Trial Outcomes & Findings for Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice (NCT NCT01111240)
NCT ID: NCT01111240
Last Updated: 2014-12-30
Results Overview
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Recruitment status
COMPLETED
Target enrollment
4635 participants
Primary outcome timeframe
Baseline and Months 3, 6, 9, 12, 18, and 24
Results posted on
2014-12-30
Participant Flow
Participant milestones
| Measure |
Psoriatic Arthritis
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Overall Study
STARTED
|
4635
|
|
Overall Study
COMPLETED
|
3569
|
|
Overall Study
NOT COMPLETED
|
1066
|
Reasons for withdrawal
| Measure |
Psoriatic Arthritis
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Overall Study
Adverse Event
|
190
|
|
Overall Study
Lack of Efficacy
|
545
|
|
Overall Study
Lack of Efficacy and Adverse Event
|
19
|
|
Overall Study
Other
|
312
|
Baseline Characteristics
Efficacy and Safety of Humira® in Patients With Psoriatic Arthritis in Normal Medical Practice
Baseline characteristics by cohort
| Measure |
Psoriatic Arthritis
n=4635 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Age, Continuous
|
49.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Gender
Female
|
2282 participants
n=5 Participants
|
|
Gender
Male
|
2297 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score greater than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Change From Baseline in Disease Activity Score (DAS)28
Month 3 [N=2757]
|
-1.7 score on a scale
Standard Deviation 1.4
|
|
Mean Change From Baseline in Disease Activity Score (DAS)28
Month 6 [N=2412]
|
-1.9 score on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Score (DAS)28
Month 9 [N=2028]
|
-1.9 score on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Score (DAS)28
Month 12 [N=1850]
|
-2.0 score on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Score (DAS)28
Month 18 [N=1572]
|
-2.0 score on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Score (DAS)28
Month 24 [N=1315]
|
-2.1 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Tender joint count represents the number of joints displaying tenderness. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Tender Joint Count (TJC) Over Time
Baseline [N=3552]
|
15.0 Tender joints
Standard Deviation 15.3
|
|
Mean Tender Joint Count (TJC) Over Time
Month 3 [N=3411]
|
7.5 Tender joints
Standard Deviation 12.3
|
|
Mean Tender Joint Count (TJC) Over Time
Month 6 [N=2975]
|
6.1 Tender joints
Standard Deviation 11.3
|
|
Mean Tender Joint Count (TJC) Over Time
Month 9 [N=2592]
|
5.5 Tender joints
Standard Deviation 10.9
|
|
Mean Tender Joint Count (TJC) Over Time
Month 12 [N=2296]
|
5.2 Tender joints
Standard Deviation 10.5
|
|
Mean Tender Joint Count (TJC) Over Time
Month 18 [N=1953]
|
5.2 Tender joints
Standard Deviation 10.5
|
|
Mean Tender Joint Count (TJC) Over Time
Month 24 [N-1624]
|
4.9 Tender joints
Standard Deviation 10.4
|
PRIMARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Swollen joint count represents the number of joints displaying swelling. Although the DAS28 includes assessments of 28 joints, additional joints are typically evaluated in examinations of participants with Psoriatic Arthritis (PsA) as the joints typically affected in these participants differ from those commonly involved in Rheumatoid Arthritis (RA). Specifically, PsA often involves distal interphalangeal joints (DIP), whereas RA does not.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Swollen Joint Count (SJC) Over Time
Month 3 [N=3411]
|
3.0 Swollen Joints
Standard Deviation 6.9
|
|
Mean Swollen Joint Count (SJC) Over Time
Month 6 [N=2975]
|
2.4 Swollen Joints
Standard Deviation 6.3
|
|
Mean Swollen Joint Count (SJC) Over Time
Month 9 [N=2592
|
2.0 Swollen Joints
