Trial Outcomes & Findings for Post-marketing Observational Study in Subjects With Rheumatoid Arthritis (NCT NCT00234884)

NCT ID: NCT00234884

Last Updated: 2011-09-30

Results Overview

DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.

• Recruitment status: COMPLETED
• Target enrollment: 3435 participants
• Primary outcome timeframe: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
• Results posted on: 2011-09-30

Participant Flow

Participant milestones

Measure	Adalimumab Participants were treated with commercially available adalimumab in normal clinical practice.
Overall Study STARTED	3435
Overall Study COMPLETED	1805
Overall Study NOT COMPLETED	1630

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Adalimumab n=3435 Participants Participants were treated with commercially available adalimumab in normal clinical practice.
Age Continuous	54.5 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	2724 Participants n=5 Participants
Sex: Female, Male Male	711 Participants n=5 Participants
Region of Enrollment Portugal	55 participants n=5 Participants
Region of Enrollment France	689 participants n=5 Participants
Region of Enrollment Greece	232 participants n=5 Participants
Region of Enrollment Spain	476 participants n=5 Participants
Region of Enrollment Belgium	318 participants n=5 Participants
Region of Enrollment Australia	20 participants n=5 Participants
Region of Enrollment Austria	95 participants n=5 Participants
Region of Enrollment Netherlands	248 participants n=5 Participants
Region of Enrollment Germany	561 participants n=5 Participants
Region of Enrollment United Kingdom	69 participants n=5 Participants
Region of Enrollment Italy	672 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Population: Results are presented as observed. The number of participants evaluated is indicated for each time point below.

DAS28 is a composite measure of disease activity in patients with rheumatoid arthritis. It is calculated on the basis of tender and swollen joint counts (each assessed in 28 joints), the patient's ESR, and the patient's subjective assessment of disease activity (assessed using a 100-mm visual analog scale). A DAS28 less than 3.2 indicates low disease activity and a DAS28 greater than 5.1 indicates high disease activity; there is no absolute range of scores due to inter-patient variability in ESR.

Outcome measures

Measure	Adalimumab n=3435 Participants Participants were treated with commercially available adalimumab in normal clinical practice.
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Baseline of NCT00448383 (Study M02-497) (N = 3407)	6.0 units on a scale Standard Deviation 1.1
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Baseline of NCT00234884 (Study M03-634) (N = 2746)	3.3 units on a scale Standard Deviation 1.3
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Month 12 (N = 2430)	3.1 units on a scale Standard Deviation 1.3
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Month 24 (N = 2033)	3.0 units on a scale Standard Deviation 1.3
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Month 36 (N = 1746)	3.0 units on a scale Standard Deviation 1.2
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Month 48 (N = 1518)	2.9 units on a scale Standard Deviation 1.2
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Month 60 (N = 1255)	2.8 units on a scale Standard Deviation 1.2
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) Last Observed Value (N = 3281)	3.3 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Population: Results are presented as observed. The number of participants evaluated is indicated for each time point below.

ACR20 response is a 20% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

Outcome measures

Measure	Adalimumab n=3435 Participants Participants were treated with commercially available adalimumab in normal clinical practice.
American College of Rheumatology 20% (ACR20) Response Rate Baseline of NCT00234884 (Study M03-634) (N = 2886)	80.3 percentage of participants
American College of Rheumatology 20% (ACR20) Response Rate Month 12 (N = 2508)	82.9 percentage of participants
American College of Rheumatology 20% (ACR20) Response Rate Month 24 (N = 2116)	84.5 percentage of participants
American College of Rheumatology 20% (ACR20) Response Rate Month 36 (N = 1811)	84.8 percentage of participants
American College of Rheumatology 20% (ACR20) Response Rate Month 48 (N = 1572)	85.8 percentage of participants
American College of Rheumatology 20% (ACR20) Response Rate Month 60 (N = 1309)	87.9 percentage of participants
American College of Rheumatology 20% (ACR20) Response Rate Last Observed Value (N = 3236)	75.8 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Population: Results are presented as observed. The number of participants evaluated is indicated for each time point below.

ACR50 response is a 50% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

Outcome measures

Measure	Adalimumab n=3435 Participants Participants were treated with commercially available adalimumab in normal clinical practice.
American College of Rheumatology 50% (ACR50) Response Rate Baseline of NCT00234884 (Study M03-634) (N = 2873)	58.8 percentage of participants
American College of Rheumatology 50% (ACR50) Response Rate Month 12 (N = 2509)	62.9 percentage of participants
American College of Rheumatology 50% (ACR50) Response Rate Month 24 (N = 2109)	66.6 percentage of participants
American College of Rheumatology 50% (ACR50) Response Rate Month 36 (N = 1797)	66.2 percentage of participants
American College of Rheumatology 50% (ACR50) Response Rate Month 48 (N = 1564)	68.3 percentage of participants
American College of Rheumatology 50% (ACR50) Response Rate Month 60 (N = 1293)	70.1 percentage of participants
American College of Rheumatology 50% (ACR50) Response Rate Last Observed Value (N = 3238)	55.8 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Population: Results are presented as observed. The number of participants evaluated is indicated for each time point below.

ACR70 response is a 70% or better improvement from Baseline in tender joint count, swollen joint count, and at least 3 of the following 5 parameters: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and C-reactive protein. Response was calculated based on values at Baseline of NCT00448383 (Study M02-497).

Outcome measures

Measure	Adalimumab n=3435 Participants Participants were treated with commercially available adalimumab in normal clinical practice.
American College of Rheumatology 70% (ACR70) Response Rate Baseline of NCT00234884 (Study M03-634) (N = 2889)	34.9 participants
American College of Rheumatology 70% (ACR70) Response Rate Month 12 (N = 2497)	40.2 participants
American College of Rheumatology 70% (ACR70) Response Rate Month 24 (N = 2106)	42.9 participants
American College of Rheumatology 70% (ACR70) Response Rate Month 36 (N = 1786)	44.1 participants
American College of Rheumatology 70% (ACR70) Response Rate Month 48 (N = 1554)	47.0 participants
American College of Rheumatology 70% (ACR70) Response Rate Month 60 (N = 1297)	47.5 participants
American College of Rheumatology 70% (ACR70) Response Rate Last Observed Value (N = 3240)	37.0 participants

PRIMARY outcome

Timeframe: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Population: Results are presented as observed. The number of participants evaluated is indicated for each time point below.

HAQ-DI is a composite measure of physical function calculated on the basis of 20 questions in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities), each evaluated on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI score is the sum of worst scores in each domain divided by the number of domains answered, and ranges from 0 (no difficulty) to 3 (unable to do). A mean change of -0.22 is considered the minimum clinically important change. Mean change in HAQ-DI was calculated from Baseline of NCT00448383 (Study M02-497).

Outcome measures

Measure	Adalimumab n=3435 Participants Participants were treated with commercially available adalimumab in normal clinical practice.
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Baseline of NCT00234884 (Study M03-634) (N = 2976)	-0.70 units on a scale Standard Deviation 0.65
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Month 12 (N = 2590)	-0.72 units on a scale Standard Deviation 0.66
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Month 24 (N = 2177)	-0.74 units on a scale Standard Deviation 0.68
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Month 36 (N = 1863)	-0.75 units on a scale Standard Deviation 0.68
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Month 48 (N = 1622)	-0.76 units on a scale Standard Deviation 0.70
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Month 60 (N = 1348)	-0.74 units on a scale Standard Deviation 0.69
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) Last Observed value (N = 3322)	-0.65 units on a scale Standard Deviation 0.73

Adverse Events

Adalimumab

Serious events: 755 serious events

Other events: 562 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=3435 participants at risk Participants were treated with commercially available adalimumab in normal clinical practice.
Infections and infestations Cystitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Cytomegalovirus infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Device related infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Diverticulitis	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Endocarditis staphylococcal	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Enterocolitis infectious	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Epstein-Barr virus infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Extrapulmonary tuberculosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Gangrene	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Gastroenteritis	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Gastroenteritis viral	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations H1N1 influenza	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Haematoma infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Helicobacter gastritis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Hepatic echinococciasis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Herpes zoster	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Histoplasmosis	0.03% 1/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Infected skin ulcer	0.03% 1/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Influenza	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Joint tuberculosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Leishmaniasis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Listeria sepsis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Lobar pneumonia	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Localised infection	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Lower respiratory tract infection	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Lung abscess	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Lung infections	0.26% 9/3435 • Number of events 10 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Lyme disease	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Lymphadenitis bacterial	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Meningitis meningococcal	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Mucocutaneous leishmaniasis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Mycobacterium avium complex infection	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Mycobacterium fortuitum infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Necrotising fasciitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Agranulocytosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Anaemia	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Hypereosinophilic syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Iron deficiency anaemia	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Leukopenia	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Lymphoadenopathy	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Microcytic anaemia	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Neutropenia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Pancytopenia	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Splenic haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Blood and lymphatic system disorders Thrombocytopenia	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Acute left ventricular failure	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Acute myocardial infarction	0.23% 8/3435 • Number of events 8 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Angina pectoris	0.35% 12/3435 • Number of events 12 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Angina unstable	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Aortic valve incompetence	0.03% 1/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Aortic valve stenosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Arrhythmia	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Atrial fibrillation	0.49% 17/3435 • Number of events 20 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Atrial flutter	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Atrioventricular block	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Atrioventricular block complete	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Cardiac arrest	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Cardiac failure	0.26% 9/3435 • Number of events 11 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Cardiac failure acute	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Cardiac failure congestive	0.26% 9/3435 • Number of events 11 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Cardio-respiratory arrest	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Coronary artery disease	0.29% 10/3435 • Number of events 10 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Coronary artery stenosis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Hypertensive heart disease	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Ischaemic cardiomyopathy	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Left ventricular dysfunction	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Left ventricular failure	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Mitral valve incompetence	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Myocardial infarction	0.73% 25/3435 • Number of events 25 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Myocardial ischaemia	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Pericardial effusion	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Stress cardiomyopathy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Cardiac disorders Tachycardia paroxysmal	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Congenital, familial and genetic disorders Branchial cyst	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia haemorrhagic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Congenital, familial and genetic disorders Odontogenic cyst	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Congenital, familial and genetic disorders Polydactyly	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Ear and labyrinth disorders Deafness neurosensory	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Ear and labyrinth disorders Hearing impaired	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Ear and labyrinth disorders Sudden hearing loss	0.03% 1/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Ear and labyrinth disorders Vertigo	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Endocrine disorders Cushing's syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Endocrine disorders Goitre	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Endocrine disorders Hyperparathyroidism	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Endocrine disorders Toxic nodular goitre	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Eye disorders Cataract	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Eye disorders Entropion	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Eye disorders Macular degeneration	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Eye disorders Optic ischaemic neuropathy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Eye disorders Retinal degeneration	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Eye disorders Retinal detachment	0.03% 1/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Abdominal discomfort	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Abdominal pain	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Abdominal pain upper	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Abdominal tenderness	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Anal fistula	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Anorectal stenosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Caecitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Colitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Colitis collagenous	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Colonic obstruction	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Constipation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Crohn's disease	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Diarrhoea	0.23% 8/3435 • Number of events 8 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Diverticular perforation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Diverticulum	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Duodenal fistula	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Duodenal ulcer	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Duodenitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Femoral hernia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Gastric haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Gastric ulcer	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Gastritis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Haemorrhoids	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Inguinal hernia	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Intestinal infarction	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Intestinal obstruction	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Intestinal perforation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Large intestine perforation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Pancreatitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Pancreatitis acute	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Peritonitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Polyp colorectal	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Rectal haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Rectal prolapse	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Reflux oesophagitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Retroperitoneal haematoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Umbilical hernia	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Vasculitis gastrointestinal	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Gastrointestinal disorders Vomiting	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Chest pain	0.23% 8/3435 • Number of events 8 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Death	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Device dislocation	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Device occlusion	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Impaired healing	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Multi-organ failure	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Pyrexia	0.26% 9/3435 • Number of events 9 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Soft tissue inflammation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
General disorders Sudden death	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Autoimmune hepatitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Biliary cirrhosis primary	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Cholecystitis	0.20% 7/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Cholecystitis acute	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Cholelithiasis	0.52% 18/3435 • Number of events 20 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Hepatic failure	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Hepatobiliary disorders Hepatotoxicity	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Immune system disorders Amyloidosis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Immune system disorders Drug hypersensitivity	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Immune system disorders Hypersensitivity	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Immune system disorders Sarcoidosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Immune system disorders Secondary amyloidosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Abdominal abscess	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Abdominal wall abscess	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Abscess	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Abscess neck	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Anal abscess	0.06% 2/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Appendicitis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Arthritis bacterial	0.32% 11/3435 • Number of events 12 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Atypical mycobacterial infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Bacteraemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Bacterial pyelonephritis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Bronchitis	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Bronchopneumonia	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Bursitis infective	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Cellulitis	0.20% 7/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Chronic sinusitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Oseophageal candidiasis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Orchitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Osteomyelitis	0.09% 3/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Parainfluenzae virus infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Peritoneal infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Peritoneal tuberculosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Peritonsillar abscess	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pharyngitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pleurisy viral	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pneumococcal sepsis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pneumonia	1.2% 42/3435 • Number of events 44 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pneumonia legionella	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pneumonia primary atypical	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Postoperative wound infection	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pseudomembranous colitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pulmonary tuberculosis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pyelonephritis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pyelonephritis acute	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Pyothorax	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Respiratory tract infection	0.20% 7/3435 • Number of events 8 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Salmonellosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Sepsis	0.29% 10/3435 • Number of events 10 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Septic arthritis staphylococcal	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Septic shock	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Sinusitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Skin infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Staphylococcal bacteraemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Staphylococcal osteomyelitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Staphylococcal sepsis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Subcutaneous abscess	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Tonsillitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Tooth infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Tracheobronchitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Tuberculosis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Upper respiratory tract infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Urinary tract infection	0.32% 11/3435 • Number of events 11 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Urosepsis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Vaginal abscess	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Varicella	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Viral infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Viral pericarditis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Viral upper respiratory tract infection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Visceral leishmaniasis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Wound infection	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Disseminated tuberculosis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Erysipelas	0.38% 13/3435 • Number of events 15 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Escherichia sepsis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Anaemia postoperative	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Ankle fracture	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Arterial injury	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Concussion	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Decompression sickness	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Diffuse axonal injury	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Fall	0.26% 9/3435 • Number of events 9 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Femoral neck fracture	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Femur fracture	0.20% 7/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Fibula fracture	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Foot fracture	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Foreign body	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Fractured ischium	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Fractured sacrum	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Graft thrombosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Heat stroke	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Hip fracture	0.26% 9/3435 • Number of events 9 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Humerus fracture	0.17% 6/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Joint dislocation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Ligament injury	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Ligament rupture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Limb injury	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Meniscus lesion	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Multiple fractures	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Overdose	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Patella fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Pelvic fracture	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Periprosthetic fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Procedural pain	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Pubis fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Radius fracture	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Rib fracture	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Road traffic accident	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Seroma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Spinal fracture	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Splenic injury	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Splenic rupture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Sternal fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Tendon rupture	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Tibia fracture	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Traumatic brain injury	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Traumatic haematoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Ulna fracture	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Upper limb fracture	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Wound	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Injury, poisoning and procedural complications Wrist fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Antiphospholipid antibodies	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Blood alkaline phosphatase increased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Blood amylase increased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Blood creatine phosphokinase increased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations C-reactive protein increased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Gamma-glutamyltransferase increased	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Mycobacterium test positive	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Platelet count decreased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Red blood cell sedimentation rate increased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Investigations Weight decreased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Central obesity	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Decreased appetite	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Dehydration	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Diabetes mellitus	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Gout	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Hypercalcaemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Hypoglycaemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Hypoglycaemic seizure	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Ketoacidosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Metabolism and nutrition disorders Obesity	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Arthralgia	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Arthritis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Atlantoaxial instability	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Back pain	0.06% 2/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Bone formation decreased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Felty's syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Fistula	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Foot deformity	0.23% 8/3435 • Number of events 8 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Joint destruction	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Joint effusion	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Osteitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.52% 18/3435 • Number of events 19 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Pathological fracture	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Periostitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Pseudarthritis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.20% 7/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.09% 3/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage I	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	50.0% 1/2 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder papilloma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.44% 15/3435 • Number of events 15 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebellopontine angle tumour	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage II	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Conjunctival melanoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Desmoid tumour	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glomus jugulare tumour	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease stage II	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease stage III	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian granulosa-theca cell tumour	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Primary mediastinal large B-cell lymphoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage 0	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.29% 10/3435 • Number of events 10 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Amnestic disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Amyotrophic lateral sclerosis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Carotid artery stenosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Carpal tunnel syndrome	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebellar atrophy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebral arteriosclerosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebral haematoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebral haemorrhage	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebral infarction	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebral ischaemia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebral venous thrombosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cerebrovascular accident	0.32% 11/3435 • Number of events 11 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cervical myelopathy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Cervicobrachial syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Coma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Dementia Alzheimer's type	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Dizziness	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Dysaesthesia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Encephalitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Epilepsy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Facial palsy	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Haemorrhagic stroke	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Headache	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Hypoglycaemic coma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Hypoxic encephalopathy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Ischaemic stroke	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Loss off consciousness	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Mononeuropathy multiplex	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Optic neuritis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Parkinson's disease	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Partial seizures	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Sciatica	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Speech disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Transient global amnesia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Transient ischaemic attack	0.17% 6/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Vascular dementia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Nervous system disorders Vascular encephalopathy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Pregnancy, puerperium and perinatal conditions Intra-uterine death	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Pregnancy, puerperium and perinatal conditions Placenta previa	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Psychiatric disorders Abnormal behaviour	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Psychiatric disorders Anxiety	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Psychiatric disorders Depression	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Psychiatric disorders Disorientation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Psychiatric disorders Suicide attempt	0.12% 4/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Calculus bladder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Calculus ureteric	0.15% 5/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Calculus urinary	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Glomerulonephritis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Hydronephrosis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Nephrolithiasis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Nephrotic syndrome	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Renal artery stenosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Renal colic	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Renal failure	0.20% 7/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Renal failure acute	0.20% 7/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Ureteric rupture	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Renal and urinary disorders Ureteric stenosis	0.03% 1/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Adnexa uteri cyst	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Breast cyst	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Breast enlargement	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Cervical dysplasia	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Cystocele	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Genital prolapse	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Ovarian cyst	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Pelvic fluid collection	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Prostatic disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Prostatitis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Rectocele	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Uterine polyp	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Reproductive system and breast disorders Uterine prolapse	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Anoxia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Asthma	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.17% 6/3435 • Number of events 7 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Cough	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Diaphragmatic hernia	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Nasal tubinate hypertrophy	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.32% 11/3435 • Number of events 11 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.26% 9/3435 • Number of events 10 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.09% 3/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Restrictive pulmonary disease	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Sinus polyp	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Acne	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Alopecia effluvium	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Eczema	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Erythema multiforme	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Hidradenitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Leukocytoclastic vasculitis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Psoriasis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Scar	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Skin necrosis	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Skin ulcer	0.15% 5/3435 • Number of events 6 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Skin and subcutaneous tissue disorders Urticaria	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Surgical and medical procedures Abortion induced	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Surgical and medical procedures Blepharoplasty	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Surgical and medical procedures Removal of internal fixation	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Aortic aneurysm	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Aortic stenosis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Arterial haemorrhage	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Arterial thrombosis limb	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Arteritis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Deep vein thrombosis	0.15% 5/3435 • Number of events 5 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Haematoma	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Haemodynamic instability	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Hypertension	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Hypertensive crisis	0.09% 3/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Hypotension	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Hypovolaemic shock	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Lymphoedema	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Peripheral arterial occlusive disease	0.09% 3/3435 • Number of events 3 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Phlebitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Raynaud's phenomenon	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Shock haemorrhagic	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Subclavian vein thrombosis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Thrombophlebitis	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Thrombosis	0.12% 4/3435 • Number of events 4 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Varicose vein	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Vasculitis	0.06% 2/3435 • Number of events 2 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Venous insufficiency	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Vascular disorders Venous thrombosis limb	0.03% 1/3435 • Number of events 1 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.

Other adverse events

Measure	Adalimumab n=3435 participants at risk Participants were treated with commercially available adalimumab in normal clinical practice.
Infections and infestations Bronchitis	7.1% 244/3435 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Nasopharyngitis	5.5% 189/3435 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.
Infections and infestations Urinary tract infection	5.7% 195/3435 • Adverse events were collected for up to 5 years. For participants who discontinued the study early, investigators were asked to record adverse events up to 3 months after last dose of adalimumab.

Additional Information

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