Trial Outcomes & Findings for A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis (NCT NCT00853385)
NCT ID: NCT00853385
Last Updated: 2013-01-18
Results Overview
ACR20 response: greater than or equal to (\>=) 20% improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
717 participants
Primary outcome timeframe
Month 6
Results posted on
2013-01-18
Participant Flow
Participant milestones
| Measure |
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
204
|
201
|
56
|
52
|
204
|
|
Overall Study
COMPLETED
|
150
|
158
|
47
|
39
|
162
|
|
Overall Study
NOT COMPLETED
|
54
|
43
|
9
|
13
|
42
|
Reasons for withdrawal
| Measure |
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo, Then CP-690,550 5 mg
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo, Then CP-690,550 10 mg
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
24
|
24
|
2
|
5
|
22
|
|
Overall Study
Lack of Efficacy
|
6
|
7
|
3
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
0
|
1
|
1
|
|
Overall Study
Other
|
18
|
9
|
4
|
4
|
12
|
Baseline Characteristics
A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
CP-690,550 5 mg
n=204 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=201 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo, Then CP-690,550 5 mg
n=56 Participants
Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo, Then CP-690,550 10 mg
n=52 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=204 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Total
n=717 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
53.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
51.9 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
52.5 years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
52.9 years
STANDARD_DEVIATION 12.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
586 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
131 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Full analysis set: all randomized participants who received \>=1 dose and had \>=1 post-baseline and baseline measurement (change from baseline endpoint). N(number of participants analyzed)=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed by non-responder imputation.
ACR20 response: greater than or equal to (\>=) 20% improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
|
51.53 percentage of participants
|
52.55 percentage of participants
|
28.30 percentage of participants
|
47.24 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Full analysis set (FAS): all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Baseline (n=201, 199, 106, 201)
|
1.50 units on a scale
Standard Deviation 0.64
|
1.53 units on a scale
Standard Deviation 0.63
|
1.42 units on a scale
Standard Deviation 0.68
|
1.50 units on a scale
Standard Deviation 0.59
|
—
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 3
Month 3 (n=188, 185, 98, 190)
|
-0.49 units on a scale
Standard Deviation 0.59
|
-0.59 units on a scale
Standard Deviation 0.58
|
-0.17 units on a scale
Standard Deviation 0.56
|
-0.45 units on a scale
Standard Deviation 0.52
|
—
|
PRIMARY outcome
Timeframe: Month 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using non-responder imputation (NRI).
DAS28-4 (ESR) calculated from SJC and TJC using 28-joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and \< 2.6 = remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
Outcome measures
| Measure |
CP-690,550 5 mg
n=177 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=176 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=92 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=178 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
|
6.21 percentage of participants
|
12.50 percentage of participants
|
1.09 percentage of participants
|
6.74 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 1, 3Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
ACR20 response: \>=20% improvement in TJC; \>= 20% improvement in SJC; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
Month 1
|
41.24 percentage of participants
|
45.92 percentage of participants
|
16.04 percentage of participants
|
37.88 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 1 and 3
Month 3
|
60.71 percentage of participants
|
58.67 percentage of participants
|
26.42 percentage of participants
|
56.28 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
ACR20 response: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=56 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=50 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
Month 9
|
49.49 percentage of participants
|
50.51 percentage of participants
|
30.36 percentage of participants
|
36.00 percentage of participants
|
47.24 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 9 and 12
Month 12
|
49.49 percentage of participants
|
49.49 percentage of participants
|
33.93 percentage of participants
|
34.00 percentage of participants
|
49.25 percentage of participants
|
SECONDARY outcome
Timeframe: Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
Month 1
|
14.95 percentage of participants
|
16.33 percentage of participants
|
4.72 percentage of participants
|
12.12 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
Month 3
|
34.18 percentage of participants
|
27.55 percentage of participants
|
6.60 percentage of participants
|
23.62 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 1, 3 and 6
Month 6
|
36.73 percentage of participants
|
34.69 percentage of participants
|
12.26 percentage of participants
|
27.64 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=56 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=50 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
Month 9
|
35.71 percentage of participants
|
37.24 percentage of participants
|
17.86 percentage of participants
|
26.00 percentage of participants
|
29.15 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 9 and 12
Month 12
|
36.73 percentage of participants
|
35.71 percentage of participants
|
21.43 percentage of participants
|
28.00 percentage of participants
|
33.67 percentage of participants
|
SECONDARY outcome
Timeframe: Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
Month 1
|
2.58 percentage of participants
|
4.08 percentage of participants
|
0.94 percentage of participants
|
3.03 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
Month 3
|
12.24 percentage of participants
|
14.80 percentage of participants
|
1.89 percentage of participants
|
8.54 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 1, 3 and 6
Month 6
|
19.90 percentage of participants
|
21.94 percentage of participants
|
1.89 percentage of participants
|
9.05 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. Missing values due to withdrawal advancement to active treatment before Month 6 were imputed using NRI.
ACR70 response: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=196 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=56 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=50 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=199 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
Month 9
|
18.37 percentage of participants
|
21.94 percentage of participants
|
8.93 percentage of participants
|
10.00 percentage of participants
|
11.06 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 9 and 12
Month 12
|
22.96 percentage of participants
|
23.47 percentage of participants
|
10.71 percentage of participants
|
14.00 percentage of participants
|
16.58 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=200 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Baseline (n=200, 199, 106, 201)
|
5.43 units on a scale
Standard Deviation 0.89
|
5.43 units on a scale
Standard Deviation 0.83
|
5.44 units on a scale
Standard Deviation 0.88
|
5.33 units on a scale
Standard Deviation 0.92
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Month 1 (n=193, 196, 104, 197)
|
4.26 units on a scale
Standard Deviation 1.09
|
4.21 units on a scale
Standard Deviation 1.05
|
5.09 units on a scale
Standard Deviation 1.15
|
4.27 units on a scale
Standard Deviation 1.06
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Month 3 (n=187, 184, 99, 190)
|
3.78 units on a scale
Standard Deviation 1.21
|
3.77 units on a scale
Standard Deviation 1.21
|
4.83 units on a scale
Standard Deviation 1.25
|
3.88 units on a scale
Standard Deviation 1.15
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6
Month 6 (n=174, 180, 46, 181)
|
3.51 units on a scale
Standard Deviation 1.27
|
3.29 units on a scale
Standard Deviation 1.22
|
3.85 units on a scale
Standard Deviation 1.14
|
3.63 units on a scale
Standard Deviation 1.19
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=160 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=167 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=41 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=171 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Month 9 (n=160, 167, 49, 41, 171)
|
3.13 units on a scale
Standard Deviation 1.11
|
3.20 units on a scale
Standard Deviation 1.20
|
3.11 units on a scale
Standard Deviation 1.11
|
3.03 units on a scale
Standard Deviation 1.10
|
3.46 units on a scale
Standard Deviation 1.21
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9 and 12
Month 12 (n=149, 150, 48, 37, 160)
|
3.05 units on a scale
Standard Deviation 1.13
|
3.00 units on a scale
Standard Deviation 1.18
|
3.12 units on a scale
Standard Deviation 0.96
|
3.02 units on a scale
Standard Deviation 1.28
|
3.18 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=195 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=194 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=103 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=194 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Baseline (n=195, 194, 103, 194)
|
6.56 units on a scale
Standard Deviation 0.93
|
6.48 units on a scale
Standard Deviation 0.89
|
6.45 units on a scale
Standard Deviation 0.90
|
6.36 units on a scale
Standard Deviation 0.93
|
—
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Month 1 (n=172, 175, 90, 176)
|
5.23 units on a scale
Standard Deviation 1.19
|
5.14 units on a scale
Standard Deviation 1.26
|
5.93 units on a scale
Standard Deviation 1.22
|
5.13 units on a scale
Standard Deviation 1.21
|
—
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Month 3 (n=170, 166, 87, 167)
|
4.64 units on a scale
Standard Deviation 1.33
|
4.66 units on a scale
Standard Deviation 1.39
|
5.60 units on a scale
Standard Deviation 1.31
|
4.66 units on a scale
Standard Deviation 1.28
|
—
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6
Month 6 (n=155, 162, 41, 158)
|
4.40 units on a scale
Standard Deviation 1.38
|
4.21 units on a scale
Standard Deviation 1.38
|
4.61 units on a scale
Standard Deviation 1.17
|
4.37 units on a scale
Standard Deviation 1.30
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=140 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=151 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=45 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=35 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=149 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
Month 9 (n=140, 151, 45, 35, 149)
|
4.00 units on a scale
Standard Deviation 1.21
|
4.08 units on a scale
Standard Deviation 1.33
|
3.99 units on a scale
Standard Deviation 1.25
|
3.93 units on a scale
Standard Deviation 1.17
|
4.20 units on a scale
Standard Deviation 1.39
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9 and 12
Month 12 (n=134, 136, 44, 32, 139)
|
3.85 units on a scale
Standard Deviation 1.22
|
3.88 units on a scale
Standard Deviation 1.35
|
4.00 units on a scale
Standard Deviation 0.95
|
3.70 units on a scale
Standard Deviation 1.24
|
3.95 units on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6, 9, 12Population: Data was not analyzed for DAS28-4 (CRP) due to change in planned analyses.
DAS28-4 \[CRP\] calculated from SJC and TJC using 28 joint count, CRP (mg/L) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (CRP) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6, 9, 12Population: Data was not analyzed for DAS28-3 (ESR) due to change in planned analyses.
DAS28-3 (ESR) was calculated from SJC and TJC using 28 joint count and ESR (mm/hour). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=194 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=196 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=198 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
Month 1 (n=194, 196, 106, 198)
|
1.15 units on a scale
Standard Deviation 0.66
|
1.11 units on a scale
Standard Deviation 0.67
|
1.32 units on a scale
Standard Deviation 0.69
|
1.12 units on a scale
Standard Deviation 0.64
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
Month 3 (n=188, 185, 99, 190)
|
1.00 units on a scale
Standard Deviation 0.72
|
0.94 units on a scale
Standard Deviation 0.75
|
1.25 units on a scale
Standard Deviation 0.67
|
1.05 units on a scale
Standard Deviation 0.64
|
—
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 1, 3 and 6
Month 6 (n=174, 181, 46, 180)
|
0.92 units on a scale
Standard Deviation 0.72
|
0.89 units on a scale
Standard Deviation 0.69
|
1.15 units on a scale
Standard Deviation 0.71
|
0.98 units on a scale
Standard Deviation 0.65
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=158 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=167 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=41 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=171 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
Month 9 (n=158, 167, 49, 41, 171)
|
0.86 units on a scale
Standard Deviation 0.66
|
0.85 units on a scale
Standard Deviation 0.66
|
0.89 units on a scale
Standard Deviation 0.69
|
0.90 units on a scale
Standard Deviation 0.64
|
0.97 units on a scale
Standard Deviation 0.67
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI) at Month 9 and 12
Month 12 (n=149, 149, 49, 38, 159)
|
0.83 units on a scale
Standard Deviation 0.68
|
0.81 units on a scale
Standard Deviation 0.71
|
0.88 units on a scale
Standard Deviation 0.71
|
0.91 units on a scale
Standard Deviation 0.72
|
0.90 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Baseline (n=201, 199, 106, 201)
|
59.29 mm
Standard Deviation 20.95
|
59.01 mm
Standard Deviation 22.18
|
55.20 mm
Standard Deviation 21.27
|
56.46 mm
Standard Deviation 21.92
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 1 (n=194, 196, 106, 198)
|
39.71 mm
Standard Deviation 22.60
|
36.77 mm
Standard Deviation 22.63
|
49.92 mm
Standard Deviation 23.94
|
39.27 mm
Standard Deviation 24.29
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 3 (n=188, 185, 99, 190)
|
32.98 mm
Standard Deviation 23.09
|
31.27 mm
Standard Deviation 22.39
|
48.53 mm
Standard Deviation 23.42
|
36.27 mm
Standard Deviation 25.67
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 6 (n=174, 181, 46, 179)
|
30.40 mm
Standard Deviation 23.26
|
28.36 mm
Standard Deviation 22.52
|
35.04 mm
Standard Deviation 20.95
|
32.78 mm
Standard Deviation 22.57
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
Outcome measures
| Measure |
CP-690,550 5 mg
n=158 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=167 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=41 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=171 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Patient Assessment of Arthritis Pain at Month 9 and 12
Month 9 (n=158, 167, 49, 41, 171)
|
27.04 mm
Standard Deviation 21.35
|
27.99 mm
Standard Deviation 22.97
|
31.31 mm
Standard Deviation 22.66
|
24.93 mm
Standard Deviation 19.38
|
32.70 mm
Standard Deviation 24.18
|
|
Patient Assessment of Arthritis Pain at Month 9 and 12
Month 12 (n=150, 150, 49, 38, 160)
|
26.99 mm
Standard Deviation 21.97
|
24.55 mm
Standard Deviation 20.68
|
28.23 mm
Standard Deviation 17.86
|
29.37 mm
Standard Deviation 20.57
|
27.94 mm
Standard Deviation 22.70
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Baseline (n=201, 199, 106, 201)
|
59.86 mm
Standard Deviation 21.38
|
56.55 mm
Standard Deviation 23.83
|
54.46 mm
Standard Deviation 21.27
|
57.22 mm
Standard Deviation 22.22
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 1 (n=194, 196, 105, 197)
|
41.85 mm
Standard Deviation 23.02
|
36.61 mm
Standard Deviation 23.51
|
50.70 mm
Standard Deviation 24.24
|
39.32 mm
Standard Deviation 23.83
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 3 (n=188, 185, 99, 190)
|
35.56 mm
Standard Deviation 23.81
|
31.25 mm
Standard Deviation 22.23
|
49.84 mm
Standard Deviation 22.45
|
36.97 mm
Standard Deviation 25.28
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 6 (n=174, 181, 46, 180)
|
32.79 mm
Standard Deviation 25.56
|
29.74 mm
Standard Deviation 22.41
|
37.76 mm
Standard Deviation 20.86
|
33.50 mm
Standard Deviation 21.97
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.
Outcome measures
| Measure |
CP-690,550 5 mg
n=158 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=167 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=41 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=171 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Month 9 (n=158, 167, 49, 41, 171)
|
28.39 mm
Standard Deviation 22.31
|
29.47 mm
Standard Deviation 21.99
|
31.78 mm
Standard Deviation 20.75
|
30.00 mm
Standard Deviation 20.31
|
34.38 mm
Standard Deviation 24.93
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Month 12 (n=149, 150, 49, 37, 160)
|
26.86 mm
Standard Deviation 22.44
|
27.70 mm
Standard Deviation 22.09
|
30.78 mm
Standard Deviation 17.65
|
29.70 mm
Standard Deviation 20.69
|
30.33 mm
Standard Deviation 24.46
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
CP-690,550 5 mg
n=199 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 1 (n=193, 195, 106, 197)
|
38.90 mm
Standard Deviation 18.56
|
36.16 mm
Standard Deviation 19.27
|
50.73 mm
Standard Deviation 22.08
|
38.81 mm
Standard Deviation 20.08
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Baseline (n=199, 199, 106, 201)
|
59.92 mm
Standard Deviation 16.77
|
59.56 mm
Standard Deviation 16.70
|
60.28 mm
Standard Deviation 16.55
|
58.64 mm
Standard Deviation 15.98
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 3 (n=186, 185, 99, 189)
|
30.28 mm
Standard Deviation 20.71
|
29.91 mm
Standard Deviation 21.04
|
45.12 mm
Standard Deviation 22.77
|
32.40 mm
Standard Deviation 21.08
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Month 1, 3 and 6
Month 6 (n=174, 180, 46, 178)
|
24.97 mm
Standard Deviation 19.26
|
24.46 mm
Standard Deviation 19.78
|
29.76 mm
Standard Deviation 20.43
|
27.77 mm
Standard Deviation 18.36
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Outcome measures
| Measure |
CP-690,550 5 mg
n=160 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=167 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=41 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=170 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
Month 9 (n=160, 167, 49, 41, 170)
|
19.93 mm
Standard Deviation 16.20
|
21.92 mm
Standard Deviation 17.87
|
25.82 mm
Standard Deviation 20.32
|
23.78 mm
Standard Deviation 15.54
|
25.45 mm
Standard Deviation 19.94
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Month 9 and 12
Month 12 (n=149, 150, 48, 38, 157)
|
18.67 mm
Standard Deviation 16.18
|
18.87 mm
Standard Deviation 16.05
|
19.77 mm
Standard Deviation 13.88
|
20.68 mm
Standard Deviation 14.51
|
20.44 mm
Standard Deviation 16.94
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Social functioning (n=188,185,99,190)
|
41.59 units on a scale
Standard Deviation 11.04
|
44.34 units on a scale
Standard Deviation 11.00
|
41.41 units on a scale
Standard Deviation 10.08
|
40.84 units on a scale
Standard Deviation 10.92
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Bodily pain (n=187,185,99,190)
|
41.08 units on a scale
Standard Deviation 9.15
|
43.09 units on a scale
Standard Deviation 9.58
|
37.05 units on a scale
Standard Deviation 7.91
|
40.60 units on a scale
Standard Deviation 9.54
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Physical functioning (n=201,199,106,201)
|
32.02 units on a scale
Standard Deviation 9.48
|
31.06 units on a scale
Standard Deviation 9.52
|
32.23 units on a scale
Standard Deviation 9.43
|
31.74 units on a scale
Standard Deviation 8.95
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Role physical (n=201,199,106,201)
|
34.00 units on a scale
Standard Deviation 9.11
|
33.54 units on a scale
Standard Deviation 9.12
|
34.70 units on a scale
Standard Deviation 8.01
|
34.79 units on a scale
Standard Deviation 8.69
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Social functioning (n=201,199,106,201)
|
36.15 units on a scale
Standard Deviation 10.76
|
36.27 units on a scale
Standard Deviation 11.59
|
39.36 units on a scale
Standard Deviation 11.17
|
36.23 units on a scale
Standard Deviation 11.52
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Bodily pain (n=201,199,106,201)
|
33.42 units on a scale
Standard Deviation 7.51
|
33.29 units on a scale
Standard Deviation 7.42
|
34.53 units on a scale
Standard Deviation 6.57
|
33.14 units on a scale
Standard Deviation 7.33
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Mental health (n=201,199,106,201)
|
39.04 units on a scale
Standard Deviation 11.42
|
39.15 units on a scale
Standard Deviation 11.19
|
41.11 units on a scale
Standard Deviation 10.51
|
39.64 units on a scale
Standard Deviation 11.19
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Role emotional (n=201,199,106,201)
|
34.15 units on a scale
Standard Deviation 12.49
|
34.11 units on a scale
Standard Deviation 12.63
|
37.32 units on a scale
Standard Deviation 11.97
|
35.54 units on a scale
Standard Deviation 12.05
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Vitality (n=201,199,106,201)
|
40.62 units on a scale
Standard Deviation 9.23
|
40.79 units on a scale
Standard Deviation 9.36
|
42.67 units on a scale
Standard Deviation 8.85
|
39.95 units on a scale
Standard Deviation 9.54
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: General health (n=201,199,106,201)
|
35.22 units on a scale
Standard Deviation 8.95
|
35.81 units on a scale
Standard Deviation 8.93
|
36.29 units on a scale
Standard Deviation 8.38
|
35.18 units on a scale
Standard Deviation 7.96
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline:Mental component (n=201,199,106,201)
|
39.82 units on a scale
Standard Deviation 11.68
|
40.21 units on a scale
Standard Deviation 11.14
|
43.29 units on a scale
Standard Deviation 10.58
|
40.58 units on a scale
Standard Deviation 11.64
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Baseline: Physical component (n=201,199,106,201)
|
33.10 units on a scale
Standard Deviation 7.69
|
32.62 units on a scale
Standard Deviation 7.78
|
33.02 units on a scale
Standard Deviation 6.23
|
32.74 units on a scale
Standard Deviation 6.83
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Physical functioning (n=194,196,106,198)
|
35.29 units on a scale
Standard Deviation 9.94
|
35.23 units on a scale
Standard Deviation 10.57
|
34.00 units on a scale
Standard Deviation 9.68
|
35.38 units on a scale
Standard Deviation 9.79
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Role physical (n=194,196,106,198)
|
38.19 units on a scale
Standard Deviation 9.34
|
38.45 units on a scale
Standard Deviation 10.01
|
36.79 units on a scale
Standard Deviation 9.39
|
38.37 units on a scale
Standard Deviation 9.06
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Social functioning (n=194,196,106,198)
|
40.77 units on a scale
Standard Deviation 10.53
|
42.22 units on a scale
Standard Deviation 10.64
|
41.74 units on a scale
Standard Deviation 10.72
|
40.98 units on a scale
Standard Deviation 10.41
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Bodily pain (n=194,196,106,198)
|
40.14 units on a scale
Standard Deviation 8.54
|
40.73 units on a scale
Standard Deviation 8.46
|
36.18 units on a scale
Standard Deviation 7.52
|
39.58 units on a scale
Standard Deviation 8.36
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Mental health (n=194,196,106,198)
|
42.31 units on a scale
Standard Deviation 10.30
|
43.35 units on a scale
Standard Deviation 11.13
|
41.79 units on a scale
Standard Deviation 10.91
|
42.83 units on a scale
Standard Deviation 10.93
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Role emotional (n=194,196,106,198)
|
38.29 units on a scale
Standard Deviation 12.54
|
38.64 units on a scale
Standard Deviation 12.05
|
38.18 units on a scale
Standard Deviation 11.89
|
39.10 units on a scale
Standard Deviation 11.55
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Vitality (n=194,196,106,198)
|
45.24 units on a scale
Standard Deviation 9.33
|
46.99 units on a scale
Standard Deviation 9.58
|
43.71 units on a scale
Standard Deviation 8.74
|
44.44 units on a scale
Standard Deviation 10.00
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: General health (n=194,196,106,198)
|
38.53 units on a scale
Standard Deviation 9.24
|
39.98 units on a scale
Standard Deviation 9.16
|
37.41 units on a scale
Standard Deviation 8.61
|
38.35 units on a scale
Standard Deviation 8.43
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Mental component (n=194,196,106,198)
|
43.56 units on a scale
Standard Deviation 10.60
|
44.92 units on a scale
Standard Deviation 11.21
|
44.03 units on a scale
Standard Deviation 11.04
|
44.05 units on a scale
Standard Deviation 10.79
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 1: Physical component (n=194,196,106,198)
|
37.50 units on a scale
Standard Deviation 7.99
|
37.86 units on a scale
Standard Deviation 8.11
|
35.01 units on a scale
Standard Deviation 7.36
|
37.08 units on a scale
Standard Deviation 7.88
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Physical functioning (n=187,185,99,190)
|
38.11 units on a scale
Standard Deviation 10.39
|
38.49 units on a scale
Standard Deviation 11.12
|
34.77 units on a scale
Standard Deviation 8.92
|
36.56 units on a scale
Standard Deviation 10.24
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Role physical (n=188,185,99,190)
|
39.79 units on a scale
Standard Deviation 9.55
|
40.93 units on a scale
Standard Deviation 10.40
|
37.25 units on a scale
Standard Deviation 8.88
|
39.51 units on a scale
Standard Deviation 8.89
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Mental health (n=188,185,99,190)
|
42.43 units on a scale
Standard Deviation 11.02
|
44.79 units on a scale
Standard Deviation 11.25
|
42.44 units on a scale
Standard Deviation 10.04
|
43.05 units on a scale
Standard Deviation 10.45
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Role emotional (n=188,185,99,190)
|
38.74 units on a scale
Standard Deviation 12.56
|
41.76 units on a scale
Standard Deviation 12.66
|
38.59 units on a scale
Standard Deviation 12.42
|
39.24 units on a scale
Standard Deviation 11.53
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Vitality (n=188,185,99,190)
|
45.63 units on a scale
Standard Deviation 9.91
|
48.09 units on a scale
Standard Deviation 10.79
|
44.06 units on a scale
Standard Deviation 9.22
|
45.57 units on a scale
Standard Deviation 9.76
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: General health (n=188,185,99,189)
|
39.15 units on a scale
Standard Deviation 9.52
|
41.35 units on a scale
Standard Deviation 8.93
|
37.51 units on a scale
Standard Deviation 8.08
|
39.33 units on a scale
Standard Deviation 9.32
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Mental component (n=187,185,99,189)
|
43.31 units on a scale
Standard Deviation 11.47
|
46.49 units on a scale
Standard Deviation 11.45
|
44.20 units on a scale
Standard Deviation 10.65
|
43.90 units on a scale
Standard Deviation 10.84
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 3: Physical component (n=187,185,99,189)
|
39.57 units on a scale
Standard Deviation 8.76
|
40.30 units on a scale
Standard Deviation 8.94
|
35.59 units on a scale
Standard Deviation 7.33
|
38.58 units on a scale
Standard Deviation 8.36
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Physical functioning (n=173,181,46,179)
|
39.31 units on a scale
Standard Deviation 10.92
|
38.56 units on a scale
Standard Deviation 11.35
|
37.00 units on a scale
Standard Deviation 8.99
|
37.29 units on a scale
Standard Deviation 10.40
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Role physical (n=173,181,46,179)
|
40.42 units on a scale
Standard Deviation 10.03
|
41.29 units on a scale
Standard Deviation 9.73
|
38.62 units on a scale
Standard Deviation 7.95
|
39.99 units on a scale
Standard Deviation 9.14
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Social functioning (n=173,181,46,180)
|
43.85 units on a scale
Standard Deviation 11.17
|
43.98 units on a scale
Standard Deviation 11.30
|
42.49 units on a scale
Standard Deviation 9.92
|
42.36 units on a scale
Standard Deviation 10.43
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Bodily pain (n=173,181,46,180)
|
42.79 units on a scale
Standard Deviation 9.41
|
43.63 units on a scale
Standard Deviation 9.31
|
39.79 units on a scale
Standard Deviation 8.05
|
41.59 units on a scale
Standard Deviation 8.95
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Mental health (n=173,181,46,180)
|
44.31 units on a scale
Standard Deviation 11.29
|
45.32 units on a scale
Standard Deviation 11.43
|
41.21 units on a scale
Standard Deviation 11.70
|
43.13 units on a scale
Standard Deviation 11.35
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Role emotional (n=173,181, 46,179)
|
40.78 units on a scale
Standard Deviation 12.03
|
40.68 units on a scale
Standard Deviation 11.77
|
39.22 units on a scale
Standard Deviation 11.82
|
39.54 units on a scale
Standard Deviation 11.85
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Vitality (n=173,181,46,180)
|
47.35 units on a scale
Standard Deviation 10.37
|
48.66 units on a scale
Standard Deviation 10.08
|
45.06 units on a scale
Standard Deviation 9.36
|
45.93 units on a scale
Standard Deviation 9.88
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: General health (n=173,180,46,180)
|
40.53 units on a scale
Standard Deviation 9.44
|
41.95 units on a scale
Standard Deviation 8.89
|
39.03 units on a scale
Standard Deviation 9.30
|
39.91 units on a scale
Standard Deviation 8.72
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Mental component (n=173,180,46,179)
|
45.44 units on a scale
Standard Deviation 11.19
|
46.14 units on a scale
Standard Deviation 11.43
|
43.43 units on a scale
Standard Deviation 10.60
|
44.24 units on a scale
Standard Deviation 11.69
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6
Month 6: Physical component (n=173,180,46,179)
|
40.45 units on a scale
Standard Deviation 9.29
|
40.86 units on a scale
Standard Deviation 8.71
|
38.44 units on a scale
Standard Deviation 6.67
|
39.36 units on a scale
Standard Deviation 8.39
|
—
|
SECONDARY outcome
Timeframe: Month 9, 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and was reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0-100 where higher scores represented higher level of functioning.
Outcome measures
| Measure |
CP-690,550 5 mg
n=159 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=167 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=41 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=171 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Physical functioning(n=158,167,49,41,171)
|
39.77 units on a scale
Standard Deviation 10.29
|
38.74 units on a scale
Standard Deviation 11.31
|
38.94 units on a scale
Standard Deviation 9.81
|
38.59 units on a scale
Standard Deviation 10.08
|
38.75 units on a scale
Standard Deviation 10.23
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Role physical (n=159,167,49,41,171)
|
41.66 units on a scale
Standard Deviation 9.62
|
40.55 units on a scale
Standard Deviation 10.15
|
41.77 units on a scale
Standard Deviation 8.36
|
39.75 units on a scale
Standard Deviation 9.20
|
41.12 units on a scale
Standard Deviation 9.44
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Social functioning (n=159,167,49,41,171)
|
43.52 units on a scale
Standard Deviation 10.65
|
44.42 units on a scale
Standard Deviation 9.96
|
44.55 units on a scale
Standard Deviation 9.82
|
42.76 units on a scale
Standard Deviation 9.78
|
42.03 units on a scale
Standard Deviation 11.55
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Bodily pain (n=159,166,49,41,171)
|
43.45 units on a scale
Standard Deviation 9.02
|
42.75 units on a scale
Standard Deviation 9.50
|
44.68 units on a scale
Standard Deviation 8.86
|
42.26 units on a scale
Standard Deviation 7.77
|
41.81 units on a scale
Standard Deviation 9.73
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Mental health (n=159,166,49,41,171)
|
44.47 units on a scale
Standard Deviation 10.27
|
45.42 units on a scale
Standard Deviation 10.44
|
44.83 units on a scale
Standard Deviation 10.70
|
43.70 units on a scale
Standard Deviation 10.16
|
43.44 units on a scale
Standard Deviation 12.04
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Role emotional (n=159,167,49,41,171)
|
39.98 units on a scale
Standard Deviation 11.99
|
40.58 units on a scale
Standard Deviation 12.07
|
39.84 units on a scale
Standard Deviation 11.40
|
41.46 units on a scale
Standard Deviation 11.81
|
40.07 units on a scale
Standard Deviation 12.15
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Vitality (n=159,166,49,41,171)
|
47.76 units on a scale
Standard Deviation 9.51
|
48.69 units on a scale
Standard Deviation 9.68
|
47.80 units on a scale
Standard Deviation 8.94
|
46.41 units on a scale
Standard Deviation 10.03
|
46.11 units on a scale
Standard Deviation 10.28
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: General health (n=159,166,49,41,171)
|
41.15 units on a scale
Standard Deviation 9.79
|
41.34 units on a scale
Standard Deviation 9.20
|
41.39 units on a scale
Standard Deviation 8.54
|
40.57 units on a scale
Standard Deviation 9.34
|
40.12 units on a scale
Standard Deviation 9.58
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month9:Mental component (n=158,165,49,41,171)
|
44.79 units on a scale
Standard Deviation 10.76
|
46.55 units on a scale
Standard Deviation 10.52
|
45.31 units on a scale
Standard Deviation 9.75
|
45.23 units on a scale
Standard Deviation 11.22
|
44.08 units on a scale
Standard Deviation 11.45
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 9: Physical component (n=158,165,49,41,171)
|
41.55 units on a scale
Standard Deviation 8.57
|
40.32 units on a scale
Standard Deviation 9.44
|
41.65 units on a scale
Standard Deviation 8.20
|
39.73 units on a scale
Standard Deviation 7.73
|
40.35 units on a scale
Standard Deviation 8.31
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12:Physical functioning(n=149,149,49,38,160)
|
40.16 units on a scale
Standard Deviation 10.25
|
40.34 units on a scale
Standard Deviation 11.59
|
39.24 units on a scale
Standard Deviation 10.07
|
40.42 units on a scale
Standard Deviation 9.84
|
39.21 units on a scale
Standard Deviation 10.63
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12: Role physical (n=150,150,49,38,160)
|
41.15 units on a scale
Standard Deviation 9.35
|
42.34 units on a scale
Standard Deviation 10.32
|
40.16 units on a scale
Standard Deviation 8.73
|
41.18 units on a scale
Standard Deviation 9.30
|
41.07 units on a scale
Standard Deviation 9.29
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12: Social functioning (n=150,150,49,38,160)
|
43.14 units on a scale
Standard Deviation 10.46
|
44.07 units on a scale
Standard Deviation 10.44
|
43.78 units on a scale
Standard Deviation 9.97
|
44.94 units on a scale
Standard Deviation 9.78
|
42.96 units on a scale
Standard Deviation 10.92
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12: Bodily pain (n=150,150,49,38,160)
|
43.44 units on a scale
Standard Deviation 9.48
|
44.02 units on a scale
Standard Deviation 10.02
|
43.90 units on a scale
Standard Deviation 8.28
|
43.18 units on a scale
Standard Deviation 7.76
|
42.73 units on a scale
Standard Deviation 9.77
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12: Mental health (n=150,149,49,38,159)
|
44.83 units on a scale
Standard Deviation 10.02
|
45.06 units on a scale
Standard Deviation 10.49
|
44.09 units on a scale
Standard Deviation 9.20
|
45.28 units on a scale
Standard Deviation 10.94
|
44.23 units on a scale
Standard Deviation 10.93
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12:Role emotional (n=150,150,49,38,159)
|
40.18 units on a scale
Standard Deviation 11.46
|
42.25 units on a scale
Standard Deviation 11.68
|
40.23 units on a scale
Standard Deviation 10.79
|
41.03 units on a scale
Standard Deviation 12.67
|
39.89 units on a scale
Standard Deviation 11.63
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12: Vitality (n=150,149,49,38,159)
|
47.60 units on a scale
Standard Deviation 9.01
|
49.12 units on a scale
Standard Deviation 9.95
|
47.31 units on a scale
Standard Deviation 9.13
|
48.17 units on a scale
Standard Deviation 9.36
|
46.27 units on a scale
Standard Deviation 9.65
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12:General health (n=150,150,49,38,160)
|
41.07 units on a scale
Standard Deviation 9.85
|
42.33 units on a scale
Standard Deviation 9.05
|
40.47 units on a scale
Standard Deviation 9.44
|
40.77 units on a scale
Standard Deviation 8.31
|
40.40 units on a scale
Standard Deviation 9.13
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12:Mental component (n=149,149,49,38,158)
|
45.02 units on a scale
Standard Deviation 10.14
|
46.29 units on a scale
Standard Deviation 10.56
|
45.02 units on a scale
Standard Deviation 9.29
|
46.12 units on a scale
Standard Deviation 11.75
|
44.42 units on a scale
Standard Deviation 10.70
|
|
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Month 12: Physical component(n=149,149,49,38,158)
|
41.44 units on a scale
Standard Deviation 8.81
|
41.96 units on a scale
Standard Deviation 9.40
|
40.82 units on a scale
Standard Deviation 8.01
|
41.12 units on a scale
Standard Deviation 6.49
|
40.72 units on a scale
Standard Deviation 8.84
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Baseline (n=201, 199, 106, 201)
|
28.18 units on a scale
Standard Deviation 10.48
|
28.56 units on a scale
Standard Deviation 10.84
|
30.49 units on a scale
Standard Deviation 10.23
|
27.95 units on a scale
Standard Deviation 10.07
|
—
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Month 1 (n=192, 196, 106, 198)
|
32.54 units on a scale
Standard Deviation 9.94
|
33.95 units on a scale
Standard Deviation 10.54
|
31.66 units on a scale
Standard Deviation 10.09
|
31.94 units on a scale
Standard Deviation 10.48
|
—
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Month 3 (n=187, 185, 99, 190)
|
33.86 units on a scale
Standard Deviation 10.18
|
35.12 units on a scale
Standard Deviation 11.07
|
30.96 units on a scale
Standard Deviation 10.21
|
32.72 units on a scale
Standard Deviation 10.27
|
—
|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Baseline, Month 1, 3 and 6
Month 6 (n=173, 181, 46, 180)
|
34.58 units on a scale
Standard Deviation 10.53
|
36.09 units on a scale
Standard Deviation 10.07
|
32.37 units on a scale
Standard Deviation 8.92
|
33.69 units on a scale
Standard Deviation 10.58
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
FACIT-Fatigue scale is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Outcome measures
| Measure |
CP-690,550 5 mg
n=150 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=151 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=38 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=159 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-Fatigue Scale at Month 12
|
35.76 units on a scale
Standard Deviation 9.53
|
37.53 units on a scale
Standard Deviation 10.41
|
36.71 units on a scale
Standard Deviation 7.81
|
35.71 units on a scale
Standard Deviation 9.65
|
34.30 units on a scale
Standard Deviation 9.83
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Outcome measures
| Measure |
CP-690,550 5 mg
n=199 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=198 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=105 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=200 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: SPS (n=199, 198, 105, 200)
|
42.13 units on a scale
Standard Deviation 20.58
|
40.20 units on a scale
Standard Deviation 19.48
|
39.14 units on a scale
Standard Deviation 19.04
|
40.90 units on a scale
Standard Deviation 19.68
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: OSP (n=199, 198, 105, 200)
|
43.24 units on a scale
Standard Deviation 19.91
|
42.27 units on a scale
Standard Deviation 19.32
|
41.27 units on a scale
Standard Deviation 19.47
|
43.12 units on a scale
Standard Deviation 19.50
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: Ade (n=200, 198, 105, 200)
|
42.95 units on a scale
Standard Deviation 27.92
|
44.04 units on a scale
Standard Deviation 28.21
|
47.43 units on a scale
Standard Deviation 26.06
|
44.25 units on a scale
Standard Deviation 27.83
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: ASOB (n=200, 198, 105, 200)
|
19.10 units on a scale
Standard Deviation 24.91
|
15.96 units on a scale
Standard Deviation 21.70
|
18.67 units on a scale
Standard Deviation 24.54
|
20.00 units on a scale
Standard Deviation 24.31
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: SD (n=200, 198, 105, 200)
|
45.46 units on a scale
Standard Deviation 26.30
|
44.67 units on a scale
Standard Deviation 25.96
|
43.95 units on a scale
Standard Deviation 27.40
|
46.55 units on a scale
Standard Deviation 26.31
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: Qua (n=200, 198, 104, 199)
|
6.46 units on a scale
Standard Deviation 1.36
|
6.61 units on a scale
Standard Deviation 1.70
|
6.70 units on a scale
Standard Deviation 1.51
|
6.65 units on a scale
Standard Deviation 1.82
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: Sno (n=198, 197, 105, 199)
|
36.06 units on a scale
Standard Deviation 31.78
|
34.62 units on a scale
Standard Deviation 31.71
|
30.10 units on a scale
Standard Deviation 28.16
|
34.77 units on a scale
Standard Deviation 30.50
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline: Som (n=199, 198, 105, 199)
|
36.52 units on a scale
Standard Deviation 21.22
|
35.66 units on a scale
Standard Deviation 22.28
|
36.70 units on a scale
Standard Deviation 20.55
|
33.47 units on a scale
Standard Deviation 19.68
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: SPS (n=194, 195, 105, 198)
|
36.25 units on a scale
Standard Deviation 19.19
|
34.03 units on a scale
Standard Deviation 18.74
|
37.62 units on a scale
Standard Deviation 18.83
|
38.16 units on a scale
Standard Deviation 20.30
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: OSP (n=194, 195, 105, 198)
|
36.70 units on a scale
Standard Deviation 18.13
|
34.81 units on a scale
Standard Deviation 18.64
|
38.77 units on a scale
Standard Deviation 18.45
|
39.18 units on a scale
Standard Deviation 19.67
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: Ade (n=194, 195, 105, 198)
|
48.97 units on a scale
Standard Deviation 27.11
|
52.62 units on a scale
Standard Deviation 27.62
|
49.81 units on a scale
Standard Deviation 25.87
|
46.87 units on a scale
Standard Deviation 27.30
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: ASOB (n=194, 195, 105, 198)
|
18.35 units on a scale
Standard Deviation 22.52
|
14.56 units on a scale
Standard Deviation 20.13
|
19.81 units on a scale
Standard Deviation 23.78
|
18.69 units on a scale
Standard Deviation 25.26
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: SD (n=194, 195, 105, 198)
|
36.52 units on a scale
Standard Deviation 23.48
|
35.46 units on a scale
Standard Deviation 24.25
|
40.43 units on a scale
Standard Deviation 26.13
|
39.41 units on a scale
Standard Deviation 25.42
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: Qua (n=193, 195, 105, 197)
|
6.70 units on a scale
Standard Deviation 1.38
|
6.97 units on a scale
Standard Deviation 1.49
|
6.74 units on a scale
Standard Deviation 1.49
|
6.89 units on a scale
Standard Deviation 1.55
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: Sno (n=194, 193, 104, 196)
|
36.08 units on a scale
Standard Deviation 32.53
|
34.30 units on a scale
Standard Deviation 29.56
|
31.35 units on a scale
Standard Deviation 27.13
|
32.76 units on a scale
Standard Deviation 28.19
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1: Som (n=194, 195, 105, 198)
|
31.68 units on a scale
Standard Deviation 21.26
|
31.04 units on a scale
Standard Deviation 22.02
|
33.90 units on a scale
Standard Deviation 21.80
|
33.91 units on a scale
Standard Deviation 19.60
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: SPS (n=186, 185, 99, 190)
|
35.39 units on a scale
Standard Deviation 18.66
|
32.86 units on a scale
Standard Deviation 20.91
|
37.54 units on a scale
Standard Deviation 19.18
|
37.21 units on a scale
Standard Deviation 20.47
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: OSP (n=186, 185, 99, 190)
|
35.74 units on a scale
Standard Deviation 18.30
|
33.44 units on a scale
Standard Deviation 20.23
|
38.55 units on a scale
Standard Deviation 18.97
|
38.32 units on a scale
Standard Deviation 20.05
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: Ade (n=187, 185, 99, 190)
|
50.59 units on a scale
Standard Deviation 27.67
|
53.24 units on a scale
Standard Deviation 28.90
|
48.99 units on a scale
Standard Deviation 28.16
|
49.21 units on a scale
Standard Deviation 28.65
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: ASOB (n=187, 185, 99, 190)