Standard Deviation 5.5
|
|
Mean Swollen Joint Count (SJC) Over Time
Baseline [N=3552]
|
8.3 Swollen Joints
Standard Deviation 10.2
|
|
Mean Swollen Joint Count (SJC) Over Time
Month 12 [N=2296]
|
1.9 Swollen Joints
Standard Deviation 5.6
|
|
Mean Swollen Joint Count (SJC) Over Time
Month 18 [N=1953]
|
1.8 Swollen Joints
Standard Deviation 5.2
|
|
Mean Swollen Joint Count (SJC) Over Time
Month 24 [N=1624]
|
1.5 Swollen Joints
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Body surface area was used to evaluate the extent of psoriatic skin involvement. At baseline, investigators classified participants as having BSA less than 3%, 3 to 10%, 11 to 20%, or greater than 20%. At all post-baseline time points, clinicians were asked to estimate BSA on a scale of 0% to 100% rather than as categories. BSA was visually determined by the investigator using the 'rule of nines' and estimating that the palm of the patient's hand was equal to 1% BSA.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Month 6 [N=2385]
|
5.1 percentage of body surface area
Standard Deviation 9.7
|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Baseline [N=3289]
|
8.9 percentage of body surface area
Standard Deviation 8.4
|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Month 3 [N=2737]
|
6.4 percentage of body surface area
Standard Deviation 11.2
|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Month 9 [N=2025]
|
4.6 percentage of body surface area
Standard Deviation 9.9
|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Month 12 [N=1844]
|
4.2 percentage of body surface area
Standard Deviation 9.3
|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Month 18 [N=1530]
|
4.1 percentage of body surface area
Standard Deviation 8.9
|
|
Mean Percent Body Surface Area (BSA) Affected by Psoriasis Over Time
Month 24 [ N=1295]
|
4.0 percentage of body surface area
Standard Deviation 8.9
|
PRIMARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
The Target Lesion Score (TLS) was based on the severity of erythema, scaling, and infiltration of a prospectively-defined psoriasis target lesion of at least 2 cm in width that was considered to be representative of all other affected areas. Each of the three characteristics was evaluated by the clinician on a scale of 0 (absent) to 5 (maximal expression), and these scores were totaled to provide a TLS ranging from 0 (lowest severity) to 15 (highest severity).
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Target Lesion Score (TLS) Over Time
Baseline [N=2929]
|
6.1 score on a scale
Standard Deviation 4.2
|
|
Mean Target Lesion Score (TLS) Over Time
Month 3 [N=2740]
|
3.2 score on a scale
Standard Deviation 3.2
|
|
Mean Target Lesion Score (TLS) Over Time
Month 6 [N=2359]
|
2.7 score on a scale
Standard Deviation 3.1
|
|
Mean Target Lesion Score (TLS) Over Time
Month 9 [N=1969]
|
2.4 score on a scale
Standard Deviation 2.9
|
|
Mean Target Lesion Score (TLS) Over Time
Month 12 [N=1756]
|
2.3 score on a scale
Standard Deviation 3.0
|
|
Mean Target Lesion Score (TLS) Over Time
Month 18 [N=1491]
|
2.2 score on a scale
Standard Deviation 2.8
|
|
Mean Target Lesion Score (TLS) Over Time
Month 24 [N=1243]
|
2.1 score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Baseline up to 24 monthsPopulation: Safety Set - All enrolled participants
Adverse Events (AEs) were reported that clinicians considered to be related to the study drug. An AE was considered to be a serious adverse event (SAE) if any of the following criteria were met: Death of participant, life-threatening event, hospitalization, prolongation of hospitalization, congenital anomaly, persistent or significant disability or incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, or spontaneous or elective abortion.
Outcome measures
| Measure |
Psoriatic Arthritis
n=4635 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Drug-related AEs excluding SAEs
|
877 participants
|
|
Number of Participants With Adverse Events (AEs)
SAEs
|
143 participants
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Enthesitis is a distinguishing characteristic of PsA. Enthesitis involves inflammation at the site where tendons and other connective tissues enter the bone. Investigators reported the presence or absence of enthesitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Number of Participants by Severity of Enthesitis Over Time
Baseline, Mild [N=3552]
|
422 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Baseline, Moderate [N=3552]
|
407 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Baseline, Severe [N=3552]
|
119 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 3, Mild [N=3432]
|
286 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 3, Moderate [N=3432]
|
130 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 3, Severe [N=3432]
|
31 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 6, Mild [N=2995]
|
230 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 6, Moderate [N=2995]
|
80 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 6, Severe [N=2995]
|
14 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 9, Mild [N=2548]
|
188 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 9, Moderate [N=2548]
|
53 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 9, Severe[N=2548]
|
12 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 12, Mild [N=2307]
|
179 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 12, Moderate [N=2307]
|
46 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 12, Severe [N=2307]
|
8 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 18, Mild [N=1966]
|
133 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 18, Moderate [N=1966]
|
49 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 18, Severe [N=1966]
|
11 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 24, Mild [N=1630]
|
107 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 24, Moderate [N=1630]
|
24 participants
|
|
Number of Participants by Severity of Enthesitis Over Time
Month 24, Severe [N=1630]
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Dactylitis is a distinguishing characteristic of PsA. Dactylitis, sometimes referred to "sausage digit," involves swelling of the entire finger. Investigators reported the presence or absence of dactylitis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of each condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Number of Participants by Severity of Dactylitis Over Time
Month 12, Moderate [N=2307]
|
86 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Baseline, Mild [N=3552]
|
452 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Baseline, Moderate [N=3552]
|
765 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Baseline, Severe [N=3552]
|
352 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 3, Mild [N=3432]
|
420 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 3, Moderate [N=3432]
|
228 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 3, Severe [N=3432]
|
42 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 6, Mild [N=2995]
|
313 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 6, Moderate [N=2995]
|
159 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 6, Severe [N=2995]
|
23 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 9, Mild [N=2548]
|
252 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 9, Moderate [N=2548]
|
114 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 9, Severe [N=2548]
|
17 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 12, Mild [N=2307]
|
219 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 12, Severe [N=2307]
|
12 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 18, Mild [N=1966]
|
167 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 18, Moderate [N=1966]
|
61 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 18, Severe [N=1966]
|
8 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 24, Mild [N=1630]
|
153 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 24, Moderate [N=1630]
|
41 participants
|
|
Number of Participants by Severity of Dactylitis Over Time
Month 24, Severe [N=1630]
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Nail psoriasis is a distinguishing characteristic of PsA. Nail psoriasis is characterized by changes in the nail and nail matrix, including pitting, onycholysis (painless separation of the nail from the nail bed), and reddish spots. Investigators reported the presence or absence of nail psoriasis on the basis of their clinical evaluation; no specific scale or score was used. If present, the severity of this condition was graded by the investigator on a scale of mild, moderate, and severe based on their clinical impression.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 12, Mild [N=2307]
|
595 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Baseline, Mild [N=3552]
|
843 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Baseline, Moderate [N=3552]
|
771 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Baseline, Severe [N=3552]
|
305 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 3, Mild [N=3432]
