Trial Outcomes & Findings for A Belgian Registry of HUMIRA® (Adalimumab) in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis ( ProAct ) (NCT NCT01078558)

NCT ID: NCT01078558

Last Updated: 2019-07-05

Results Overview

Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.

• Recruitment status: COMPLETED
• Target enrollment: 5940 participants
• Primary outcome timeframe: Baseline, Months 3, 6, 12, 24, 60
• Results posted on: 2019-07-05

Participant Flow

A total of 5940 participants (2845 with rheumatoid arthritis [RA], 1128 with psoriatic arthritis [PsA], and 1967 with ankylosing spondylitis [AS]) were enrolled. Twenty of these participants were younger than 18 years old (9 RA participants, 1 PsA participant, and 10 AS participants); these participants were not included in any analysis.

Participant milestones

Measure	Participants With RA Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Overall Study STARTED	2836	1127	1957
Overall Study Oligoarticular PsA	0	197	0
Overall Study COMPLETED	818	372	596
Overall Study NOT COMPLETED	2018	755	1361

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant in the AS arm had missing data.

Baseline characteristics by cohort

Measure	Participants With RA n=2836 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=1127 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=1957 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Total n=5920 Participants Total of all reporting groups
Age, Continuous	56.64 years STANDARD_DEVIATION 12.96 • n=2836 Participants • 1 participant in the AS arm had missing data.	49.52 years STANDARD_DEVIATION 12.36 • n=1127 Participants • 1 participant in the AS arm had missing data.	43.62 years STANDARD_DEVIATION 12.47 • n=1956 Participants • 1 participant in the AS arm had missing data.	50.98 years STANDARD_DEVIATION 13.95 • n=5919 Participants • 1 participant in the AS arm had missing data.
Sex/Gender, Customized Female	2004 Participants n=2836 Participants	523 Participants n=1127 Participants	903 Participants n=1957 Participants	3430 Participants n=5920 Participants
Sex/Gender, Customized Male	787 Participants n=2836 Participants	591 Participants n=1127 Participants	1033 Participants n=1957 Participants	2411 Participants n=5920 Participants
Sex/Gender, Customized Missing	45 Participants n=2836 Participants	13 Participants n=1127 Participants	21 Participants n=1957 Participants	79 Participants n=5920 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Physician's Assessment of Disease Activity	58.47 units on a scale STANDARD_DEVIATION 22.93 • n=2579 Participants • Includes all participants with a Baseline assessment.	54.58 units on a scale STANDARD_DEVIATION 22.59 • n=1026 Participants • Includes all participants with a Baseline assessment.	59.21 units on a scale STANDARD_DEVIATION 25.32 • n=1741 Participants • Includes all participants with a Baseline assessment.	57.96 units on a scale STANDARD_DEVIATION 23.73 • n=5346 Participants • Includes all participants with a Baseline assessment.
Tender Joints	13.73 tender joints STANDARD_DEVIATION 8.90 • n=2664 Participants • Includes all participants with a Baseline assessment.	10.47 tender joints STANDARD_DEVIATION 8.34 • n=1046 Participants • Includes all participants with a Baseline assessment.	2.40 tender joints STANDARD_DEVIATION 4.31 • n=959 Participants • Includes all participants with a Baseline assessment.	10.67 tender joints STANDARD_DEVIATION 9.16 • n=4669 Participants • Includes all participants with a Baseline assessment.
Swollen Joints	10.79 swollen joints STANDARD_DEVIATION 7.18 • n=2719 Participants • Includes all participants with a Baseline assessment.	7.46 swollen joints STANDARD_DEVIATION 5.37 • n=1049 Participants • Includes all participants with a Baseline assessment.	1.44 swollen joints STANDARD_DEVIATION 3.21 • n=940 Participants • Includes all participants with a Baseline assessment.	8.18 swollen joints STANDARD_DEVIATION 7.17 • n=4708 Participants • Includes all participants with a Baseline assessment.
Inflammatory Parameter: C-Reactive Protein (CRP)	3.68 mg/dL STANDARD_DEVIATION 8.44 • n=2437 Participants • Includes all participants with a Baseline assessment.	2.53 mg/dL STANDARD_DEVIATION 6.90 • n=937 Participants • Includes all participants with a Baseline assessment.	3.24 mg/dL STANDARD_DEVIATION 19.11 • n=1528 Participants • Includes all participants with a Baseline assessment.	3.32 mg/dL STANDARD_DEVIATION 12.59 • n=4902 Participants • Includes all participants with a Baseline assessment.
Inflammatory Parameter: Erythrocyte Sedimentation Rate (ESR)	27.58 mm/hour STANDARD_DEVIATION 21.84 • n=2320 Participants • Includes all participants with a Baseline assessment.	18.87 mm/hour STANDARD_DEVIATION 18.45 • n=836 Participants • Includes all participants with a Baseline assessment.	21.09 mm/hour STANDARD_DEVIATION 19.23 • n=1257 Participants • Includes all participants with a Baseline assessment.	24.08 mm/hour STANDARD_DEVIATION 20.84 • n=4413 Participants • Includes all participants with a Baseline assessment.
Health Assessment Questionnaire (HAQ%)	47.80 percentage of maximum HAQ score STANDARD_DEVIATION 19.22 • n=2555 Participants • Includes all participants with a Baseline assessment.	41.01 percentage of maximum HAQ score STANDARD_DEVIATION 18.65 • n=845 Participants • Includes all participants with a Baseline assessment.	40.80 percentage of maximum HAQ score STANDARD_DEVIATION 24.57 • n=69 Participants • Includes all participants with a Baseline assessment.	46.00 percentage of maximum HAQ score STANDARD_DEVIATION 19.43 • n=3469 Participants • Includes all participants with a Baseline assessment.
Disease Activity Score for 28 Joints (DAS28): RA Participants	5.04 score on a scale STANDARD_DEVIATION 1.21 • n=383 Participants • Includes all RA participants with a Baseline assessment.	—	—	5.04 score on a scale STANDARD_DEVIATION 1.21 • n=383 Participants • Includes all RA participants with a Baseline assessment.
DAS28 Category < 2.6	16 Participants n=383 Participants • Includes all RA participants with a Baseline assessment.	—	—	16 Participants n=383 Participants • Includes all RA participants with a Baseline assessment.
DAS28 Category ≥ 2.6 to ≤ 3.2	4 Participants n=383 Participants • Includes all RA participants with a Baseline assessment.	—	—	4 Participants n=383 Participants • Includes all RA participants with a Baseline assessment.
DAS28 Category > 3.2	363 Participants n=383 Participants • Includes all RA participants with a Baseline assessment.	—	—	363 Participants n=383 Participants • Includes all RA participants with a Baseline assessment.
Body Surface Area (BSA) with PsA < 3% of BSA	—	353 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.	—	353 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.
Body Surface Area (BSA) with PsA 3% to 10% of BSA	—	211 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.	—	211 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.
Body Surface Area (BSA) with PsA 11% to 20% of BSA	—	134 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.	—	134 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.
Body Surface Area (BSA) with PsA > 20% of BSA	—	85 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.	—	85 Participants n=783 Participants • Includes all PsA participants with a Baseline assessment.
Patient's Numerical Rating Scale for Oligarticular PsA Participants	—	6.6 units on a scale STANDARD_DEVIATION 2.0 • n=94 Participants • Includes all oligoarticular PsA participants with a Baseline assessment.	—	6.6 units on a scale STANDARD_DEVIATION 2.0 • n=94 Participants • Includes all oligoarticular PsA participants with a Baseline assessment.
Physician's Numerical Rating Scale for Oligoarticular PsA Participants	—	6.2 units on a scale STANDARD_DEVIATION 2.0 • n=95 Participants • Includes all oligoarticular PsA participants with a Baseline assessment by the physican.	—	6.2 units on a scale STANDARD_DEVIATION 2.0 • n=95 Participants • Includes all oligoarticular PsA participants with a Baseline assessment by the physican.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS Participants	—	—	6.2 units on a scale STANDARD_DEVIATION 1.9 • n=1698 Participants • Includes all AS participants with a Baseline assessment.	6.2 units on a scale STANDARD_DEVIATION 1.9 • n=1698 Participants • Includes all AS participants with a Baseline assessment.

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All participants with a Baseline and post-baseline assessment at given time point.

Physician's assessment of disease activity is measured on a visual analogue scale (VAS) from 0 to 100, with the highest values indicating the worst disease activity.

Outcome measures

Measure	Participants With RA n=1781 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=687 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=1232 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in Physician's Assessment of Disease Activity Over Time Month 3	-34.4 units on a scale Standard Deviation 24.7	-36.2 units on a scale Standard Deviation 24.8	-40.2 units on a scale Standard Deviation 28.4
Change From Baseline in Physician's Assessment of Disease Activity Over Time Month 6	-38.6 units on a scale Standard Deviation 26.4	-40.2 units on a scale Standard Deviation 25.6	-44.5 units on a scale Standard Deviation 28.7
Change From Baseline in Physician's Assessment of Disease Activity Over Time Month 12	-40.4 units on a scale Standard Deviation 27.2	-43.2 units on a scale Standard Deviation 26.6	-46.6 units on a scale Standard Deviation 28.7
Change From Baseline in Physician's Assessment of Disease Activity Over Time Month 24	-42.4 units on a scale Standard Deviation 26.9	-42.2 units on a scale Standard Deviation 27.2	-46.6 units on a scale Standard Deviation 28.7
Change From Baseline in Physician's Assessment of Disease Activity Over Time Month 60	-44.2 units on a scale Standard Deviation 27.3	-44.8 units on a scale Standard Deviation 29.3	-50.2 units on a scale Standard Deviation 29.9

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All participants with a Baseline and post-baseline assessment at given time point.

A total of 28 joints were assessed for tenderness.

Outcome measures

Measure	Participants With RA n=1959 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=755 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=634 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in Tender Joints Over Time Month 3	-8.5 tender joints Standard Deviation 8.0	-6.8 tender joints Standard Deviation 7.8	-1.6 tender joints Standard Deviation 3.5
Change From Baseline in Tender Joints Over Time Month 6	-9.4 tender joints Standard Deviation 8.6	-7.6 tender joints Standard Deviation 7.6	-1.9 tender joints Standard Deviation 4.6
Change From Baseline in Tender Joints Over Time Month 12	-10.2 tender joints Standard Deviation 8.9	-8.0 tender joints Standard Deviation 7.7	-1.9 tender joints Standard Deviation 4.1
Change From Baseline in Tender Joints Over Time Month 24	-10.4 tender joints Standard Deviation 8.9	-7.9 tender joints Standard Deviation 7.9	-2.0 tender joints Standard Deviation 3.9
Change From Baseline in Tender Joints Over Time Month 60	-11.2 tender joints Standard Deviation 8.2	-8.3 tender joints Standard Deviation 8.7	-1.9 tender joints Standard Deviation 3.2

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All participants with a Baseline and post-baseline assessment at given time point.

A total of 28 joints were assessed for swelling.

Outcome measures

Measure	Participants With RA n=1982 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=755 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=623 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in Swollen Joints Over Time Month 3	-7.3 swollen joints Standard Deviation 6.7	-5.6 swollen joints Standard Deviation 5.7	-1.3 swollen joints Standard Deviation 3.1
Change From Baseline in Swollen Joints Over Time Month 6	-8.2 swollen joints Standard Deviation 7.1	-6.1 swollen joints Standard Deviation 5.2	-1.4 swollen joints Standard Deviation 3.4
Change From Baseline in Swollen Joints Over Time Month 12	-8.5 swollen joints Standard Deviation 7.3	-6.5 swollen joints Standard Deviation 5.4	-1.3 swollen joints Standard Deviation 2.9
Change From Baseline in Swollen Joints Over Time Month 24	-9.0 swollen joints Standard Deviation 7.4	-6.5 swollen joints Standard Deviation 5.8	-1.4 swollen joints Standard Deviation 2.8
Change From Baseline in Swollen Joints Over Time Month 60	-9.4 swollen joints Standard Deviation 6.7	-6.8 swollen joints Standard Deviation 6.4	-1.4 swollen joints Standard Deviation 2.4

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All participants with a Baseline and post-baseline assessment at given time point.

Outcome measures

Measure	Participants With RA n=1607 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=568 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=838 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Inflammatory Parameter: Change From Baseline in CRP Over Time Month 6	-1.9 mg/dL Standard Deviation 6.7	-1.8 mg/dL Standard Deviation 9.0	-2.6 mg/dL Standard Deviation 26.1
Inflammatory Parameter: Change From Baseline in CRP Over Time Month 12	-1.9 mg/dL Standard Deviation 7.3	-1.6 mg/dL Standard Deviation 5.5	-2.7 mg/dL Standard Deviation 27.5
Inflammatory Parameter: Change From Baseline in CRP Over Time Month 3	-2.1 mg/dL Standard Deviation 8.0	-1.6 mg/dL Standard Deviation 7.1	-2.8 mg/dL Standard Deviation 25.1
Inflammatory Parameter: Change From Baseline in CRP Over Time Month 24	-1.9 mg/dL Standard Deviation 7.0	-1.2 mg/dL Standard Deviation 9.0	-1.3 mg/dL Standard Deviation 9.3
Inflammatory Parameter: Change From Baseline in CRP Over Time Month 60	-1.6 mg/dL Standard Deviation 13.2	0.0 mg/dL Standard Deviation 13.8	-0.7 mg/dL Standard Deviation 4.6

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All participants with a Baseline and post-baseline assessment at given time point.

Outcome measures

Measure	Participants With RA n=1478 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=497 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=670 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Inflammatory Parameter: Change From Baseline in ESR Over Time Month 3	-8.3 mm/hour Standard Deviation 18.3	-7.0 mm/hour Standard Deviation 17.6	-11.7 mm/hour Standard Deviation 17.8
Inflammatory Parameter: Change From Baseline in ESR Over Time Month 6	-8.1 mm/hour Standard Deviation 18.8	-8.1 mm/hour Standard Deviation 18.8	-10.5 mm/hour Standard Deviation 19.2
Inflammatory Parameter: Change From Baseline in ESR Over Time Month 12	-8.4 mm/hour Standard Deviation 19.4	-8.7 mm/hour Standard Deviation 18.0	-10.3 mm/hour Standard Deviation 18.5
Inflammatory Parameter: Change From Baseline in ESR Over Time Month 24	-9.2 mm/hour Standard Deviation 20.5	-6.2 mm/hour Standard Deviation 22.6	-8.6 mm/hour Standard Deviation 18.8
Inflammatory Parameter: Change From Baseline in ESR Over Time Month 60	-8.6 mm/hour Standard Deviation 19.9	-5.5 mm/hour Standard Deviation 17.4	-9.8 mm/hour Standard Deviation 19.9

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All participants with a Baseline and post-baseline assessment at given time point.

The HAQ score measures quality of life in terms of physical function and consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past 7 days using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). In the classical HAQ questionnaire, the potential maximum score (60) indicates the most severe disability and the minimum score (0) indicates no disability. The HAQ% is a typical 'Belgian scoring method,' where the actual total score on 60 is converted to a percentage. The HAQ% is performed by all Belgian rheumatologists and is required for obtaining reimbursement.

Outcome measures

Measure	Participants With RA n=1580 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=489 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=38 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Physical Function: Change From Baseline in HAQ% Over Time Month 3	-19.4 percentage of maximum HAQ score Standard Deviation 18.5	-19.1 percentage of maximum HAQ score Standard Deviation 18.8	-19.6 percentage of maximum HAQ score Standard Deviation 19.3
Physical Function: Change From Baseline in HAQ% Over Time Month 6	-22.9 percentage of maximum HAQ score Standard Deviation 20.0	-23.2 percentage of maximum HAQ score Standard Deviation 18.7	-25.8 percentage of maximum HAQ score Standard Deviation 21.9
Physical Function: Change From Baseline in HAQ% Over Time Month 12	-22.7 percentage of maximum HAQ score Standard Deviation 21.2	-24.5 percentage of maximum HAQ score Standard Deviation 19.3	-33.4 percentage of maximum HAQ score Standard Deviation 22.7
Physical Function: Change From Baseline in HAQ% Over Time Month 24	-24.4 percentage of maximum HAQ score Standard Deviation 21.9	-24.5 percentage of maximum HAQ score Standard Deviation 20.9	-32.3 percentage of maximum HAQ score Standard Deviation 20.7
Physical Function: Change From Baseline in HAQ% Over Time Month 60	-25.4 percentage of maximum HAQ score Standard Deviation 22.0	-27.1 percentage of maximum HAQ score Standard Deviation 21.8	-34.9 percentage of maximum HAQ score Standard Deviation 24.4

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All RA participants with a Baseline and post-baseline assessment at given time point.

The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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	Participants With RA n=198 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in DAS28 Over Time: RA Participants Month 3	-1.77 score on a scale Standard Deviation 1.21	—	—
Change From Baseline in DAS28 Over Time: RA Participants Month 6	-2.01 score on a scale Standard Deviation 1.55	—	—
Change From Baseline in DAS28 Over Time: RA Participants Month 12	-2.38 score on a scale Standard Deviation 1.29	—	—
Change From Baseline in DAS28 Over Time: RA Participants Month 24	-2.29 score on a scale Standard Deviation 1.49	—	—
Change From Baseline in DAS28 Over Time: RA Participants Month 60	-2.53 score on a scale Standard Deviation 1.44	—	—

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All RA participants with a Baseline and post-baseline assessment at given time point.

The DAS28 score includes 28 tender joint counts, 28 swollen joint counts, CRP/ESR, and participant's global assessment of disease activity. 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	Participants With RA n=352 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
DAS28 Category Over Time: RA Participants Month 3 DAS28 < 2.6	106 Participants	—	—
DAS28 Category Over Time: RA Participants Month 3 DAS28 ≥ 2.6 to ≤ 3.2	50 Participants	—	—
DAS28 Category Over Time: RA Participants Month 3 DAS28 < 3.2	118 Participants	—	—
DAS28 Category Over Time: RA Participants Month 6 DAS28 < 2.6	135 Participants	—	—
DAS28 Category Over Time: RA Participants Month 6 DAS28 ≥ 2.6 to ≤ 3.2	49 Participants	—	—
DAS28 Category Over Time: RA Participants Month 6 DAS28 < 3.2	97 Participants	—	—
DAS28 Category Over Time: RA Participants Month 12 DAS28 < 2.6	161 Participants	—	—
DAS28 Category Over Time: RA Participants Month 12 DAS28 ≥ 2.6 to ≤ 3.2	56 Participants	—	—
DAS28 Category Over Time: RA Participants Month 12 DAS28 < 3.2	95 Participants	—	—
DAS28 Category Over Time: RA Participants Month 24 DAS28 < 2.6	195 Participants	—	—
DAS28 Category Over Time: RA Participants Month 24 DAS28 ≥ 2.6 to ≤ 3.2	60 Participants	—	—
DAS28 Category Over Time: RA Participants Month 24 DAS28 < 3.2	97 Participants	—	—
DAS28 Category Over Time: RA Participants Month 60 DAS28 < 2.6	187 Participants	—	—
DAS28 Category Over Time: RA Participants Month 60 DAS28 ≥ 2.6 to ≤ 3.2	75 Participants	—	—
DAS28 Category Over Time: RA Participants Month 60 DAS28 < 3.2	72 Participants	—	—

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All PsA participants with a Baseline and post-baseline assessment at given time point.

Outcome measures

Measure	Participants With RA n=538 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
BSA With PsA Over Time: PsA Participants Month 3: < 3% of BSA	398 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 3: 3% to 10% of BSA	97 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 3: 11% to 20% of BSA	32 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 3: > 20% of BSA	11 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 6: < 3% of BSA	378 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 6: 3% to 10% of BSA	59 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 6: 11% to 20% of BSA	24 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 6: > 20% of BSA	10 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 12: < 3% of BSA	356 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 12: 3% to 10% of BSA	41 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 12: 11% to 20% of BSA	27 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 12: > 20% of BSA	2 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 24: < 3% of BSA	298 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 24: 3% to 10% of BSA	38 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 24: 11% to 20% of BSA	9 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 24: > 20% of BSA	7 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 60: < 3% of BSA	195 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 60: 3% to 10% of BSA	15 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 60: 11% to 20% of BSA	1 Participants	—	—
BSA With PsA Over Time: PsA Participants Month 60: > 20% of BSA	1 Participants	—	—

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.

Participants used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.

Outcome measures

Measure	Participants With RA n=48 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 24	-4.1 units on a scale Standard Deviation 2.8	—	—
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 3	-3.4 units on a scale Standard Deviation 2.4	—	—
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 6	-3.8 units on a scale Standard Deviation 2.7	—	—
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 12	-2.8 units on a scale Standard Deviation 5.7	—	—
Change From Baseline in Patient's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 60	-5.3 units on a scale Standard Deviation 2.4	—	—

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.

Physicians used a Numerical Rating Scale of 0 to 10 to assess the most important joint, where 0=no disease activity during the previous days and 10=maximal activity during the previous days.

Outcome measures

Measure	Participants With RA n=47 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 3	-3.8 units on a scale Standard Deviation 2.3	—	—
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 6	-4.3 units on a scale Standard Deviation 2.6	—	—
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 12	-3.3 units on a scale Standard Deviation 4.5	—	—
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 24	-4.0 units on a scale Standard Deviation 2.6	—	—
Change From Baseline in Physician's Numerical Rating Scale Over Time: Oligoarticular PsA Participants Month 60	-5.2 units on a scale Standard Deviation 2.6	—	—

PRIMARY outcome

Timeframe: Baseline, Months 3, 6, 12, 24, 60

Population: All oligoarticular PsA participants with a Baseline and post-baseline assessment at given time point.

BASDAI score measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness, and is calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe). The final BASDAI score ranges from 0 to 10 with higher score indicating more severe symptoms.

Outcome measures

Measure	Participants With RA n=1011 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Change From Baseline in BASDAI Over Time: AS Participants Month 3	-3.1 score on a scale Standard Deviation 2.4	—	—
Change From Baseline in BASDAI Over Time: AS Participants Month 6	-3.2 score on a scale Standard Deviation 2.4	—	—
Change From Baseline in BASDAI Over Time: AS Participants Month 12	-3.4 score on a scale Standard Deviation 2.5	—	—
Change From Baseline in BASDAI Over Time: AS Participants Month 24	-3.1 score on a scale Standard Deviation 2.5	—	—
Change From Baseline in BASDAI Over Time: AS Participants Month 60	-3.3 score on a scale Standard Deviation 2.8	—	—

PRIMARY outcome

Timeframe: up to 60 months

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An SAE is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.

Outcome measures

Measure	Participants With RA n=2836 Participants Participants diagnosed with RA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With PsA n=1127 Participants Participants diagnosed with PsA in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.	Participants With AS n=1957 Participants Participants diagnosed with AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation Any AE (Includes SAEs)	976 Participants	323 Participants	493 Participants
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation Any SAE	560 Participants	164 Participants	210 Participants
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation Any Fatal AE	41 Participants	4 Participants	9 Participants
Number of Participants With Adverse Events (AEs) Serious AEs (SAEs), and AEs Leading to Study Drug Discontinuation Any AE Leading to Study Drug Discontinuation	577 Participants	171 Participants	295 Participants

Adverse Events

All Participants

Serious events: 934 serious events

Other events: 0 other events

Deaths: 54 deaths

Serious adverse events

Measure	All Participants n=5920 participants at risk Participants diagnosed with RA, PsA or AS in whom Humira® (adalimumab) was prescribed within local reimbursement guidelines.
Cardiac disorders Extrasystoles	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Heart valve incompetence	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Intracardiac mass	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Ischaemic cardiomyopathy	0.05% 3/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Left ventricular dysfunction	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Left ventricular hypertrophy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Mitral valve calcification	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Mitral valve incompetence	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Mitral valve prolapse	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Myocardial calcification	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Myocardial infarction	0.20% 12/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Myocardial ischaemia	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Palpitations	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Pericardial effusion	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Pericarditis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Pleuropericarditis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Pulseless electrical activity	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Rheumatic heart disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Right ventricular failure	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Exercise electrocardiogram abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Fibrin D dimer increased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Gamma-glutamyltransferase increased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Liver function test increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Lymphocyte count abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Neutrophil count decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Nuclear magnetic resonance imaging abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Oxygen saturation decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations General physical condition abnormal	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Haemoglobin decreased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Heart rate decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Platelet count decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Heart rate irregular	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Heart sounds abnormal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Hepatic enzyme abnormal	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Protein total decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Pulmonary function test decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Hepatic enzyme increased	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Immunology test abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Inflammatory marker increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Pulse abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations International normalised ratio abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Laboratory test abnormal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Lipids abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Liver function test abnormal	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Pulse absent	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Red blood cell sedimentation rate increased	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Rheumatoid factor increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Sleep study	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Sputum abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Synovial fluid analysis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Total lung capacity abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Transaminases abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Transaminases increased	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Troponin increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Ultrasound Doppler abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Urine analysis abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Urine output decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Venous pressure jugular increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Vitamin D decreased	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Weight decreased	0.32% 19/5920 • Number of events 19 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Weight increased	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations White blood cells urine positive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Cachexia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Sinus bradycardia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Supraventricular extrasystoles	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Electrocardiogram repolarisation abnormality	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Epstein-Barr virus antibody positive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Cell death	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Central obesity	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Decreased appetite	0.29% 17/5920 • Number of events 17 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Dehydration	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Diabetes mellitus	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Electrolyte imbalance	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Fluid intake reduced	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Fluid retention	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypercholesterolaemia	0.12% 7/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Electrocardiogram Q wave abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Electrocardiogram ST segment depression	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Electrocardiogram abnormal	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Arrhythmia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Arteriosclerosis coronary artery	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Coronary artery occlusion	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Coronary artery stenosis	0.10% 6/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Arteritis coronary	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cyanosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Atrial fibrillation	0.41% 24/5920 • Number of events 25 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Atrial flutter	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Diastolic dysfunction	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Dilatation atrial	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Atrioventricular block	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Atrioventricular block complete	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Bundle branch block	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Bundle branch block left	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Bundle branch block right	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac arrest	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac asthma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac disorder	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac failure	0.30% 18/5920 • Number of events 19 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac failure congestive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac fibrillation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac hypertrophy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiac valve disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardio-respiratory arrest	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiomegaly	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiomyopathy	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiomyopathy alcoholic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Cardiovascular disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Congestive cardiomyopathy	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Coronary artery dilatation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Coronary artery disease	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Anaemia	0.29% 17/5920 • Number of events 17 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Antiphospholipid syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Aplasia pure red cell	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Aplastic anaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Coagulopathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Eosinophilia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Haemolysis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.02% 1/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Iron deficiency anaemia	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Leukocytosis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Leukopenia	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Lymphadenitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Lymphadenopathy	0.24% 14/5920 • Number of events 14 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Lymphocytosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Microcytic anaemia	0.05% 3/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Nephrogenic anaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Neutropenia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Neutrophilia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Normochromic anaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Normocytic anaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Pseudolymphoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Retroperitoneal lymphadenopathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Spleen disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Thrombocytopenia	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Blood and lymphatic system disorders Thrombocytosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Acute coronary syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Acute myocardial infarction	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Angina pectoris	0.24% 14/5920 • Number of events 14 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Angina unstable	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Aortic valve incompetence	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Aortic valve stenosis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Supraventricular tachycardia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Tachycardia	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Tricuspid valve incompetence	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Ventricular extrasystoles	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Ventricular fibrillation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Ventricular flutter	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Cardiac disorders Ventricular tachycardia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Atrial septal defect	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Dolichocolon	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Phimosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Thalassaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Trisomy 18	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Congenital, familial and genetic disorders Truncus arteriosus persistent	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Ear and labyrinth disorders Ear pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Ear and labyrinth disorders Hypoacusis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Ear and labyrinth disorders Vertigo	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Acromegaly	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Addison's disease	0.02% 1/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Adrenal insufficiency	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Autoimmune thyroiditis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Basedow's disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Cushing's syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Goitre	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Hyperparathyroidism	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Hyperthyroidism	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Hypothyroidism	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Thyroid cyst	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Thyroid mass	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Endocrine disorders Toxic nodular goitre	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Altered visual depth perception	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Arcus lipoides	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Blindness	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Cataract	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Diplopia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Exophthalmos	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Eye discharge	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Eye inflammation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Eye pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Eye pruritus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Eyelid oedema	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Eyelids pruritus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Glaucoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Iridocyclitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Keratitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Ocular discomfort	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Ocular hyperaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Uveitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Visual acuity reduced	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Eye disorders Visual impairment	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal adhesions	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal discomfort	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal distension	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal hernia	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal mass	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal pain	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal pain lower	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal pain upper	0.14% 8/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abdominal symptom	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Abnormal faeces	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Acute abdomen	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Anal fissure	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Anal fistula	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Anal haemorrhage	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Aphthous ulcer	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Ascites	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Barrett's oesophagus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Chronic gastritis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Colitis	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Colitis ischaemic	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Constipation	0.22% 13/5920 • Number of events 13 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Crohn's disease	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Diaphragmatic hernia	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Diarrhoea	0.42% 25/5920 • Number of events 26 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Diverticular perforation	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Diverticulum	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Diverticulum intestinal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Dry mouth	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Duodenal ulcer	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Duodenitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Dyspepsia	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Flatulence	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastric disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastric perforation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastric polyps	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastric ulcer	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastritis	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastritis erosive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastritis haemorrhagic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal inflammation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal melanosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal motility disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal necrosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrointestinal obstruction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Glossodynia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Haematochezia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Haemorrhoids	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Hiatus hernia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Ileal ulcer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Ileus paralytic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Impaired gastric emptying	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Inguinal hernia	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Intestinal ischaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Intestinal obstruction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Intestinal perforation	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Intestinal polyp	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Intra-abdominal fluid collection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Intussusception	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Irritable bowel syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Large intestinal stenosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Large intestinal ulcer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Large intestine polyp	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Lip swelling	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Lip ulceration	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Melaena	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Mouth swelling	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Mouth ulceration	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Nausea	0.19% 11/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Odynophagia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Oesophageal achalasia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Oesophagitis	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Oral pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Pancreatitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Pancreatitis haemorrhagic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Pancreatitis necrotising	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Proctalgia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Proctitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Rectal haemorrhage	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Rectal polyp	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Regurgitation	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Sensitivity of teeth	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Small intestinal haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Small intestinal obstruction	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Small intestinal ulcer haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Spigelian hernia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Stomatitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Tongue coated	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Tongue oedema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Toothache	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Umbilical hernia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Varices oesophageal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Vasculitis gastrointestinal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Gastrointestinal disorders Vomiting	0.15% 9/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Adverse event	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Asthenia	0.34% 20/5920 • Number of events 21 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Catheter site phlebitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Chest discomfort	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Chest pain	0.32% 19/5920 • Number of events 20 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Chills	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Condition aggravated	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Crepitations	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Cyst	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Death	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Discomfort	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Drug effect decreased	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Drug ineffective	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Drug interaction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Drug intolerance	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Face oedema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Facial pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Fatigue	0.47% 28/5920 • Number of events 28 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Feeling abnormal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Feeling cold	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Feeling hot	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Feeling of body temperature change	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Gait disturbance	0.07% 4/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders General physical health deterioration	0.25% 15/5920 • Number of events 15 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Generalised oedema	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Hernia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Hyperthermia	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Ill-defined disorder	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Impaired healing	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Inflammation	0.27% 16/5920 • Number of events 16 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Inflammatory pain	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Influenza like illness	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Injection site erythema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Injection site pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Injection site pruritus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Injection site reaction	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Injection site urticaria	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Local reaction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Malaise	0.25% 15/5920 • Number of events 15 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Mass	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Microlithiasis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Multiple organ dysfunction syndrome	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Multiple-drug resistance	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Necrosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders No adverse event	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Nodule	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Oedema	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Oedema peripheral	0.22% 13/5920 • Number of events 14 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Pain	0.20% 12/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Papillitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Paradoxical drug reaction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Peripheral swelling	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Pyrexia	0.64% 38/5920 • Number of events 39 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Sudden death	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Swelling	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Therapy non-responder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Treatment noncompliance	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Ulcer	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
General disorders Unevaluable event	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Autoimmune hepatitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Biliary cyst	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Cholangitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Cholecystitis	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Cholecystitis acute	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Cholelithiasis	0.29% 17/5920 • Number of events 17 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Cholestasis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Cryptogenic cirrhosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Fatty liver alcoholic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Gallbladder enlargement	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatic cirrhosis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatic congestion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatic failure	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatic function abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatic steatosis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatitis alcoholic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatitis toxic	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatomegaly	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatorenal syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Hepatosplenomegaly	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Jaundice	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Liver disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Portal hypertension	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Hepatobiliary disorders Portal vein thrombosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Allergic oedema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Autoimmune disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Drug hypersensitivity	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Hypersensitivity	0.19% 11/5920 • Number of events 11 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Immune system disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Immunodeficiency	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Immunosuppression	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Immune system disorders Seasonal allergy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Abscess	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Abscess intestinal	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Abscess limb	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Acute sinusitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Anal abscess	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Appendicitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Appendicitis perforated	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Arthritis bacterial	0.20% 12/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Arthritis infective	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Arthritis salmonella	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Aspergillus infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Bacterial infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Bacterial pyelonephritis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Breast abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Bronchitis	0.29% 17/5920 • Number of events 17 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Bronchopulmonary aspergillosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Bursitis infective	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Bursitis infective staphylococcal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Candida infection	0.03% 2/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Cellulitis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Chronic sinusitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Clostridial infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Clostridium difficile colitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Clostridium difficile infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Conjunctivitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Cranial nerve infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Cystitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Cystitis klebsiella	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Cytomegalovirus infection	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Device related infection	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Disseminated tuberculosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Diverticulitis	0.20% 12/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Ear infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Empyema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Endocarditis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Enterobacter infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Enterococcal infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Enterococcal sepsis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Epstein-Barr virus infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Erysipelas	0.32% 19/5920 • Number of events 19 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Escherichia infection	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Escherichia sepsis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Escherichia urinary tract infection	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Extradural abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Fungal infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Gastroenteritis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Gastroenteritis Escherichia coli	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Gastroenteritis salmonella	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Gastroenteritis viral	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Gastrointestinal infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Groin abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations H1N1 influenza	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Haematoma infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Hepatitis B reactivation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Herpes virus infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Herpes zoster	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Infected skin ulcer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Infection	0.27% 16/5920 • Number of events 16 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Influenza	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Intervertebral discitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Legionella infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Leishmaniasis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Localised infection	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Lower respiratory tract infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Lung abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Lung infection	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Lymph node tuberculosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Lymphangitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Mastitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Mastoiditis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Meningitis herpes	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Meningitis tuberculous	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Nasopharyngitis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Necrotising fasciitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Nocardiosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Ophthalmic herpes zoster	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Osteomyelitis	0.08% 5/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Ovarian abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Papilloma viral infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pathogen resistance	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pelvic infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pelvic inflammatory disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pericarditis tuberculous	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Peritonitis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Peritonsillar abscess	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pharyngitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pharyngotonsillitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumocystis jirovecii infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia	1.1% 65/5920 • Number of events 67 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia legionella	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia mycoplasmal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia pneumococcal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia staphylococcal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia streptococcal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pneumonia viral	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Post procedural infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Post procedural pneumonia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Postoperative wound infection	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Proteus infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pseudomonal sepsis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pseudomonas infection	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pulmonary sepsis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pulmonary tuberculosis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Purulent discharge	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pyelonephritis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pyelonephritis acute	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Pyuria	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Rash pustular	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Respiratory tract infection	0.10% 6/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Rhinitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Sepsis	0.20% 12/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Sepsis syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Septic arthritis staphylococcal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Septic shock	0.20% 12/5920 • Number of events 12 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Serratia infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Sinusitis	0.19% 11/5920 • Number of events 11 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Skin infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Soft tissue infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Staphylococcal abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Staphylococcal infection	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Staphylococcal sepsis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Streptococcal sepsis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Subcutaneous abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Superinfection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Tick-borne viral encephalitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Tinea pedis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Tonsillitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Tooth abscess	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Toxic shock syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Toxoplasmosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Tuberculosis	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Tuberculosis gastrointestinal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Upper respiratory tract infection	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Urinary tract infection	0.37% 22/5920 • Number of events 24 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Urinary tract infection bacterial	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Urosepsis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Uterine infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Vaginal abscess	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Varicella zoster virus infection	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Viral infection	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Viral upper respiratory tract infection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Wound infection	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Infections and infestations Wound infection staphylococcal	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Alcohol poisoning	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Ankle fracture	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Cartilage injury	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Compression fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Concussion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Contusion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Drug dose omission	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Epicondylitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Eyelid injury	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Facial bones fracture	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Fall	0.52% 31/5920 • Number of events 32 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Femur fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Foetal exposure during pregnancy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Foot fracture	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Fractured ischium	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Gastroparesis postoperative	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Hip fracture	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Humerus fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Ilium fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Incision site haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Injury	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Jaw fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Joint dislocation	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Joint injury	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Kidney rupture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Laceration	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Ligament rupture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Ligament sprain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Meniscus injury	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Multiple fractures	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Nerve injury	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Overdose	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Pelvic fracture	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Post procedural fever	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Procedural haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Procedural pain	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Procedural site reaction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Rib fracture	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Road traffic accident	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Skull fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Spinal fracture	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Splenic rupture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Stress fracture	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Subdural haematoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Subdural haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Synovial rupture	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Tendon rupture	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Tibia fracture	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Toxicity to various agents	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Traumatic fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Traumatic lung injury	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Upper limb fracture	0.07% 4/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Vaccination complication	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Wound	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Wound dehiscence	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Wound haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Wound necrosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Injury, poisoning and procedural complications Wrist fracture	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Albumin globulin ratio increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Alpha 2 globulin increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Angiogram peripheral abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Anti-cyclic citrullinated peptide antibody	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Antibody test abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Antinuclear antibody positive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Biopsy breast abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Biopsy skin abnormal	0.02% 1/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood calcium increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood creatinine decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood creatinine increased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood culture positive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood glucose increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood immunoglobulin M increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood lactate dehydrogenase increased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood phosphorus decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood potassium decreased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood pressure increased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood prolactin increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood sodium decreased	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood test abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood thyroid stimulating hormone abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood thyroid stimulating hormone increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood triglycerides increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Blood uric acid increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Body temperature decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Breath sounds abnormal	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Bronchoscopy abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations C-reactive protein abnormal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations C-reactive protein increased	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Carcinoembryonic antigen increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Cardiac murmur	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Cardiac murmur functional	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Chest X-ray abnormal	0.02% 1/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Colonoscopy abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Computerised tomogram abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Double stranded DNA antibody positive	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Drug level increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Ejection fraction abnormal	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Investigations Ejection fraction decreased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hyperglycaemia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hyperinsulinaemic hypoglycaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hyperkalaemia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hyperuricaemia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypoalbuminaemia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypocalcaemia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypoglycaemia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypokalaemia	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hyponatraemia	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypophagia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hypoproteinaemia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Hyposideraemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Increased insulin requirement	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Insulin-requiring type 2 diabetes mellitus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Iron deficiency	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Lactic acidosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Malnutrition	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Metabolic acidosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Metabolic syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Obesity	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Polydipsia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Metabolism and nutrition disorders Vitamin D deficiency	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Amyotrophy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Arthralgia	0.47% 28/5920 • Number of events 29 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Arthritis	0.32% 19/5920 • Number of events 20 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Arthropathy	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Back disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Back pain	0.37% 22/5920 • Number of events 22 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Bone disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Bone erosion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Bone lesion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Bone pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Bursitis	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Calcification of muscle	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Chondropathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Eosinophilic fasciitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Foot deformity	0.27% 16/5920 • Number of events 19 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Fracture nonunion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Groin pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Inguinal mass	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.34% 20/5920 • Number of events 21 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Intervertebral disc space narrowing	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Joint destruction	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Joint effusion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Joint stiffness	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Joint swelling	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Knee deformity	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Kyphosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Limb discomfort	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Lupus-like syndrome	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Mobility decreased	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Muscle atrophy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Muscle necrosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Muscle spasms	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Muscular weakness	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Myalgia	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Myopathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Myositis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Neck pain	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.32% 19/5920 • Number of events 19 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteoporosis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteoporosis postmenopausal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.07% 4/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Osteosclerosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Pain in extremity	0.22% 13/5920 • Number of events 14 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Pathological fracture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Periarthritis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Polyarthritis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Polychondritis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.34% 20/5920 • Number of events 20 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Scoliosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Still's disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Synovial cyst	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Synovitis	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Tendon calcification	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Tendon disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Tendon pain	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Tendonitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Trigger finger	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Trismus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Musculoskeletal and connective tissue disorders Vertebral lesion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large cell lymphoma T- and null-cell types recurrent	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angioimmunoblastic T-cell lymphoma refractory	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hydatidiform mole	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of adrenal gland	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma stage I	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer female	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour pulmonary	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage IV	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic leukaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cystadenocarcinoma ovary	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Extranodal marginal zone B-cell lymphoma (MALT type)	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroma	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicle centre lymphoma, follicular grade I, II, III	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large cell lung cancer stage III	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Linitis plastica	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lobular breast carcinoma in situ	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesenteric neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to adrenals	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to vagina	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraproteinaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer stage 0	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine neoplasm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Waldenstrom's macroglobulinaemia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Acute disseminated encephalomyelitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Amnesia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Amyotrophic lateral sclerosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Anosognosia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Aphasia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Apraxia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Axonal neuropathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Balance disorder	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Brain compression	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Brain oedema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Carotid arteriosclerosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Carotid artery stenosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Carotid artery thrombosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Carpal tunnel syndrome	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Central nervous system lesion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cerebral disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cerebral haemorrhage	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cerebral infarction	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cerebral ischaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cerebrovascular accident	0.22% 13/5920 • Number of events 13 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cervical radiculopathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cervicobrachial syndrome	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Cognitive disorder	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Coma	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Complex regional pain syndrome	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Dementia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Demyelination	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Disturbance in attention	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Dizziness	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Dyskinesia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Dysstasia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Encephalitis autoimmune	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Epilepsy	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Facial paralysis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Generalised tonic-clonic seizure	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Guillain-Barre syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Haemorrhagic transformation stroke	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Head discomfort	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Headache	0.30% 18/5920 • Number of events 18 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Hemiparesis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Hemiplegia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Hypersomnia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Hypoaesthesia	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Hypokinesia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Intracranial haematoma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Intracranial pressure increased	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Ischaemic stroke	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Lethargy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Leukoencephalopathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Locked-in syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Loss of consciousness	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Lumbar radiculopathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Memory impairment	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Meningoradiculitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Mental impairment	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Micrographia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Monoparesis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Multiple sclerosis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Nerve compression	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Nervous system disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Neuralgia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Neurodegenerative disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Neuropathy peripheral	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Optic neuritis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Paraesthesia	0.12% 7/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Parkinson's disease	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Peripheral sensorimotor neuropathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Peripheral sensory neuropathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Polyneuropathy	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Poor quality sleep	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Presyncope	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Radicular pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Radiculopathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Sciatica	