|
18.18 units on a scale
Standard Deviation 22.12
|
14.81 units on a scale
Standard Deviation 20.62
|
18.59 units on a scale
Standard Deviation 20.85
|
18.42 units on a scale
Standard Deviation 24.42
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: SD (n=186, 185, 99, 190)
|
35.93 units on a scale
Standard Deviation 24.29
|
32.86 units on a scale
Standard Deviation 25.10
|
38.66 units on a scale
Standard Deviation 26.24
|
39.95 units on a scale
Standard Deviation 25.83
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: Qua (n=188, 185, 99, 190)
|
6.82 units on a scale
Standard Deviation 1.32
|
7.03 units on a scale
Standard Deviation 1.45
|
6.51 units on a scale
Standard Deviation 1.56
|
6.83 units on a scale
Standard Deviation 1.47
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: Sno (n=186, 184, 99, 189)
|
33.66 units on a scale
Standard Deviation 30.78
|
34.35 units on a scale
Standard Deviation 30.06
|
30.10 units on a scale
Standard Deviation 22.92
|
34.60 units on a scale
Standard Deviation 27.80
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3: Som (n=187, 185, 99, 190)
|
29.41 units on a scale
Standard Deviation 19.66
|
30.74 units on a scale
Standard Deviation 22.65
|
36.50 units on a scale
Standard Deviation 20.10
|
31.05 units on a scale
Standard Deviation 20.26
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: SPS (n=173, 181, 46, 179)
|
32.66 units on a scale
Standard Deviation 18.60
|
31.79 units on a scale
Standard Deviation 18.64
|
36.52 units on a scale
Standard Deviation 19.89
|
36.31 units on a scale
Standard Deviation 19.25
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: OSP (n=173, 181, 46, 179)
|
33.28 units on a scale
Standard Deviation 17.93
|
32.46 units on a scale
Standard Deviation 18.50
|
36.87 units on a scale
Standard Deviation 18.51
|
36.73 units on a scale
Standard Deviation 19.04
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: Ade (n=173, 181, 46, 179)
|
53.12 units on a scale
Standard Deviation 28.85
|
53.76 units on a scale
Standard Deviation 27.87
|
50.00 units on a scale
Standard Deviation 26.83
|
50.22 units on a scale
Standard Deviation 27.33
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: ASOB (n=173, 181, 46, 179)
|
16.65 units on a scale
Standard Deviation 22.00
|
13.48 units on a scale
Standard Deviation 20.21
|
16.52 units on a scale
Standard Deviation 20.79
|
19.22 units on a scale
Standard Deviation 22.37
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: SD (n=173, 181, 46, 179)
|
32.95 units on a scale
Standard Deviation 23.76
|
32.00 units on a scale
Standard Deviation 24.30
|
37.31 units on a scale
Standard Deviation 24.73
|
36.39 units on a scale
Standard Deviation 24.20
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: Qua (n=173, 181, 45, 178)
|
6.86 units on a scale
Standard Deviation 1.18
|
7.10 units on a scale
Standard Deviation 1.60
|
6.71 units on a scale
Standard Deviation 1.50
|
6.81 units on a scale
Standard Deviation 1.36
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: Sno (n=171, 180, 46, 179)
|
31.46 units on a scale
Standard Deviation 31.43
|
35.00 units on a scale
Standard Deviation 29.13
|
23.91 units on a scale
Standard Deviation 23.33
|
33.18 units on a scale
Standard Deviation 27.32
|
—
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6: Som (n=173, 181, 46, 179)
|
28.17 units on a scale
Standard Deviation 17.55
|
30.39 units on a scale
Standard Deviation 22.37
|
33.62 units on a scale
Standard Deviation 17.72
|
31.84 units on a scale
Standard Deviation 20.38
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0) and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Outcome measures
| Measure |
CP-690,550 5 mg
n=148 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=150 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=37 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=158 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
SPS (n=148, 150, 49, 37, 159)
|
34.62 units on a scale
Standard Deviation 18.58
|
30.64 units on a scale
Standard Deviation 18.42
|
34.69 units on a scale
Standard Deviation 19.10
|
34.68 units on a scale
Standard Deviation 21.32
|
35.72 units on a scale
Standard Deviation 20.25
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
OSP (n=148, 150, 49, 37, 158)
|
34.86 units on a scale
Standard Deviation 17.87
|
31.49 units on a scale
Standard Deviation 17.90
|
36.00 units on a scale
Standard Deviation 17.63
|
35.38 units on a scale
Standard Deviation 20.40
|
36.52 units on a scale
Standard Deviation 19.68
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Ade (n=149, 150, 49, 37, 159)
|
51.21 units on a scale
Standard Deviation 26.96
|
57.20 units on a scale
Standard Deviation 28.48
|
54.29 units on a scale
Standard Deviation 27.84
|
50.00 units on a scale
Standard Deviation 30.18
|
49.81 units on a scale
Standard Deviation 27.20
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
ASOB (n=149, 150, 49, 37, 159)
|
16.78 units on a scale
Standard Deviation 19.74
|
14.13 units on a scale
Standard Deviation 20.67
|
21.22 units on a scale
Standard Deviation 22.14
|
18.38 units on a scale
Standard Deviation 18.49
|
17.48 units on a scale
Standard Deviation 21.79
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
SD (n=149, 150, 49, 37, 159)
|
34.82 units on a scale
Standard Deviation 23.95
|
32.32 units on a scale
Standard Deviation 22.41
|
37.12 units on a scale
Standard Deviation 23.55
|
34.86 units on a scale
Standard Deviation 23.94
|
37.36 units on a scale
Standard Deviation 25.19
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Qua (n=148, 150, 49, 37, 158)
|
6.78 units on a scale
Standard Deviation 1.19
|
7.03 units on a scale
Standard Deviation 1.47
|
6.86 units on a scale
Standard Deviation 1.34
|
6.84 units on a scale
Standard Deviation 1.34
|
6.72 units on a scale
Standard Deviation 1.31
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Sno (n=148, 150, 48, 37, 159)
|
33.78 units on a scale
Standard Deviation 29.95
|
30.53 units on a scale
Standard Deviation 27.29
|
27.50 units on a scale
Standard Deviation 22.83
|
32.43 units on a scale
Standard Deviation 26.81
|
34.47 units on a scale
Standard Deviation 30.01
|
|
Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
Som (n=148, 150, 49, 37, 158)
|
29.41 units on a scale
Standard Deviation 18.95
|
27.07 units on a scale
Standard Deviation 19.36
|
32.38 units on a scale
Standard Deviation 17.53
|
29.37 units on a scale
Standard Deviation 22.25
|
30.00 units on a scale
Standard Deviation 21.21
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Baseline (n=201, 199, 106, 201)
|
94 participants
|
94 participants
|
49 participants
|
88 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 1 (n=194, 196, 106, 198)
|
93 participants
|
107 participants
|
55 participants
|
95 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 3 (n=188, 185, 99, 190)
|
100 participants
|
110 participants
|
37 participants
|
93 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6
Month 6 (n=174, 181, 94, 182)
|
100 participants
|
100 participants
|
46 participants
|
93 participants
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Number of participants with optimal sleep are reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=150 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=151 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=38 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=160 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) at Month 12
|
80 participants
|
84 participants
|
28 participants
|
19 participants
|
75 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
CP-690,550 5 mg
n=200 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Baseline (n=200, 199, 106, 201)
|
0.43 units on a scale
Standard Deviation 0.32
|
0.43 units on a scale
Standard Deviation 0.32
|
0.50 units on a scale
Standard Deviation 0.28
|
0.45 units on a scale
Standard Deviation 0.29
|
—
|
|
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Month 1 (n=192, 195, 106, 198)
|
0.61 units on a scale
Standard Deviation 0.23
|
0.60 units on a scale
Standard Deviation 0.25
|
0.56 units on a scale
Standard Deviation 0.25
|
0.58 units on a scale
Standard Deviation 0.27
|
—
|
|
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Month 3 (n=187, 184, 99, 189)
|
0.62 units on a scale
Standard Deviation 0.28
|
0.64 units on a scale
Standard Deviation 0.28
|
0.55 units on a scale
Standard Deviation 0.27
|
0.61 units on a scale
Standard Deviation 0.26
|
—
|
|
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Baseline, Month 1, 3 and 6
Month 6 (n=172, 180, 46, 178)
|
0.66 units on a scale
Standard Deviation 0.26
|
0.65 units on a scale
Standard Deviation 0.25
|
0.58 units on a scale
Standard Deviation 0.28
|
0.64 units on a scale
Standard Deviation 0.24
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure.
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
CP-690,550 5 mg
n=147 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=151 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=38 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=159 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Euro Quality of Life-5 Dimension (EQ-5D) Health State Profile Utility Score at Month 12
|
0.69 units on a scale
Standard Deviation 0.22
|
0.69 units on a scale
Standard Deviation 0.22
|
0.68 units on a scale
Standard Deviation 0.20
|
0.66 units on a scale
Standard Deviation 0.19
|
0.66 units on a scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Month 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Outcome measures
| Measure |
CP-690,550 5 mg
n=85 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=81 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=42 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=78 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 3: TMS (n=74, 68, 40, 70)
|
31.31 units on a scale
Standard Deviation 25.50
|
21.97 units on a scale
Standard Deviation 25.52
|
34.26 units on a scale
Standard Deviation 26.40
|
35.73 units on a scale
Standard Deviation 28.50
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Baseline: TMS (n=79, 77, 40, 76)
|
41.46 units on a scale
Standard Deviation 23.42
|
42.09 units on a scale
Standard Deviation 28.98
|
37.65 units on a scale
Standard Deviation 23.69
|
46.43 units on a scale
Standard Deviation 25.94
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Baseline: PDS (n=85, 76, 40, 77)
|
49.99 units on a scale
Standard Deviation 23.16
|
52.14 units on a scale
Standard Deviation 24.22
|
53.24 units on a scale
Standard Deviation 23.62
|
44.51 units on a scale
Standard Deviation 21.15
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Baseline: MIDS (n=82, 79, 41, 77)
|
26.80 units on a scale
Standard Deviation 22.80
|
27.30 units on a scale
Standard Deviation 22.32
|
24.85 units on a scale
Standard Deviation 28.33
|
28.45 units on a scale
Standard Deviation 23.77
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Baseline: ODS (n=80, 74, 40, 77)
|
36.34 units on a scale
Standard Deviation 26.55
|
37.29 units on a scale
Standard Deviation 28.16
|
29.28 units on a scale
Standard Deviation 26.41
|
36.82 units on a scale
Standard Deviation 22.71
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Baseline: WLI (n=85, 81, 42, 81)
|
9.76 units on a scale
Standard Deviation 5.34
|
9.85 units on a scale
Standard Deviation 5.67
|
8.83 units on a scale
Standard Deviation 5.90
|
9.92 units on a scale
Standard Deviation 5.01
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 3: PDS (n=77, 72, 39, 76)
|
53.03 units on a scale
Standard Deviation 26.21
|
47.04 units on a scale
Standard Deviation 33.97
|
55.57 units on a scale
Standard Deviation 27.38
|
54.38 units on a scale
Standard Deviation 28.15
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 3: MIDS (n=78, 72, 41, 73)
|
21.45 units on a scale
Standard Deviation 22.03
|
15.14 units on a scale
Standard Deviation 20.53
|
23.20 units on a scale
Standard Deviation 26.04
|
22.64 units on a scale
Standard Deviation 21.97
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 3: ODS (n=75, 70, 39, 76)
|
26.64 units on a scale
Standard Deviation 23.61
|
19.31 units on a scale
Standard Deviation 23.89
|
27.44 units on a scale
Standard Deviation 25.18
|
26.57 units on a scale
Standard Deviation 22.50
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 3: WLI (n=80, 74, 41, 78)
|
7.89 units on a scale
Standard Deviation 5.12
|
5.92 units on a scale
Standard Deviation 5.17
|
8.39 units on a scale
Standard Deviation 5.73
|
8.23 units on a scale
Standard Deviation 5.47
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 6: PDS (n=66, 65, 15, 71)
|
55.62 units on a scale
Standard Deviation 30.05
|
53.57 units on a scale
Standard Deviation 36.13
|
55.03 units on a scale
Standard Deviation 29.84
|
52.17 units on a scale
Standard Deviation 28.69
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 6: TMS (n=68, 65, 16, 67)
|
29.87 units on a scale
Standard Deviation 26.81
|
21.30 units on a scale
Standard Deviation 27.67
|
24.53 units on a scale
Standard Deviation 24.19
|
29.70 units on a scale
Standard Deviation 25.24
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 6: MIDS (n=70, 68, 16, 71)
|
17.50 units on a scale
Standard Deviation 21.18
|
12.87 units on a scale
Standard Deviation 22.77
|
18.26 units on a scale
Standard Deviation 23.15
|
22.61 units on a scale
Standard Deviation 22.38
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 6: ODS (n=67, 67, 16, 69)
|
23.18 units on a scale
Standard Deviation 25.53
|
16.44 units on a scale
Standard Deviation 23.79
|
19.69 units on a scale
Standard Deviation 20.77
|
25.82 units on a scale
Standard Deviation 22.93
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Month 3 and 6
Month 6: WLI (n= 70, 69, 16, 73)
|
7.32 units on a scale
Standard Deviation 5.47
|
5.69 units on a scale
Standard Deviation 5.54
|
6.89 units on a scale
Standard Deviation 4.90
|
7.84 units on a scale
Standard Deviation 5.04
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: 5-items Time Management scale (TMS); 6-items Physical Demands scale (PDS); 9-items Mental-Interpersonal Demands Scale (MIDS); 5-items Output Demands scale (ODS). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index (WLI), which represented percentage of lost work over time period relative to a normative population, was derived (total score: 0 \[no loss\] to 100 \[complete loss of work\]).
Outcome measures
| Measure |
CP-690,550 5 mg
n=57 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=55 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=21 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=14 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=60 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
TMS (n=55, 53, 20, 14, 57)
|
25.59 units on a scale
Standard Deviation 25.10
|
20.77 units on a scale
Standard Deviation 28.68
|
32.69 units on a scale
Standard Deviation 29.07
|
28.75 units on a scale
Standard Deviation 28.26
|
26.57 units on a scale
Standard Deviation 26.68
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
PDS (n=55, 52, 18, 14, 58)
|
54.35 units on a scale
Standard Deviation 32.96
|
55.69 units on a scale
Standard Deviation 38.22
|
51.81 units on a scale
Standard Deviation 32.57
|
59.02 units on a scale
Standard Deviation 36.59
|
50.41 units on a scale
Standard Deviation 33.98
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
MIDS (n=55, 51, 21, 14, 58)
|
14.72 units on a scale
Standard Deviation 19.96
|
13.96 units on a scale
Standard Deviation 23.76
|
21.46 units on a scale
Standard Deviation 27.11
|
19.44 units on a scale
Standard Deviation 24.29
|
17.99 units on a scale
Standard Deviation 20.10
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
ODS (n=57, 50, 19, 14, 58)
|
20.51 units on a scale
Standard Deviation 23.13
|
17.35 units on a scale
Standard Deviation 27.77
|
27.11 units on a scale
Standard Deviation 27.29
|
25.36 units on a scale
Standard Deviation 29.64
|
21.55 units on a scale
Standard Deviation 22.63
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 12
WLI (n=57, 55, 21, 14, 60)
|
6.61 units on a scale
Standard Deviation 5.07
|
5.78 units on a scale
Standard Deviation 5.59
|
7.75 units on a scale
Standard Deviation 6.53
|
8.06 units on a scale
Standard Deviation 6.01
|
6.85 units on a scale
Standard Deviation 5.21
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: any RA/non-RA related medical/non-medical (NM) practitioner visit, nursing home, hospital, surgery, emergency room (ER) treatment, diagnostic tests, over-night stay, home healthcare (HC) services, aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Outcome measures
| Measure |
CP-690,550 5 mg
n=201 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=199 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=106 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=201 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Seen any doctor (n=201, 199, 106, 201)
|
1.16 units on a scale
Standard Deviation 0.37
|
1.13 units on a scale
Standard Deviation 0.34
|
1.15 units on a scale
Standard Deviation 0.36
|
1.15 units on a scale
Standard Deviation 0.36
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Treated in ER (n=201, 199, 106, 201)
|
1.95 units on a scale
Standard Deviation 0.23
|
1.93 units on a scale
Standard Deviation 0.26
|
1.93 units on a scale
Standard Deviation 0.25
|
1.94 units on a scale
Standard Deviation 0.25
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Admitted overnight stay (n=11,14,6,12)
|
0.45 units on a scale
Standard Deviation 0.82
|
0.21 units on a scale
Standard Deviation 0.43
|
0.17 units on a scale
Standard Deviation 0.41
|
0.08 units on a scale
Standard Deviation 0.29
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Hospitalization (n=201, 199, 106, 201)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.97 units on a scale
Standard Deviation 0.17
|
1.93 units on a scale
Standard Deviation 0.25
|
1.95 units on a scale
Standard Deviation 0.23
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Outpatient surgeries (n=200,199,106,201)
|
1.96 units on a scale
Standard Deviation 0.20
|
1.97 units on a scale
Standard Deviation 0.17
|
1.98 units on a scale
Standard Deviation 0.14
|
1.97 units on a scale
Standard Deviation 0.18
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Diagnostic tests (n=200,199,106,200)
|
1.81 units on a scale
Standard Deviation 0.39
|
1.83 units on a scale
Standard Deviation 0.37
|
1.82 units on a scale
Standard Deviation 0.39
|
1.82 units on a scale
Standard Deviation 0.39
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: In nursing home (n=201, 199, 106, 201)
|
1.99 units on a scale
Standard Deviation 0.12
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
1.98 units on a scale
Standard Deviation 0.14
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Home HC services (n=201, 198, 106, 201)
|
1.99 units on a scale
Standard Deviation 0.10
|
1.99 units on a scale
Standard Deviation 0.10
|
1.99 units on a scale
Standard Deviation 0.10
|
1.99 units on a scale
Standard Deviation 0.12
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline:Required aids/devices (n=201,199,106,201)
|
1.92 units on a scale
Standard Deviation 0.28
|
1.86 units on a scale
Standard Deviation 0.35
|
1.92 units on a scale
Standard Deviation 0.28
|
1.91 units on a scale
Standard Deviation 0.29
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Seen NM practitioner (n=201,199,106,201)
|
1.99 units on a scale
Standard Deviation 0.12
|
1.97 units on a scale
Standard Deviation 0.17
|
1.98 units on a scale
Standard Deviation 0.14
|
1.97 units on a scale
Standard Deviation 0.17
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Currently employed (n=201,199,106,201)
|
1.64 units on a scale
Standard Deviation 0.48
|
1.65 units on a scale
Standard Deviation 0.48
|
1.64 units on a scale
Standard Deviation 0.48
|
1.65 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Feel well enough to work (n=73,83,39,81)
|
1.90 units on a scale
Standard Deviation 0.30
|
1.89 units on a scale
Standard Deviation 0.31
|
1.82 units on a scale
Standard Deviation 0.39
|
1.80 units on a scale
Standard Deviation 0.40
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Retired (n=80,88,45,89)
|
1.41 units on a scale
Standard Deviation 0.50
|
1.41 units on a scale
Standard Deviation 0.49
|
1.40 units on a scale
Standard Deviation 0.50
|
1.39 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Lost job/retired early(n=66,82,39,81)
|
1.50 units on a scale
Standard Deviation 0.50
|
1.70 units on a scale
Standard Deviation 0.46
|
1.74 units on a scale
Standard Deviation 0.44
|
1.57 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Unable to work due to RA (n=76,84,40,78)
|
1.36 units on a scale
Standard Deviation 0.48
|
1.37 units on a scale
Standard Deviation 0.49
|
1.45 units on a scale
Standard Deviation 0.50
|
1.37 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Work disabled due to RA (n=66,82,40,79)
|
1.56 units on a scale
Standard Deviation 0.50
|
1.70 units on a scale
Standard Deviation 0.46
|
1.70 units on a scale
Standard Deviation 0.46
|
1.65 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Sick leave due to RA (n=167,166,92,167)
|
1.85 units on a scale
Standard Deviation 0.36
|
1.86 units on a scale
Standard Deviation 0.35
|
1.84 units on a scale
Standard Deviation 0.37
|
1.83 units on a scale
Standard Deviation 0.38
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Part time work (n=169,166,92,167)
|
1.92 units on a scale
Standard Deviation 0.27
|
1.92 units on a scale
Standard Deviation 0.27
|
1.93 units on a scale
Standard Deviation 0.25
|
1.94 units on a scale
Standard Deviation 0.24
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Performed paid work(n=169,166,91,167)
|
1.69 units on a scale
Standard Deviation 0.46
|
1.70 units on a scale
Standard Deviation 0.46
|
1.66 units on a scale
Standard Deviation 0.48
|
1.67 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Unable to do chores (n=201,199,105,198)
|
1.41 units on a scale
Standard Deviation 0.49
|
1.46 units on a scale
Standard Deviation 0.50
|
1.53 units on a scale
Standard Deviation 0.50
|
1.41 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Chores by housekeeper(n=201,199,106,201)
|
1.89 units on a scale
Standard Deviation 0.32
|
1.90 units on a scale
Standard Deviation 0.29
|
1.93 units on a scale
Standard Deviation 0.25
|
1.91 units on a scale
Standard Deviation 0.29
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Baseline: Chores by family (n=200,199,106,201)
|
1.50 units on a scale
Standard Deviation 0.50
|
1.48 units on a scale
Standard Deviation 0.50
|
1.62 units on a scale
Standard Deviation 0.49
|
1.51 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Seen any doctor (n=186,185,99,190)
|
1.27 units on a scale
Standard Deviation 0.45
|
1.28 units on a scale
Standard Deviation 0.45
|
1.22 units on a scale
Standard Deviation 0.42
|
1.29 units on a scale
Standard Deviation 0.45
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Treated in ER (n=186,185,99,190)
|
1.96 units on a scale
Standard Deviation 0.20
|
1.96 units on a scale
Standard Deviation 0.19
|
1.96 units on a scale
Standard Deviation 0.20
|
1.95 units on a scale
Standard Deviation 0.22
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Admitted overnight stay (n=8,8,4,9)
|
0.25 units on a scale
Standard Deviation 0.46
|
0.88 units on a scale
Standard Deviation 0.99
|
0.00 units on a scale
Standard Deviation 0.00
|
0.22 units on a scale
Standard Deviation 0.44
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Hospitalization (n=185,185,99,190)
|
1.98 units on a scale
Standard Deviation 0.15
|
1.97 units on a scale
Standard Deviation 0.16
|
1.99 units on a scale
Standard Deviation 0.10
|
1.98 units on a scale
Standard Deviation 0.12
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Outpatient surgeries (n=185,185,99,190)
|
1.98 units on a scale
Standard Deviation 0.13
|
1.98 units on a scale
Standard Deviation 0.15
|
1.96 units on a scale
Standard Deviation 0.20
|
1.97 units on a scale
Standard Deviation 0.18
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Diagnostic tests (n=184,185,99,190)
|
1.90 units on a scale
Standard Deviation 0.30
|
1.87 units on a scale
Standard Deviation 0.34
|
1.91 units on a scale
Standard Deviation 0.29
|
1.89 units on a scale
Standard Deviation 0.31
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: In nursing home (n=185,185,99,190)
|
1.99 units on a scale
Standard Deviation 0.07
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
1.99 units on a scale
Standard Deviation 0.10
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Home HC services (n=184,185,99,190)
|
1.99 units on a scale
Standard Deviation 0.07
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Required aids/devices (n=185,185,99,190)
|
1.94 units on a scale
Standard Deviation 0.25
|
1.91 units on a scale
Standard Deviation 0.29
|
1.92 units on a scale
Standard Deviation 0.27
|
1.92 units on a scale
Standard Deviation 0.28
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Seen NM practitioner (n=185,185,99,190)
|
1.97 units on a scale
Standard Deviation 0.16
|
2.00 units on a scale
Standard Deviation 0.00
|
1.98 units on a scale
Standard Deviation 0.14
|
1.98 units on a scale
Standard Deviation 0.12
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Currently employed (n=185,185,99,190)
|
1.62 units on a scale
Standard Deviation 0.49
|
1.64 units on a scale
Standard Deviation 0.48
|
1.63 units on a scale
Standard Deviation 0.49
|
1.64 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Feel well enough to work (n=74,79,41,80)
|
1.70 units on a scale
Standard Deviation 0.46
|
1.73 units on a scale
Standard Deviation 0.44
|
1.93 units on a scale
Standard Deviation 0.26
|
1.74 units on a scale
Standard Deviation 0.44
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Retired (n=80,86,47,86)
|
1.39 units on a scale
Standard Deviation 0.49
|
1.34 units on a scale
Standard Deviation 0.48
|
1.38 units on a scale
Standard Deviation 0.49
|
1.38 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Lost job/retired early(n=73,78,40,79)
|
1.55 units on a scale
Standard Deviation 0.50
|
1.59 units on a scale
Standard Deviation 0.50
|
1.75 units on a scale
Standard Deviation 0.44
|
1.65 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Unable to work due to RA (n=76,83,44,77)
|
1.42 units on a scale
Standard Deviation 0.50
|
1.46 units on a scale
Standard Deviation 0.50
|
1.45 units on a scale
Standard Deviation 0.50
|
1.58 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Work disabled due to RA (n=71,82,41,73)
|
1.63 units on a scale
Standard Deviation 0.49
|
1.68 units on a scale
Standard Deviation 0.47
|
1.61 units on a scale
Standard Deviation 0.49
|
1.74 units on a scale
Standard Deviation 0.44
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Sick leave due to RA (n=153,146,85,157)
|
1.93 units on a scale
Standard Deviation 0.26
|
1.94 units on a scale
Standard Deviation 0.24
|
1.81 units on a scale
Standard Deviation 0.39
|
1.90 units on a scale
Standard Deviation 0.29
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Part time work (n=153,145,85,155)
|
1.95 units on a scale
Standard Deviation 0.21
|
1.97 units on a scale
Standard Deviation 0.16
|
1.94 units on a scale
Standard Deviation 0.24
|
1.94 units on a scale
Standard Deviation 0.25
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Performed paid work(n=153,145,85,157)
|
1.73 units on a scale
Standard Deviation 0.45
|
1.81 units on a scale
Standard Deviation 0.39
|
1.68 units on a scale
Standard Deviation 0.47
|
1.70 units on a scale
Standard Deviation 0.46
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Unable to do chores(n=182,182,99,189)
|
1.62 units on a scale
Standard Deviation 0.49
|
1.71 units on a scale
Standard Deviation 0.46
|
1.59 units on a scale
Standard Deviation 0.50
|
1.66 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Chores by housekeeper (n=184,183,99,190)
|
1.91 units on a scale
Standard Deviation 0.29
|
1.94 units on a scale
Standard Deviation 0.24
|
1.93 units on a scale
Standard Deviation 0.26
|
1.94 units on a scale
Standard Deviation 0.24
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 3: Chores by family (n=183,183,99,190)
|
1.67 units on a scale
Standard Deviation 0.47
|
1.74 units on a scale
Standard Deviation 0.44
|
1.66 units on a scale
Standard Deviation 0.48
|
1.68 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Seen any doctor (n=173,180,45,179)
|
1.25 units on a scale
Standard Deviation 0.43
|
1.28 units on a scale
Standard Deviation 0.45
|
1.27 units on a scale
Standard Deviation 0.45
|
1.31 units on a scale
Standard Deviation 0.46
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Treated in ER (n=173,180,46,179)
|
1.93 units on a scale
Standard Deviation 0.25
|
1.97 units on a scale
Standard Deviation 0.18
|
1.91 units on a scale
Standard Deviation 0.28
|
1.98 units on a scale
Standard Deviation 0.15
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Admitted overnight stay (n=12,6,4,3)
|
0.58 units on a scale
Standard Deviation 0.67
|
0.17 units on a scale
Standard Deviation 0.41
|
0.00 units on a scale
Standard Deviation 0.00
|
0.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Hospitalization (n=172,180,46,179)
|
1.95 units on a scale
Standard Deviation 0.22
|
1.97 units on a scale
Standard Deviation 0.16
|
1.96 units on a scale
Standard Deviation 0.21
|
1.99 units on a scale
Standard Deviation 0.07
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Outpatient surgeries (n=173,180,46,178)
|
1.98 units on a scale
Standard Deviation 0.15
|
1.96 units on a scale
Standard Deviation 0.19
|
1.98 units on a scale
Standard Deviation 0.15
|
1.99 units on a scale
Standard Deviation 0.11
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Diagnostic tests (n=173,180,46,178)
|
1.87 units on a scale
Standard Deviation 0.33
|
1.86 units on a scale
Standard Deviation 0.35
|
1.89 units on a scale
Standard Deviation 0.31
|
1.89 units on a scale
Standard Deviation 0.31
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: In nursing home (n=173,180,46,178)
|
1.99 units on a scale
Standard Deviation 0.11
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Home HC services (n=173,180,46,177)
|
1.99 units on a scale
Standard Deviation 0.11
|
1.99 units on a scale
Standard Deviation 0.11
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Required aids/devices (n=173,180,46,178)
|
1.91 units on a scale
Standard Deviation 0.28
|
1.91 units on a scale
Standard Deviation 0.29
|
1.87 units on a scale
Standard Deviation 0.34
|
1.92 units on a scale
Standard Deviation 0.27
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Seen NM practitioner (n=173,180,45,178)
|
2.00 units on a scale
Standard Deviation 0.00
|
1.98 units on a scale
Standard Deviation 0.13
|
2.00 units on a scale
Standard Deviation 0.00
|
1.99 units on a scale
Standard Deviation 0.07
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Currently employed (n=173,180,46,179)
|
1.62 units on a scale
Standard Deviation 0.49
|
1.66 units on a scale
Standard Deviation 0.48
|
1.63 units on a scale
Standard Deviation 0.49
|
1.63 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Feel well enough to work (72,81,23,76)
|
1.75 units on a scale
Standard Deviation 0.44
|
1.77 units on a scale
Standard Deviation 0.43
|
1.83 units on a scale
Standard Deviation 0.39
|
1.71 units on a scale
Standard Deviation 0.46
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Retired (n=77,87,22,82)
|
1.32 units on a scale
Standard Deviation 0.47
|
1.30 units on a scale
Standard Deviation 0.46
|
1.32 units on a scale
Standard Deviation 0.48
|
1.35 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Lost job/retired early (n=70,82,22,72)
|
1.57 units on a scale
Standard Deviation 0.50
|
1.66 units on a scale
Standard Deviation 0.48
|
1.68 units on a scale
Standard Deviation 0.48
|
1.67 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Unable to work due to RA (n=73,83,23,74)
|
1.51 units on a scale
Standard Deviation 0.50
|
1.54 units on a scale
Standard Deviation 0.50
|
1.48 units on a scale
Standard Deviation 0.51
|
1.57 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Work disabled due to RA (n=67,80,22,72)
|
1.72 units on a scale
Standard Deviation 0.45
|
1.70 units on a scale
Standard Deviation 0.46
|
1.73 units on a scale
Standard Deviation 0.46
|
1.72 units on a scale
Standard Deviation 0.45
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Sick leave due to RA (n=138,134,38,144)
|
1.93 units on a scale
Standard Deviation 0.25
|
1.93 units on a scale
Standard Deviation 0.25
|
1.92 units on a scale
Standard Deviation 0.27
|
1.94 units on a scale
Standard Deviation 0.24
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Part time work (n=135,134,37,142)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.96 units on a scale
Standard Deviation 0.21
|
1.97 units on a scale
Standard Deviation 0.16
|
1.95 units on a scale
Standard Deviation 0.22
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Performed paid work (n=136,136,38,142)
|
1.75 units on a scale
Standard Deviation 0.43
|
1.80 units on a scale
Standard Deviation 0.40
|
1.74 units on a scale
Standard Deviation 0.45
|
1.76 units on a scale
Standard Deviation 0.43
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Unable to do chores(n=171,178,45,175)
|
1.70 units on a scale
Standard Deviation 0.46
|
1.74 units on a scale
Standard Deviation 0.44
|
1.62 units on a scale
Standard Deviation 0.49
|
1.67 units on a scale
Standard Deviation 0.47
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Chores by housekeeper (n=172,180,45,180)
|
1.92 units on a scale
Standard Deviation 0.27
|
1.94 units on a scale
Standard Deviation 0.23
|
1.93 units on a scale
Standard Deviation 0.25
|
1.96 units on a scale
Standard Deviation 0.19
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Month 6: Chores by family (n=172,180,46,180)
|
1.72 units on a scale
Standard Deviation 0.45
|
1.74 units on a scale
Standard Deviation 0.44
|
1.67 units on a scale
Standard Deviation 0.47
|
1.71 units on a scale
Standard Deviation 0.45
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost: visit to doctor, NM practitioner, nursing home, hospital, surgery, ER treatment, diagnostic tests, over-night stay, home HC services, and aids/devices used. Indirect costs associated with functional disability: employment status, willingness to work, work disability due to RA, sick leave, part time work, ability to perform chores, chores done by family/friends/housekeeper. Assessment was based on 0 to 2-point scale; higher score indicated higher medical cost.
Outcome measures
| Measure |
CP-690,550 5 mg
n=148 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=151 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=49 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=38 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=160 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Seen any doctor (n=148,151,49,38,160)
|
1.31 units on a scale
Standard Deviation 0.46
|
1.27 units on a scale
Standard Deviation 0.45
|
1.24 units on a scale
Standard Deviation 0.43
|
1.24 units on a scale
Standard Deviation 0.43
|
1.23 units on a scale
Standard Deviation 0.42
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Treated in ER (n=149,151,49,38,160)
|
1.98 units on a scale
Standard Deviation 0.14
|
1.97 units on a scale
Standard Deviation 0.18
|
2.00 units on a scale
Standard Deviation 0.00
|
1.97 units on a scale
Standard Deviation 0.16
|
1.96 units on a scale
Standard Deviation 0.19
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Admitted overnight stay (n=3,5,0,1,6)
|
0.33 units on a scale
Standard Deviation 0.58
|
0.20 units on a scale
Standard Deviation 0.45
|
NA units on a scale
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
0.00 units on a scale
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.17 units on a scale
Standard Deviation 0.41
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Hospitalization (n=148,151,49,38,160)
|
1.98 units on a scale
Standard Deviation 0.14
|
1.97 units on a scale
Standard Deviation 0.18
|
1.98 units on a scale
Standard Deviation 0.14
|
1.97 units on a scale
Standard Deviation 0.16
|
1.98 units on a scale
Standard Deviation 0.14
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Outpatient surgeries (n=148,151,49,38,160)
|
1.97 units on a scale
Standard Deviation 0.18
|
1.99 units on a scale
Standard Deviation 0.11
|
2.00 units on a scale
Standard Deviation 0.00
|
1.95 units on a scale
Standard Deviation 0.23
|
1.97 units on a scale
Standard Deviation 0.17
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Diagnostic tests (n=149,151,49,38,159)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.87 units on a scale
Standard Deviation 0.33
|
1.88 units on a scale
Standard Deviation 0.33
|
1.84 units on a scale
Standard Deviation 0.37
|
1.86 units on a scale
Standard Deviation 0.35
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
In nursing home (n=149,151,49,38,159)
|
1.99 units on a scale
Standard Deviation 0.12
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
1.99 units on a scale
Standard Deviation 0.08
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Home HC services (n=148,151,49,38,159)
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
1.99 units on a scale
Standard Deviation 0.08
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Required aids/devices (n=148,151,49,38,160)
|
1.93 units on a scale
Standard Deviation 0.26
|
1.92 units on a scale
Standard Deviation 0.27
|
1.94 units on a scale
Standard Deviation 0.24
|
1.92 units on a scale
Standard Deviation 0.27
|
1.91 units on a scale
Standard Deviation 0.29
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Seen NM practitioner(n=149,151,49,38,160)
|
1.98 units on a scale
Standard Deviation 0.14
|
1.97 units on a scale
Standard Deviation 0.16
|
1.98 units on a scale
Standard Deviation 0.14
|
1.95 units on a scale
Standard Deviation 0.23
|
2.00 units on a scale
Standard Deviation 0.00
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Currently employed (n=148,151,49,38,160)
|
1.59 units on a scale
Standard Deviation 0.49
|
1.68 units on a scale
Standard Deviation 0.47
|
1.61 units on a scale
Standard Deviation 0.49
|
1.61 units on a scale
Standard Deviation 0.50
|
1.64 units on a scale
Standard Deviation 0.48
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Feel well enough to work (n=61,79,19,19,76)
|
1.72 units on a scale
Standard Deviation 0.45
|
1.75 units on a scale
Standard Deviation 0.44
|
1.84 units on a scale
Standard Deviation 0.37
|
1.84 units on a scale
Standard Deviation 0.37
|
1.68 units on a scale
Standard Deviation 0.47
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Retired (n=64,84,21,19,80)
|
1.25 units on a scale
Standard Deviation 0.44
|
1.31 units on a scale
Standard Deviation 0.47
|
1.19 units on a scale
Standard Deviation 0.40
|
1.53 units on a scale
Standard Deviation 0.51
|
1.35 units on a scale
Standard Deviation 0.48
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Lost job/retired early (n=58,75,19,18,75)
|
1.53 units on a scale
Standard Deviation 0.50
|
1.72 units on a scale
Standard Deviation 0.45
|
1.68 units on a scale
Standard Deviation 0.48
|
1.78 units on a scale
Standard Deviation 0.43
|
1.67 units on a scale
Standard Deviation 0.47
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Unable to work due to RA (n=59,77,19,19,77)
|
1.56 units on a scale
Standard Deviation 0.50
|
1.61 units on a scale
Standard Deviation 0.49
|
1.58 units on a scale
Standard Deviation 0.51
|
1.58 units on a scale
Standard Deviation 0.51
|
1.57 units on a scale
Standard Deviation 0.50
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Work disabled due to RA (n=58,76,19,18,75)
|
1.64 units on a scale
Standard Deviation 0.48
|
1.75 units on a scale
Standard Deviation 0.44
|
1.79 units on a scale
Standard Deviation 0.42
|
1.67 units on a scale
Standard Deviation 0.49
|
1.67 units on a scale
Standard Deviation 0.47
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Sick leave due to RA (n=118,112,37,30,124)
|
1.96 units on a scale
Standard Deviation 0.20
|
1.96 units on a scale
Standard Deviation 0.19
|
1.95 units on a scale
Standard Deviation 0.23
|
2.00 units on a scale
Standard Deviation 0.00
|
1.97 units on a scale
Standard Deviation 0.18
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Part time work (n=117,112,37,30,123)
|
1.95 units on a scale
Standard Deviation 0.22
|
1.99 units on a scale
Standard Deviation 0.09
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.00
|
1.99 units on a scale
Standard Deviation 0.09
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Performed paid work (n=118,114,37,31,123)
|
1.83 units on a scale
Standard Deviation 0.38
|
1.82 units on a scale
Standard Deviation 0.39
|
1.78 units on a scale
Standard Deviation 0.42
|
1.71 units on a scale
Standard Deviation 0.46
|
1.82 units on a scale
Standard Deviation 0.38
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Unable to do chores (n=146,150,47,38,154)
|
1.81 units on a scale
Standard Deviation 0.40
|
1.75 units on a scale
Standard Deviation 0.44
|
1.79 units on a scale
Standard Deviation 0.41
|
1.84 units on a scale
Standard Deviation 0.37
|
1.73 units on a scale
Standard Deviation 0.45
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Chores by housekeeper (n=148,151,49,38,160)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.97 units on a scale
Standard Deviation 0.16
|
1.96 units on a scale
Standard Deviation 0.20
|
1.95 units on a scale
Standard Deviation 0.23
|
1.93 units on a scale
Standard Deviation 0.25
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Chores by family (n=145,151,49,38,160)
|
1.76 units on a scale
Standard Deviation 0.43
|
1.80 units on a scale
Standard Deviation 0.40
|
1.84 units on a scale
Standard Deviation 0.37
|
1.71 units on a scale
Standard Deviation 0.46
|
1.71 units on a scale
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=168 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=174 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=90 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=172 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Hospital ER visits (n=12,6,4,4)
|
1.08 events
Standard Deviation 0.29
|
1.17 events
Standard Deviation 0.41
|
1.00 events
Standard Deviation 0.00
|
1.75 events
Standard Deviation 0.96
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Number visits hospitalized (n=9,5,2,1)
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Non-study diagnostic tests (n=21,25,5,19)
|
2.33 events
Standard Deviation 3.89
|
1.96 events
Standard Deviation 1.31
|
1.80 events
Standard Deviation 0.45
|
1.53 events
Standard Deviation 0.61
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related doctor visit(n=132,131,33,129)
|
0.81 events
Standard Deviation 0.63
|
0.96 events
Standard Deviation 0.74
|
0.88 events
Standard Deviation 0.86
|
1.00 events
Standard Deviation 0.56
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related ER visit (n=12,6,4,3)
|
0.25 events
Standard Deviation 0.62
|
0.67 events
Standard Deviation 0.82
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA-diagnostic tests (n=21,25,5,19)
|
0.18 events
Standard Deviation 0.50
|
0.16 events
Standard Deviation 0.37
|
0.20 events
Standard Deviation 0.45
|
0.11 events
Standard Deviation 0.32
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Number of outpatient surgeries(n=4,7,1,2)
|
1.25 events
Standard Deviation 0.50
|
1.14 events
Standard Deviation 0.38
|
1.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.50 events
Standard Deviation 0.71
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Doctor visits (n=168,174,90,172)
|
4.26 events
Standard Deviation 3.51
|
4.06 events
Standard Deviation 3.57
|
4.50 events
Standard Deviation 5.32
|
3.87 events
Standard Deviation 3.74
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: NM practitioners visits (n=3,6,2,6)
|
1.33 events
Standard Deviation 0.58
|
3.00 events
Standard Deviation 1.79
|
4.50 events
Standard Deviation 4.95
|
10.00 events
Standard Deviation 10.51
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Hospital ER visits (n=12,14,7,12)
|
1.08 events
Standard Deviation 0.51
|
1.93 events
Standard Deviation 1.59
|
1.57 events
Standard Deviation 0.79
|
1.58 events
Standard Deviation 1.73
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Number visits hospitalized(n=11,5,7,11)
|
2.82 events
Standard Deviation 5.71
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
1.27 events
Standard Deviation 0.90
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline:Number of outpatient surgeries(n=8,6,2,7)
|
1.13 events
Standard Deviation 0.35
|
1.33 events
Standard Deviation 0.82
|
1.00 events
Standard Deviation 0.00
|
2.57 events
Standard Deviation 4.16
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline:Non-study diagnostic tests(n=37,33,19,36)
|
1.73 events
Standard Deviation 1.04
|
1.79 events
Standard Deviation 1.17
|
1.21 events
Standard Deviation 0.54
|
1.64 events
Standard Deviation 1.10
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline:RA related doctor visit(n=169,175,91,172)
|
1.33 events
Standard Deviation 1.03
|
1.17 events
Standard Deviation 0.70
|
1.26 events
Standard Deviation 0.81
|
1.19 events
Standard Deviation 0.73
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: RA related ER visit (n=11,14,6,12)
|
0.64 events
Standard Deviation 0.81
|
0.64 events
Standard Deviation 0.74
|
0.17 events
Standard Deviation 0.41
|
0.25 events
Standard Deviation 0.45
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: RA diagnostic tests (n=38,33,19,37)
|
0.50 events
Standard Deviation 0.76
|
0.55 events
Standard Deviation 0.62
|
0.47 events
Standard Deviation 0.61
|
0.84 events
Standard Deviation 0.73
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: RA related hospitalization (n=11,6,7,11)
|
0.91 events
Standard Deviation 0.83
|
0.67 events
Standard Deviation 0.52
|
0.57 events
Standard Deviation 0.79
|
0.82 events
Standard Deviation 0.60
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: RA related outpatient surgery(n=7,6,3,7)
|
0.43 events
Standard Deviation 0.79
|
0.33 events
Standard Deviation 0.82
|
0.33 events
Standard Deviation 0.58
|
0.43 events
Standard Deviation 0.79
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: RA related NM visit (n=3,6,2,6)
|
0.67 events
Standard Deviation 0.58
|
0.50 events
Standard Deviation 0.84
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.63
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Doctor visits (n=136,138,78,136)
|
3.62 events
Standard Deviation 4.25
|
2.86 events
Standard Deviation 2.99
|
3.27 events
Standard Deviation 3.93
|
3.05 events
Standard Deviation 2.87
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: NM practitioners visits (n=5,0,2,2)
|
2.40 events
Standard Deviation 0.89
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
17.00 events
Standard Deviation 21.21
|
7.50 events
Standard Deviation 9.19
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Hospital ER visits (n=8,8,4,10)
|
1.38 events
Standard Deviation 0.74
|
1.00 events
Standard Deviation 0.00
|
1.75 events
Standard Deviation 1.50
|
1.90 events
Standard Deviation 1.10
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Number visits hospitalized (n=4,6,1,3)
|
1.50 events
Standard Deviation 1.00
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Number of outpatient surgeries(n=3,4,4,6)
|
1.67 events
Standard Deviation 0.58
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
1.33 events
Standard Deviation 0.52
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Non-study diagnostic tests (n=18,23,9,20)
|
1.72 events
Standard Deviation 1.41
|
1.52 events
Standard Deviation 0.79
|
1.56 events
Standard Deviation 0.88
|
1.45 events
Standard Deviation 0.83
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related doctor visit(n=136,138,78,136)
|
0.91 events
Standard Deviation 0.75
|
0.92 events
Standard Deviation 0.67
|
0.90 events
Standard Deviation 0.71
|
0.93 events
Standard Deviation 0.65
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related ER visit (n=8,8,4,9)
|
0.25 events
Standard Deviation 0.46
|
0.50 events
Standard Deviation 0.76
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA-diagnostic tests (n=19,24,9,21)
|
0.11 events
Standard Deviation 0.32
|
0.21 events
Standard Deviation 0.51
|
0.11 events
Standard Deviation 0.33
|
0.24 events
Standard Deviation 0.44
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related hospitalization (n=4,6,1,3)
|
0.00 events
Standard Deviation 0.00
|
0.17 events
Standard Deviation 0.41
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant were evaluable.
