Trial Outcomes & Findings for EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries (NCT NCT01078402)

NCT ID: NCT01078402

Last Updated: 2013-02-12

Results Overview

DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.

• Recruitment status: COMPLETED
• Target enrollment: 809 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2013-02-12

Participant Flow

Investigational sites in 7 countries participated in this study: Croatia, Hungary, Israel, Poland, Romania, Slovakia and Ukraine.

Out of 809 participants recruited, 789 were included in the statistical evaluation dataset (SES). 20 participants were not included due to no documented Humira therapy and/or missing primary diagnosis.

Participant milestones

Measure	Rheumatoid Arthritis (RA) Participants with active rheumatoid arthritis	Psoriatic Arthritis (PsA) Participants with active psoriatic arthritis	Ankylosing Spondylitis (AS) Participants with active ankylosing spondylitis
Overall Study STARTED	431	124	234
Overall Study COMPLETED	324	95	166
Overall Study NOT COMPLETED	107	29	68

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EValuation of HumIRA® in Patients With Active Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in EASTern European Countries

Baseline characteristics by cohort

Measure	Rheumatoid Arthritis (RA) n=431 Participants Participants with active rheumatoid arthritis	Psoriatic Arthritis (PsA) n=124 Participants Participants with active psoriatic arthritis	Ankylosing Spondylitis (AS) n=234 Participants Participants with active ankylosing spondylitis	Total n=789 Participants Total of all reporting groups
Age Continuous	54.0 years STANDARD_DEVIATION 11.5 • n=5 Participants	47.8 years STANDARD_DEVIATION 12.4 • n=7 Participants	41.5 years STANDARD_DEVIATION 13.0 • n=5 Participants	49.3 years STANDARD_DEVIATION 13.3 • n=4 Participants
Sex: Female, Male Female	360 Participants n=5 Participants	61 Participants n=7 Participants	60 Participants n=5 Participants	481 Participants n=4 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	63 Participants n=7 Participants	174 Participants n=5 Participants	308 Participants n=4 Participants
Disease Activity Score (DAS28) Missing	17 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	17 participants n=4 Participants
Disease Activity Score (DAS28) Low Disease Activity (score ≥2.6 and <3.2)	1 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	1 participants n=4 Participants
Disease Activity Score (DAS28) Moderate Disease Activity (score ≥3.2 and <5.1)	37 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	37 participants n=4 Participants
Disease Activity Score (DAS28) High Disease Activity (score ≥5.1)	376 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	376 participants n=4 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score Missing	NA participants n=5 Participants	64 participants n=7 Participants	7 participants n=5 Participants	71 participants n=4 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score Low Disease Activity (BASDAI score <4)	NA participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants	17 participants n=4 Participants
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score High Disease Activity (BASDAI score ≥4)	NA participants n=5 Participants	53 participants n=7 Participants	217 participants n=5 Participants	270 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.

DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=385 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA Missing	56 participants	—	—	—
Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA Positive (DAS28 Decrease ≥1.2)	251 participants	—	—	—
Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA Negative (DAS28 Decrease <1.2 or No Decrease)	78 participants	—	—	—

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.

BASDAI score was 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) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=52 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) n=216 Participants Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS Missing	2 participants	12 participants	—	—
Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS Positive (BASDAI Decrease ≥50%)	24 participants	138 participants	—	—
Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS Negative (BASDAI Decrease <50% or No Decrease)	26 participants	66 participants	—	—

SECONDARY outcome

Timeframe: Baseline, 4, 7 and 13 months

Population: SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.

HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=431 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) n=124 Participants Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) n=234 Participants Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) n=789 Participants Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy Score at Baseline (n=314, 81, 106, 501)	1.8 units on a scale Standard Deviation 0.6	1.5 units on a scale Standard Deviation 0.6	1.3 units on a scale Standard Deviation 0.6	1.6 units on a scale Standard Deviation 0.6
Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy Score at 4 Months (n=232, 56, 76, 364)	1.3 units on a scale Standard Deviation 0.7	0.8 units on a scale Standard Deviation 0.6	0.7 units on a scale Standard Deviation 0.5	1.1 units on a scale Standard Deviation 0.7
Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy Score at 7 Months (n=211, 49, 63, 323)	1.2 units on a scale Standard Deviation 0.7	0.7 units on a scale Standard Deviation 0.6	0.7 units on a scale Standard Deviation 0.6	1.0 units on a scale Standard Deviation 0.7
Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy Score at 13 Months (n=174, 47, 31, 252)	1.1 units on a scale Standard Deviation 0.7	0.8 units on a scale Standard Deviation 0.6	0.6 units on a scale Standard Deviation 0.5	1.0 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 13 months

Population: Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.

Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=428 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) n=121 Participants Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) n=233 Participants Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) n=782 Participants Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Participant Acceptability of Self-injection at Month 13 (End of Study) Able to Self-inject, Assessed as Convenient	86.2 percentage of participants	95.9 percentage of participants	92.3 percentage of participants	89.5 percentage of participants
Participant Acceptability of Self-injection at Month 13 (End of Study) Able to Self-inject, Assessed as Inconvenient	7.2 percentage of participants	0.8 percentage of participants	6.4 percentage of participants	6.0 percentage of participants
Participant Acceptability of Self-injection at Month 13 (End of Study) Unable to Self-inject With Need for Retraining	0.5 percentage of participants	0.0 percentage of participants	0.4 percentage of participants	0.4 percentage of participants
Participant Acceptability of Self-injection at Month 13 (End of Study) Unable to Self-inject Due to Disease Condition	6.1 percentage of participants	3.3 percentage of participants	0.9 percentage of participants	4.1 percentage of participants

SECONDARY outcome

Timeframe: Month 13

Population: Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.

Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=428 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) n=121 Participants Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) n=233 Participants Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) n=782 Participants Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Compliance With the Humira Administration Schedule at Month 13 (End of Study) None	403 participants	109 participants	210 participants	722 participants
Compliance With the Humira Administration Schedule at Month 13 (End of Study) 1 Injection Missed	11 participants	5 participants	7 participants	23 participants
Compliance With the Humira Administration Schedule at Month 13 (End of Study) 2 Injections Missed	0 participants	3 participants	8 participants	11 participants
Compliance With the Humira Administration Schedule at Month 13 (End of Study) 3 or More Injections Missed	14 participants	4 participants	8 participants	26 participants

SECONDARY outcome

Timeframe: From first treatment until study discontinuation, up to 13 months.

Population: Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.

Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=106 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) n=29 Participants Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) n=67 Participants Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) n=202 Participants Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy	28.6 weeks Standard Deviation 17.6	29.7 weeks Standard Deviation 19.0	29.9 weeks Standard Deviation 14.1	29.2 weeks Standard Deviation 16.7

SECONDARY outcome

Timeframe: From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.

Population: SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.

Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.

Outcome measures

Measure	Rheumatoid Arthritis (RA) n=431 Participants Participants with active rheumatoid arthritis	Ankylosing Spondylitis (AS) n=124 Participants Participants with active ankylosing spondylitis	Ankylosing Spondylitis (AS) n=234 Participants Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) n=789 Participants Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Participants with Any AE	78 participants	30 participants	36 participants	144 participants
Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Participants with Any SAE	18 participants	4 participants	5 participants	27 participants

Adverse Events

Rheumatoid Arthritis (RA)

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Psoriatic Arthritis (PsA)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Ankylosing Spondylitis (AS)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

All Participants (RA, PsA, AS)

Serious events: 27 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rheumatoid Arthritis (RA) n=431 participants at risk Participants with active rheumatoid arthritis	Psoriatic Arthritis (PsA) n=124 participants at risk Participants with active psoriatic arthritis	Ankylosing Spondylitis (AS) n=234 participants at risk Participants with active ankylosing spondylitis	All Participants (RA, PsA, AS) n=789 participants at risk Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
Cardiac disorders Acute myocardial infarction	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.25% 2/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Cardiac disorders Angina pectoris	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Cardiac disorders Atrial fibrillation	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.81% 1/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.25% 2/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Cardiac disorders Cardiac failure	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.81% 1/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Cardiac disorders Myocardial ischaemia	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Gastrointestinal disorders Gastritis erosive	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
General disorders Death	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
General disorders Oedema peripheral	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
General disorders Sudden cardiac death	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Hepatobiliary disorders Cholecystitis	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.81% 1/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Hepatobiliary disorders Cholelithiasis	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.81% 1/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Erysipelas	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Hepatitis B	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Pneumonia viral	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Postoperative wound infection	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Pyelonephritis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Pyelonephritis acute	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.81% 1/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Sepsis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Septic shock	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Staphylococcal sepsis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Infections and infestations Urinary tract infection	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.81% 1/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Injury, poisoning and procedural complications Femur fracture	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Nervous system disorders Cerebral ischaemia	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Nervous system disorders Paraesthesia	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Renal and urinary disorders Nephrolithiasis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Renal and urinary disorders Renal colic	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.43% 1/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Skin and subcutaneous tissue disorders Eczema	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Skin and subcutaneous tissue disorders Panniculitis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Surgical and medical procedures Nephrectomy	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Vascular disorders Hypertension	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Vascular disorders Thrombophlebitis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.
Vascular disorders Vasculitis	0.23% 1/431 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/124 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.00% 0/234 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.	0.13% 1/789 • From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the intake of the last dose of physician-prescribed treatment. Mean (SD) duration of treatment was 49.0 (16.0) weeks.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER