Trial Outcomes & Findings for Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis (NCT NCT01163318)

Last Updated: 2015-06-10

Results Overview

An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.

Recruitment status

COMPLETED

Target enrollment

552 participants

Primary outcome timeframe

From the initiation of adalimumab treatment, every 6 months up to 3 years.

Results posted on

2015-06-10

Participant Flow

The primary reason for discontinuation was not collected for 224 participants listed under the category of 'multiple reasons per participant' (Insufficient effect (n=76), other reasons (n=43), economic reasons (n=2), AEs (n=41), no further visits (including change of hospital) (n=39), discontinued by the patient request (n=17), and unknown (n=8)).

Participant milestones

Participant milestones
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection Participants with rheumatoid arthritis who received adalimumab, per approved label
Overall Study STARTED	552
Overall Study COMPLETED	284
Overall Study NOT COMPLETED	268

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection Participants with rheumatoid arthritis who received adalimumab, per approved label
Overall Study Off-Label Use of Adalimumab	8
Overall Study Did Not Continue Use of Adalimumab	26
Overall Study History/comorbidity of malignant tumor	3
Overall Study Participants Without Case Report Form	7
Overall Study Multiple Reasons Per Participant	224

Baseline Characteristics

Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=508 Participants Participants with rheumatoid arthritis who received adalimumab, per approved label
Age, Continuous	59.5 Years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	416 Participants n=5 Participants
Sex: Female, Male Male	92 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the initiation of adalimumab treatment, every 6 months up to 3 years.

Population: Safety analysis set, defined as participants who did not violate protocol criteria.

An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=508 Participants Participants with rheumatoid arthritis who received adalimumab, per approved label
Incidence of Adverse Drug Reactions (ADRs)	33.3 Percentage of participants

SECONDARY outcome

Timeframe: From the initiation of adalimumab treatment, every 6 months up to 3 years.

Population: Safety analysis set, defined as participants who did not violate protocol criteria.

Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=508 Participants Participants with rheumatoid arthritis who received adalimumab, per approved label
Incidence of Infections and Malignant Tumors Infections	16.1 Percentage of participants
Incidence of Infections and Malignant Tumors Malignant Tumors	1.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3

Population: Efficacy analysis set, defined as safety analysis set excluding participants without evaluable DAS28-4ESR score and lack of Modified Health Assessment Questionnaire (MHAQ) data prior to drug administration.

DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score \< 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=429 Participants Participants with rheumatoid arthritis who received adalimumab, per approved label
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Baseline (Week 0)	2.8 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Week 4	14.5 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Week 12	20.0 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Week 24	29.6 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Year 1	33.6 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Year 1.5	37.1 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Year 2	36.6 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Year 2.5	38.2 Percentage of participants
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit Year 3	36.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3

MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.

Outcome measures

Outcome measures
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=426 Participants Participants with rheumatoid arthritis who received adalimumab, per approved label
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Baseline (Week 0)	43.4 Percentage of participants
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Week 24	53.5 Percentage of participants
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Year 1	63.6 Percentage of participants
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Year 1.5	63.6 Percentage of participants
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Year 2	66.0 Percentage of participants
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Year 2.5	65.7 Percentage of participants
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit Year 3	66.2 Percentage of participants

Adverse Events

Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection

Serious events: 86 serious events

Other events: 211 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=508 participants at risk Participants with rheumatoid arthritis who received adalimumab, per approved label
Infections and infestations Acute tonsillitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Atypical pneumonia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Bronchitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Bronchopneumonia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Epstein-Barr virus infection	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Erysipelas	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Herpes zoster	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Listeriosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Lung abscess	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Meningitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Peritonitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia	0.98% 5/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia haemophilus	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia mycoplasmal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia pneumococcal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia streptococcal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pulmonary mycosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pyelonephritis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pyelonephritis acute	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Sepsis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Skin infection	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Subcutaneous abscess	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Urinary tract infection	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Arthritis bacterial	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Enteritis infectious	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia bacterial	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Purulence	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia cryptococcal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Anaemia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Iron deficiency anaemia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Lymphadenopathy	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Pancytopenia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Splenic lesion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Immune system disorders Amyloidosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Immune system disorders Sarcoidosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Decreased appetite	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Anxiety disorder	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Cerebral infarction	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Ear and labyrinth disorders Vertigo	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Cardiac disorders Acute myocardial infarction	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Cardiac disorders Cardiac failure	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Cardiac disorders Myocardial infarction	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Vascular disorders Aortic rupture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Asthma	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.2% 6/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Enterocolitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Pancreatitis acute	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Diverticular perforation	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Hepatobiliary disorders Hepatic function abnormal	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Drug eruption	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Skin ulcer	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Arthralgia	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Arthritis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.2% 6/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Nephrolithiasis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Renal failure	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Renal failure chronic	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Reproductive system and breast disorders Ovarian cyst torsion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Pyrexia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Abasia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Deformity	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Computerised tomogram thorax abnormal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Femoral neck fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Foot fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Radius fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Spinal compression fracture	0.98% 5/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Subdural haematoma	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Tibia fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Ulna fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Contusion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Lower limb fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Pubis fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.