|
996 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 3, Moderate [N=3432]
|
446 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 3, Severe [N=3432]
|
99 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 6, Mild [N=2995]
|
814 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 6, Moderate [N=2995]
|
266 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 6, Severe [N=2995]
|
67 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 9, Mild [N=2548]
|
664 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 9, Moderate [N=2548]
|
150 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 9, Severe [N=2548]
|
46 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 12, Moderate [N=2307]
|
143 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 12, Severe [N=2307]
|
30 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 18, Mild [N=1966]
|
464 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 18, Moderate [N=1966]
|
123 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 18, Severe [N=1966]
|
21 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 24, Mild [N=1630]
|
393 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 24, Moderate [N=1630]
|
81 participants
|
|
Number of Participants by Severity of Nail Psoriasis Levels Over Time
Month 24, Severe [N=1630]
|
11 participants
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
The Erythrocyte Sedimentation Rate (ESR) is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Month 24 [N=1391]
|
14.5 mm/hour
Standard Deviation 13.3
|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Month 9 [N=2161]
|
14.3 mm/hour
Standard Deviation 14.4
|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Baseline [N=3149]
|
23.3 mm/hour
Standard Deviation 20.0
|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Month 3 [N=2925]
|
14.3 mm/hour
Standard Deviation 14.6
|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Month 6 [N=2566]
|
14.2 mm/hour
Standard Deviation 14.4
|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Month 12 [N=1970]
|
14.5 mm/hour
Standard Deviation 14.5
|
|
Mean Erythrocyte Sedimentation Rate (ESR) Over Time
Month 18 [N=1659]
|
14.5 mm/hour
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
The C-Reactive Protein (CRP) is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Baseline [N=3522]
|
12.8 mg/L
Standard Deviation 26.4
|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Month 3 [N=3022]
|
6.2 mg/L
Standard Deviation 12.9
|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Month 6 [N=2642]
|
5.9 mg/L
Standard Deviation 10.9
|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Month 9 [N=2247]
|
5.6 mg/L
Standard Deviation 10.0
|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Month 12 [N=2047]
|
6.0 mg/L
Standard Deviation 18.1
|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Month 18 [N=1751]
|
5.4 mg/L
Standard Deviation 10.4
|
|
Mean C-Reactive Protein (CRP) Levels Over Time
Month 24 [N=1440]
|
5.4 mg/L
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Patients Global Assessment of Disease Activity Over Time
Baseline [N=3534]
|
6.8 scores on a scale
Standard Deviation 1.8
|
|
Patients Global Assessment of Disease Activity Over Time
Month 3 [N=3397]
|
3.9 scores on a scale
Standard Deviation 2.3
|
|
Patients Global Assessment of Disease Activity Over Time
Month 6 [N=2973]
|
3.4 scores on a scale
Standard Deviation 2.4
|
|
Patients Global Assessment of Disease Activity Over Time
Month 9 [N=2520]
|
3.2 scores on a scale
Standard Deviation 2.3
|
|
Patients Global Assessment of Disease Activity Over Time
Month 12 [N=2289]
|
3.1 scores on a scale
Standard Deviation 2.2
|
|
Patients Global Assessment of Disease Activity Over Time
Month 18 [N=1952]
|
3.1 scores on a scale
Standard Deviation 2.3
|
|
Patients Global Assessment of Disease Activity Over Time
Month 24 [N=1624]
|
2.9 scores on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Participants Assessment of Fatigue Over Time
Baseline [N=3385]
|
5.5 scores on a scale
Standard Deviation 2.7
|
|
Participants Assessment of Fatigue Over Time
Month 3 [N=3250]
|
4.1 scores on a scale
Standard Deviation 2.7
|
|
Participants Assessment of Fatigue Over Time
Month 6 [N=2829]
|
3.9 scores on a scale
Standard Deviation 2.7
|
|
Participants Assessment of Fatigue Over Time
Month 9 [N=2435]
|
3.7 scores on a scale
Standard Deviation 2.7
|
|
Participants Assessment of Fatigue Over Time
Month 12 [N=2200]
|
3.6 scores on a scale
Standard Deviation 2.6
|
|
Participants Assessment of Fatigue Over Time
Month 18 [N=1897]
|
3.6 scores on a scale
Standard Deviation 2.7
|
|
Participants Assessment of Fatigue Over Time
Month 24 [N=1570]
|
3.4 scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Measured on a visual analog scale (VAS) of 0 to 10 cm; lower scores indicate better participant's status.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Participants Assessment of Pain Over Time
Baseline [N=3387]
|
6.1 scores on a scale
Standard Deviation 2.2
|
|
Participants Assessment of Pain Over Time
Month 3 [N=3249]
|
4.0 scores on a scale
Standard Deviation 2.5
|
|
Participants Assessment of Pain Over Time
Month 6 [N=2827]
|
3.7 scores on a scale
Standard Deviation 2.5
|
|
Participants Assessment of Pain Over Time
Month 9 [N=2436]
|
3.6 scores on a scale
Standard Deviation 2.5
|
|
Participants Assessment of Pain Over Time
Month 12 [N=2204]
|
3.5 scores on a scale
Standard Deviation 2.5
|
|
Participants Assessment of Pain Over Time
Month 18 [N=1897]
|
3.5 scores on a scale
Standard Deviation 2.6
|
|
Participants Assessment of Pain Over Time
Month 24 [N=1573]
|
3.3 scores on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
A self-administered participant questionnaire used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units; the FFbH score indicates the remaining percentage of participant function.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Baseline [N=3401]
|
69.6 scores on a scale
Standard Deviation 21.1
|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Month 3 [N=3257]
|
76.3 scores on a scale
Standard Deviation 20.7
|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Month 6 [N=2835]
|
77.3 scores on a scale
Standard Deviation 20.9
|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Month 9 [N=2431]
|
78.3 scores on a scale
Standard Deviation 20.8
|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Month 12 [N=2213]
|
78.7 scores on a scale
Standard Deviation 21.1
|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Month 18 [N=1897]
|
79.1 scores on a scale
Standard Deviation 20.8
|
|
Mean Funktionsfragebogen Hannover (FFbH) Questionnaire Scores Over Time
Month 24 [N=1580]
|
79.8 scores on a scale
Standard Deviation 20.5
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Baseline, 0 days [N=3307]
|
29.3 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Baseline, <7 days [N=3307]
|
28.2 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Baseline, 7 to 14 days [N=3307]
|
21.7 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Baseline, >14 days [N=3307]
|
20.9 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 3, 0 days [N=3193]
|
49.0 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 3, <7 days [N=3193]
|
28.4 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 3, 7 to 14 days [N=3193]
|
13.4 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 3, >14 days [N=3193]
|
9.2 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 6, 0 days [N=2779]
|
55.4 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 6, <7 days [N=2779]
|
25.2 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 6, 7 to 14 days [N=2779]
|
11.3 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 6, >14 days [N=2779]
|
8.2 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 9, 0 days [N=2390]
|
58.5 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 9, <7 days [N=2390]
|
23.3 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 9, 7 to 14 days [N=2390]
|
10.6 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 9, >14 days [N=2390]
|
7.5 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 12, 0 days [N=2164]
|
59.8 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 12, <7 days [N=2164]
|
24.2 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 12, 7 to 14 days [N=2164]
|
9.7 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 12, >14 days [N=2164]
|
6.4 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 18, 0 days [N=1856]
|
59.9 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 18, <7 days [N=1856]
|
25.0 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 18, 7 to 14 days [N=1856]
|
9.1 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 18, >14 days [N=1856]
|
6.0 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 24, 0 days [N=1553]
|
61.6 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 24, <7 days [N=1553]
|
24.5 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 24, 7 to 14 days [N=1553]
|
8.6 percentage of participants
|
|
Percentage of Participants With Impairment in Daily Activities During the Last 4 Weeks of Each Visit
Month 24, >14 days [N=1553]
|
5.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Mean number of days missed from work were derived from patient recall of events in the preceding 12 months (at baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Basline [N=2004]
|
22.6 days
Standard Deviation 58.2
|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Month 3 [N=1886]
|
5.1 days
Standard Deviation 15.7
|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Month 6 [N=1682]
|
3.8 days
Standard Deviation 13.5
|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Month 9 [N=1440]
|
3.0 days
Standard Deviation 12.5
|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Month 12 [N=1325]
|
2.5 days
Standard Deviation 11.2
|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Month 18 [N=1133]
|
3.4 days
Standard Deviation 17.9
|
|
Mean Number of Days Missed From Work Due to Psoriatic Arthritis
Month 24 [N=929]
|
2.8 days
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: Baseline, and Months 3, 6, 9, 12, 18, and 24Population: Effectiveness analyses were performed on the full analysis set (FAS). Participants with inadequate data or who met other exclusion criteria were not included in the FAS.
Percentage of participants with in-patient hospitalization were derived from patient recall of events in the preceding 12 months (at Baseline), in the preceding 3 months (at months 3, 6, 9, and 12), or in the preceding 6 months (at months 18 and 24).
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Percentage of Participants With In-Patient Hospitalization
Baseline [N=3365]
|
17.7 percentage of particpants
|
|
Percentage of Participants With In-Patient Hospitalization
Month 3 [ N=3232]
|
12.0 percentage of particpants
|
|
Percentage of Participants With In-Patient Hospitalization
Month 6 [N=2804]
|
9.1 percentage of particpants
|
|
Percentage of Participants With In-Patient Hospitalization
Month 9 [N=2417]
|
7.0 percentage of particpants
|
|
Percentage of Participants With In-Patient Hospitalization
Month 12 [N=2183]
|
4.8 percentage of particpants
|
|
Percentage of Participants With In-Patient Hospitalization
Month 18 [N=1877]
|
3.8 percentage of particpants
|
|
Percentage of Participants With In-Patient Hospitalization
Month 24 [N=1568]
|
3.3 percentage of particpants
|
SECONDARY outcome
Timeframe: Baseline, and Months 6 and 24Population: FAS
Prior and concomitant non-biologic disease-modifying antirheumatic drugs (DMARDs): methotrexate (MTX) and other DMARDs
Outcome measures
| Measure |
Psoriatic Arthritis
n=3552 Participants
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Baseline, MTX [N=3552]
|
43.7 percentage of participants
|
|
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Month 6, MTX [N=2823]
|
43.2 percentage of participants
|
|
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Month 24, MTX [N=1555]
|
42.7 percentage of participants
|
|
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Baseline, Other DMARD [N=3552]
|
2.4 percentage of participants
|
|
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Month 6, Other DMARD [N=2823]
|
1.4 percentage of participants
|
|
Percentage of Participants on Concomitant Systemic Rheumatic and Pain Relief Medication
Month 24, Other DMARD [N=1555]
|
0.9 percentage of participants
|
Adverse Events
Psoriatic Arthritis
Serious events: 143 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Psoriatic Arthritis
n=4635 participants at risk
Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.15%
7/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Erysipelas
|
0.06%
3/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Nasopharyngitis
|
0.06%
3/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Diverticulitis
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Urinary tract infection
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Abscess limb
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Acute tonsillitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Appendicitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Bronchitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Cellulitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Cystitis klebsiella
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Endocarditis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Escherichia sepsis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Gastroenteritis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Hepatitis B
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Herpes zoster
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Infection
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Intervertebral discitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Lobar pneumonia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Lung abscess
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Mycotoxicosis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Rash pustular
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Respiratory tract infection
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Skin bacterial infection
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Superinfection bacterial
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Tuberculosis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Infections and infestations
Urosepsis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Appendectomy
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Carpal tunnel decompression
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Adhesiolysis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Analgesic therapy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Antibiotics prophylaxis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Aortic bypass
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Arthrodesis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Bile duct stent insertion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Breast operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Dupuytren's contracture operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Foot operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Gallbladder operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Hospitalization
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Hysterectomy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Knee operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Large intestine operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Lung cyst removal
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Osteosynthesis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Pilonidal sinus repair
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Renal stone removal
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Shoulder operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Spinal operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Stent placement
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Thyroid operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Ureteric calculus removal
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Surgical and medical procedures
Uterine operation
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Lupus-like syndrome
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Cerebral infarction
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Convulsion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Dizziness
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Grand mal convulsion
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Headache
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Loss of consciousness
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Movement disorder
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Myasthenia gravis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Optic neuritis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Paresthesia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Polyneuropathy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Somnolence
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Speech disorder
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Nervous system disorders
Syncope
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Pyrexia
|
0.06%
3/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Drug ineffective
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Cardiac death
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Fatigue
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Feeling hot
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Impaired healing
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Injection site urticaria
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Malaise
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Obstruction
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Edema
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
General disorders
Edema peripheral
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Myocardial infarction
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Acute right ventricular failure
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Arrhythmia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Cardiac failure
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Cardiomyopathy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Coronary artery disease
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Endocardial disease
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Palpitations
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Diarrhea
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Dysphagia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Lip edema
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
3/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
C-reactive protein increased
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Antiphospholipid antibodies positive
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Arthroscopy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Biopsy liver
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Body temperature
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
General physical condition abnormal
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Hepatic enzyme increased
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Immunology test
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Transaminases increased
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Investigations
Ureteroscopy
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Renal colic
|
0.06%
3/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Hematuria
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Calculus urinary
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Post streptococcal glomerulonephritis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Renal cyst
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Renal failure acute
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.09%
4/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.06%
3/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Injury, poisoning and procedural complications
Traumatic hematoma
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Vascular disorders
Vasculitis
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Vascular disorders
Hypertension
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Vascular disorders
Temporal arteritis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Blood and lymphatic system disorders
Anemia
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Hepatobiliary disorders
Hepatitis
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Hepatobiliary disorders
Hepatocellular damage
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Psychiatric disorders
Depression
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Reproductive system and breast disorders
Breast pain
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Reproductive system and breast disorders
Genital rash
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Ear and labyrinth disorders
Vertigo
|
0.04%
2/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Immune system disorders
Anaphylactic reaction
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Eye disorders
Eyelid edema
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
|
Social circumstances
Walking disability
|
0.02%
1/4635 • From baseline up to 24 months
Other Adverse Events (not including Serious Adverse Events) were measured at \>1% frequency, but none occurred above this threshold, therefore 0 is listed for this field.
|
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 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