|
0.67 events
Standard Deviation 1.15
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related outpatient surgery (n=3,4,4,6)
|
0.00 events
Standard Deviation 0.00
|
0.25 events
Standard Deviation 0.50
|
0.25 events
Standard Deviation 0.50
|
0.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related NM visit (n=5,0,2,2)
|
0.60 events
Standard Deviation 0.89
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.50 events
Standard Deviation 0.71
|
0.50 events
Standard Deviation 0.71
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Doctor visits (n=132,131,33,128)
|
3.30 events
Standard Deviation 4.17
|
2.86 events
Standard Deviation 4.23
|
2.52 events
Standard Deviation 1.91
|
2.73 events
Standard Deviation 2.96
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: NM practitioners visits (n=1,3,0,1)
|
1.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
2.67 events
Standard Deviation 2.89
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
14.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related hospitalization (n=9,5,2,1)
|
0.22 events
Standard Deviation 0.67
|
0.40 events
Standard Deviation 0.89
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant were evaluable.
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related outpatient surgery (n=4,7,1,2)
|
0.00 events
Standard Deviation 0.00
|
0.43 events
Standard Deviation 0.79
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant were evaluable.
|
1.00 events
Standard Deviation 1.41
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related NM visit (n=1,3,0,1)
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant were evaluable.
|
0.67 events
Standard Deviation 1.15
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA/non-RA related number of events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=104 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=111 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=37 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=30 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=125 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Doctor visit (n=102,111,37,30,125)
|
2.73 events
Standard Deviation 2.78
|
2.80 events
Standard Deviation 2.46
|
3.92 events
Standard Deviation 5.97
|
3.50 events
Standard Deviation 3.34
|
2.94 events
Standard Deviation 3.93
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
NM practitioners visits (n=3,4,1,2,0)
|
10.67 events
Standard Deviation 11.72
|
9.75 events
Standard Deviation 10.97
|
192.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
10.50 events
Standard Deviation 6.36
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Hospital ER visits (n=3,5,0,1,6)
|
1.00 events
Standard Deviation 0.00
|
2.40 events
Standard Deviation 1.34
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
3.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Number of visits hospitalized (n=3,5,1,1,3)
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Number of outpatient surgeries (n=5,2,0,2,5)
|
1.40 events
Standard Deviation 0.89
|
1.50 events
Standard Deviation 0.71
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.00 events
Standard Deviation 0.00
|
2.20 events
Standard Deviation 2.17
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
Non-study diagnostic tests (n=8,19,6,6,22)
|
1.13 events
Standard Deviation 0.35
|
1.95 events
Standard Deviation 1.31
|
3.17 events
Standard Deviation 2.64
|
1.33 events
Standard Deviation 0.82
|
1.64 events
Standard Deviation 0.90
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA related doctor visit (n=104,111,37,30,125)
|
0.82 events
Standard Deviation 0.59
|
0.93 events
Standard Deviation 0.57
|
0.89 events
Standard Deviation 0.52
|
0.87 events
Standard Deviation 0.68
|
0.84 events
Standard Deviation 0.80
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA related ER visits (n=3,5,0,1,6)
|
0.33 events
Standard Deviation 0.58
|
0.00 events
Standard Deviation 0.00
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.17 events
Standard Deviation 0.41
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA-diagnostic tests (n=9,19,6,6,22)
|
0.11 events
Standard Deviation 0.33
|
0.21 events
Standard Deviation 0.42
|
0.17 events
Standard Deviation 0.41
|
0.00 events
Standard Deviation 0.00
|
0.05 events
Standard Deviation 0.21
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA related hospitalization (n=3,5,1,1,3)
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant were evaluable.
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable since only 1 participant were evaluable.
|
0.67 events
Standard Deviation 0.58
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA related outpatient surgery (n=5,2,0,2,5)
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12
RA related NM visits (n=3,4,1,2,0)
|
0.00 events
Standard Deviation 0.00
|
0.50 events
Standard Deviation 1.00
|
0.00 events
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
0.00 events
Standard Deviation 0.00
|
NA events
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Outcome measures
| Measure |
CP-690,550 5 mg
n=101 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=102 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=39 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=97 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Hospital length of stay (n=11,6,7,11)
|
13.64 days
Standard Deviation 12.91
|
10.83 days
Standard Deviation 9.89
|
13.43 days
Standard Deviation 9.78
|
12.82 days
Standard Deviation 10.93
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Days in nursing home (n=3,0,0,4)
|
19.33 days
Standard Deviation 17.56
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
14.25 days
Standard Deviation 9.95
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Days devices/aids used (n=17,28,8,16)
|
133.88 days
Standard Deviation 111.17
|
67.32 days
Standard Deviation 61.88
|
172.75 days
Standard Deviation 94.28
|
66.13 days
Standard Deviation 65.33
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Days of work per week (n=71,69,38,70)
|
4.94 days
Standard Deviation 1.18
|
4.80 days
Standard Deviation 1.05
|
4.95 days
Standard Deviation 0.98
|
5.01 days
Standard Deviation 1.04
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Chores by housekeeper (n=23,19,6,18)
|
15.57 days
Standard Deviation 25.73
|
14.95 days
Standard Deviation 27.24
|
38.83 days
Standard Deviation 41.44
|
6.94 days
Standard Deviation 6.86
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Chores by family (n=101,102,39,97)
|
24.06 days
Standard Deviation 29.27
|
26.57 days
Standard Deviation 31.02
|
26.95 days
Standard Deviation 32.87
|
29.80 days
Standard Deviation 32.91
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Days on sick leave (n=24,24,15,29)
|
19.58 days
Standard Deviation 27.78
|
16.33 days
Standard Deviation 27.21
|
29.60 days
Standard Deviation 34.88
|
16.31 days
Standard Deviation 26.05
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Days of part time work (n=13,13,6,10)
|
13.31 days
Standard Deviation 18.94
|
25.31 days
Standard Deviation 61.19
|
5.33 days
Standard Deviation 3.44
|
18.50 days
Standard Deviation 26.88
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: Paid work, bothered by RA(n=51,47,31,53)
|
29.10 days
Standard Deviation 27.47
|
29.45 days
Standard Deviation 31.37
|
28.74 days
Standard Deviation 28.76
|
42.74 days
Standard Deviation 31.81
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline: RA related devices/aids (n=17,28,9,17)
|
1.76 days
Standard Deviation 1.15
|
1.39 days
Standard Deviation 0.69
|
2.33 days
Standard Deviation 1.66
|
1.65 days
Standard Deviation 1.06
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Hospital length of stay (n=4,6,1,3)
|
6.25 days
Standard Deviation 4.03
|
10.00 days
Standard Deviation 10.75
|
2.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
10.33 days
Standard Deviation 8.14
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Days in nursing home (n=0,0,0,2)
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
17.50 days
Standard Deviation 4.95
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Days devices/aids used (n=11,17,6,15)
|
117.91 days
Standard Deviation 112.91
|
60.41 days
Standard Deviation 88.79
|
163.83 days
Standard Deviation 153.63
|
91.80 days
Standard Deviation 95.18
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Days of work per week (n=70,66,38,68)
|
4.83 days
Standard Deviation 0.95
|
4.68 days
Standard Deviation 1.18
|
4.95 days
Standard Deviation 0.80
|
4.75 days
Standard Deviation 1.25
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Chores by housekeeper (n=17,11,7,12)
|
12.59 days
Standard Deviation 23.15
|
6.00 days
Standard Deviation 8.63
|
8.00 days
Standard Deviation 12.54
|
10.50 days
Standard Deviation 16.08
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Chores by family (n=60,47,34,58)
|
24.10 days
Standard Deviation 32.38
|
18.32 days
Standard Deviation 24.03
|
24.97 days
Standard Deviation 31.72
|
25.41 days
Standard Deviation 30.46
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Days on sick leave (n=11,9,17,15)
|
24.27 days
Standard Deviation 33.73
|
18.44 days
Standard Deviation 29.37
|
27.12 days
Standard Deviation 31.42
|
5.13 days
Standard Deviation 4.60
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Days of part time work (n=7,4,6,10)
|
13.29 days
Standard Deviation 13.76
|
25.50 days
Standard Deviation 27.77
|
5.50 days
Standard Deviation 3.27
|
14.90 days
Standard Deviation 27.04
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: Paid work, bothered by RA (n=39,28,28,44)
|
16.08 days
Standard Deviation 21.77
|
26.57 days
Standard Deviation 32.41
|
19.93 days
Standard Deviation 20.79
|
33.61 days
Standard Deviation 30.31
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related devices/aids (n=12,17,8,16)
|
1.75 days
Standard Deviation 1.22
|
1.12 days
Standard Deviation 1.36
|
2.38 days
Standard Deviation 1.60
|
1.81 days
Standard Deviation 0.98
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Hospital length of stay (n=9,5,2,1)
|
10.00 days
Standard Deviation 8.20
|
12.80 days
Standard Deviation 16.71
|
8.50 days
Standard Deviation 2.12
|
6.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Days in nursing home (n=2,0,0,0)
|
27.00 days
Standard Deviation 18.38
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Days devices/aids used (n=14,16,5,14)
|
102.29 days
Standard Deviation 115.01
|
126.25 days
Standard Deviation 134.08
|
80.20 days
Standard Deviation 73.45
|
94.21 days
Standard Deviation 76.92
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Days of work per week (n=65,61,17,66)
|
4.94 days
Standard Deviation 0.85
|
4.70 days
Standard Deviation 1.09
|
5.35 days
Standard Deviation 0.93
|
4.95 days
Standard Deviation 0.92
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Chores by housekeeper (n=11,10,3,7)
|
7.73 days
Standard Deviation 8.25
|
15.80 days
Standard Deviation 22.73
|
44.00 days
Standard Deviation 42.57
|
7.29 days
Standard Deviation 3.82
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Chores by family (n=46,46,15,50)
|
13.59 days
Standard Deviation 16.95
|
29.09 days
Standard Deviation 35.16
|
35.53 days
Standard Deviation 39.39
|
22.64 days
Standard Deviation 29.51
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Days on sick leave (n=7,9,3,9)
|
29.57 days
Standard Deviation 41.48
|
12.44 days
Standard Deviation 14.60
|
3.00 days
Standard Deviation 2.00
|
8.67 days
Standard Deviation 13.13
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Days of part time work (n=7,6,1,7)
|
7.57 days
Standard Deviation 6.80
|
24.67 days
Standard Deviation 33.07
|
4.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
9.29 days
Standard Deviation 8.67
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: Paid work, bothered by RA (n=31,25,10,33)
|
14.71 days
Standard Deviation 18.47
|
20.40 days
Standard Deviation 25.93
|
11.00 days
Standard Deviation 9.13
|
24.55 days
Standard Deviation 26.88
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related devices/aids (n=15,16,6,14)
|
2.00 days
Standard Deviation 1.73
|
1.56 days
Standard Deviation 1.46
|
2.17 days
Standard Deviation 1.83
|
2.07 days
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
Outcome measures
| Measure |
CP-690,550 5 mg
n=60 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=49 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=19 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=15 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=58 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Hospital length of stay (n=3,5,1,1,3)
|
8.00 days
Standard Deviation 6.93
|
5.60 days
Standard Deviation 2.70
|
15.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
15.33 days
Standard Deviation 4.51
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Days in nursing home (n=2,0,0,0,1)
|
24.50 days
Standard Deviation 4.95
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
10.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Days devices/aids used (n=11,12,3,2,15)
|
144.55 days
Standard Deviation 258.85
|
51.75 days
Standard Deviation 41.51
|
163.67 days
Standard Deviation 173.70
|
321.50 days
Standard Deviation 327.39
|
79.33 days
Standard Deviation 74.00
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Days of work per week (n=60,49,19,15,58)
|
4.83 days
Standard Deviation 1.04
|
5.04 days
Standard Deviation 0.93
|
5.16 days
Standard Deviation 0.90
|
4.93 days
Standard Deviation 0.70
|
4.95 days
Standard Deviation 1.07
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Chores by housekeeper (n=9,4,1,2,10)
|
4.44 days
Standard Deviation 3.40
|
7.75 days
Standard Deviation 5.06
|
90.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
24.00 days
Standard Deviation 16.97
|
4.90 days
Standard Deviation 3.78
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Chores by family (n=35,30,8,10,45)
|
22.06 days
Standard Deviation 27.84
|
13.13 days
Standard Deviation 12.28
|
51.88 days
Standard Deviation 40.91
|
28.40 days
Standard Deviation 33.88
|
23.49 days
Standard Deviation 28.68
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Days on sick leave (n=5,3,2,0,4)
|
10.40 days
Standard Deviation 11.41
|
36.00 days
Standard Deviation 45.97
|
50.00 days
Standard Deviation 56.57
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
18.25 days
Standard Deviation 14.06
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Days of part time work (n=6,1,0,0,1)
|
11.33 days
Standard Deviation 12.55
|
33.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA days
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
30.00 days
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
Paid work, bothered by RA (n=20,20,7,9,22)
|
24.10 days
Standard Deviation 30.75
|
20.40 days
Standard Deviation 27.90
|
11.43 days
Standard Deviation 8.60
|
12.33 days
Standard Deviation 12.32
|
22.86 days
Standard Deviation 24.20
|
|
Number of Days as Assessed Using RA-HCRU at Month 12
RA related devices/aids used (n=11,12,3,3,15)
|
2.18 days
Standard Deviation 2.79
|
0.75 days
Standard Deviation 0.62
|
2.33 days
Standard Deviation 1.53
|
3.00 days
Standard Deviation 2.65
|
1.53 days
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=101 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=102 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=39 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=95 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Baseline: Home HC services (n=2,2,1,2)
|
3.00 hours per day
Standard Deviation 2.83
|
1.50 hours per day
Standard Deviation 0.71
|
2.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
1.00 hours per day
Standard Deviation 0.00
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Baseline: Work done (n=72,69,38,70)
|
7.76 hours per day
Standard Deviation 2.40
|
7.54 hours per day
Standard Deviation 2.25
|
7.79 hours per day
Standard Deviation 1.76
|
8.16 hours per day
Standard Deviation 2.85
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Baseline: Chores by housekeeper (n=22,19,7,18)
|
5.23 hours per day
Standard Deviation 4.60
|
5.53 hours per day
Standard Deviation 5.36
|
8.00 hours per day
Standard Deviation 7.55
|
3.89 hours per day
Standard Deviation 2.37
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Baseline: Chores by family (n=101,102,39,95)
|
4.24 hours per day
Standard Deviation 4.75
|
3.31 hours per day
Standard Deviation 2.76
|
4.21 hours per day
Standard Deviation 4.71
|
2.82 hours per day
Standard Deviation 1.79
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Baseline: Missed work due to RA (n=13,13,6,10)
|
6.38 hours per day
Standard Deviation 7.22
|
5.00 hours per day
Standard Deviation 5.85
|
4.00 hours per day
Standard Deviation 1.26
|
4.00 hours per day
Standard Deviation 4.11
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Baseline: RA related home HC services (n=2,2,1,3)
|
0.50 hours per day
Standard Deviation 0.71
|
1.00 hours per day
Standard Deviation 0.00
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
0.33 hours per day
Standard Deviation 0.58
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 3: Home HC services (n=1,0,0,0)
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 3: Work done (n=70,66,38,68)
|
8.06 hours per day
Standard Deviation 3.59
|
7.53 hours per day
Standard Deviation 1.92
|
8.53 hours per day
Standard Deviation 5.62
|
8.38 hours per day
Standard Deviation 4.89
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 3: Chores by housekeeper (n=17,11,7,12)
|
4.00 hours per day
Standard Deviation 2.12
|
5.73 hours per day
Standard Deviation 2.61
|
5.00 hours per day
Standard Deviation 2.00
|
4.17 hours per day
Standard Deviation 1.99
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 3: Chores by family (n=59,46,34,59)
|
3.46 hours per day
Standard Deviation 3.67
|
3.28 hours per day
Standard Deviation 2.60
|
3.41 hours per day
Standard Deviation 2.72
|
3.68 hours per day
Standard Deviation 3.72
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 3: Missed work due to RA (n=7,4,6,9)
|
4.57 hours per day
Standard Deviation 5.03
|
20.75 hours per day
Standard Deviation 39.51
|
5.50 hours per day
Standard Deviation 5.01
|
3.56 hours per day
Standard Deviation 1.59
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 3: RA related home HC services (n=1,0,0,0)
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 6: Home HC services (n=2,2,0,0)
|
2.50 hours per day
Standard Deviation 2.12
|
16.00 hours per day
Standard Deviation 5.66
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 6: Work done (n=65,61,17,66)
|
8.35 hours per day
Standard Deviation 4.46
|
7.72 hours per day
Standard Deviation 2.24
|
9.71 hours per day
Standard Deviation 7.59
|
8.00 hours per day
Standard Deviation 4.27
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 6: Chores by housekeeper (n=11,10,3,7)
|
3.36 hours per day
Standard Deviation 2.58
|
5.40 hours per day
Standard Deviation 2.50
|
5.33 hours per day
Standard Deviation 1.53
|
6.29 hours per day
Standard Deviation 7.95
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 6: Chores by family (n=47,45,13,51)
|
3.30 hours per day
Standard Deviation 2.69
|
2.91 hours per day
Standard Deviation 2.00
|
3.69 hours per day
Standard Deviation 2.32
|
3.33 hours per day
Standard Deviation 3.55
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 6: Missed work due to RA (n=7,6,1,7)
|
4.57 hours per day
Standard Deviation 5.19
|
3.17 hours per day
Standard Deviation 2.32
|
5.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
3.29 hours per day
Standard Deviation 1.70
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Month 6: RA related home HC services (n=2,2,0,0)
|
1.00 hours per day
Standard Deviation 1.41
|
0.50 hours per day
Standard Deviation 0.71
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, hours affected per day and average number of hours missed work per day were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=60 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=49 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=19 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=15 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=58 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Home HC services (n=0,0,0,0,1)
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Work done (n=60,49,19,15,58)
|
7.52 hours per day
Standard Deviation 2.27
|
7.82 hours per day
Standard Deviation 1.60
|
9.53 hours per day
Standard Deviation 7.65
|
7.73 hours per day
Standard Deviation 2.40
|
7.93 hours per day
Standard Deviation 3.12
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Chores by housekeeper (n=8,4,1,2,10)
|
4.63 hours per day
Standard Deviation 3.16
|
4.75 hours per day
Standard Deviation 0.96
|
3.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
6.00 hours per day
Standard Deviation 1.41
|
4.10 hours per day
Standard Deviation 2.08
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Chores by family (n=34,30,8,10,44)
|
2.65 hours per day
Standard Deviation 1.95
|
4.00 hours per day
Standard Deviation 4.11
|
2.88 hours per day
Standard Deviation 2.17
|
2.70 hours per day
Standard Deviation 2.26
|
2.55 hours per day
Standard Deviation 1.81
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Missed work due to RA (n=6,1,0,0,1)
|
2.00 hours per day
Standard Deviation 1.67
|
4.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
4.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Number of Hours Per Day as Assessed RA-HCRU at Month 12
RA related home HC services (n=0,0,0,0,1)
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
NA hours per day
Standard Deviation NA
Data not available as no participant was evaluable for the treatment arm at the given time point.
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
SECONDARY outcome
Timeframe: Baseline, Month 3, 6Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). N=participants evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Outcome measures
| Measure |
CP-690,550 5 mg
n=139 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=141 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=83 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=142 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Baseline (n=139,141,83,142)
|
4.16 units on a scale
Standard Deviation 3.05
|
4.16 units on a scale
Standard Deviation 3.33
|
4.08 units on a scale
Standard Deviation 3.32
|
4.19 units on a scale
Standard Deviation 3.09
|
—
|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 3 (n=137,129,76,139)
|
2.68 units on a scale
Standard Deviation 2.75
|
2.81 units on a scale
Standard Deviation 2.89
|
3.38 units on a scale
Standard Deviation 2.84
|
3.09 units on a scale
Standard Deviation 2.81
|
—
|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Month 6 (n=125,125,35,127)
|
2.31 units on a scale
Standard Deviation 2.51
|
2.39 units on a scale
Standard Deviation 2.84
|
2.17 units on a scale
Standard Deviation 2.64
|
2.66 units on a scale
Standard Deviation 2.54
|
—
|
SECONDARY outcome
Timeframe: Month 12Population: FAS: all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline and baseline measurement (for change from baseline endpoint). n=number of participants evaluable at specific time points for each arm group, respectively.
Work performance of participants on number of days bothered was based on 10-point scale, where higher score indicated lower work performance.
Outcome measures
| Measure |
CP-690,550 5 mg
n=101 Participants
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
CP-690,550 10 mg
n=101 Participants
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Placebo
n=32 Participants
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab
n=30 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
Adalimumab
n=107 Participants
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
|
|---|---|---|---|---|---|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
|
2.18 units on a scale
Standard Deviation 2.65
|
1.92 units on a scale
Standard Deviation 2.50
|
2.69 units on a scale
Standard Deviation 2.66
|
2.23 units on a scale
Standard Deviation 3.02
|
1.93 units on a scale
Standard Deviation 2.45
|
Adverse Events
CP-690,550 5 mg (Up To Month 3)
Serious events: 12 serious events
Other events: 51 other events
Deaths: 0 deaths
CP-690,550 10 mg (Up To Month 3)
Serious events: 10 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo (Up To Month 3)
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Adalimumab (Up To Month 3)
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
CP-690,550 5 mg (Month 3 to 6)
Serious events: 10 serious events
Other events: 18 other events
Deaths: 0 deaths
CP-690,550 10 mg (Month 3 to 6)
Serious events: 7 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (Month 3 to 6)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Adalimumab (Month 3 to 6)
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
CP-690,550 5 mg (Post Month 6)
Serious events: 11 serious events
Other events: 36 other events
Deaths: 0 deaths
CP-690,550 10 mg (Post Month 6)
Serious events: 10 serious events
Other events: 44 other events
Deaths: 0 deaths
Adalimumab (Post Month 6)
Serious events: 7 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP-690,550 5 mg (Up To Month 3)
n=204 participants at risk
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
|
CP-690,550 10 mg (Up To Month 3)
n=201 participants at risk
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
|
Placebo (Up To Month 3)
n=108 participants at risk
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab (Up To Month 3)
n=204 participants at risk
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
|
CP-690,550 5 mg (Month 3 to 6)
n=232 participants at risk
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
|
CP-690,550 10 mg (Month 3 to 6)
n=222 participants at risk
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
|
Placebo (Month 3 to 6)
n=59 participants at risk
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab (Month 3 to 6)
n=204 participants at risk
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
|
CP-690,550 5 mg (Post Month 6)
n=260 participants at risk
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
|
CP-690,550 10 mg (Post Month 6)
n=253 participants at risk
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
|
Adalimumab (Post Month 6)
n=204 participants at risk
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Impaired healing
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.98%
2/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Osteomyelitis
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.7%
1/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.7%
1/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Ovarian torsion
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.79%
2/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.40%
1/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.86%
2/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
CP-690,550 5 mg (Up To Month 3)
n=204 participants at risk
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
|
CP-690,550 10 mg (Up To Month 3)
n=201 participants at risk
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
|
Placebo (Up To Month 3)
n=108 participants at risk
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab (Up To Month 3)
n=204 participants at risk
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
|
CP-690,550 5 mg (Month 3 to 6)
n=232 participants at risk
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
|
CP-690,550 10 mg (Month 3 to 6)
n=222 participants at risk
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
|
Placebo (Month 3 to 6)
n=59 participants at risk
Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
|
Adalimumab (Month 3 to 6)
n=204 participants at risk
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
|
CP-690,550 5 mg (Post Month 6)
n=260 participants at risk
CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
|
CP-690,550 10 mg (Post Month 6)
n=253 participants at risk
CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
|
Adalimumab (Post Month 6)
n=204 participants at risk
Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
2/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.38%
1/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
7/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
5/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
2/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
2/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
2/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
1.5%
3/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
3/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.98%
2/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
7/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
10/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
5/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.2%
3/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
6/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
8/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.4%
7/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
5/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.90%
2/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.7%
1/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.1%
8/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.2%
3/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
5/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
9/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.5%
7/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.4%
7/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.5%
9/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.4%
6/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
5/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
2/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.4%
7/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.2%
5/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.9%
6/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.77%
2/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.6%
4/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
5/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
3/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.2%
3/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
5/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.98%
2/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.50%
1/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
7/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
2/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
3/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
3.9%
8/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.0%
6/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
2/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
5/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
2/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.8%
3/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.5%
3/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.93%
1/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.98%
2/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
5/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
2/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.7%
7/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.2%
3/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.98%
2/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.45%
1/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.0%
4/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
3/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.90%
2/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.5%
5/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.77%
2/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.2%
3/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/201 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/108 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.7%
4/232 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.90%
2/222 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.4%
2/59 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.49%
1/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/260 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/253 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/204 • Baseline Through Month 12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER