Trial Outcomes & Findings for Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis (NCT NCT01076205)

NCT ID: NCT01076205

Last Updated: 2019-02-07

Results Overview

Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.

• Recruitment status: COMPLETED
• Target enrollment: 7229 participants
• Primary outcome timeframe: Baseline and 6, 12, 24, 36, 48, and 60 months
• Results posted on: 2019-02-07

Participant Flow

Adults with rheumatoid arthritis (RA) were enrolled at 326 clinical centers in Germany and seen during regular visits for routine clinical care.

Participant milestones

Measure	Adalimumab Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
Overall Study STARTED	7229
Overall Study COMPLETED	1210
Overall Study NOT COMPLETED	6019

Reasons for withdrawal

Measure	Adalimumab Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
Overall Study Adverse Drug Reaction	299
Overall Study Lack of Effectiveness	1423
Overall Study Other Reason	1075
Overall Study Unknown Reason	71
Overall Study Lost to Follow-up	3151

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Measure	Adalimumab n=7229 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
Age, Continuous	54.9 years STANDARD_DEVIATION 13.2 • n=7165 Participants • Participants with available data
Sex: Female, Male Female	5267 Participants n=7176 Participants • Participants with available data
Sex: Female, Male Male	1909 Participants n=7176 Participants • Participants with available data
Duration of Disease	9.6 years STANDARD_DEVIATION 8.8 • n=7039 Participants • Participants with available data
Number of Missed Work Days in Last 6 Months	19.9 days STANDARD_DEVIATION 41.7 • n=3887 Participants • Participants who were employed part-time or full-time
Work Productivity and Activity Impairment Absenteeism	21.4 percent impairment STANDARD_DEVIATION 36.9 • n=2362 Participants • Participants with available WPAI data; The first 3 scores were assessed in participants who were employed.
Work Productivity and Activity Impairment Presenteeism	47.2 percent impairment STANDARD_DEVIATION 27.3 • n=3046 Participants • Participants with available WPAI data; The first 3 scores were assessed in participants who were employed.
Work Productivity and Activity Impairment Total work productivity impairment	50.9 percent impairment STANDARD_DEVIATION 29.2 • n=2124 Participants • Participants with available WPAI data; The first 3 scores were assessed in participants who were employed.
Work Productivity and Activity Impairment Total activity impairment	54.9 percent impairment STANDARD_DEVIATION 25.0 • n=6862 Participants • Participants with available WPAI data; The first 3 scores were assessed in participants who were employed.
Work Activity Index	32.1 units on a scale STANDARD_DEVIATION 7.8 • n=2183 Participants • Participants who were employed part-time or full-time
Disease Activity Score - 28 Joints (DAS28)	4.63 units on a scale STANDARD_DEVIATION 1.51 • n=6132 Participants • Participants with available data
Tender Joint Count	7.4 joints STANDARD_DEVIATION 6.8 • n=7111 Participants • Participants with available data
Swollen Joint Count	5.0 joints STANDARD_DEVIATION 5.3 • n=7111 Participants • Participants with available data
Erythrocyte Sedimentation Rate	26.5 mm/hr STANDARD_DEVIATION 21.7 • n=6348 Participants • Participants with available data
C-reactive Protein	17.3 mg/L STANDARD_DEVIATION 48.7 • n=6764 Participants • Participants with available data
Health-Assessment Questionnaire-Disability Index (HAQ-DI)	1.19 units on a scale STANDARD_DEVIATION 0.74 • n=6977 Participants • Participants with available data
Euroqol Visual Analog Scale (VAS)	52.2 units on a scale STANDARD_DEVIATION 22.0 • n=6912 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at baseline and each time point.

Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.

Outcome measures

Measure	Adalimumab n=3156 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months Month 6	-4.3 days Standard Deviation 32.7	—	—	—	—	—	—	—
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months Month 12	-3.4 days Standard Deviation 37.3	—	—	—	—	—	—	—
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months Month 24	-5.6 days Standard Deviation 30.3	—	—	—	—	—	—	—
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months Month 36	-6.7 days Standard Deviation 32.2	—	—	—	—	—	—	—
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months Month 48	-6.4 days Standard Deviation 27.7	—	—	—	—	—	—	—
Change From Baseline in Number of Missed Working Days Due to Sick Leave in the Past 6 Months Month 60	-4.1 days Standard Deviation 32.0	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set), with available data at each time point.

Primary effectiveness outcomes related to employment were performed in patients who were employed part- or full-time at baseline. Sick leave days were based on patient recall.

Outcome measures

Measure	Adalimumab n=3156 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Baseline	44.7 percentage of participants	—	—	—	—	—	—	—
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Month 6	29.5 percentage of participants	—	—	—	—	—	—	—
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Month 12	28.5 percentage of participants	—	—	—	—	—	—	—
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Month 24	27.9 percentage of participants	—	—	—	—	—	—	—
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Month 36	26.2 percentage of participants	—	—	—	—	—	—	—
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Month 48	24.1 percentage of participants	—	—	—	—	—	—	—
Percentage of Participants With > 5 Missed Working Days Due to Sick Leave in the Past 6 Months Month 60	26.1 percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

Outcome measures

Measure	Adalimumab n=2253 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 3	-7.9 percent impairment Standard Deviation 34.6	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 6	-8.0 percent impairment Standard Deviation 37.2	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 12	-7.3 percent impairment Standard Deviation 38.3	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 24	-6.5 percent impairment Standard Deviation 36.1	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 36	-8.0 percent impairment Standard Deviation 34.7	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 48	-5.2 percent impairment Standard Deviation 34.6	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Absenteeism Month 60	-5.2 percent impairment Standard Deviation 40.7	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

Outcome measures

Measure	Adalimumab n=2758 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 12	-12.7 percent impairment Standard Deviation 28.2	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 60	-15.2 percent impairment Standard Deviation 27.8	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 3	-11.3 percent impairment Standard Deviation 25.8	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 6	-11.8 percent impairment Standard Deviation 26.7	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 24	-12.9 percent impairment Standard Deviation 28.6	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 36	-15.3 percent impairment Standard Deviation 28.8	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Presenteeism Month 48	-16.4 percent impairment Standard Deviation 29.4	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WPAI data.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

Outcome measures

Measure	Adalimumab n=2026 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 3	-13.0 percent impairment Standard Deviation 27.7	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 6	-14.4 percent impairment Standard Deviation 28.8	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 12	-16.4 percent impairment Standard Deviation 30.3	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 24	-15.3 percent impairment Standard Deviation 30.6	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 36	-18.8 percent impairment Standard Deviation 29.3	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 48	-16.7 percent impairment Standard Deviation 31.6	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Work Productivity Impairment Month 60	-16.5 percent impairment Standard Deviation 33.8	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and with available WPAI data.

The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), total work productivity impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health.

WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes.

Outcome measures

Measure	Adalimumab n=3248 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 3	-11.9 percent impairment Standard Deviation 26.5	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 6	-12.8 percent impairment Standard Deviation 27.5	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 12	-13.8 percent impairment Standard Deviation 28.6	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 24	-14.3 percent impairment Standard Deviation 28.4	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 36	-15.4 percent impairment Standard Deviation 29.7	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 48	-14.8 percent impairment Standard Deviation 29.4	—	—	—	—	—	—	—
Change From Baseline in Work Productivity and Activity Impairment: Total Activity Impairment Month 60	-14.8 percent impairment Standard Deviation 28.6	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 6, 12, 24, 36, 48, and 60 months

Population: Participants who were employed outside of the home, on either a part-time or full-time basis, at baseline (employed patient set) and at each time point, and with available WAI data.

The WAI is a tool designed to record the work ability of employees and consists of 7 questions. The modified WAI used in this study included Questions 1, 2, 4, 6, and 7 of the WAI. Question 3, which involves the number of current diseases diagnosed by a physician, was omitted because this parameter was unlikely to reflect change due to treatment. Question 5 (sick leave during the past year) was replaced with the previous question concerning sick leave days.WAI scores range from 7 (worst) to 49 (best).

Outcome measures

Measure	Adalimumab n=2110 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Work Activity Index (WAI) Month 60	3.0 units on a scale Standard Deviation 7.0	—	—	—	—	—	—	—
Change From Baseline in Work Activity Index (WAI) Month 6	2.5 units on a scale Standard Deviation 5.9	—	—	—	—	—	—	—
Change From Baseline in Work Activity Index (WAI) Month 12	3.0 units on a scale Standard Deviation 6.7	—	—	—	—	—	—	—
Change From Baseline in Work Activity Index (WAI) Month 24	3.2 units on a scale Standard Deviation 6.8	—	—	—	—	—	—	—
Change From Baseline in Work Activity Index (WAI) Month 36	3.6 units on a scale Standard Deviation 7.0	—	—	—	—	—	—	—
Change From Baseline in Work Activity Index (WAI) Month 48	3.3 units on a scale Standard Deviation 6.6	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, a DAS28 score < 3.2 indicates low disease activity, and a DAS28 score < 2.6 indicates clinical remission.

Outcome measures

Measure	Adalimumab n=4466 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 3	-1.34 units on a scale Standard Deviation 1.39	—	—	—	—	—	—	—
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 6	-1.56 units on a scale Standard Deviation 1.46	—	—	—	—	—	—	—
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 12	-1.71 units on a scale Standard Deviation 1.55	—	—	—	—	—	—	—
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 24	-1.84 units on a scale Standard Deviation 1.57	—	—	—	—	—	—	—
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 36	-1.94 units on a scale Standard Deviation 1.61	—	—	—	—	—	—	—
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 48	-2.01 units on a scale Standard Deviation 1.59	—	—	—	—	—	—	—
Change From Baseline in Disease Activity Score - 28 Joints (DAS28) Month 60	-2.15 units on a scale Standard Deviation 1.63	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.

Outcome measures

Measure	Adalimumab n=4466 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Tender Joint Count Month 3	-4.3 joints Standard Deviation 6.2	—	—	—	—	—	—	—
Change From Baseline in Tender Joint Count Month 6	-4.9 joints Standard Deviation 6.5	—	—	—	—	—	—	—
Change From Baseline in Tender Joint Count Month 12	-5.3 joints Standard Deviation 6.7	—	—	—	—	—	—	—
Change From Baseline in Tender Joint Count Month 24	-5.6 joints Standard Deviation 6.5	—	—	—	—	—	—	—
Change From Baseline in Tender Joint Count Month 36	-5.9 joints Standard Deviation 6.7	—	—	—	—	—	—	—
Change From Baseline in Tender Joint Count Month 48	-6.1 joints Standard Deviation 6.7	—	—	—	—	—	—	—
Change From Baseline in Tender Joint Count Month 60	-6.4 joints Standard Deviation 6.5	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.

Outcome measures

Measure	Adalimumab n=4466 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Swollen Joint Count Month 3	-3.2 joints Standard Deviation 4.9	—	—	—	—	—	—	—
Change From Baseline in Swollen Joint Count Month 6	-3.8 joints Standard Deviation 5.2	—	—	—	—	—	—	—
Change From Baseline in Swollen Joint Count Month 12	-4.1 joints Standard Deviation 5.4	—	—	—	—	—	—	—
Change From Baseline in Swollen Joint Count Month 24	-4.4 joints Standard Deviation 5.6	—	—	—	—	—	—	—
Change From Baseline in Swollen Joint Count Month 36	-4.8 joints Standard Deviation 5.7	—	—	—	—	—	—	—
Change From Baseline in Swollen Joint Count Month 48	-5.0 joints Standard Deviation 5.7	—	—	—	—	—	—	—
Change From Baseline in Swollen Joint Count Month 60	-5.5 joints Standard Deviation 6.1	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Outcome measures

Measure	Adalimumab n=4466 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Erythrocyte Sedimentation Rate Month 3	-7.1 mm/hr Standard Deviation 20.5	—	—	—	—	—	—	—
Change From Baseline in Erythrocyte Sedimentation Rate Month 6	-7.9 mm/hr Standard Deviation 20.6	—	—	—	—	—	—	—
Change From Baseline in Erythrocyte Sedimentation Rate Month 12	-8.5 mm/hr Standard Deviation 21.6	—	—	—	—	—	—	—
Change From Baseline in Erythrocyte Sedimentation Rate Month 24	-9.0 mm/hr Standard Deviation 22.2	—	—	—	—	—	—	—
Change From Baseline in Erythrocyte Sedimentation Rate Month 36	-8.9 mm/hr Standard Deviation 22.1	—	—	—	—	—	—	—
Change From Baseline in Erythrocyte Sedimentation Rate Month 48	-9.3 mm/hr Standard Deviation 22.7	—	—	—	—	—	—	—
Change From Baseline in Erythrocyte Sedimentation Rate Month 60	-9.9 mm/hr Standard Deviation 22.5	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Outcome measures

Measure	Adalimumab n=4353 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in C-reactive Protein Month 36	-8.6 mg/L Standard Deviation 65.9	—	—	—	—	—	—	—
Change From Baseline in C-reactive Protein Month 48	-5.8 mg/L Standard Deviation 47.5	—	—	—	—	—	—	—
Change From Baseline in C-reactive Protein Month 60	-7.8 mg/L Standard Deviation 39.3	—	—	—	—	—	—	—
Change From Baseline in C-reactive Protein Month 3	-7.1 mg/L Standard Deviation 45.2	—	—	—	—	—	—	—
Change From Baseline in C-reactive Protein Month 6	-7.3 mg/L Standard Deviation 49.1	—	—	—	—	—	—	—
Change From Baseline in C-reactive Protein Month 12	-7.5 mg/L Standard Deviation 59.4	—	—	—	—	—	—	—
Change From Baseline in C-reactive Protein Month 24	-8.0 mg/L Standard Deviation 64.0	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing, eating, walking, and hygiene. Patients are asked about their ability to complete these tasks in the past week using the following categories: 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 ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.

Outcome measures

Measure	Adalimumab n=4449 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 3	-0.22 units on a scale Standard Deviation 0.51	—	—	—	—	—	—	—
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 6	-0.24 units on a scale Standard Deviation 0.54	—	—	—	—	—	—	—
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 12	-0.27 units on a scale Standard Deviation 0.58	—	—	—	—	—	—	—
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 24	-0.28 units on a scale Standard Deviation 0.60	—	—	—	—	—	—	—
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 36	-0.30 units on a scale Standard Deviation 0.62	—	—	—	—	—	—	—
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 48	-0.32 units on a scale Standard Deviation 0.61	—	—	—	—	—	—	—
Change From Baseline in Health-Assessment Questionnaire-Disability Index (HAQ-DI) Month 60	-0.28 units on a scale Standard Deviation 0.63	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

The EuroQol-5 Dimensions (EQ-5D) is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The first part includes statements for the following five areas (dimensions):

• agility/mobility
• self-care
• usual activities
• pain, bodily discomfort
• anxiety, depression

For each dimension the patient is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3).

Outcome measures

Measure	Adalimumab n=4400 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 n=4118 Participants 3 months after enrollment	Month 6 n=3524 Participants 6 months after enrollment	Month 12 n=2856 Participants 12 months after enrollment	Month 24 n=2020 Participants 24 months after enrollment	Month 36 n=1401 Participants 36 months after enrollment	Month 48 n=992 Participants 48 months after enrollment	Month 60 n=732 Participants 60 months after enrollment
EuroQol-5 Dimensions (EQ-5D) Scores Self-care · Extreme problems	115 Participants	98 Participants	75 Participants	62 Participants	33 Participants	25 Participants	20 Participants	18 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Usual activities · Some problems	3236 Participants	2511 Participants	1989 Participants	1455 Participants	1015 Participants	696 Participants	464 Participants	362 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Usual activities · Extreme problems	206 Participants	142 Participants	103 Participants	98 Participants	47 Participants	28 Participants	25 Participants	17 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Pain/discomfort · Some problems	2965 Participants	2932 Participants	2508 Participants	1989 Participants	1381 Participants	917 Participants	631 Participants	461 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Pain/discomfort · Extreme problems	1288 Participants	601 Participants	429 Participants	285 Participants	161 Participants	101 Participants	63 Participants	46 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Anxiety/depression · No problems	2159 Participants	2328 Participants	2141 Participants	1791 Participants	1349 Participants	977 Participants	705 Participants	526 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Mobility · No problems	1662 Participants	2072 Participants	1937 Participants	1644 Participants	1190 Participants	843 Participants	614 Participants	447 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Mobility · Some problems	2728 Participants	2034 Participants	1575 Participants	1200 Participants	824 Participants	554 Participants	376 Participants	282 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Mobility · Extreme problems	8 Participants	12 Participants	12 Participants	12 Participants	6 Participants	4 Participants	2 Participants	3 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Self-care · No problems	2599 Participants	2792 Participants	2476 Participants	2088 Participants	1484 Participants	1038 Participants	729 Participants	506 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Self-care · Some problems	1680 Participants	1226 Participants	972 Participants	706 Participants	503 Participants	338 Participants	243 Participants	208 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Usual activities · No problems	953 Participants	1463 Participants	1431 Participants	1303 Participants	958 Participants	677 Participants	503 Participants	353 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Pain/discomfort · No problems	147 Participants	585 Participants	587 Participants	582 Participants	478 Participants	383 Participants	298 Participants	225 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Anxiety/depression · Some problems	1961 Participants	1601 Participants	1238 Participants	956 Participants	607 Participants	395 Participants	265 Participants	190 Participants
EuroQol-5 Dimensions (EQ-5D) Scores Anxiety/depression · Extreme problems	275 Participants	187 Participants	144 Participants	107 Participants	64 Participants	28 Participants	22 Participants	16 Participants

PRIMARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

EuroQol-5 Dimensions (EQ-5D): The EQ-5D is a generic instrument for measuring health-related quality of life. The patient questionnaire consists of two parts. The second part is a vertical, thermometer-like, VAS ranging from 0 to 100 that provides a patient-reported assessment of overall health. Patients are asked to mark how good or bad their health is on that day, with 100 meaning "the best health you can imagine" and 0 meaning "the worst health you can imagine."

Outcome measures

Measure	Adalimumab n=4405 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 3	10.0 units on a scale Standard Deviation 24.0	—	—	—	—	—	—	—
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 6	11.7 units on a scale Standard Deviation 24.9	—	—	—	—	—	—	—
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 12	12.9 units on a scale Standard Deviation 25.8	—	—	—	—	—	—	—
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 24	14.9 units on a scale Standard Deviation 25.4	—	—	—	—	—	—	—
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 36	16.2 units on a scale Standard Deviation 25.4	—	—	—	—	—	—	—
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 48	15.8 units on a scale Standard Deviation 25.2	—	—	—	—	—	—	—
Change From Baseline in Euroqol Visual Analog Scale (VAS) Month 60	14.9 units on a scale Standard Deviation 25.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Participants self-reported the number of physician visits they had in the past 6 months.

Outcome measures

Measure	Adalimumab n=4344 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 n=3408 Participants 3 months after enrollment	Month 6 n=2774 Participants 6 months after enrollment	Month 12 n=1946 Participants 12 months after enrollment	Month 24 n=1357 Participants 24 months after enrollment	Month 36 n=960 Participants 36 months after enrollment	Month 48 n=703 Participants 48 months after enrollment	Month 60 60 months after enrollment
Number of Physician Visits in Past 6 Months Rheumatologist	3.3 visits Standard Deviation 3.1	2.5 visits Standard Deviation 2.7	2.2 visits Standard Deviation 2.0	1.9 visits Standard Deviation 1.5	1.8 visits Standard Deviation 1.4	1.9 visits Standard Deviation 1.4	1.8 visits Standard Deviation 1.6	—
Number of Physician Visits in Past 6 Months General practitioner	4.0 visits Standard Deviation 4.6	2.9 visits Standard Deviation 4.4	2.6 visits Standard Deviation 3.2	2.1 visits Standard Deviation 2.5	2.1 visits Standard Deviation 3.0	1.9 visits Standard Deviation 2.4	1.8 visits Standard Deviation 2.5	—
Number of Physician Visits in Past 6 Months Orthopedic specialist	0.9 visits Standard Deviation 2.2	0.6 visits Standard Deviation 1.9	0.7 visits Standard Deviation 1.6	0.5 visits Standard Deviation 1.3	0.5 visits Standard Deviation 1.3	0.5 visits Standard Deviation 1.0	0.5 visits Standard Deviation 1.9	—
Number of Physician Visits in Past 6 Months Other specialists	1.2 visits Standard Deviation 2.4	0.9 visits Standard Deviation 1.8	0.9 visits Standard Deviation 1.8	0.8 visits Standard Deviation 1.4	0.8 visits Standard Deviation 1.5	0.8 visits Standard Deviation 1.5	0.8 visits Standard Deviation 1.5	—

SECONDARY outcome

Timeframe: Baseline, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Participants self-reported the number of hospitalizations they had in the past 6 months.

Outcome measures

Measure	Adalimumab n=4344 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Number of Inpatient Hospitalizations in Past 6 Months Baseline	0.4 hospitalizations Standard Deviation 1.5	—	—	—	—	—	—	—
Number of Inpatient Hospitalizations in Past 6 Months Month 6	0.2 hospitalizations Standard Deviation 1.0	—	—	—	—	—	—	—
Number of Inpatient Hospitalizations in Past 6 Months Month 12	0.2 hospitalizations Standard Deviation 1.0	—	—	—	—	—	—	—
Number of Inpatient Hospitalizations in Past 6 Months Month 24	0.1 hospitalizations Standard Deviation 0.5	—	—	—	—	—	—	—
Number of Inpatient Hospitalizations in Past 6 Months Month 36	0.1 hospitalizations Standard Deviation 0.4	—	—	—	—	—	—	—
Number of Inpatient Hospitalizations in Past 6 Months Month 48	0.1 hospitalizations Standard Deviation 0.7	—	—	—	—	—	—	—
Number of Inpatient Hospitalizations in Past 6 Months Month 60	0.1 hospitalizations Standard Deviation 0.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Participants who had been hospitalized were asked how many days they were hospitalized in the past 6 months.

