Trial Outcomes & Findings for Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (NCT NCT01383421)
NCT ID: NCT01383421
Last Updated: 2017-06-26
Results Overview
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Recruitment status
COMPLETED
Target enrollment
1036 participants
Primary outcome timeframe
Baseline, Week 78
Results posted on
2017-06-26
Participant Flow
Participant milestones
| Measure |
Participants With RA Receiving Adalimumab
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated by ADA for their RA.
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|---|---|
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Overall Study
STARTED
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1025
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Overall Study
COMPLETED
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679
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Overall Study
NOT COMPLETED
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346
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)
Baseline characteristics by cohort
| Measure |
Participants With RA Receiving Adalimumab
n=1025 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated by ADA for their RA.
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|---|---|
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Age, Continuous
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54.3 years
STANDARD_DEVIATION 13.33 • n=5 Participants
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Sex: Female, Male
Female
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790 Participants
n=5 Participants
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Sex: Female, Male
Male
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235 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
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Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78
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48.1 percentage of participants
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37.8 percentage of participants
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—
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SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12
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60.9 percentage of participants
Interval 56.6 to 65.2
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50.0 percentage of participants
Interval 45.7 to 54.3
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—
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24
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52.3 percentage of participants
Interval 47.9 to 56.7
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46.4 percentage of participants
Interval 42.1 to 50.6
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—
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SECONDARY outcome
Timeframe: Baseline, Week 36Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36
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49.9 percentage of participants
Interval 45.5 to 54.3
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43.0 percentage of participants
Interval 38.7 to 47.2
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—
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SECONDARY outcome
Timeframe: Baseline, Week 52Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52
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48.5 percentage of participants
Interval 44.1 to 52.9
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39.2 percentage of participants
Interval 35.0 to 43.3
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—
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SECONDARY outcome
Timeframe: Baseline, Week 64Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
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Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64
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48.3 percentage of participants
Interval 43.9 to 52.7
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37.3 percentage of participants
Interval 33.1 to 41.4
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—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Weeks 24, 52, 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
The DAS28 is a validated combined index of RA 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, with higher numbers indicating more disease activity.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=852 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
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Participants With RA Receiving Adalimumab: PSP Non-User
n=427 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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Participants With RA Receiving Adalimumab: PSP Non-User
n=425 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78
Change at Week 24
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-2.09 units on a scale
Standard Deviation 1.48
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-2.24 units on a scale
Standard Deviation 1.55
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-1.94 units on a scale
Standard Deviation 1.39
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Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78
Change at Week 52
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-2.11 units on a scale
Standard Deviation 1.56
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-2.31 units on a scale
Standard Deviation 1.62
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-1.92 units on a scale
Standard Deviation 1.49
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Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78
Change at Week 78
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-2.15 units on a scale
Standard Deviation 1.63
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-2.33 units on a scale
Standard Deviation 1.68
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-1.97 units on a scale
Standard Deviation 1.56
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 24, 52, and 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=831 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=411 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=420 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78
Change at Week 78
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-22.12 units on a scale
Standard Deviation 17.70
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-24.50 units on a scale
Standard Deviation 18.49
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-19.80 units on a scale
Standard Deviation 16.58
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Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78
Change at Week 24
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-21.78 units on a scale
Standard Deviation 16.42
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-23.59 units on a scale
Standard Deviation 17.62
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-20.00 units on a scale
Standard Deviation 14.95
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Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78
Change at Week 52
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-21.97 units on a scale
Standard Deviation 17.01
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-24.46 units on a scale
Standard Deviation 17.88
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-19.54 units on a scale
Standard Deviation 15.77
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Weeks 24, 52, and 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=893 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=438 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=455 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78
Change at Week 24
|
-20.42 units on a scale
Standard Deviation 15.16
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-21.94 units on a scale
Standard Deviation 15.60
|
-18.93 units on a scale
Standard Deviation 14.58
|
|
Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78
Change at Week 52
|
-20.61 units on a scale
Standard Deviation 15.63
|
-22.58 units on a scale
Standard Deviation 15.84
|
-18.71 units on a scale
Standard Deviation 15.21
|
|
Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78
Change at Week 78
|
-20.56 units on a scale
Standard Deviation 16.52
|
-22.66 units on a scale
Standard Deviation 16.67
|
-18.55 units on a scale
Standard Deviation 16.13
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.
ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * HAQ-DI * Acute phase reactant value (CRP or erythrocyte sedimentation date \[ESR\])
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=316 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=274 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
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|---|---|---|---|
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Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78
ACR20
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75.9 percentage of participants
|
72.6 percentage of participants
|
—
|
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Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78
ACR50
|
58.5 percentage of participants
|
50.4 percentage of participants
|
—
|
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Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78
ACR70
|
38.6 percentage of participants
|
32.5 percentage of participants
|
—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity. * A Good Response is defined as an improvement (decrease) in the DAS28 of \> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. * A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. * No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=268 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=208 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78
Good
|
58.6 percentage of participants
|
59.1 percentage of participants
|
—
|
|
Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78
Moderate
|
28.4 percentage of participants
|
31.3 percentage of participants
|
—
|
|
Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78
No Response
|
13.1 percentage of participants
|
9.6 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity. * A Good Response is defined as an improvement (decrease) in the DAS28 of \>1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. * A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. * No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=275 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=237 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78
Good
|
65.1 percentage of participants
|
70.9 percentage of participants
|
—
|
|
Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78
Moderate
|
22.9 percentage of participants
|
19.8 percentage of participants
|
—
|
|
Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78
None
|
12.0 percentage of participants
|
9.3 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.
The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=932 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=474 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=458 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
WPAI absenteeism
|
-3.81 units on a scale
Standard Deviation 29.07
|
-2.32 units on a scale
Standard Deviation 25.40
|
-5.43 units on a scale
Standard Deviation 32.58
|
|
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
WPAI overall work impairment
|
-17.85 units on a scale
Standard Deviation 31.74
|
-17.55 units on a scale
Standard Deviation 31.79
|
-18.17 units on a scale
Standard Deviation 31.80
|
|
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
WPAI activity impairment
|
-22.04 units on a scale
Standard Deviation 27.49
|
-23.90 units on a scale
Standard Deviation 29.03
|
-20.11 units on a scale
Standard Deviation 25.69
|
|
Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
WPAI presenteeism
|
-17.88 units on a scale
Standard Deviation 27.75
|
-18.68 units on a scale
Standard Deviation 27.41
|
-17.06 units on a scale
Standard Deviation 28.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.
The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=944 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=478 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=466 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in WPAI at Week 52
WPAI absenteeism
|
-3.97 units on a scale
Standard Deviation 30.75
|
-2.80 units on a scale
Standard Deviation 29.25
|
-5.18 units on a scale
Standard Deviation 32.28
|
|
Mean Change From Baseline in WPAI at Week 52
WPAI activity impairment
|
-23.04 units on a scale
Standard Deviation 28.63
|
-25.06 units on a scale
Standard Deviation 29.23
|
-20.97 units on a scale
Standard Deviation 27.89
|
|
Mean Change From Baseline in WPAI at Week 52
WPAI presenteeism
|
-17.69 units on a scale
Standard Deviation 28.23
|
-18.34 units on a scale
Standard Deviation 26.56
|
-17.02 units on a scale
Standard Deviation 29.88
|
|
Mean Change From Baseline in WPAI at Week 52
WPAI overall work impairment
|
-17.24 units on a scale
Standard Deviation 33.21
|
-17.77 units on a scale
Standard Deviation 32.09
|
-16.69 units on a scale
Standard Deviation 34.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.
The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=946 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=478 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=468 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in WPAI at Week 78
WPAI absenteeism
|
-6.92 units on a scale
Standard Deviation 29.92
|
-5.71 units on a scale
Standard Deviation 27.55
|
-8.17 units on a scale
Standard Deviation 32.23
|
|
Mean Change From Baseline in WPAI at Week 78
WPAI presenteeism
|
-18.41 units on a scale
Standard Deviation 29.43
|
-19.07 units on a scale
Standard Deviation 28.19
|
-17.75 units on a scale
Standard Deviation 30.69
|
|
Mean Change From Baseline in WPAI at Week 78
WPAI overall work impairment
|
-21.13 units on a scale
Standard Deviation 33.33
|
-22.28 units on a scale
Standard Deviation 30.70
|
-19.94 units on a scale
Standard Deviation 35.90
|
|
Mean Change From Baseline in WPAI at Week 78
WPAI activity impairment
|
-23.52 units on a scale
Standard Deviation 29.41
|
-26.42 units on a scale
Standard Deviation 29.28
|
-20.56 units on a scale
Standard Deviation 29.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=656 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=387 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=269 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
TSQM effectiveness
|
14.45 units on a scale
Standard Deviation 31.12
|
14.56 units on a scale
Standard Deviation 32.25
|
14.29 units on a scale
Standard Deviation 29.53
|
|
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
TSQM convenience
|
5.51 units on a scale
Standard Deviation 20.02
|
6.67 units on a scale
Standard Deviation 20.27
|
3.85 units on a scale
Standard Deviation 19.58
|
|
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
TSQM global satisfaction
|
11.20 units on a scale
Standard Deviation 26.90
|
11.44 units on a scale
Standard Deviation 26.43
|
10.85 units on a scale
Standard Deviation 27.60
|
|
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
TSQM side effects
|
8.17 units on a scale
Standard Deviation 32.05
|
8.21 units on a scale
Standard Deviation 30.91
|
8.10 units on a scale
Standard Deviation 33.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=705 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=413 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=292 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in TSQM Scores at Week 52
TSQM convenience
|
6.30 units on a scale
Standard Deviation 20.15
|
7.38 units on a scale
Standard Deviation 19.94
|
4.77 units on a scale
Standard Deviation 20.38
|
|
Mean Change From Baseline in TSQM Scores at Week 52
TSQM effectiveness
|
15.79 units on a scale
Standard Deviation 30.80
|
16.06 units on a scale
Standard Deviation 31.84
|
15.41 units on a scale
Standard Deviation 29.38
|
|
Mean Change From Baseline in TSQM Scores at Week 52
TSQM global satisfaction
|
11.94 units on a scale
Standard Deviation 26.68
|
12.53 units on a scale
Standard Deviation 26.35
|
11.12 units on a scale
Standard Deviation 27.15
|
|
Mean Change From Baseline in TSQM Scores at Week 52
TSQM side effects
|
8.28 units on a scale
Standard Deviation 32.29
|
8.09 units on a scale
Standard Deviation 31.23
|
8.55 units on a scale
Standard Deviation 33.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=722 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=422 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=300 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in TSQM Scores at Week 78
TSQM convenience
|
6.20 units on a scale
Standard Deviation 20.14
|
7.23 units on a scale
Standard Deviation 19.87
|
4.76 units on a scale
Standard Deviation 20.47
|
|
Mean Change From Baseline in TSQM Scores at Week 78
TSQM effectiveness
|
15.14 units on a scale
Standard Deviation 30.58
|
16.24 units on a scale
Standard Deviation 31.22
|
13.62 units on a scale
Standard Deviation 29.68
|
|
Mean Change From Baseline in TSQM Scores at Week 78
TSQM global satisfaction
|
10.93 units on a scale
Standard Deviation 27.07
|
11.68 units on a scale
Standard Deviation 26.67
|
9.87 units on a scale
Standard Deviation 27.63
|
|
Mean Change From Baseline in TSQM Scores at Week 78
TSQM side effects
|
8.32 units on a scale
Standard Deviation 31.72
|
8.37 units on a scale
Standard Deviation 30.98
|
8.25 units on a scale
Standard Deviation 32.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 24, 52, and 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.
The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors "don't agree at all" (score = 1), "don't agree" (score = 2), "agree" (score = 3), and "agree very much" (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance).
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=957 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=490 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=467 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78
Change at Week 24
|
2.23 units on a scale
Standard Deviation 10.11
|
2.44 units on a scale
Standard Deviation 9.78
|
2.01 units on a scale
Standard Deviation 10.45
|
|
Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78
Change at Week 52
|
2.20 units on a scale
Standard Deviation 10.75
|
2.39 units on a scale
Standard Deviation 10.20
|
1.99 units on a scale
Standard Deviation 11.30
|
|
Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78
Change at Week 78
|
2.06 units on a scale
Standard Deviation 10.53
|
2.30 units on a scale
Standard Deviation 9.63
|
1.80 units on a scale
Standard Deviation 11.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=499 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=526 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78
|
35.7 percentage of participants
|
28.1 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 4 at Baseline. Non-responder imputation.
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=103 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=83 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13
|
52.4 percentage of participants
|
28.9 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 3 or 4 at Baseline. Non-responder imputation.
The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=203 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=208 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78
|
64.5 percentage of participants
|
53.8 percentage of participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing Baseline and at least 1 non-missing post-Baseline value. Observed cases.
The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=409 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
n=362 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78
Necessity
|
-0.03 units on a scale
Standard Deviation 0.743
|
-0.04 units on a scale
Standard Deviation 0.729
|
—
|
|
Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78
Concern
|
-0.12 units on a scale
Standard Deviation 0.902
|
-0.17 units on a scale
Standard Deviation 0.842
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=465 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
PSP Satisfaction Questionnaire Responses at Week 12
Nursing services: score 4
|
43.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Email contact: score 1
|
9.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Relieves my daily burden: score 1
|
24.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Relieves my daily burden: score 2
|
32.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Relieves my daily burden: score 3
|
14.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Relieves my daily burden: score 4
|
28.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is always there for me: score 1
|
32.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is always there for me: score 2
|
39.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is always there for me: score 3
|
7.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is always there for me: score 4
|
20.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Offers real added value service: score 1
|
29.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Offers real added value service: score 2
|
38.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Offers real added value service: score 3
|
8.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Offers real added value service: score 4
|
23.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is exceptional: score 1
|
28.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is exceptional: score 2
|
40.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is exceptional: score 3
|
10.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Is exceptional: score 4
|
21.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
PSP in total: score 1
|
39.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
PSP in total: score 2
|
35.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
PSP in total: score 3
|
2.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
PSP in total: score 4
|
23.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Call center/hotline: score 1
|
33.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Call center/hotline: score 2
|
23.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Call center/hotline: score 3
|
2.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Call center/hotline: score 4
|
41.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about life with RA: score 1
|
41.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about life with RA: score 2
|
40.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about life with RA: score 3
|
2.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about life with RA: score 4
|
16.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about adalimumab: score 1
|
40.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about adalimumab: score 2
|
41.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about adalimumab: score 3
|
1.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Educational materials about adalimumab: score 4
|
16.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Injection guide: score 1
|
52.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Injection guide: score 2
|
38.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Injection guide: score 3
|
0.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Injection guide: score 4
|
8.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Nursing services: score 1
|
37.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Nursing services: score 2
|
18.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Nursing services: score 3
|
0.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Email contact: score 2
|
11.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Email contact: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Email contact: score 4
|
77.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Refill reminders: score 1
|
27.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Refill reminders: score 2
|
21.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Refill reminders: score 3
|
1.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Refill reminders: score 4
|
50.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Newsletters: score 1
|
15.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Newsletters: score 2
|
19.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Newsletters: score 3
|
1.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Newsletters: score 4
|
63.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Reimbursement support: score 1
|
6.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Reimbursement support: score 2
|
7.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Reimbursement support: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Reimbursement support: score 4
|
84.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Financial assistance: score 1
|
4.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Financial assistance: score 2
|
4.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Financial assistance: score 3
|
1.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Financial assistance: score 4
|
89.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Other educational materials: score 1
|
15.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Other educational materials: score 2
|
26.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Other educational materials: score 3
|
0.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Other educational materials: score 4
|
57.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Collection/disposal of sharps container: score 1
|
30.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Collection/disposal of sharps container: score 2
|
23.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Collection/disposal of sharps container: score 3
|
2.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Collection/disposal of sharps container: score 4
|
44.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Starter pack: score 1
|
44.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Starter pack: score 2
|
32.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Starter pack: score 3
|
1.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 12
Starter pack: score 4
|
21.6 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 24Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=405 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
PSP Satisfaction Questionnaire Responses at Week 24
Relieves my daily burden: score 1
|
22.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Relieves my daily burden: score 2
|
34.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Relieves my daily burden: score 3
|
15.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Relieves my daily burden: score 4
|
27.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is always there for me: score 1
|
28.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is always there for me: score 2
|
38.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is always there for me: score 3
|
11.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is always there for me: score 4
|
21.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Offers real added value service: score 1
|
27.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Offers real added value service: score 2
|
39.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Offers real added value service: score 3
|
8.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Offers real added value service: score 4
|
25.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is exceptional: score 1
|
22.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is exceptional: score 2
|
43.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is exceptional: score 3
|
10.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Is exceptional: score 4
|
22.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
PSP in total: score 1
|
33.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
PSP in total: score 2
|
36.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
PSP in total: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
PSP in total: score 4
|
28.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Call center/hotline: score 1
|
28.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Call center/hotline: score 2
|
27.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Call center/hotline: score 3
|
1.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Call center/hotline: score 4
|
42.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about life with RA: score 1
|
31.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about life with RA: score 2
|
45.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about life with RA: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about life with RA: score 4
|
21.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about adalimumab: score 1
|
34.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about adalimumab: score 2
|
42.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about adalimumab: score 3
|
0.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Educational materials about adalimumab: score 4
|
22.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Injection guide: score 1
|
44.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Injection guide: score 2
|
39.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Injection guide: score 3
|
0.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Injection guide: score 4
|
15.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Nursing services: score 1
|
27.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Nursing services: score 2
|
16.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Nursing services: score 3
|
1.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Nursing services: score 4
|
54.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Email contact: score 1
|
7.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Email contact: score 2
|
10.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Email contact: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Email contact: score 4
|
80.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Refill reminders: score 1
|
26.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Refill reminders: score 2
|
18.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Refill reminders: score 3
|
0.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Refill reminders: score 4
|
54.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Newsletters: score 1
|
11.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Newsletters: score 2
|
22.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Newsletters: score 3
|
2.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Newsletters: score 4
|
64.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Reimbursement support: score 1
|
7.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Reimbursement support: score 2
|
7.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Reimbursement support: score 3
|
0.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Reimbursement support: score 4
|
84.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Financial assistance: score 1
|
4.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Financial assistance: score 2
|
3.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Financial assistance: score 3
|
0.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Financial assistance: score 4
|
90.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Other educational materials: score 1
|
12.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Other educational materials: score 2
|
25.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Other educational materials: score 3
|
0.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Other educational materials: score 4
|
60.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Collection/disposal of sharps container: score 1
|
29.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Collection/disposal of sharps container: score 2
|
22.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Collection/disposal of sharps container: score 3
|
1.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Collection/disposal of sharps container: score 4
|
47.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Starter pack: score 1
|
0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Starter pack: score 2
|
50.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Starter pack: score 3
|
0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 24
Starter pack: score 4
|
50.0 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 52Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=346 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is exceptional: score 2
|
42.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is exceptional: score 3
|
9.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is exceptional: score 4
|
26.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Relieves my daily burden: score 2
|
32.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
PSP in total: score 1
|
33.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
PSP in total: score 2
|
36.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
PSP in total: score 3
|
1.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Relieves my daily burden: score 1
|
21.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Relieves my daily burden: score 3
|
12.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Relieves my daily burden: score 4
|
33.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is always there for me: score 1
|
28.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is always there for me: score 2
|
37.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is always there for me: score 3
|
8.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is always there for me: score 4
|
26.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Offers real added value service: score 1
|
25.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Offers real added value service: score 2
|
39.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Offers real added value service: score 3
|
9.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Offers real added value service: score 4
|
26.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Is exceptional: score 1
|
21.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
PSP in total: score 4
|
28.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Call center/hotline: score 1
|
27.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Call center/hotline: score 2
|
25.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Call center/hotline: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Call center/hotline: score 4
|
45.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about life with RA: score 1
|
33.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about life with RA: score 2
|
41.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about life with RA: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about life with RA: score 4
|
24.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about adalimumab: score 1
|
33.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about adalimumab: score 2
|
41.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about adalimumab: score 3
|
1.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Educational materials about adalimumab: score 4
|
23.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Injection guide: score 1
|
38.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Injection guide: score 2
|
37.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Injection guide: score 3
|
0.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Injection guide: score 4
|
23.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Nursing services: score 1
|
22.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Nursing services: score 2
|
15.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Nursing services: score 3
|
1.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Nursing services: score 4
|
60.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Email contact: score 1
|
5.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Email contact: score 2
|
10.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Email contact: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Email contact: score 4
|
83.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Refill reminders: score 1
|
20.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Refill reminders: score 2
|
17.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Refill reminders: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Refill reminders: score 4
|
60.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Newsletters: score 1
|
13.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Newsletters: score 2
|
20.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Newsletters: score 3
|
1.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Newsletters: score 4
|
64.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Reimbursement support: score 1
|
6.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Reimbursement support: score 2
|
7.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Reimbursement support: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Reimbursement support: score 4
|
85.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Financial assistance: score 1
|
4.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Financial assistance: score 2
|
5.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Financial assistance: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Financial assistance: score 4
|
89.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Other educational materials: score 1
|
9.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Other educational materials: score 2
|
26.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Other educational materials: score 3
|
1.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Other educational materials: score 4
|
62.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Collection/disposal of sharps container: score 1
|
28.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Collection/disposal of sharps container: score 2
|
19.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Collection/disposal of sharps container: score 3
|
2.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 52
Collection/disposal of sharps container: score 4
|
49.9 percentage of participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 78Population: Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.
The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.
Outcome measures
| Measure |
Participants With RA Receiving Adalimumab: PSP User
n=337 Participants
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
Participants With RA Receiving Adalimumab: PSP Non-User
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants did not utilize the PSP that was offered.
|
|---|---|---|---|
|
PSP Satisfaction Questionnaire Responses at Week 78
Offers real added value service: score 2
|
42.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about life with RA: score 2
|
46.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about life with RA: score 3
|
1.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Financial assistance: score 4
|
89.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Other educational materials: score 1
|
12.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Relieves my daily burden: score 1
|
22.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Relieves my daily burden: score 2
|
32.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Relieves my daily burden: score 3
|
14.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Relieves my daily burden: score 4
|
30.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is always there for me: score 1
|
29.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is always there for me: score 2
|
38.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is always there for me: score 3
|
7.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is always there for me: score 4
|
24.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Offers real added value service: score 1
|
25.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Offers real added value service: score 3
|
7.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Offers real added value service: score 4
|
24.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is exceptional: score 1
|
22.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is exceptional: score 2
|
42.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is exceptional: score 3
|
9.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Is exceptional: score 4
|
26.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
PSP in total: score 1
|
34.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
PSP in total: score 2
|
35.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
PSP in total: score 3
|
1.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
PSP in total: score 4
|
28.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Call center/hotline: score 1
|
27.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Call center/hotline: score 2
|
22.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Call center/hotline: score 3
|
1.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Call center/hotline: score 4
|
48.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about life with RA: score 1
|
30.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about life with RA: score 4
|
22.3 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about adalimumab: score 1
|
30.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about adalimumab: score 2
|
46.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about adalimumab: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Educational materials about adalimumab: score 4
|
22.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Injection guide: score 1
|
42.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Injection guide: score 2
|
36.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Injection guide: score 3
|
0.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Injection guide: score 4
|
20.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Nursing services: score 1
|
22.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Nursing services: score 2
|
15.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Nursing services: score 3
|
0.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Nursing services: score 4
|
61.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Email contact: score 1
|
6.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Email contact: score 2
|
9.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Email contact: score 3
|
0.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Email contact: score 4
|
82.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Refill reminders: score 1
|
25.5 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Refill reminders: score 2
|
16.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Refill reminders: score 3
|
1.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Refill reminders: score 4
|
56.7 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Newsletters: score 1
|
11.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Newsletters: score 2
|
19.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Newsletters: score 3
|
1.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Newsletters: score 4
|
67.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Reimbursement support: score 1
|
6.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Reimbursement support: score 2
|
7.4 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Reimbursement support: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Reimbursement support: score 4
|
85.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Financial assistance: score 1
|
4.0 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Financial assistance: score 2
|
5.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Financial assistance: score 3
|
0.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Other educational materials: score 2
|
24.9 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Other educational materials: score 3
|
0.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Other educational materials: score 4
|
62.2 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Collection/disposal of sharps container: score 1
|
31.6 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Collection/disposal of sharps container: score 2
|
19.8 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Collection/disposal of sharps container: score 3
|
2.1 percentage of participants
|
—
|
—
|
|
PSP Satisfaction Questionnaire Responses at Week 78
Collection/disposal of sharps container: score 4
|
46.5 percentage of participants
|
—
|
—
|
Adverse Events
Participants With RA Receiving Adalimumab
Serious events: 97 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With RA Receiving Adalimumab
n=1025 participants at risk
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA.
|
|---|---|
|
Blood and lymphatic system disorders
HAEMORRHAGIC DISORDER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Endocrine disorders
GOITRE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
OESOPHAGEAL HAEMORRHAGE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
PROTEIN-LOSING GASTROENTEROPATHY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
RECTAL PROLAPSE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
DEVICE DAMAGE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
MEDICAL DEVICE PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
NODULE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
PYREXIA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
APPENDICITIS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
BRONCHIOLITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
BRONCHITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
CELLULITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
CHRONIC TONSILLITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
DIVERTICULITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
GASTROENTERITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
MENINGITIS STREPTOCOCCAL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
MYCOBACTERIUM MARINUM INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
PNEUMONIA
|
0.88%
9/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
SALMONELLOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
SALPINGO-OOPHORITIS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
UROSEPSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
VIRAL INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
WHIPPLE'S DISEASE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
FALL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
WOUND
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Metabolism and nutrition disorders
OBESITY
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
COMPARTMENT SYNDROME
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
MONARTHRITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.49%
5/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.78%
8/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID NODULE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
TENDON DISORDER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA METASTATIC
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
DEMYELINATION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
HYPOTONIA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
ISCHAEMIC CEREBRAL INFARCTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
SCIATICA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
ANXIETY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Reproductive system and breast disorders
UTERINE PROLAPSE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL DISORDER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
RASH PAPULAR
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
HYPERTENSION
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
Other adverse events
| Measure |
Participants With RA Receiving Adalimumab
n=1025 participants at risk
Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
All participants were offered to participate in the PSP while treated with ADA for their RA.
|
|---|---|
|
Blood and lymphatic system disorders
NORMOCHROMIC NORMOCYTIC ANAEMIA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Cardiac disorders
PALPITATIONS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Ear and labyrinth disorders
TINNITUS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Eye disorders
BLEPHARITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Eye disorders
CATARACT
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Eye disorders
KERATITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Eye disorders
VISION BLURRED
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
NAUSEA
|
0.39%
4/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Gastrointestinal disorders
VOMITING
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
ASTHENIA
|
0.49%
5/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
CHEST PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
DEVICE MATERIAL ISSUE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
FATIGUE
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
INJECTION SITE PAIN
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
INJECTION SITE RASH
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
INJECTION SITE REACTION
|
0.39%
4/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
General disorders
MALAISE
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
BRONCHITIS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
CELLULITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
EYE INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
GASTROENTERITIS
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
GENITAL INFECTION FUNGAL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
HERPES ZOSTER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
INFECTION SUSCEPTIBILITY INCREASED
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
INFLUENZA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
PERIODONTITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
PNEUMONIA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
PYELONEPHRITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
RASH PUSTULAR
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
RHINITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
TOOTH ABSCESS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.49%
5/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Infections and infestations
WOUND INFECTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
FALL
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Investigations
DRUG SPECIFIC ANTIBODY PRESENT
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Investigations
WEIGHT DECREASED
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Metabolism and nutrition disorders
HYPERALBUMINAEMIA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
ACQUIRED CLAW TOE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
ANXIETY
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE FATIGUE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.39%
4/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
TENDON DISORDER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN NEOPLASM OF PROSTATE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
DIZZINESS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
HEADACHE
|
0.68%
7/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
MIGRAINE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
PINEAL GLAND CYST
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
SCIATICA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Nervous system disorders
SENSORY LOSS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
DEPRESSION
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
INSOMNIA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
IRRITABILITY
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
LOSS OF LIBIDO
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS PSORIASIFORM
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.29%
3/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.78%
8/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
SKIN REACTION
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.20%
2/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
FLUSHING
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
HAEMORRHAGE
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
HOT FLUSH
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
HYPERTENSION
|
0.39%
4/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
PHLEBITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
|
Vascular disorders
VASCULITIS
|
0.10%
1/1025 • Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
|
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