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Seizure	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Sensory disturbance	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Somnolence	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Speech disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Spinal claudication	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Status epilepticus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Syncope	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Thalamus haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Transient ischaemic attack	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Tremor	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Vasculitis cerebral	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Nervous system disorders Vocal cord paralysis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.03% 2/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Product Issues Device dislocation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Product Issues Device loosening	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Abnormal behaviour	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Affect lability	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Agitation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Alcohol abuse	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Anxiety	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Bipolar I disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Bruxism	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Confusional state	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Depression	0.22% 13/5920 • Number of events 14 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Depression suicidal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Disorientation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Dysphoria	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Emotional disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Mental disorder	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Mood altered	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Nervousness	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Psychiatric decompensation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Stress	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Psychiatric disorders Suicidal ideation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Acute kidney injury	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Anuria	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Bladder disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Bladder irritation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Bladder prolapse	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Calculus urethral	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Calculus urinary	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Chronic kidney disease	0.05% 3/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Cystitis interstitial	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Diabetic end stage renal disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Diabetic nephropathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Dysuria	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Haematuria	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Hydronephrosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Hypertensive nephropathy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Incontinence	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Leukocyturia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Microalbuminuria	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Nephroangiosclerosis	0.02% 1/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Nephrolithiasis	0.22% 13/5920 • Number of events 14 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Nephrotic syndrome	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Nocturia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Pollakiuria	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Polyuria	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Prerenal failure	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Proteinuria	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal artery stenosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal atrophy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal cyst	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal failure	0.27% 16/5920 • Number of events 17 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal impairment	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Renal pain	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Ureterolithiasis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Urge incontinence	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Urinary incontinence	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Urinary retention	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Urinary tract disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Renal and urinary disorders Urine odour abnormal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Acquired hydrocele	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Amenorrhoea	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Breast hyperplasia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Breast pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Cervical dysplasia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Cystocele	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Endometriosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Epididymal cyst	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Gynaecomastia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Menorrhagia	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Menstrual disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Ovarian cyst	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Pelvic fluid collection	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Pelvic haemorrhage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Pelvic pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Prostatitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Reproductive system and breast disorders Uterine polyp	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Apnoeic attack	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Asthma	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.10% 6/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Cough	0.29% 17/5920 • Number of events 18 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.69% 41/5920 • Number of events 41 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Emphysema	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Nasal inflammation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Nasal septum disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Obliterative bronchiolitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pharyngeal disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pharyngeal ulceration	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.14% 8/5920 • Number of events 8 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Productive cough	0.15% 9/5920 • Number of events 9 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.19% 11/5920 • Number of events 11 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary hilum mass	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Rales	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Respiratory tract irritation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Rhonchi	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Snoring	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Wheezing	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Respiratory, thoracic and mediastinal disorders Yawning	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Acanthosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Alopecia	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Angioedema	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Dermatitis	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Dermatitis psoriasiform	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Dry skin	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Ecchymosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Eczema	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Erythema	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Excessive skin	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Generalised erythema	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Henoch-Schonlein purpura	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Hidradenitis	0.03% 2/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Ingrowing nail	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Nail disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Nail dystrophy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Nail toxicity	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Night sweats	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Parakeratosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Pruritus	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Pruritus generalised	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Psoriasis	0.19% 11/5920 • Number of events 11 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Purpura	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Rash	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Rash erythematous	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Rash generalised	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Rash pruritic	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Rosacea	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Scar pain	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin discolouration	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin dystrophy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin erosion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin exfoliation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin lesion	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin necrosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin plaque	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Skin ulcer	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Swelling face	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Systemic lupus erythematosus rash	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Urticaria	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Skin and subcutaneous tissue disorders Vitiligo	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Social circumstances Alcoholic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Social circumstances Bedridden	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Social circumstances Impaired driving ability	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Social circumstances Impaired work ability	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Social circumstances Loss of personal independence in daily activities	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Social circumstances Poor personal hygiene	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Abortion induced	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Angioplasty	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Arterial catheterisation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Arterial stent insertion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Arthrodesis	0.10% 6/5920 • Number of events 6 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Bladder operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Bone debridement	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Breast prosthesis removal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Bunion operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Caesarean section	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Cataract operation	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Cholecystectomy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Corneal transplant	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Coronary arterial stent insertion	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Coronary artery bypass	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Debridement	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Elbow operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Foot operation	0.05% 3/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Gastrectomy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Gastric bypass	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Hip arthroplasty	0.44% 26/5920 • Number of events 26 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Hospitalisation	0.17% 10/5920 • Number of events 10 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Hysterectomy	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Intervertebral disc operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Joint arthroplasty	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Joint stabilisation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Knee arthroplasty	0.37% 22/5920 • Number of events 23 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Knee operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Mammoplasty	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Mastectomy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Medical device removal	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Meniscus removal	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Metabolic surgery	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Metatarsal excision	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Nasal operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Peripheral nerve decompression	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Peripheral nerve operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Plastic surgery	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Prosthesis implantation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Salpingo-oophorectomy unilateral	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Shoulder arthroplasty	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Shoulder operation	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Spinal fusion surgery	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Spinal operation	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Steroid therapy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Surgery	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Suture insertion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Tendon operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Toe operation	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Transurethral prostatectomy	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Urinary tract operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Varicose vein operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Vascular operation	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Vascular stent insertion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Surgical and medical procedures Wound drainage	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Aneurysm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Aneurysm ruptured	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Angiopathy	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Aortic aneurysm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Aortic aneurysm rupture	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Aortic stenosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Aortitis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Arterial disorder	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Arterial occlusive disease	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Arteriosclerosis	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Arteriovenous fistula	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Arteritis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Capillary leak syndrome	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Circulatory collapse	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Deep vein thrombosis	0.12% 7/5920 • Number of events 7 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Embolism	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Haemodynamic instability	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Haemorrhage	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Hot flush	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Hypertension	0.27% 16/5920 • Number of events 17 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Hypertensive crisis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Hypotension	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Hypovolaemic shock	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Infarction	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Intermittent claudication	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Ischaemia	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Lymphoedema	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Orthostatic hypotension	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Pallor	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Peripheral arterial occlusive disease	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Peripheral artery occlusion	0.05% 3/5920 • Number of events 3 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Peripheral artery stenosis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Peripheral coldness	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Peripheral embolism	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Peripheral venous disease	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Phlebitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Shock	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Shock haemorrhagic	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Thrombophlebitis	0.03% 2/5920 • Number of events 2 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Thrombophlebitis superficial	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Thrombosis	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Varicose vein	0.08% 5/5920 • Number of events 5 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Vascular insufficiency	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Vascular occlusion	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Vasculitis	0.07% 4/5920 • Number of events 4 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Vasculitis necrotising	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Vein disorder	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.
Vascular disorders Venous aneurysm	0.02% 1/5920 • Number of events 1 • up to Month 60 The protocol required all SAEs to be actively solicited. Non-serious events were not to be actively solicited, and any non-serious AEs were to be collected as spontaneous reports if AbbVie was notified.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie

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