Outcome measures

Measure	Adalimumab n=4344 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Duration of Inpatient Hospitalizations in Past 6 Months Baseline	2.3 days Standard Deviation 7.3	—	—	—	—	—	—	—
Duration of Inpatient Hospitalizations in Past 6 Months Month 6	1.1 days Standard Deviation 4.4	—	—	—	—	—	—	—
Duration of Inpatient Hospitalizations in Past 6 Months Month 12	1.1 days Standard Deviation 4.8	—	—	—	—	—	—	—
Duration of Inpatient Hospitalizations in Past 6 Months Month 24	0.8 days Standard Deviation 3.5	—	—	—	—	—	—	—
Duration of Inpatient Hospitalizations in Past 6 Months Month 36	0.7 days Standard Deviation 3.1	—	—	—	—	—	—	—
Duration of Inpatient Hospitalizations in Past 6 Months Month 48	0.7 days Standard Deviation 3.5	—	—	—	—	—	—	—
Duration of Inpatient Hospitalizations in Past 6 Months Month 60	0.5 days Standard Deviation 2.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Patients reported the number of days that sickness affected non-occupational activities in four categories: household, child-rearing/parenting, education, and recreational (free-time). Participants with no impairment were considered to have 0 days.

Outcome measures

Measure	Adalimumab n=3368 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 n=2666 Participants 3 months after enrollment	Month 6 n=2199 Participants 6 months after enrollment	Month 12 n=1572 Participants 12 months after enrollment	Month 24 n=1093 Participants 24 months after enrollment	Month 36 n=784 Participants 36 months after enrollment	Month 48 n=574 Participants 48 months after enrollment	Month 60 60 months after enrollment
Number of Days With Impairment of Non-Occupational Activities in Past 6 Months Household	56.9 days Standard Deviation 64.3	27.7 days Standard Deviation 50.6	22.4 days Standard Deviation 46.1	20.6 days Standard Deviation 46.3	18.2 days Standard Deviation 43.7	19.2 days Standard Deviation 46.1	16.1 days Standard Deviation 39.8	—
Number of Days With Impairment of Non-Occupational Activities in Past 6 Months Child-rearing/parenting	15.1 days Standard Deviation 41.6	4.7 days Standard Deviation 23.1	3.1 days Standard Deviation 18.1	2.8 days Standard Deviation 18.4	1.9 days Standard Deviation 13.6	3.0 days Standard Deviation 19.7	1.6 days Standard Deviation 8.2	—
Number of Days With Impairment of Non-Occupational Activities in Past 6 Months Educational	8.3 days Standard Deviation 31.6	2.5 days Standard Deviation 17.1	1.6 days Standard Deviation 13.3	1.1 days Standard Deviation 10.1	1.0 days Standard Deviation 10.1	0.9 days Standard Deviation 11.5	1.4 days Standard Deviation 12.6	—
Number of Days With Impairment of Non-Occupational Activities in Past 6 Months Recreational	59.1 days Standard Deviation 65.6	28.3 days Standard Deviation 50.9	23.0 days Standard Deviation 47.4	19.5 days Standard Deviation 45.0	18.5 days Standard Deviation 44.9	19.1 days Standard Deviation 46.0	16.3 days Standard Deviation 41.7	—

SECONDARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Outcome measures

Measure	Adalimumab n=4370 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Duration of Morning Stiffness Baseline	65.3 minutes Standard Deviation 72.8	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 3	34.6 minutes Standard Deviation 55.6	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 6	27.4 minutes Standard Deviation 44.3	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 12	24.2 minutes Standard Deviation 43.5	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 24	20.9 minutes Standard Deviation 39.8	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 36	19.0 minutes Standard Deviation 41.0	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 48	15.0 minutes Standard Deviation 29.8	—	—	—	—	—	—	—
Duration of Morning Stiffness Month 60	15.2 minutes Standard Deviation 32.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Participants were asked to evaluate their level of pain in the past 7 days on a scale from 0 (no pain) to 10 (unbearable pain).

Outcome measures

Measure	Adalimumab n=4455 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Participant's Assessment of Pain Baseline	6.1 units on a scale Standard Deviation 2.3	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 3	4.4 units on a scale Standard Deviation 2.5	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 6	4.2 units on a scale Standard Deviation 2.5	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 12	3.9 units on a scale Standard Deviation 2.5	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 24	3.7 units on a scale Standard Deviation 2.4	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 36	3.5 units on a scale Standard Deviation 2.4	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 48	3.3 units on a scale Standard Deviation 2.4	—	—	—	—	—	—	—
Participant's Assessment of Pain Month 60	3.3 units on a scale Standard Deviation 2.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 3, 6, 12, 24, 36, 48, and 60 months

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), and with available data at each time point.

Participants were asked to indicate how much they had suffered from abnormal exhaustion and fatigue during the past 7 days on a scale from 0 (none) to 10 (strongly).

Outcome measures

Measure	Adalimumab n=4449 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Participant's Assessment of Fatigue Baseline	5.8 units on a scale Standard Deviation 2.7	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 3	4.4 units on a scale Standard Deviation 2.7	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 6	4.2 units on a scale Standard Deviation 2.7	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 12	4.0 units on a scale Standard Deviation 2.7	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 24	3.8 units on a scale Standard Deviation 2.7	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 36	3.5 units on a scale Standard Deviation 2.6	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 48	3.5 units on a scale Standard Deviation 2.6	—	—	—	—	—	—	—
Participant's Assessment of Fatigue Month 60	3.4 units on a scale Standard Deviation 2.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to month 60

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set).

Assessment of concomitant medications included disease-modifying antirheumatic drugs (DMARDs) (methotrexate, Leflunomid, sulfasalazine), systemic glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), Cox-2 inhibitors (coxibs), analgesics and others.

Outcome measures

Measure	Adalimumab n=4466 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 n=4466 Participants 3 months after enrollment	Month 6 6 months after enrollment	Month 12 12 months after enrollment	Month 24 24 months after enrollment	Month 36 36 months after enrollment	Month 48 48 months after enrollment	Month 60 60 months after enrollment
Percentage of Participants Taking Concomitant RA Medications Methotrexate	53.4 percentage of participants	58.6 percentage of participants	—	—	—	—	—	—
Percentage of Participants Taking Concomitant RA Medications Leflunomide	12.0 percentage of participants	13.0 percentage of participants	—	—	—	—	—	—
Percentage of Participants Taking Concomitant RA Medications Sulfasalazine	3.6 percentage of participants	4.1 percentage of participants	—	—	—	—	—	—
Percentage of Participants Taking Concomitant RA Medications Analgesics	10.9 percentage of participants	12.5 percentage of participants	—	—	—	—	—	—
Percentage of Participants Taking Concomitant RA Medications NSAIDs or coxibs	22.1 percentage of participants	24.2 percentage of participants	—	—	—	—	—	—
Percentage of Participants Taking Concomitant RA Medications Systemic glucocorticoids	68.1 percentage of participants	73.4 percentage of participants	—	—	—	—	—	—
Percentage of Participants Taking Concomitant RA Medications Other	3.8 percentage of participants	9.8 percentage of participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Months 3, 6, 12, 24, 36, 48, and 60

Population: Participants with sufficient data to evaluate clinical outcomes and baseline disease activity high enough to evaluate effectiveness (full analysis set), with available data at each time point.

Participants were asked to rate therapy with adalimumab in comparison with other previous therapies according to the following response options:

• Considerably better
• Better
• About the same
• Worse
• Noticeably worse

Outcome measures

Measure	Adalimumab n=4007 Participants Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.	Month 3 n=3452 Participants 3 months after enrollment	Month 6 n=2814 Participants 6 months after enrollment	Month 12 n=1983 Participants 12 months after enrollment	Month 24 n=1366 Participants 24 months after enrollment	Month 36 n=971 Participants 36 months after enrollment	Month 48 n=716 Participants 48 months after enrollment	Month 60 60 months after enrollment
Patient Assessment of Adalimumab Therapy About the same	19.2 percentage of participants	14.9 percentage of participants	12.2 percentage of participants	9.1 percentage of participants	6.7 percentage of participants	5.6 percentage of participants	5.6 percentage of participants	—
Patient Assessment of Adalimumab Therapy Considerably better	35.6 percentage of participants	39.6 percentage of participants	46.3 percentage of participants	51.6 percentage of participants	51.5 percentage of participants	55.5 percentage of participants	53.6 percentage of participants	—
Patient Assessment of Adalimumab Therapy Better	36.6 percentage of participants	39.7 percentage of participants	37.3 percentage of participants	37.1 percentage of participants	40.4 percentage of participants	38.1 percentage of participants	38.8 percentage of participants	—
Patient Assessment of Adalimumab Therapy Worse	6.9 percentage of participants	5.0 percentage of participants	3.8 percentage of participants	1.9 percentage of participants	1.3 percentage of participants	0.5 percentage of participants	1.1 percentage of participants	—
Patient Assessment of Adalimumab Therapy Noticeably worse	1.6 percentage of participants	0.9 percentage of participants	0.4 percentage of participants	0.3 percentage of participants	0.1 percentage of participants	0.3 percentage of participants	0.8 percentage of participants	—

Adverse Events

Adalimumab

Serious events: 932 serious events

Other events: 831 other events

Deaths: 23 deaths

Serious adverse events

Measure	Adalimumab n=7229 participants at risk Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
Surgical and medical procedures Hospitalisation	1.5% 110/7229 • 60 months
Surgical and medical procedures Knee arthroplasty	0.41% 30/7229 • 60 months
Surgical and medical procedures Elective surgery	0.37% 27/7229 • 60 months
Surgical and medical procedures Arthrodesis	0.35% 25/7229 • 60 months
Surgical and medical procedures Hip arthroplasty	0.33% 24/7229 • 60 months
Surgical and medical procedures Synovectomy	0.26% 19/7229 • 60 months
Surgical and medical procedures Foot operation	0.25% 18/7229 • 60 months
Surgical and medical procedures Joint arthroplasty	0.25% 18/7229 • 60 months
Surgical and medical procedures Bunion operation	0.19% 14/7229 • 60 months
Surgical and medical procedures Cholecystectomy	0.17% 12/7229 • 60 months
Surgical and medical procedures Therapy cessation	0.17% 12/7229 • 60 months
Surgical and medical procedures Surgery	0.14% 10/7229 • 60 months
Surgical and medical procedures Therapy change	0.14% 10/7229 • 60 months
Surgical and medical procedures Rehabilitation therapy	0.12% 9/7229 • 60 months
Surgical and medical procedures Laparoscopic surgery	0.11% 8/7229 • 60 months
Surgical and medical procedures Spinal operation	0.11% 8/7229 • 60 months
Surgical and medical procedures Coronary arterial stent insertion	0.10% 7/7229 • 60 months
Surgical and medical procedures Intervertebral disc operation	0.10% 7/7229 • 60 months
Surgical and medical procedures Osteosynthesis	0.10% 7/7229 • 60 months
Surgical and medical procedures Osteotomy	0.10% 7/7229 • 60 months
Surgical and medical procedures Antibiotic therapy	0.08% 6/7229 • 60 months
Surgical and medical procedures Arthroscopic surgery	0.08% 6/7229 • 60 months
Surgical and medical procedures Coronary artery bypass	0.08% 6/7229 • 60 months
Surgical and medical procedures Knee operation	0.08% 6/7229 • 60 months
Surgical and medical procedures Rheumatoid nodule removal	0.08% 6/7229 • 60 months
Surgical and medical procedures Antibiotic prophylaxis	0.07% 5/7229 • 60 months
Surgical and medical procedures Aortic valve replacement	0.07% 5/7229 • 60 months
Surgical and medical procedures Bursa removal	0.07% 5/7229 • 60 months
Surgical and medical procedures Cardiac pacemaker insertion	0.07% 5/7229 • 60 months
Surgical and medical procedures Inguinal hernia repair	0.07% 5/7229 • 60 months
Surgical and medical procedures Ankle arthroplasty	0.06% 4/7229 • 60 months
Surgical and medical procedures Baker's cyst excision	0.06% 4/7229 • 60 months
Surgical and medical procedures Cataract operation	0.06% 4/7229 • 60 months
Surgical and medical procedures Fracture treatment	0.06% 4/7229 • 60 months
Surgical and medical procedures Renal stone removal	0.06% 4/7229 • 60 months
Surgical and medical procedures Rotator cuff repair	0.06% 4/7229 • 60 months
Surgical and medical procedures Shoulder operation	0.06% 4/7229 • 60 months
Surgical and medical procedures Spinal fusion surgery	0.06% 4/7229 • 60 months
Surgical and medical procedures Thyroidectomy	0.06% 4/7229 • 60 months
Surgical and medical procedures Abdominal operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Abscess drainage	0.04% 3/7229 • 60 months
Surgical and medical procedures Ankle operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Breast conserving surgery	0.04% 3/7229 • 60 months
Surgical and medical procedures Cancer surgery	0.04% 3/7229 • 60 months
Surgical and medical procedures Cardiac operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Coronary angioplasty	0.04% 3/7229 • 60 months
Surgical and medical procedures Emergency care	0.04% 3/7229 • 60 months
Surgical and medical procedures Gallbladder operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Haematoma evacuation	0.04% 3/7229 • 60 months
Surgical and medical procedures Hysterectomy	0.04% 3/7229 • 60 months
Surgical and medical procedures Joint surgery	0.04% 3/7229 • 60 months
Surgical and medical procedures Meniscus operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Pain management	0.04% 3/7229 • 60 months
Surgical and medical procedures Shoulder arthroplasty	0.04% 3/7229 • 60 months
Surgical and medical procedures Sigmoidectomy	0.04% 3/7229 • 60 months
Surgical and medical procedures Skin graft	0.04% 3/7229 • 60 months
Surgical and medical procedures Skin neoplasm excision	0.04% 3/7229 • 60 months
Surgical and medical procedures Spinal decompression	0.04% 3/7229 • 60 months
Surgical and medical procedures Stent placement	0.04% 3/7229 • 60 months
Surgical and medical procedures Tendon operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Toe operation	0.04% 3/7229 • 60 months
Surgical and medical procedures Tooth extraction	0.04% 3/7229 • 60 months
Surgical and medical procedures Arterial stent insertion	0.03% 2/7229 • 60 months
Surgical and medical procedures Breast reconstruction	0.03% 2/7229 • 60 months
Surgical and medical procedures Cardiac ablation	0.03% 2/7229 • 60 months
Surgical and medical procedures Carpal tunnel decompression	0.03% 2/7229 • 60 months
Surgical and medical procedures Cartilage operation	0.03% 2/7229 • 60 months
Surgical and medical procedures Chemotherapy	0.03% 2/7229 • 60 months
Surgical and medical procedures Gastrectomy	0.03% 2/7229 • 60 months
Surgical and medical procedures Hernia repair	0.03% 2/7229 • 60 months
Surgical and medical procedures Hip surgery	0.03% 2/7229 • 60 months
Surgical and medical procedures Infiltration anaesthesia	0.03% 2/7229 • 60 months
Surgical and medical procedures Joint dislocation reduction	0.03% 2/7229 • 60 months
Surgical and medical procedures Massage	0.03% 2/7229 • 60 months
Surgical and medical procedures Mastectomy	0.03% 2/7229 • 60 months
Surgical and medical procedures Medical device removal	0.03% 2/7229 • 60 months
Surgical and medical procedures Nasal operation	0.03% 2/7229 • 60 months
Surgical and medical procedures Nasal polypectomy	0.03% 2/7229 • 60 months
Surgical and medical procedures Open reduction of fracture	0.03% 2/7229 • 60 months
Surgical and medical procedures Ovarian cystectomy	0.03% 2/7229 • 60 months
Surgical and medical procedures Postoperative care	0.03% 2/7229 • 60 months
Surgical and medical procedures Prostatic operation	0.03% 2/7229 • 60 months
Surgical and medical procedures Pulmonary resection	0.03% 2/7229 • 60 months
Surgical and medical procedures Radiotherapy	0.03% 2/7229 • 60 months
Surgical and medical procedures Removal of internal fixation	0.03% 2/7229 • 60 months
Surgical and medical procedures Sinus operation	0.03% 2/7229 • 60 months
Surgical and medical procedures Tendon sheath incision	0.03% 2/7229 • 60 months
Surgical and medical procedures Tenoplasty	0.03% 2/7229 • 60 months
Surgical and medical procedures Thyroid operation	0.03% 2/7229 • 60 months
Surgical and medical procedures Transurethral prostatectomy	0.03% 2/7229 • 60 months
Surgical and medical procedures Ureteral stent insertion	0.03% 2/7229 • 60 months
Surgical and medical procedures Wound treatment	0.03% 2/7229 • 60 months
Surgical and medical procedures Abdominal hernia repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Adhesiolysis	0.01% 1/7229 • 60 months
Surgical and medical procedures Adrenocortical steroid therapy	0.01% 1/7229 • 60 months
Surgical and medical procedures Aneurysm repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Angioplasty	0.01% 1/7229 • 60 months
Surgical and medical procedures Antiallergic therapy	0.01% 1/7229 • 60 months
Surgical and medical procedures Anticoagulant therapy	0.01% 1/7229 • 60 months
Surgical and medical procedures Aortic aneurysm repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Appendicectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Arterial aneurysm repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Arterial bypass operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Arterial catheterisation	0.01% 1/7229 • 60 months
Surgical and medical procedures Arthrotomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Bone operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Bronchial lesion excision	0.01% 1/7229 • 60 months
Surgical and medical procedures Bursal operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Cardiac pacemaker replacement	0.01% 1/7229 • 60 months
Surgical and medical procedures Cerebrovascular operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Chest wall operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Coronary revascularisation	0.01% 1/7229 • 60 months
Surgical and medical procedures Cryotherapy	0.01% 1/7229 • 60 months
Surgical and medical procedures Cyst removal	0.01% 1/7229 • 60 months
Surgical and medical procedures Debridement	0.01% 1/7229 • 60 months
Surgical and medical procedures Diabetes mellitus management	0.01% 1/7229 • 60 months
Surgical and medical procedures Eye operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Femoral hernia repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Fistula repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Fluid replacement	0.01% 1/7229 • 60 months
Surgical and medical procedures Fracture debridement	0.01% 1/7229 • 60 months
Surgical and medical procedures Frontal sinus operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Gastric operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Gingival operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Haemostasis	0.01% 1/7229 • 60 months
Surgical and medical procedures Implantable defibrillator insertion	0.01% 1/7229 • 60 months
Surgical and medical procedures Infusion	0.01% 1/7229 • 60 months
Surgical and medical procedures Injection	0.01% 1/7229 • 60 months
Surgical and medical procedures Intestinal operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Jaw operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Joint debridement	0.01% 1/7229 • 60 months
Surgical and medical procedures Joint injection	0.01% 1/7229 • 60 months
Surgical and medical procedures Joint stabilisation	0.01% 1/7229 • 60 months
Surgical and medical procedures Laparotomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Leg amputation	0.01% 1/7229 • 60 months
Surgical and medical procedures Ligament operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Limb operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Lip repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Lithotripsy	0.01% 1/7229 • 60 months
Surgical and medical procedures Lung transplant	0.01% 1/7229 • 60 months
Surgical and medical procedures Lymphoma operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Meniscus removal	0.01% 1/7229 • 60 months
Surgical and medical procedures Nasal septal operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Nephrectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Nephroplasty	0.01% 1/7229 • 60 months
Surgical and medical procedures Nephrostomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Neurectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Oophorectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Ossiculoplasty	0.01% 1/7229 • 60 months
Surgical and medical procedures Ostectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Pancreatic operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Parotidectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Percutaneous coronary intervention	0.01% 1/7229 • 60 months
Surgical and medical procedures Peritoneal lavage	0.01% 1/7229 • 60 months
