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ABDOMINAL ADHESIONS	0.12% 5/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ABDOMINAL MASS	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ABDOMINAL PAIN	0.41% 17/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.24% 10/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ANAL FISSURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ANAL FISTULA	0.54% 22/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ANAL SKIN TAGS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ANAL STENOSIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders BARRETT'S OESOPHAGUS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders CHRONIC GASTRITIS	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders COLONIC FISTULA	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders CONSTIPATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders CROHN'S DISEASE	1.4% 57/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders DIARRHOEA	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders DIARRHOEA HAEMORRHAGIC	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders DUODENAL PERFORATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders DUODENAL STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ENTEROCOLONIC FISTULA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ENTEROCUTANEOUS FISTULA	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ENTEROVESICAL FISTULA	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders EPIGASTRIC DISCOMFORT	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders FLATULENCE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTRIC STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTRIC ULCER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTRITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTROINTESTINAL FISTULA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTROINTESTINAL INFLAMMATION	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTROINTESTINAL WALL THICKENING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders GINGIVAL BLEEDING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ILEAL STENOSIS	0.61% 25/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ILEUS	0.39% 16/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders ILEUS PARALYTIC	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INGUINAL HERNIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL DILATATION	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL FISTULA	0.24% 10/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL HAEMATOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL MASS	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL PERFORATION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL SCARRING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders INTESTINAL STENOSIS	0.83% 34/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders JEJUNAL STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders LARGE INTESTINAL STENOSIS	0.37% 15/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders LOCALISED INTRAABDOMINAL FLUID COLLECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders MECHANICAL ILEUS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders NAUSEA	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders OBSTRUCTION GASTRIC	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders OESOPHAGEAL OBSTRUCTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders PAINFUL DEFAECATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders PANCREATITIS ACUTE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders RECTAL STENOSIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders SMALL INTESTINAL HAEMORRHAGE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders SMALL INTESTINAL STENOSIS	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders STOMATITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders SUBILEUS	0.41% 17/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders VARICES OESOPHAGEAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders VOLVULUS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Gastrointestinal disorders VOMITING	0.22% 9/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders ADVERSE EVENT	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders CHEST PAIN	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders CHILLS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders EMBOLIA CUTIS MEDICAMENTOSA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders FATIGUE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders FEELING HOT	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders IMPAIRED HEALING	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders INFLAMMATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders INJECTION SITE HYPERSENSITIVITY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders OEDEMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders OEDEMA PERIPHERAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders PAIN	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
General disorders PYREXIA	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders CHOLANGITIS SCLEROSING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders CHOLECYSTITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders CHOLECYSTITIS CHRONIC	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders CHOLELITHIASIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders GALLBLADDER PERFORATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders GALLBLADDER POLYP	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders HEPATIC STEATOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders HEPATITIS CHOLESTATIC	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Hepatobiliary disorders HYDROCHOLECYSTIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Immune system disorders ALLERGY TO ANIMAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Immune system disorders ANAPHYLACTIC REACTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Immune system disorders ANAPHYLACTIC SHOCK	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Immune system disorders HYPERSENSITIVITY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Immune system disorders SERUM SICKNESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ABDOMINAL ABSCESS	0.12% 5/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ABDOMINAL WALL ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ABSCESS	0.46% 19/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ABSCESS INTESTINAL	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ABSCESS JAW	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ANAL ABSCESS	0.58% 24/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ANGULAR CHEILITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations APPENDICITIS PERFORATED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ARTHRITIS BACTERIAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations BARTHOLIN'S ABSCESS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations BREAST ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations CELLULITIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations CENTRAL NERVOUS SYSTEM VIRAL INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations CHRONIC SINUSITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations CONJUNCTIVITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations CYTOMEGALOVIRUS COLITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations DEVICE RELATED INFECTION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations DIARRHOEA INFECTIOUS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations DISSEMINATED TUBERCULOSIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ECZEMA INFECTED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ERYSIPELAS	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ESCHERICHIA SEPSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations FOLLICULITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations FUNGAL INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations GASTROENTERITIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations GASTROENTERITIS VIRAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations GASTROINTESTINAL INFECTION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations GONORRHOEA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations GROIN ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations HAEMATOMA INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations HELICOBACTER GASTRITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations HERPES VIRUS INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations HERPES ZOSTER	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations INFECTED FISTULA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations INFECTION	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations INJECTION SITE ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations LOCALISED INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations LUNG INFECTION	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations MENINGOCOCCAL SEPSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations NASOPHARYNGITIS	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations OESOPHAGEAL CANDIDIASIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations OPPORTUNISTIC INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations ORAL CANDIDIASIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations OTITIS MEDIA ACUTE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PARONYCHIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PERIRECTAL ABSCESS	0.34% 14/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PERITONEAL ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PERITONITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PERITONITIS BACTERIAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PERIUMBILICAL ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PILONIDAL CYST	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PNEUMONIA	0.12% 5/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PULMONARY TUBERCULOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations PYELONEPHRITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations RECTAL ABSCESS	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations RENAL ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations RESPIRATORY TRACT INFECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations SEPSIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations SUBCUTANEOUS ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations TONSILLITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations TONSILLITIS STREPTOCOCCAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations TUBERCULOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations TUBO-OVARIAN ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations URINARY TRACT INFECTION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations UROSEPSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations VARICELLA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Infections and infestations VULVAL ABSCESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications ABDOMINAL INJURY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications ACCIDENT AT WORK	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications ANASTOMOTIC LEAK	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications ANASTOMOTIC STENOSIS	0.12% 5/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications CONCUSSION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications CONTUSION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications CRANIOCEREBRAL INJURY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications FALL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications FOOT FRACTURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications INTESTINAL ANASTOMOSIS COMPLICATION	0.24% 10/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications LUMBAR VERTEBRAL FRACTURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications PROCEDURAL COMPLICATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications PROCEDURAL INTESTINAL PERFORATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications RIB FRACTURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications SPLENIC RUPTURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications STOMA COMPLICATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Injury, poisoning and procedural complications STOMAL HERNIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations C-REACTIVE PROTEIN INCREASED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations COLONOSCOPY	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations DIAGNOSTIC PROCEDURE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations EMERGENCY CARE EXAMINATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations ENDOSCOPY SMALL INTESTINE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations ENDOSCOPY UPPER GASTROINTESTINAL TRACT	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations ENTEROCLYSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations HAEMOGLOBIN DECREASED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations HEPATIC ENZYME INCREASED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations LAPAROSCOPY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations NUCLEAR MAGNETIC RESONANCE IMAGING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations OESOPHAGOGASTRODUODENOSCOPY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations RENAL FUNCTION TEST ABNORMAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations TRANSAMINASES INCREASED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Investigations WEIGHT DECREASED	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders CACHEXIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders DECREASED APPETITE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders DIABETES MELLITUS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders HYPERLIPIDAEMIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders MALNUTRITION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Metabolism and nutrition disorders OBESITY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.12% 5/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders ARTHRITIS ENTEROPATHIC	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders ARTHROPATHY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders BACK PAIN	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders ENTHESOPATHY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders FISTULA	0.24% 10/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders JOINT SWELLING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders LUPUS-LIKE SYNDROME	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders MUSCLE TWITCHING	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders MYALGIA	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders MYOPATHY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders PERIOSTITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders SACROILIITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders SPONDYLITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Musculoskeletal and connective tissue disorders SYSTEMIC LUPUS ERYTHEMATOSUS	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANAPLASTIC ASTROCYTOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ANOGENITAL WARTS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-CELL LYMPHOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST NEOPLASM	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BURKITT'S LYMPHOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL ADENOCARCINOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICULAR DENDRITIC CELL SARCOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) GASTROINTESTINAL STROMAL TUMOUR	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE STAGE II	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTESTINAL ADENOCARCINOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL CARCINOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL NEOPLASM	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PHAEOCHROMOCYTOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PHARYNGEAL CANCER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL CANCER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CELL CARCINOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SEMINOMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL INTESTINE CARCINOMA METASTATIC	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders AUTONOMIC NERVOUS SYSTEM IMBALANCE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders BASAL GANGLIA INFARCTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders BRAIN OEDEMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders CAROTID ARTERY STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders CENTRAL NERVOUS SYSTEM INFLAMMATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders DYSAESTHESIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders EPILEPSY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders HEADACHE	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders HEMIPARESIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders HYPOAESTHESIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders INTRACRANIAL VENOUS SINUS THROMBOSIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders MULTIPLE SCLEROSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders SIMPLE PARTIAL SEIZURES	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders SYNCOPE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Pregnancy, puerperium and perinatal conditions ABORTION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Pregnancy, puerperium and perinatal conditions ABORTION EARLY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Pregnancy, puerperium and perinatal conditions ABORTION SPONTANEOUS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Pregnancy, puerperium and perinatal conditions DELIVERY	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Pregnancy, puerperium and perinatal conditions PREGNANCY	0.19% 8/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Product Issues DEVICE OCCLUSION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Psychiatric disorders BIPOLAR DISORDER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Psychiatric disorders DEPRESSION	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Psychiatric disorders SUICIDE ATTEMPT	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders ACUTE PRERENAL FAILURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders BLADDER NECK OBSTRUCTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders CALCULUS BLADDER	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders NEPHROLITHIASIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders RENAL COLIC	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders RENAL FAILURE	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders URETERIC STENOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders URETEROLITHIASIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders URINARY RETENTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders UROGENITAL FISTULA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Renal and urinary disorders VESICAL FISTULA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Reproductive system and breast disorders BREAST PAIN	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Reproductive system and breast disorders CERVICAL DYSPLASIA	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Reproductive system and breast disorders FEMALE GENITAL TRACT FISTULA	0.24% 10/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Reproductive system and breast disorders VAGINAL FISTULA	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Respiratory, thoracic and mediastinal disorders COUGH	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Respiratory, thoracic and mediastinal disorders LUNG INFILTRATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Respiratory, thoracic and mediastinal disorders NASAL SEPTUM DEVIATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Respiratory, thoracic and mediastinal disorders NASAL TURBINATE HYPERTROPHY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders DERMAL CYST	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders DERMATITIS PSORIASIFORM	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders ECZEMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders ERYTHEMA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders ERYTHEMA NODOSUM	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders HIDRADENITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders NEURODERMATITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders PSORIASIS	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders PUSTULAR PSORIASIS	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders RASH	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders RASH GENERALISED	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders ROSACEA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders SKIN FISSURES	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Skin and subcutaneous tissue disorders URTICARIA	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Social circumstances INADEQUATE DIET	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ABSCESS DRAINAGE	0.46% 19/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ADHESIOLYSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ANAL FISTULA EXCISION	0.15% 6/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ANOPLASTY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ANORECTAL OPERATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures APPENDICECTOMY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures BLADDER CATHETERISATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures BREAST CONSERVING SURGERY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures CAESAREAN SECTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures CANCER SURGERY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures CHOLECYSTECTOMY	0.10% 4/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures COLECTOMY	0.19% 8/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures COLECTOMY TOTAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures COLORECTOSTOMY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures COLOSTOMY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures DEBRIDEMENT	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ENTEROSTOMY	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures FISTULA REPAIR	0.34% 14/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures GALLBLADDER OPERATION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures GASTROINTESTINAL DILATION PROCEDURE	0.32% 13/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures HOSPITALISATION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ILEECTOMY	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ILEOCOLOSTOMY	0.22% 9/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures ILEOSTOMY	0.22% 9/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures INGUINAL HERNIA REPAIR	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures INTESTINAL ANASTOMOSIS	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures INTESTINAL FISTULA REPAIR	0.12% 5/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures INTESTINAL OPERATION	0.39% 16/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures INTESTINAL RESECTION	1.2% 50/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures JEJUNECTOMY	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures JEJUNOSTOMY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures LIPOMA EXCISION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures MAMMOPLASTY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures MASS EXCISION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures NASAL SEPTAL OPERATION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures OVARIAN CYSTECTOMY	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures PROCTECTOMY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures PROCTOCOLECTOMY	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures PYLORUS DILATION PROCEDURE	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures RECTAL FISTULA REPAIR	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures RESUSCITATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures SHOULDER OPERATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures SIGMOIDECTOMY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures SKIN NEOPLASM EXCISION	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures SMALL INTESTINAL RESECTION	0.17% 7/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures STRICTUROPLASTY	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures SURGERY	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures THYROID ADENOMA REMOVAL	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures TOOTH EXTRACTION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures TRANSFUSION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures TUMOUR EXCISION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures TYMPANOPLASTY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures URETERIC OPERATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures URINARY TRACT OPERATION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures VAGINOPLASTY	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Surgical and medical procedures WOUND TREATMENT	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Vascular disorders CIRCULATORY COLLAPSE	0.07% 3/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Vascular disorders DEEP VEIN THROMBOSIS	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Vascular disorders HYPERTENSION	0.05% 2/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Vascular disorders HYPOTENSION	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Vascular disorders THROMBOPHLEBITIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.
Vascular disorders THROMBOSIS	0.02% 1/4107 • Adverse events were collected from start of study (month 0) through month 60 following the start of treatment with adalimumab. Analysis included safety analysis population i.e., all participants who received at least 1 dose of adalimumab with evaluable safety data.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Information

AbbVie

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER