Trial Outcomes & Findings for Long Term Open Label Continuation Study (NCT NCT00195650)

NCT ID: NCT00195650

Last Updated: 2012-08-31

Results Overview

ACR20 response criteria were: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 846 participants
• Primary outcome timeframe: Week 520
• Results posted on: 2012-08-31

Participant Flow

Participant milestones

Measure	Adalimumab Open-label adalimumab 40 mg
Overall Study STARTED	846
Overall Study COMPLETED	321
Overall Study NOT COMPLETED	525

Reasons for withdrawal

Measure	Adalimumab Open-label adalimumab 40 mg
Overall Study Adverse Event	194
Overall Study Lack of Efficacy	99
Overall Study Withdrawal by Subject	67
Overall Study Lost to Follow-up	44
Overall Study Death	23
Overall Study Protocol Violation	15
Overall Study Administrative reasons	83

Baseline Characteristics

Long Term Open Label Continuation Study

Baseline characteristics by cohort

Measure	Adalimumab n=846 Participants Open-label adalimumab 40 mg
Age Continuous	55.6 years STANDARD_DEVIATION 12.19 • n=93 Participants
Sex: Female, Male Female	661 Participants n=93 Participants
Sex: Female, Male Male	185 Participants n=93 Participants

PRIMARY outcome

Timeframe: Week 520

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

Outcome measures

Measure	Adalimumab n=238 Participants Open-label adalimumab 40 mg
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 520	187 participants

PRIMARY outcome

Timeframe: Week 260

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

ACR20 response criteria were: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

Outcome measures

Measure	Adalimumab n=516 Participants Open-label adalimumab 40 mg
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260	402 participants

PRIMARY outcome

Timeframe: Week 520

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

Outcome measures

Measure	Adalimumab n=238 Participants Open-label adalimumab 40 mg
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 520	132 participants

PRIMARY outcome

Timeframe: Week 260

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

ACR50 response criteria were: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

Outcome measures

Measure	Adalimumab n=516 Participants Open-label adalimumab 40 mg
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260	279 participants

PRIMARY outcome

Timeframe: Week 520

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

Outcome measures

Measure	Adalimumab n=238 Participants Open-label adalimumab 40 mg
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 520	78 participants

PRIMARY outcome

Timeframe: Week 260

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

ACR70 response criteria were: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.

Outcome measures

Measure	Adalimumab n=516 Participants Open-label adalimumab 40 mg
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 260	179 participants

PRIMARY outcome

Timeframe: Week 520

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).

Outcome measures

Measure	Adalimumab n=236 Participants Open-label adalimumab 40 mg
Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 520	135 participants

PRIMARY outcome

Timeframe: Week 260

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 260 visit. Analysis used observed data (no imputation).

Clinical remission on modified Disease Activity Score (DAS28) was a value <2.6; >=2.6 to <=3.2 indicated low disease activity; >3.2 to <=5.1 indicated moderate disease activity; and >5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).

Outcome measures

Measure	Adalimumab n=513 Participants Open-label adalimumab 40 mg
Number of Participants in Clinical Remission (Based on Modified Disease Activity Score) at Week 260	243 participants

PRIMARY outcome

Timeframe: Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 520

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set) and had a Week 520 visit. Analysis used observed data (no imputation).

The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.

Outcome measures

Measure	Adalimumab n=238 Participants Open-label adalimumab 40 mg
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520	-0.52 units on a scale Standard Deviation 0.662

PRIMARY outcome

Timeframe: Baseline of prior Phase 1, 2, or 3 adalimumab study and Week 260

Population: All participants who received at least 1 dose of open-label adalimumab (Full Analysis Set) in the continuation study and had a Week 260 visit. Analysis used observed data (no imputation).

The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.

Outcome measures

Measure	Adalimumab n=515 Participants Open-label adalimumab 40 mg
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260	-0.59 units on a scale Standard Deviation 0.628

SECONDARY outcome

Timeframe: Duration of study (up to 520 weeks [10 years])

Population: All participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set).

Adverse events were collected during the course of the study (after the first adalimumab injection in this continuation study DE020 through 70 days after the last adalimumab injection) for all participants who received at least 1 dose of open-label adalimumab in the continuation study (Full Analysis Set). The number of participants experiencing any adverse event (serious and non-serious) are summarized. See the Reported Adverse Events section for details.

Outcome measures

Measure	Adalimumab n=846 Participants Open-label adalimumab 40 mg
Reported Adverse Events	808 participants

Adverse Events

Adalimumab

Serious events: 432 serious events

Other events: 768 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adalimumab n=846 participants at risk Open-label adalimumab 40 mg
Gastrointestinal disorders Abdominal hernia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Abdominal pain	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Abdominal pain lower	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Abscess limb	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Abscess rupture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Acute abdomen	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Acute myocardial infarction	0.95% 8/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Endocrine disorders Adrenal insufficiency	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Anaemia	0.95% 8/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Anaemia postoperative	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Immune system disorders Anaphylactic reaction	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Angina pectoris	1.7% 14/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Angina unstable	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Ankle fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Immune system disorders Antiphospholipid syndrome	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Aortic aneurysm	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Aortic stenosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Appendiceal abscess	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Appendicitis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Arrhythmia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Arteriosclerosis coronary artery	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 11/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Arthritis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Arthritis bacterial	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Arthritis infective	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Arthropathy	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Ascites	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Asthenia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Asthma	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Atrial fibrillation	1.1% 9/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Atrial flutter	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Congenital, familial and genetic disorders Atrial septal defect	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Atrioventricular block complete	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Atypical mycobacterial infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Back pain	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Bacteraemia	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign biliary neoplasm	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Bradycardia	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Brain contusion	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Bronchitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Bronchitis viral	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Bronchopneumonia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Bunion	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Bursitis infective	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Renal and urinary disorders Calculus ureteric	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Cardiac arrest	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Cardiac failure congestive	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Cardiac tamponade	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Cardio-respiratory arrest	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Carotid artery stenosis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Carpal tunnel syndrome	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Cellulitis	2.4% 20/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Cellulitis orbital	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Cellulitis staphylococcal	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Cerebral haemorrhage	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Cerebrovascular accident	1.1% 9/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Cervical cord compression	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Cervical dysplasia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Cervical myelopathy	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage 0	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Chest discomfort	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Chest pain	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Hepatobiliary disorders Cholecystitis	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Hepatobiliary disorders Cholecystitis acute	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Hepatobiliary disorders Cholelithiasis	0.71% 6/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.95% 8/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Clavicle fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Coccidioidomycosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Colitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Colitis ischaemic	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Colonic polyp	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Surgical and medical procedures Colostomy closure	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Confusional state	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Constipation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Contusion	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Coronary artery disease	1.2% 10/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Coronary artery occlusion	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Costochondritis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Crystal arthropathy	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Skin and subcutaneous tissue disorders Cutis laxa	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Death	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Deep vein thrombosis	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Dehydration	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Depression	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Device dislocation	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Device failure	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Diabetes mellitus	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Diarrhoea	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Eye disorders Diplopia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Diverticular perforation	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Diverticulitis	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Dysmenorrhoea	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Endocarditis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Endometriosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Enterovesical fistula	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Epidural lipomatosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Escherichia urinary tract infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Exostosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Faecaloma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Fall	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Female genital tract fistula	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Femur fracture	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Flank pain	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Foot deformity	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Surgical and medical procedures Foot operation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Fracture delayed union	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Fractured sacrum	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Gait disturbance	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gallbladder abscess	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gangrene	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Gastric ulcer	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Gastritis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gastroenteritis	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gastroenteritis salmonella	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gastroenteritis viral	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia haemorrhagic	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gastrointestinal infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Gastrointestinal perforation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Endocrine disorders Goitre	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Granuloma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Haematochezia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Haemorrhage intracranial	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Congenital, familial and genetic disorders Heart disease congenital	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Investigations Heart rate irregular	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Hepatobiliary disorders Hepatic ischaemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Herpes zoster opthalmic	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Hiatus hernia, obstructive	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Surgical and medical procedures Hip arthroplasty	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Hip fracture	0.95% 8/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Humerus fracture	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Hyperkalaemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Immune system disorders Hypersensitivity	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Hypertensive encephalopathy	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Hypoaesthesia	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Hypokalaemia	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Hyponatraemia	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Hypotension	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Endocrine disorders Hypothyroidism	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Hypovolaemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Ileus	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Impaired gastric emptying	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Influenza	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Inguinal hernia	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Intestinal infarction	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Intestinal perforation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Intracranial aneurysm	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Iron deficiency aenemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Irritable bowel syndrome	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Jejunal perforation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Joint contracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Joint destruction	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Joint dislocation	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Joint instability	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Jugular vein thrombosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Surgical and medical procedures Knee arthroplasty	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Labyrinthitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large granular lymphocytosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Surgical and medical procedures Leg amputation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna stage unspecified	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Limb deformity	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Lobar pneumonia	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Localised infection	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Loss of consciousness	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Lung abscess	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Lyme disease	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Eye disorders Maculopathy	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Medical device complication	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Meningitis viral	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Menometrorrhagia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Menorrhagia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Mental status changes	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Migraine	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Multi-organ failure	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Multiple injuries	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Muscular weakness	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Mycobacterium avium complex infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Myocardial infarction	1.2% 10/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Myocardial ischaemia	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Nausea	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Neck injury	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Necrotising fasciitis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Renal and urinary disorders Nephrolithiasis	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Nocardiosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodal marginal zone B-cell lymphoma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Non-cardiac chest pain	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IIIB	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Obesity	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Obstruction gastric	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Renal and urinary disorders Obstructive uropathy	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Oesophageal perforation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Oesophageal ulcer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Operative haemorrhage	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.2% 44/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Osteolysis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Osteomyelitis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Ovarian cyst	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Ovarian cyst ruptured	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of the breast	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Pancreatic pseudocyst	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Pancreatitis	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Pancreatitis acute	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Pancytopenia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Paresthesia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Patella fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Pathological fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Pelvic inflammatory disease	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Peptic ulcer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Pericardial disease	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Pericardial effusion	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Pericarditis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Pericarditis adhesive	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Peripheral artery aneurysm	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Peritoneal tuberculosis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Peritonitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Peritonsillar abscess	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Phlebitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Pneumonia	4.3% 36/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Pneumonia bacterial	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Pneumonia legionella	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Post procedural complication	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Post procedural haematoma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Post procedural infection	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Post-traumatic pain	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Postoperative wound infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Presyncope	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Procedural complication	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Procedural hypotension	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Procedural vomiting	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.1% 9/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Skin and subcutaneous tissue disorders Pyoderma gangrenosum	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Radiculopathy	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Rectal prolapse	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Renal and urinary disorders Renal failure acute	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	8.6% 73/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Rib fracture	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Immune system disorders Sarcoidosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Sciatica	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Sepsis	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Septic shock	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Sick sinus syndrome	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Sinusitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Small intestinal obstruction	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Spinal compression fracture	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Spinal cord compression	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Surgical and medical procedures Spinal decompression	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Staphylococcal abscess	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Staphylococcal bacteraemia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Staphylococcal infection	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Staphylococcal sepsis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Renal and urinary disorders Stress urinary incontinence	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Subarachnoid haemorrhage	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Sudden death	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Suicidal ideation	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Supraventricular tachycardia	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Syncope	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Synovitis	0.35% 3/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-cell lymphoma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Tachycardia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Tendon rupture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Tendonitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Thrombocytopenia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Thrombosis	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Tibia fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Toxicity to various agents	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Tracheobronchitis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Transient ischaemic attack	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Traumatic haematoma	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Upper limb fracture	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Renal and urinary disorders Urinary retention	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Urinary tract infection	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Urosepsis	0.83% 7/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.59% 5/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine neoplasm	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Uterine prolapse	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Reproductive system and breast disorders Vaginal haemorrhage	0.47% 4/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Vascular bypass dysfunction	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Cardiac disorders Ventricular tachycardia	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Ear and labyrinth disorders Vertigo	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Ear and labyrinth disorders Vertigo positional	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Viral infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Eye disorders Vitreous haemorrhage	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Volvulus	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Vomiting	0.24% 2/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations West nile viral infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Wound dehiscence	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Wound infection	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Wound infection staphylococcal	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Xerosis	0.12% 1/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.

Other adverse events

Measure	Adalimumab n=846 participants at risk Open-label adalimumab 40 mg
Gastrointestinal disorders Abdominal pain	5.7% 48/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Abdominal pain upper	6.1% 52/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Investigations Alanine aminotransferase increased	6.1% 52/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Blood and lymphatic system disorders Anaemia	7.3% 62/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Anxiety	8.7% 74/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Arthralgia	13.9% 118/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Investigations Aspartate aminotransferase increased	5.4% 46/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Back pain	17.4% 147/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Bronchitis	21.2% 179/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Bursitis	10.0% 85/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Eye disorders Cataract	8.4% 71/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Constipation	6.7% 57/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Contusion	8.6% 73/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Cough	14.7% 124/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Cystitis	5.4% 46/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Depression	12.4% 105/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Diarrhoea	15.8% 134/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Dizziness	10.6% 90/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Dyspepsia	7.1% 60/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.4% 54/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Fall	6.5% 55/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Fatigue	12.6% 107/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Gastroenteritis viral	7.0% 59/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Gastrooesophageal reflux disease	10.4% 88/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Headache	12.3% 104/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Herpes zoster	10.6% 90/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Hypercholesterolaemia	9.0% 76/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Metabolism and nutrition disorders Hyperlipidaemia	5.7% 48/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Vascular disorders Hypertension	20.8% 176/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Nervous system disorders Hypoaesthesia	5.1% 43/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Influenza	10.3% 87/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Injection site pain	6.6% 56/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Psychiatric disorders Insomnia	11.0% 93/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Joint injury	5.8% 49/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Limb injury	5.6% 47/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Localised infection	5.4% 46/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Muscle spasms	7.8% 66/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Muscle strain	6.0% 51/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.4% 54/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Nasopharyngitis	22.8% 193/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Nausea	14.1% 119/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Neck pain	5.4% 46/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Oedema peripheral	10.8% 91/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Oral herpes	5.7% 48/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 70/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.0% 59/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Osteoporosis	7.6% 64/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Pain in extremity	10.4% 88/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Pneumonia	7.4% 63/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Injury, poisoning and procedural complications Procedural pain	7.7% 65/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
General disorders Pyrexia	5.4% 46/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Skin and subcutaneous tissue disorders Rash	15.5% 131/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	25.4% 215/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Sinusitis	24.9% 211/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Tooth abscess	5.8% 49/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Upper respiratory tract infection	46.3% 392/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Urinary tract infection	20.1% 170/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Gastrointestinal disorders Vomiting	6.1% 52/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.
Infections and infestations Vulvovaginal mycotic infection	6.7% 57/846 • After the first adalimumab injection in this continuation study DE020 to 70 days after the last adalimumab injection.

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