Surgical and medical procedures Pharyngeal operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Polypectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Pyeloplasty	0.01% 1/7229 • 60 months
Surgical and medical procedures Radical prostatectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Radioactive iodine therapy	0.01% 1/7229 • 60 months
Surgical and medical procedures Rectal polypectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Renal artery stent placement	0.01% 1/7229 • 60 months
Surgical and medical procedures Resuscitation	0.01% 1/7229 • 60 months
Surgical and medical procedures Skin lesion removal	0.01% 1/7229 • 60 months
Surgical and medical procedures Spinal cord operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Sternotomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Therapeutic embolisation	0.01% 1/7229 • 60 months
Surgical and medical procedures Thrombolysis	0.01% 1/7229 • 60 months
Surgical and medical procedures Toe amputation	0.01% 1/7229 • 60 months
Surgical and medical procedures Tongue operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Tonsillectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Transfusion	0.01% 1/7229 • 60 months
Surgical and medical procedures Tumour excision	0.01% 1/7229 • 60 months
Surgical and medical procedures Umbilical hernia repair	0.01% 1/7229 • 60 months
Surgical and medical procedures Unevaluable therapy	0.01% 1/7229 • 60 months
Surgical and medical procedures Ureterectomy	0.01% 1/7229 • 60 months
Surgical and medical procedures Ureteric operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Urinary incontinence surgery	0.01% 1/7229 • 60 months
Surgical and medical procedures Varicose vein operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Venous operation	0.01% 1/7229 • 60 months
Surgical and medical procedures Vertebral body replacement	0.01% 1/7229 • 60 months
Surgical and medical procedures Wound closure	0.01% 1/7229 • 60 months
Surgical and medical procedures Wound drainage	0.01% 1/7229 • 60 months
Surgical and medical procedures Wrist surgery	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia	0.82% 59/7229 • 60 months
Infections and infestations Infection	0.19% 14/7229 • 60 months
Infections and infestations Bronchitis	0.18% 13/7229 • 60 months
Infections and infestations Urosepsis	0.15% 11/7229 • 60 months
Infections and infestations Diverticulitis	0.14% 10/7229 • 60 months
Infections and infestations Urinary tract infection	0.14% 10/7229 • 60 months
Infections and infestations Gastroenteritis	0.11% 8/7229 • 60 months
Infections and infestations Herpes zoster	0.11% 8/7229 • 60 months
Infections and infestations Postoperative wound infection	0.10% 7/7229 • 60 months
Infections and infestations Abscess limb	0.08% 6/7229 • 60 months
Infections and infestations Post procedural infection	0.08% 6/7229 • 60 months
Infections and infestations Sepsis	0.08% 6/7229 • 60 months
Infections and infestations Cellulitis	0.07% 5/7229 • 60 months
Infections and infestations Respiratory tract infection	0.07% 5/7229 • 60 months
Infections and infestations Device related infection	0.06% 4/7229 • 60 months
Infections and infestations Endocarditis	0.06% 4/7229 • 60 months
Infections and infestations Erysipelas	0.06% 4/7229 • 60 months
Infections and infestations Meningitis	0.06% 4/7229 • 60 months
Infections and infestations Osteomyelitis	0.06% 4/7229 • 60 months
Infections and infestations Subcutaneous abscess	0.06% 4/7229 • 60 months
Infections and infestations Upper respiratory tract infection	0.06% 4/7229 • 60 months
Infections and infestations Abscess	0.04% 3/7229 • 60 months
Infections and infestations Gastroenteritis norovirus	0.04% 3/7229 • 60 months
Infections and infestations Intervertebral discitis	0.04% 3/7229 • 60 months
Infections and infestations Pyelonephritis	0.04% 3/7229 • 60 months
Infections and infestations Septic shock	0.04% 3/7229 • 60 months
Infections and infestations Sinusitis	0.04% 3/7229 • 60 months
Infections and infestations Tuberculosis	0.04% 3/7229 • 60 months
Infections and infestations Viral infection	0.04% 3/7229 • 60 months
Infections and infestations Wound infection	0.04% 3/7229 • 60 months
Infections and infestations Appendicitis perforated	0.03% 2/7229 • 60 months
Infections and infestations Breast abscess	0.03% 2/7229 • 60 months
Infections and infestations Chronic sinusitis	0.03% 2/7229 • 60 months
Infections and infestations Escherichia sepsis	0.03% 2/7229 • 60 months
Infections and infestations Genital herpes	0.03% 2/7229 • 60 months
Infections and infestations Infectious colitis	0.03% 2/7229 • 60 months
Infections and infestations Infectious pleural effusion	0.03% 2/7229 • 60 months
Infections and infestations Lung infection	0.03% 2/7229 • 60 months
Infections and infestations Lymph node tuberculosis	0.03% 2/7229 • 60 months
Infections and infestations Nasal herpes	0.03% 2/7229 • 60 months
Infections and infestations Nasopharyngitis	0.03% 2/7229 • 60 months
Infections and infestations Oral herpes	0.03% 2/7229 • 60 months
Infections and infestations Peritonitis	0.03% 2/7229 • 60 months
Infections and infestations Pertussis	0.03% 2/7229 • 60 months
Infections and infestations Pulmonary tuberculosis	0.03% 2/7229 • 60 months
Infections and infestations Soft tissue infection	0.03% 2/7229 • 60 months
Infections and infestations Staphylococcal infection	0.03% 2/7229 • 60 months
Infections and infestations Tooth abscess	0.03% 2/7229 • 60 months
Infections and infestations Vestibular neuronitis	0.03% 2/7229 • 60 months
Infections and infestations Abdominal abscess	0.01% 1/7229 • 60 months
Infections and infestations Abscess neck	0.01% 1/7229 • 60 months
Infections and infestations Abscess soft tissue	0.01% 1/7229 • 60 months
Infections and infestations Acne pustular	0.01% 1/7229 • 60 months
Infections and infestations Anal abscess	0.01% 1/7229 • 60 months
Infections and infestations Arthritis bacterial	0.01% 1/7229 • 60 months
Infections and infestations Atypical pneumonia	0.01% 1/7229 • 60 months
Infections and infestations Bronchiolitis	0.01% 1/7229 • 60 months
Infections and infestations Bronchitis bacterial	0.01% 1/7229 • 60 months
Infections and infestations Bursitis infective	0.01% 1/7229 • 60 months
Infections and infestations Candida infection	0.01% 1/7229 • 60 months
Infections and infestations Candida pneumonia	0.01% 1/7229 • 60 months
Infections and infestations Carbuncle	0.01% 1/7229 • 60 months
Infections and infestations Cholangitis infective	0.01% 1/7229 • 60 months
Infections and infestations Chronic hepatitis C	0.01% 1/7229 • 60 months
Infections and infestations Clostridial infection	0.01% 1/7229 • 60 months
Infections and infestations Conjunctivitis	0.01% 1/7229 • 60 months
Infections and infestations Cystitis	0.01% 1/7229 • 60 months
Infections and infestations Diabetic gangrene	0.01% 1/7229 • 60 months
Infections and infestations Disseminated tuberculosis	0.01% 1/7229 • 60 months
Infections and infestations Emphysematous cholecystitis	0.01% 1/7229 • 60 months
Infections and infestations Encephalitis viral	0.01% 1/7229 • 60 months
Infections and infestations Endocarditis staphylococcal	0.01% 1/7229 • 60 months
Infections and infestations Epstein-Barr virus infection	0.01% 1/7229 • 60 months
Infections and infestations Escherichia urinary tract infection	0.01% 1/7229 • 60 months
Infections and infestations Folliculitis	0.01% 1/7229 • 60 months
Infections and infestations Furuncle	0.01% 1/7229 • 60 months
Infections and infestations Gallbladder empyema	0.01% 1/7229 • 60 months
Infections and infestations Gastroenteritis viral	0.01% 1/7229 • 60 months
Infections and infestations Gastrointestinal infection	0.01% 1/7229 • 60 months
Infections and infestations Genital candidiasis	0.01% 1/7229 • 60 months
Infections and infestations Gingivitis	0.01% 1/7229 • 60 months
Infections and infestations Groin abscess	0.01% 1/7229 • 60 months
Infections and infestations Herpes ophthalmic	0.01% 1/7229 • 60 months
Infections and infestations Herpes simplex encephalitis	0.01% 1/7229 • 60 months
Infections and infestations Herpes virus infection	0.01% 1/7229 • 60 months
Infections and infestations Infected seroma	0.01% 1/7229 • 60 months
Infections and infestations Infection susceptibility increased	0.01% 1/7229 • 60 months
Infections and infestations Keratouveitis	0.01% 1/7229 • 60 months
Infections and infestations Laryngitis	0.01% 1/7229 • 60 months
Infections and infestations Liver abscess	0.01% 1/7229 • 60 months
Infections and infestations Localised infection	0.01% 1/7229 • 60 months
Infections and infestations Lung abscess	0.01% 1/7229 • 60 months
Infections and infestations Lymphangitis	0.01% 1/7229 • 60 months
Infections and infestations Meningoencephalitis herpetic	0.01% 1/7229 • 60 months
Infections and infestations Mycobacterium marinum infection	0.01% 1/7229 • 60 months
Infections and infestations Necrotising fasciitis	0.01% 1/7229 • 60 months
Infections and infestations Otitis media	0.01% 1/7229 • 60 months
Infections and infestations Paronychia	0.01% 1/7229 • 60 months
Infections and infestations Parotitis	0.01% 1/7229 • 60 months
Infections and infestations Peritoneal abscess	0.01% 1/7229 • 60 months
Infections and infestations Pharyngitis	0.01% 1/7229 • 60 months
Infections and infestations Pneumococcal sepsis	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia bacterial	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia escherichia	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia fungal	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia legionella	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia necrotising	0.01% 1/7229 • 60 months
Infections and infestations Pneumonia viral	0.01% 1/7229 • 60 months
Infections and infestations Poliomyelitis	0.01% 1/7229 • 60 months
Infections and infestations Pulmonary sepsis	0.01% 1/7229 • 60 months
Infections and infestations Pulpitis dental	0.01% 1/7229 • 60 months
Infections and infestations Purulence	0.01% 1/7229 • 60 months
Infections and infestations Pyonephrosis	0.01% 1/7229 • 60 months
Infections and infestations Rash pustular	0.01% 1/7229 • 60 months
Infections and infestations Salmonellosis	0.01% 1/7229 • 60 months
Infections and infestations Septic encephalopathy	0.01% 1/7229 • 60 months
Infections and infestations Staphylococcal sepsis	0.01% 1/7229 • 60 months
Infections and infestations Superinfection	0.01% 1/7229 • 60 months
Infections and infestations Testicular abscess	0.01% 1/7229 • 60 months
Infections and infestations Tonsillitis	0.01% 1/7229 • 60 months
Infections and infestations Tracheitis	0.01% 1/7229 • 60 months
Infections and infestations Tuberculosis gastrointestinal	0.01% 1/7229 • 60 months
Infections and infestations Tuberculosis of genitourinary system	0.01% 1/7229 • 60 months
Infections and infestations Tuberculosis of intrathoracic lymph nodes	0.01% 1/7229 • 60 months
Infections and infestations Tuberculous pleurisy	0.01% 1/7229 • 60 months
Infections and infestations Vulvovaginal mycotic infection	0.01% 1/7229 • 60 months
Infections and infestations Wound infection bacterial	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.48% 35/7229 • 60 months
Musculoskeletal and connective tissue disorders Osteoarthritis	0.21% 15/7229 • 60 months
Musculoskeletal and connective tissue disorders Foot deformity	0.19% 14/7229 • 60 months
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.18% 13/7229 • 60 months
Musculoskeletal and connective tissue disorders Bursitis	0.14% 10/7229 • 60 months
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.14% 10/7229 • 60 months
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 9/7229 • 60 months
Musculoskeletal and connective tissue disorders Synovial cyst	0.10% 7/7229 • 60 months
Musculoskeletal and connective tissue disorders Synovitis	0.10% 7/7229 • 60 months
Musculoskeletal and connective tissue disorders Arthritis	0.08% 6/7229 • 60 months
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.08% 6/7229 • 60 months
Musculoskeletal and connective tissue disorders Acquired claw toe	0.07% 5/7229 • 60 months
Musculoskeletal and connective tissue disorders Back pain	0.07% 5/7229 • 60 months
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.07% 5/7229 • 60 months
Musculoskeletal and connective tissue disorders Pain in extremity	0.07% 5/7229 • 60 months
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.07% 5/7229 • 60 months
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.06% 4/7229 • 60 months
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.04% 3/7229 • 60 months
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.04% 3/7229 • 60 months
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.04% 3/7229 • 60 months
Musculoskeletal and connective tissue disorders Arthropathy	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Metatarsalgia	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Osteochondrosis	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Scoliosis	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Spinal instability	0.03% 2/7229 • 60 months
Musculoskeletal and connective tissue disorders Ankle impingement	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Arthritis reactive	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Bursal haematoma	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Chondromalacia	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Compartment syndrome	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Exostosis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Felty's syndrome	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Fibromyalgia	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Groin pain	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Haemarthrosis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Hip deformity	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Joint destruction	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Joint swelling	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Ligament pain	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Meniscal degeneration	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Myalgia	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Neck pain	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Osteonecrosis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Osteoporosis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Polyarthritis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders SAPHO syndrome	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Synovial disorder	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Tenosynovitis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.01% 1/7229 • 60 months
Musculoskeletal and connective tissue disorders Wrist deformity	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Fall	0.26% 19/7229 • 60 months
Injury, poisoning and procedural complications Femoral neck fracture	0.10% 7/7229 • 60 months
Injury, poisoning and procedural complications Humerus fracture	0.10% 7/7229 • 60 months
Injury, poisoning and procedural complications Multiple fractures	0.10% 7/7229 • 60 months
Injury, poisoning and procedural complications Tendon rupture	0.10% 7/7229 • 60 months
Injury, poisoning and procedural complications Joint dislocation	0.08% 6/7229 • 60 months
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.08% 6/7229 • 60 months
Injury, poisoning and procedural complications Radius fracture	0.08% 6/7229 • 60 months
Injury, poisoning and procedural complications Ulna fracture	0.08% 6/7229 • 60 months
Injury, poisoning and procedural complications Accident at work	0.07% 5/7229 • 60 months
Injury, poisoning and procedural complications Foot fracture	0.07% 5/7229 • 60 months
Injury, poisoning and procedural complications Ankle fracture	0.06% 4/7229 • 60 months
Injury, poisoning and procedural complications Femur fracture	0.06% 4/7229 • 60 months
Injury, poisoning and procedural complications Fracture displacement	0.06% 4/7229 • 60 months
Injury, poisoning and procedural complications Tibia fracture	0.06% 4/7229 • 60 months
Injury, poisoning and procedural complications Lower limb fracture	0.04% 3/7229 • 60 months
Injury, poisoning and procedural complications Road traffic accident	0.04% 3/7229 • 60 months
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.04% 3/7229 • 60 months
Injury, poisoning and procedural complications Accident at home	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Arthropod bite	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Fracture	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Injury	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Limb injury	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Pelvic fracture	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Post procedural complication	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Post procedural fistula	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Wound	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Wrist fracture	0.03% 2/7229 • 60 months
Injury, poisoning and procedural complications Acetabulum fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Animal bite	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Burns second degree	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Clavicle fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Contusion	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Craniocerebral injury	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Fibula fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Forearm fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Fractured ischium	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Ilium fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Kidney rupture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Ligament sprain	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Limb crushing injury	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Limb traumatic amputation	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Meniscus injury	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Multiple injuries	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Muscle strain	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Nerve injury	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Pancreatic duct rupture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Patella fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Post procedural haemorrhage	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Rib fracture	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Skin abrasion	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Skin wound	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Soft tissue injury	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Stab wound	0.01% 1/7229 • 60 months
Injury, poisoning and procedural complications Suture related complication	0.01% 1/7229 • 60 months
General disorders Death	0.22% 16/7229 • 60 months
General disorders Pyrexia	0.19% 14/7229 • 60 months
General disorders Unevaluable event	0.17% 12/7229 • 60 months
General disorders Complication associated with device	0.12% 9/7229 • 60 months
General disorders Impaired healing	0.12% 9/7229 • 60 months
General disorders Drug ineffective	0.11% 8/7229 • 60 months
General disorders Chest pain	0.10% 7/7229 • 60 months
General disorders Fatigue	0.06% 4/7229 • 60 months
General disorders Influenza like illness	0.06% 4/7229 • 60 months
General disorders Pain	0.06% 4/7229 • 60 months
General disorders Perforated ulcer	0.06% 4/7229 • 60 months
General disorders Peripheral swelling	0.06% 4/7229 • 60 months
General disorders Inflammation	0.04% 3/7229 • 60 months
General disorders No adverse event	0.04% 3/7229 • 60 months
General disorders Asthenia	0.03% 2/7229 • 60 months
General disorders Condition aggravated	0.03% 2/7229 • 60 months
General disorders Cyst	0.03% 2/7229 • 60 months
General disorders General physical health deterioration	0.03% 2/7229 • 60 months
General disorders Swelling	0.03% 2/7229 • 60 months
General disorders Adverse drug reaction	0.01% 1/7229 • 60 months
General disorders Chest discomfort	0.01% 1/7229 • 60 months
General disorders Drug interaction	0.01% 1/7229 • 60 months
General disorders Exercise tolerance decreased	0.01% 1/7229 • 60 months
General disorders Granuloma	0.01% 1/7229 • 60 months
General disorders Injection site erythema	0.01% 1/7229 • 60 months
General disorders Injection site pruritus	0.01% 1/7229 • 60 months
General disorders Injection site reaction	0.01% 1/7229 • 60 months
General disorders Injection site warmth	0.01% 1/7229 • 60 months
General disorders Multiple organ dysfunction syndrome	0.01% 1/7229 • 60 months
General disorders Oedema peripheral	0.01% 1/7229 • 60 months
General disorders Precancerous mucosal lesion	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.21% 15/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.07% 5/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.06% 4/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.06% 4/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.04% 3/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.04% 3/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.04% 3/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.04% 3/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.03% 2/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical fibroxanthoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign cardiac neoplasm	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ear neoplasm malignant	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epiglottic carcinoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage I	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage III	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease mixed cellularity stage unspecified	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma recurrent	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.01% 1/7229 • 60 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.01% 1/7229 • 60 months
Cardiac disorders Myocardial infarction	0.21% 15/7229 • 60 months
Cardiac disorders Coronary artery disease	0.19% 14/7229 • 60 months
Cardiac disorders Atrial fibrillation	0.18% 13/7229 • 60 months
Cardiac disorders Acute myocardial infarction	0.17% 12/7229 • 60 months
Cardiac disorders Cardiac failure	0.10% 7/7229 • 60 months
Cardiac disorders Coronary artery stenosis	0.10% 7/7229 • 60 months
Cardiac disorders Angina pectoris	0.04% 3/7229 • 60 months
Cardiac disorders Aortic valve stenosis	0.04% 3/7229 • 60 months
Cardiac disorders Arrhythmia	0.04% 3/7229 • 60 months
Cardiac disorders Palpitations	0.04% 3/7229 • 60 months
Cardiac disorders Angina unstable	0.03% 2/7229 • 60 months
Cardiac disorders Cardiac failure chronic	0.03% 2/7229 • 60 months
Cardiac disorders Left ventricular failure	0.03% 2/7229 • 60 months
Cardiac disorders Pericarditis	0.03% 2/7229 • 60 months
Cardiac disorders Sinus node dysfunction	0.03% 2/7229 • 60 months
Cardiac disorders Sinus tachycardia	0.03% 2/7229 • 60 months
Cardiac disorders Adams-Stokes syndrome	0.01% 1/7229 • 60 months