Other adverse events

Other adverse events
Measure	Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection n=508 participants at risk Participants with rheumatoid arthritis who received adalimumab, per approved label
Infections and infestations Acute tonsillitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Atypical pneumonia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Bronchitis	4.1% 21/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Bronchopneumonia	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Cellulitis	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Chronic sinusitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Clostridium difficile colitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Conjunctivitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Cystitis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Epstein-Barr virus infection	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Erysipelas	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Gastroenteritis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Herpes zoster	1.8% 9/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Impetigo	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Influenza	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Listeriosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Lung abscess	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Meningitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Nasopharyngitis	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Otitis media	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Periodontitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Peritonitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pharyngitis	1.2% 6/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia	2.0% 10/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia haemophilus	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia mycoplasmal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia pneumococcal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia streptococcal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pulmonary mycosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pyelonephritis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pyelonephritis acute	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Sepsis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Sinusitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Skin infection	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Subcutaneous abscess	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Tinea pedis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Tonsillitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Upper respiratory tract infection	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Urinary tract infection	0.98% 5/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Arthritis bacterial	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Enteritis infectious	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia bacterial	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Atypical mycobacterial infection	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Purulence	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Oral herpes	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Tinea manuum	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Pneumonia cryptococcal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Infections and infestations Gastroenteritis norovirus	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Anaemia	0.98% 5/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Iron deficiency anaemia	0.98% 5/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Lymphadenopathy	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Pancytopenia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Blood and lymphatic system disorders Splenic lesion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Immune system disorders Amyloidosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Immune system disorders Sarcoidosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Immune system disorders Seasonal allergy	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Endocrine disorders Hypothyroidism	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Diabetes mellitus	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Hypercholesterolaemia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Hyperuricaemia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Hyponatraemia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Decreased appetite	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Metabolism and nutrition disorders Hyperlipidaemia	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Psychiatric disorders Insomnia	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Psychiatric disorders Anxiety disorder	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Cerebral infarction	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Diabetic neuropathy	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Dizziness	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Dyslalia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Headache	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Hypoaesthesia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders Migraine	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Nervous system disorders VIIth nerve paralysis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Eye disorders Conjunctivitis allergic	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Ear and labyrinth disorders Vertigo	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Cardiac disorders Acute myocardial infarction	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Cardiac disorders Cardiac failure	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Cardiac disorders Myocardial infarction	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Vascular disorders Hypertension	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Vascular disorders Aortic rupture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Asthma	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Cough	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Emphysema	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.6% 8/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Productive cough	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	3.9% 20/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Abdominal discomfort	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Abdominal pain upper	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Constipation	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Diarrhoea	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Dry mouth	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Enterocolitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Gastric ulcer	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Gastritis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Gingival swelling	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Nausea	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Pancreatitis acute	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Parotid gland enlargement	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Periodontal disease	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Stomatitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Hypoaesthesia oral	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Gastrointestinal disorders Diverticular perforation	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Hepatobiliary disorders Chronic hepatitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Hepatobiliary disorders Hepatic function abnormal	5.1% 26/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Hepatobiliary disorders Liver disorder	0.98% 5/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Hepatobiliary disorders Non-alcoholic steatohepatitis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Dermatitis contact	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Drug eruption	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Eczema	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Erythema nodosum	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Pruritus	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Rash	2.0% 10/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Rash erythematous	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Rash pruritic	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Skin ulcer	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Skin and subcutaneous tissue disorders Urticaria	1.2% 6/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Arthralgia	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Arthritis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Back pain	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Osteoporosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.2% 6/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Nephrolithiasis	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Nephrotic syndrome	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Neurogenic bladder	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Renal failure	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Renal failure chronic	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Renal and urinary disorders Renal impairment	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Reproductive system and breast disorders Ovarian cyst torsion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Chest discomfort	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Chills	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Influenza like illness	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Injection site erythema	1.8% 9/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Injection site pruritus	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Injection site rash	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Injection site reaction	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Pyrexia	0.79% 4/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Abasia	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Injection site swelling	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
General disorders Deformity	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Alanine aminotransferase increased	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Aspartate aminotransferase increased	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Blood creatinine increased	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations C-reactive protein increased	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Eosinophil count increased	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Liver function test abnormal	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Platelet count decreased	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations White blood cell count decreased	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Blood beta-D-glucan increased	0.39% 2/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Computerised tomogram thorax abnormal	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Hepatic enzyme increased	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Investigations Cell marker increased	0.59% 3/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Arthropod sting	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Chillblains	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Femoral neck fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Foot fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Frostbite	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Radius fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Spinal compression fracture	1.4% 7/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Subdural haematoma	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Tibia fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Ulna fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Contusion	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Lower limb fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.
Injury, poisoning and procedural complications Pubis fracture	0.20% 1/508 • From the initiation of adalimumab treatment, every 6 months up to 3 years. The occurrence, type of adverse events, date of onset, seriousness (reasons for serious events), outcome (type of outcome and date of evaluation), measures taken regarding adalimumab and use of symptomatic treatment, causal relationship between adalimumab and adverse events, and laboratory findings were assessed.

Additional Information

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