Cardiac disorders Aortic valve incompetence	0.01% 1/7229 • 60 months
Cardiac disorders Atrial flutter	0.01% 1/7229 • 60 months
Cardiac disorders Bradyarrhythmia	0.01% 1/7229 • 60 months
Cardiac disorders Bradycardia	0.01% 1/7229 • 60 months
Cardiac disorders Hypertensive heart disease	0.01% 1/7229 • 60 months
Cardiac disorders Mitral valve incompetence	0.01% 1/7229 • 60 months
Cardiac disorders Myocarditis	0.01% 1/7229 • 60 months
Cardiac disorders Stress cardiomyopathy	0.01% 1/7229 • 60 months
Cardiac disorders Supraventricular tachycardia	0.01% 1/7229 • 60 months
Cardiac disorders Tachyarrhythmia	0.01% 1/7229 • 60 months
Cardiac disorders Tachycardia	0.01% 1/7229 • 60 months
Cardiac disorders Tachycardia induced cardiomyopathy	0.01% 1/7229 • 60 months
Cardiac disorders Ventricular extrasystoles	0.01% 1/7229 • 60 months
Cardiac disorders Ventricular fibrillation	0.01% 1/7229 • 60 months
Cardiac disorders Wolff-Parkinson-White syndrome	0.01% 1/7229 • 60 months
Nervous system disorders Cerebrovascular accident	0.21% 15/7229 • 60 months
Nervous system disorders Cerebral infarction	0.07% 5/7229 • 60 months
Nervous system disorders Headache	0.07% 5/7229 • 60 months
Nervous system disorders Cerebellar infarction	0.06% 4/7229 • 60 months
Nervous system disorders Dizziness	0.06% 4/7229 • 60 months
Nervous system disorders Syncope	0.06% 4/7229 • 60 months
Nervous system disorders Epilepsy	0.04% 3/7229 • 60 months
Nervous system disorders Hemiparesis	0.04% 3/7229 • 60 months
Nervous system disorders Movement disorder	0.04% 3/7229 • 60 months
Nervous system disorders Seizure	0.04% 3/7229 • 60 months
Nervous system disorders Transient ischaemic attack	0.04% 3/7229 • 60 months
Nervous system disorders Aphasia	0.03% 2/7229 • 60 months
Nervous system disorders Cerebral ischaemia	0.03% 2/7229 • 60 months
Nervous system disorders Dizziness postural	0.03% 2/7229 • 60 months
Nervous system disorders Hypoaesthesia	0.03% 2/7229 • 60 months
Nervous system disorders Monoparesis	0.03% 2/7229 • 60 months
Nervous system disorders Paraesthesia	0.03% 2/7229 • 60 months
Nervous system disorders Sciatica	0.03% 2/7229 • 60 months
Nervous system disorders Somnolence	0.03% 2/7229 • 60 months
Nervous system disorders Brain stem infarction	0.01% 1/7229 • 60 months
Nervous system disorders Carotid artery stenosis	0.01% 1/7229 • 60 months
Nervous system disorders Carpal tunnel syndrome	0.01% 1/7229 • 60 months
Nervous system disorders Cerebral haemorrhage	0.01% 1/7229 • 60 months
Nervous system disorders Cognitive disorder	0.01% 1/7229 • 60 months
Nervous system disorders Complex regional pain syndrome	0.01% 1/7229 • 60 months
Nervous system disorders Diabetic neuropathy	0.01% 1/7229 • 60 months
Nervous system disorders Dysaesthesia	0.01% 1/7229 • 60 months
Nervous system disorders Dyskinesia	0.01% 1/7229 • 60 months
Nervous system disorders Facial paresis	0.01% 1/7229 • 60 months
Nervous system disorders Generalised tonic-clonic seizure	0.01% 1/7229 • 60 months
Nervous system disorders Gliosis	0.01% 1/7229 • 60 months
Nervous system disorders Intercostal neuralgia	0.01% 1/7229 • 60 months
Nervous system disorders Intracranial aneurysm	0.01% 1/7229 • 60 months
Nervous system disorders Intracranial venous sinus thrombosis	0.01% 1/7229 • 60 months
Nervous system disorders Lacunar infarction	0.01% 1/7229 • 60 months
Nervous system disorders Migraine	0.01% 1/7229 • 60 months
Nervous system disorders Nerve root compression	0.01% 1/7229 • 60 months
Nervous system disorders Orthostatic intolerance	0.01% 1/7229 • 60 months
Nervous system disorders Paraplegia	0.01% 1/7229 • 60 months
Nervous system disorders Partial seizures	0.01% 1/7229 • 60 months
Nervous system disorders Polyneuropathy	0.01% 1/7229 • 60 months
Nervous system disorders Post herpetic neuralgia	0.01% 1/7229 • 60 months
Nervous system disorders Post polio syndrome	0.01% 1/7229 • 60 months
Nervous system disorders Presyncope	0.01% 1/7229 • 60 months
Nervous system disorders Spinal cord ischaemia	0.01% 1/7229 • 60 months
Nervous system disorders Thalamic infarction	0.01% 1/7229 • 60 months
Nervous system disorders Toxic encephalopathy	0.01% 1/7229 • 60 months
Nervous system disorders Vertebral artery dissection	0.01% 1/7229 • 60 months
Gastrointestinal disorders Vomiting	0.12% 9/7229 • 60 months
Gastrointestinal disorders Diarrhoea	0.07% 5/7229 • 60 months
Gastrointestinal disorders Nausea	0.07% 5/7229 • 60 months
Gastrointestinal disorders Abdominal pain upper	0.04% 3/7229 • 60 months
Gastrointestinal disorders Gastric ulcer	0.04% 3/7229 • 60 months
Gastrointestinal disorders Gastritis	0.04% 3/7229 • 60 months
Gastrointestinal disorders Inguinal hernia	0.04% 3/7229 • 60 months
Gastrointestinal disorders Abdominal discomfort	0.03% 2/7229 • 60 months
Gastrointestinal disorders Colitis	0.03% 2/7229 • 60 months
Gastrointestinal disorders Colitis microscopic	0.03% 2/7229 • 60 months
Gastrointestinal disorders Diverticular perforation	0.03% 2/7229 • 60 months
Gastrointestinal disorders Dry mouth	0.03% 2/7229 • 60 months
Gastrointestinal disorders Dysphagia	0.03% 2/7229 • 60 months
Gastrointestinal disorders Enteritis	0.03% 2/7229 • 60 months
Gastrointestinal disorders Gastritis erosive	0.03% 2/7229 • 60 months
Gastrointestinal disorders Haematochezia	0.03% 2/7229 • 60 months
Gastrointestinal disorders Pancreatitis acute	0.03% 2/7229 • 60 months
Gastrointestinal disorders Stomatitis	0.03% 2/7229 • 60 months
Gastrointestinal disorders Abdominal hernia	0.01% 1/7229 • 60 months
Gastrointestinal disorders Abdominal pain lower	0.01% 1/7229 • 60 months
Gastrointestinal disorders Abdominal tenderness	0.01% 1/7229 • 60 months
Gastrointestinal disorders Aphthous ulcer	0.01% 1/7229 • 60 months
Gastrointestinal disorders Chronic gastritis	0.01% 1/7229 • 60 months
Gastrointestinal disorders Colitis ulcerative	0.01% 1/7229 • 60 months
Gastrointestinal disorders Constipation	0.01% 1/7229 • 60 months
Gastrointestinal disorders Crohn's disease	0.01% 1/7229 • 60 months
Gastrointestinal disorders Diverticulum intestinal	0.01% 1/7229 • 60 months
Gastrointestinal disorders Duodenal ulcer	0.01% 1/7229 • 60 months
Gastrointestinal disorders Erosive duodenitis	0.01% 1/7229 • 60 months
Gastrointestinal disorders Faecaloma	0.01% 1/7229 • 60 months
Gastrointestinal disorders Femoral hernia	0.01% 1/7229 • 60 months
Gastrointestinal disorders Gastrointestinal haemorrhage	0.01% 1/7229 • 60 months
Gastrointestinal disorders Gastrointestinal pain	0.01% 1/7229 • 60 months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.01% 1/7229 • 60 months
Gastrointestinal disorders Gingival recession	0.01% 1/7229 • 60 months
Gastrointestinal disorders Haemorrhoids	0.01% 1/7229 • 60 months
Gastrointestinal disorders Hypoaesthesia oral	0.01% 1/7229 • 60 months
Gastrointestinal disorders Ileus	0.01% 1/7229 • 60 months
Gastrointestinal disorders Intestinal stenosis	0.01% 1/7229 • 60 months
Gastrointestinal disorders Leukoplakia oral	0.01% 1/7229 • 60 months
Gastrointestinal disorders Melaena	0.01% 1/7229 • 60 months
Gastrointestinal disorders Pancreatic duct stenosis	0.01% 1/7229 • 60 months
Gastrointestinal disorders Pancreatic mass	0.01% 1/7229 • 60 months
Gastrointestinal disorders Pancreatitis	0.01% 1/7229 • 60 months
Gastrointestinal disorders Pancreatitis chronic	0.01% 1/7229 • 60 months
Gastrointestinal disorders Rectal polyp	0.01% 1/7229 • 60 months
Gastrointestinal disorders Salivary gland pain	0.01% 1/7229 • 60 months
Gastrointestinal disorders Subileus	0.01% 1/7229 • 60 months
Gastrointestinal disorders Ulcerative gastritis	0.01% 1/7229 • 60 months
Gastrointestinal disorders Umbilical hernia	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.11% 8/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.08% 6/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.08% 6/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.07% 5/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.06% 4/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pleurisy	0.06% 4/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Alveolitis	0.04% 3/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.04% 3/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.04% 3/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Cough	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Emphysema	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Nasal inflammation	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.03% 2/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Asthma	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pleural fibrosis	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Productive cough	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pulmonary hilum mass	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.01% 1/7229 • 60 months
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.01% 1/7229 • 60 months
Investigations Arthroscopy	0.11% 8/7229 • 60 months
Investigations Blood pressure increased	0.08% 6/7229 • 60 months
Investigations Liver function test increased	0.07% 5/7229 • 60 months
Investigations Bronchoscopy	0.04% 3/7229 • 60 months
Investigations Weight decreased	0.04% 3/7229 • 60 months
Investigations Biopsy bone marrow	0.03% 2/7229 • 60 months
Investigations Biopsy liver	0.03% 2/7229 • 60 months
Investigations C-reactive protein increased	0.03% 2/7229 • 60 months
Investigations Computerised tomogram thorax abnormal	0.03% 2/7229 • 60 months
Investigations Double stranded DNA antibody positive	0.03% 2/7229 • 60 months
Investigations Angiogram peripheral	0.01% 1/7229 • 60 months
Investigations Antinuclear antibody positive	0.01% 1/7229 • 60 months
Investigations Arteriogram coronary	0.01% 1/7229 • 60 months
Investigations Autoantibody test	0.01% 1/7229 • 60 months
Investigations Biopsy lymph gland	0.01% 1/7229 • 60 months
Investigations Blood bactericidal activity	0.01% 1/7229 • 60 months
Investigations Blood calcium	0.01% 1/7229 • 60 months
Investigations Blood creatine phosphokinase increased	0.01% 1/7229 • 60 months
Investigations Catheterisation cardiac	0.01% 1/7229 • 60 months
Investigations Colonoscopy normal	0.01% 1/7229 • 60 months
Investigations DNA antibody positive	0.01% 1/7229 • 60 months
Investigations Ejection fraction decreased	0.01% 1/7229 • 60 months
Investigations Emergency care examination	0.01% 1/7229 • 60 months
Investigations Endoscopic retrograde cholangiopancreatography	0.01% 1/7229 • 60 months
Investigations Endoscopy	0.01% 1/7229 • 60 months
Investigations Epstein-Barr virus antibody positive	0.01% 1/7229 • 60 months
Investigations Fibrin D dimer increased	0.01% 1/7229 • 60 months
Investigations Gamma-glutamyltransferase increased	0.01% 1/7229 • 60 months
Investigations Haematocrit decreased	0.01% 1/7229 • 60 months
Investigations Haemoglobin decreased	0.01% 1/7229 • 60 months
Investigations Heart rate irregular	0.01% 1/7229 • 60 months
Investigations Laboratory test abnormal	0.01% 1/7229 • 60 months
Investigations Laparoscopy	0.01% 1/7229 • 60 months
Investigations Mediastinoscopy	0.01% 1/7229 • 60 months
Investigations Mycobacterium tuberculosis complex test positive	0.01% 1/7229 • 60 months
Investigations Neurological examination	0.01% 1/7229 • 60 months
Investigations Neutrophil count decreased	0.01% 1/7229 • 60 months
Investigations Proteus test positive	0.01% 1/7229 • 60 months
Investigations Red blood cell sedimentation rate increased	0.01% 1/7229 • 60 months
Investigations Staphylococcus test positive	0.01% 1/7229 • 60 months
Investigations Transaminases abnormal	0.01% 1/7229 • 60 months
Investigations Ultrasound abdomen abnormal	0.01% 1/7229 • 60 months
Investigations Wound healing normal	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Skin ulcer	0.10% 7/7229 • 60 months
Skin and subcutaneous tissue disorders Urticaria	0.06% 4/7229 • 60 months
Skin and subcutaneous tissue disorders Dermatitis allergic	0.04% 3/7229 • 60 months
Skin and subcutaneous tissue disorders Rash	0.04% 3/7229 • 60 months
Skin and subcutaneous tissue disorders Diabetic foot	0.03% 2/7229 • 60 months
Skin and subcutaneous tissue disorders Drug eruption	0.03% 2/7229 • 60 months
Skin and subcutaneous tissue disorders Erythema	0.03% 2/7229 • 60 months
Skin and subcutaneous tissue disorders Hyperhidrosis	0.03% 2/7229 • 60 months
Skin and subcutaneous tissue disorders Night sweats	0.03% 2/7229 • 60 months
Skin and subcutaneous tissue disorders Pustular psoriasis	0.03% 2/7229 • 60 months
Skin and subcutaneous tissue disorders Alopecia	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Decubitus ulcer	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Dermatitis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Dermatosis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Erythema multiforme	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Hand dermatitis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Hidradenitis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Lividity	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Mucocutaneous ulceration	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Neurodermatitis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Petechiae	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Pruritus	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Psoriasis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Purpura	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Rash generalised	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Rash vesicular	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Rosacea	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Skin hypertrophy	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Skin necrosis	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Swelling face	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.01% 1/7229 • 60 months
Skin and subcutaneous tissue disorders Urticarial vasculitis	0.01% 1/7229 • 60 months
Vascular disorders Hypertension	0.12% 9/7229 • 60 months
Vascular disorders Haematoma	0.07% 5/7229 • 60 months
Vascular disorders Thrombosis	0.07% 5/7229 • 60 months
Vascular disorders Deep vein thrombosis	0.06% 4/7229 • 60 months
Vascular disorders Peripheral arterial occlusive disease	0.06% 4/7229 • 60 months
Vascular disorders Hypertensive crisis	0.04% 3/7229 • 60 months
Vascular disorders Aortic aneurysm	0.03% 2/7229 • 60 months
Vascular disorders Vasculitis	0.03% 2/7229 • 60 months
Vascular disorders Aortic dilatation	0.01% 1/7229 • 60 months
Vascular disorders Arterial occlusive disease	0.01% 1/7229 • 60 months
Vascular disorders Arteriosclerosis	0.01% 1/7229 • 60 months
Vascular disorders Circulatory collapse	0.01% 1/7229 • 60 months
Vascular disorders Flushing	0.01% 1/7229 • 60 months
Vascular disorders Lymphatic fistula	0.01% 1/7229 • 60 months
Vascular disorders Microembolism	0.01% 1/7229 • 60 months
Vascular disorders Pelvic venous thrombosis	0.01% 1/7229 • 60 months
Vascular disorders Peripheral artery aneurysm	0.01% 1/7229 • 60 months
Vascular disorders Peripheral artery occlusion	0.01% 1/7229 • 60 months
Vascular disorders Peripheral artery thrombosis	0.01% 1/7229 • 60 months
Vascular disorders Peripheral ischaemia	0.01% 1/7229 • 60 months
Vascular disorders Shock haemorrhagic	0.01% 1/7229 • 60 months
Vascular disorders Venous thrombosis	0.01% 1/7229 • 60 months
Vascular disorders Venous thrombosis limb	0.01% 1/7229 • 60 months
Renal and urinary disorders Acute kidney injury	0.07% 5/7229 • 60 months
Renal and urinary disorders Renal failure	0.07% 5/7229 • 60 months
Renal and urinary disorders Nephrolithiasis	0.04% 3/7229 • 60 months
Renal and urinary disorders Haematuria	0.03% 2/7229 • 60 months
Renal and urinary disorders Renal colic	0.03% 2/7229 • 60 months
Renal and urinary disorders Renal impairment	0.03% 2/7229 • 60 months
Renal and urinary disorders Ureterolithiasis	0.03% 2/7229 • 60 months
Renal and urinary disorders Urinary tract obstruction	0.03% 2/7229 • 60 months
Renal and urinary disorders Azotaemia	0.01% 1/7229 • 60 months
Renal and urinary disorders Bladder diverticulum	0.01% 1/7229 • 60 months
Renal and urinary disorders Bladder stenosis	0.01% 1/7229 • 60 months
Renal and urinary disorders Calculus urinary	0.01% 1/7229 • 60 months
Renal and urinary disorders Renal artery arteriosclerosis	0.01% 1/7229 • 60 months
Renal and urinary disorders Stress urinary incontinence	0.01% 1/7229 • 60 months
Renal and urinary disorders Ureteric stenosis	0.01% 1/7229 • 60 months
Renal and urinary disorders Urinary hesitation	0.01% 1/7229 • 60 months
Renal and urinary disorders Urinary tract inflammation	0.01% 1/7229 • 60 months
Hepatobiliary disorders Cholelithiasis	0.14% 10/7229 • 60 months
Hepatobiliary disorders Cholecystitis acute	0.07% 5/7229 • 60 months
Hepatobiliary disorders Cholecystitis	0.06% 4/7229 • 60 months
Hepatobiliary disorders Bile duct stone	0.04% 3/7229 • 60 months
Hepatobiliary disorders Cholangitis	0.03% 2/7229 • 60 months
Hepatobiliary disorders Cholestasis	0.03% 2/7229 • 60 months
Hepatobiliary disorders Jaundice	0.03% 2/7229 • 60 months
Hepatobiliary disorders Biliary cirrhosis primary	0.01% 1/7229 • 60 months
Hepatobiliary disorders Cholecystitis chronic	0.01% 1/7229 • 60 months
Hepatobiliary disorders Gallbladder perforation	0.01% 1/7229 • 60 months
Hepatobiliary disorders Hepatic cirrhosis	0.01% 1/7229 • 60 months
Hepatobiliary disorders Hepatitis cholestatic	0.01% 1/7229 • 60 months
Hepatobiliary disorders Liver disorder	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Leukopenia	0.08% 6/7229 • 60 months
Blood and lymphatic system disorders Anaemia	0.07% 5/7229 • 60 months
Blood and lymphatic system disorders Leukocytosis	0.04% 3/7229 • 60 months
Blood and lymphatic system disorders Lymphadenopathy	0.03% 2/7229 • 60 months
Blood and lymphatic system disorders Thrombocytopenia	0.03% 2/7229 • 60 months
Blood and lymphatic system disorders Agranulocytosis	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Bicytopenia	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Cytopenia	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Erythropenia	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Hypochromic anaemia	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Iron deficiency anaemia	0.01% 1/7229 • 60 months
Blood and lymphatic system disorders Pancytopenia	0.01% 1/7229 • 60 months
Psychiatric disorders Depression	0.11% 8/7229 • 60 months
Psychiatric disorders Sleep disorder	0.03% 2/7229 • 60 months
Psychiatric disorders Stress	0.03% 2/7229 • 60 months
Psychiatric disorders Acute stress disorder	0.01% 1/7229 • 60 months
Psychiatric disorders Anxiety	0.01% 1/7229 • 60 months
Psychiatric disorders Mania	0.01% 1/7229 • 60 months
Psychiatric disorders Middle insomnia	0.01% 1/7229 • 60 months
Psychiatric disorders Panic reaction	0.01% 1/7229 • 60 months
Psychiatric disorders Tobacco abuse	0.01% 1/7229 • 60 months
Metabolism and nutrition disorders Diabetes mellitus	0.04% 3/7229 • 60 months
Metabolism and nutrition disorders Dehydration	0.03% 2/7229 • 60 months
Metabolism and nutrition disorders Obesity	0.03% 2/7229 • 60 months
Metabolism and nutrition disorders Decreased appetite	0.01% 1/7229 • 60 months
Metabolism and nutrition disorders Gout	0.01% 1/7229 • 60 months
Metabolism and nutrition disorders Hypercalcaemia	0.01% 1/7229 • 60 months
Metabolism and nutrition disorders Hyperglycaemia	0.01% 1/7229 • 60 months
Metabolism and nutrition disorders Shock hypoglycaemic	0.01% 1/7229 • 60 months
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.01% 1/7229 • 60 months
Reproductive system and breast disorders Benign prostatic hyperplasia	0.07% 5/7229 • 60 months
Reproductive system and breast disorders Ovarian cyst	0.03% 2/7229 • 60 months
Reproductive system and breast disorders Menorrhagia	0.01% 1/7229 • 60 months
Reproductive system and breast disorders Menstrual disorder	0.01% 1/7229 • 60 months
Reproductive system and breast disorders Ovarian adhesion	0.01% 1/7229 • 60 months
Reproductive system and breast disorders Prostatic dysplasia	0.01% 1/7229 • 60 months
Reproductive system and breast disorders Prostatic haemorrhage	0.01% 1/7229 • 60 months
Endocrine disorders Goitre	0.07% 5/7229 • 60 months
Endocrine disorders Thyroid mass	0.04% 3/7229 • 60 months
Endocrine disorders Adrenocortical insufficiency acute	0.01% 1/7229 • 60 months
Endocrine disorders Basedow's disease	0.01% 1/7229 • 60 months
Endocrine disorders Hyperthyroidism	0.01% 1/7229 • 60 months
Ear and labyrinth disorders Sudden hearing loss	0.04% 3/7229 • 60 months
Ear and labyrinth disorders Vertigo	0.03% 2/7229 • 60 months
Ear and labyrinth disorders Vertigo positional	0.03% 2/7229 • 60 months
Ear and labyrinth disorders Otosclerosis	0.01% 1/7229 • 60 months
Ear and labyrinth disorders Tinnitus	0.01% 1/7229 • 60 months
Eye disorders Blepharitis	0.03% 2/7229 • 60 months
Eye disorders Cataract	0.01% 1/7229 • 60 months
Eye disorders Eye disorder	0.01% 1/7229 • 60 months
Eye disorders Eye haemorrhage	0.01% 1/7229 • 60 months
Eye disorders Glaucoma	0.01% 1/7229 • 60 months
Eye disorders Iritis	0.01% 1/7229 • 60 months
Eye disorders Ophthalmic vein thrombosis	0.01% 1/7229 • 60 months
Eye disorders Retinal detachment	0.01% 1/7229 • 60 months
Immune system disorders Drug hypersensitivity	0.01% 1/7229 • 60 months
Immune system disorders Hypersensitivity	0.01% 1/7229 • 60 months
Immune system disorders Immunosuppression	0.01% 1/7229 • 60 months
Immune system disorders Sarcoidosis	0.01% 1/7229 • 60 months
Product Issues Device dislocation	0.04% 3/7229 • 60 months
Product Issues Device breakage	0.01% 1/7229 • 60 months
Pregnancy, puerperium and perinatal conditions Pregnancy	0.03% 2/7229 • 60 months
Pregnancy, puerperium and perinatal conditions Delivery	0.01% 1/7229 • 60 months
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.01% 1/7229 • 60 months
Social circumstances Alcohol use	0.01% 1/7229 • 60 months
Social circumstances Foreign travel	0.01% 1/7229 • 60 months
Social circumstances Postmenopause	0.01% 1/7229 • 60 months
Congenital, familial and genetic disorders Developmental hip dysplasia	0.01% 1/7229 • 60 months
Congenital, familial and genetic disorders Hereditary neuropathic amyloidosis	0.01% 1/7229 • 60 months

Other adverse events

Measure	Adalimumab n=7229 participants at risk Participants with moderate to severe active rheumatoid arthritis who initiated adalimumab therapy during routine clinical care.
Infections and infestations Bronchitis	2.4% 177/7229 • 60 months
Infections and infestations Nasopharyngitis	1.9% 137/7229 • 60 months
Infections and infestations Upper respiratory tract infection	1.8% 130/7229 • 60 months
Infections and infestations Respiratory tract infection	1.5% 106/7229 • 60 months
Infections and infestations Infection	1.2% 88/7229 • 60 months
Infections and infestations Herpes zoster	1.1% 79/7229 • 60 months
General disorders Influenza like illness	2.9% 213/7229 • 60 months
Surgical and medical procedures Therapy cessation	1.1% 78/7229 • 60 months

Additional Information

Global Medical Services

AbbVie (prior sponsor Abbott)

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

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

Restriction type: OTHER