Trial Outcomes & Findings for A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis (NCT NCT00814307)
NCT ID: NCT00814307
Last Updated: 2013-01-18
Results Overview
ACR20 response: greater than or equal to (\>=) 20 percent (%) 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 Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
COMPLETED
PHASE3
611 participants
Month 3
2013-01-18
Participant Flow
Participant milestones
| Measure |
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 5 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
244
|
245
|
61
|
61
|
|
Overall Study
Treated
|
243
|
245
|
61
|
61
|
|
Overall Study
COMPLETED
|
232
|
218
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
12
|
27
|
7
|
10
|
Reasons for withdrawal
| Measure |
CP-690,550 5 mg
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 5 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Overall Study
Randomized but not treated
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
3
|
9
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
3
|
4
|
|
Overall Study
Other
|
1
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
8
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
CP-690,550 5 mg
n=243 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=245 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo, Then CP-690,550 5 mg
n=61 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
Placebo, Then CP-690,550 10 mg
n=61 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
Total
n=610 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
52.2 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
52.4 Years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
50.7 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
48.8 Years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
51.8 Years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=5 Participants
|
216 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
528 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Month 3Population: Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed)=participants evaluable for this measure.
ACR20 response: greater than or equal to (\>=) 20 percent (%) 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 Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CP-690,550 5 mg
n=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
|
59.75 percentage of participants
|
65.70 percentage of participants
|
26.67 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at given time points for each group respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=240 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=241 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Baseline (n=240,241,122)
|
1.53 units on a scale
Standard Deviation 0.66
|
1.50 units on a scale
Standard Deviation 0.64
|
1.53 units on a scale
Standard Deviation 0.65
|
—
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3
Change at Month 3 (n=237,227,109)
|
-0.48 units on a scale
Standard Deviation 0.66
|
-0.54 units on a scale
Standard Deviation 0.60
|
-0.18 units on a scale
Standard Deviation 0.61
|
—
|
PRIMARY outcome
Timeframe: Month 3Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (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, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=229 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=219 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=104 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
|
6.11 percentage of participants
|
10.05 percentage of participants
|
4.81 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 2, Month 1, 2Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
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=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2
Week 2
|
29.58 percentage of participants
|
39.17 percentage of participants
|
11.76 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2
Month 1
|
46.47 percentage of participants
|
52.07 percentage of participants
|
21.67 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, Month 1 and 2
Month 2
|
56.85 percentage of participants
|
60.74 percentage of participants
|
25.83 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
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=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=60 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=60 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6
Month 4
|
69.29 percentage of participants
|
69.01 percentage of participants
|
51.67 percentage of participants
|
61.67 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6
Month 5
|
68.46 percentage of participants
|
69.83 percentage of participants
|
61.67 percentage of participants
|
63.33 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 4, 5 and 6
Month 6
|
69.29 percentage of participants
|
71.07 percentage of participants
|
58.33 percentage of participants
|
56.67 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Month 1, 2, 3Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
ACR50 response: greater than or equal to \>=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 HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
Week 2
|
5.83 percentage of participants
|
12.92 percentage of participants
|
4.20 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
Month 1
|
17.43 percentage of participants
|
23.97 percentage of participants
|
4.17 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
Month 2
|
26.14 percentage of participants
|
33.88 percentage of participants
|
5.83 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, Month 1, 2 and 3
Month 3
|
31.12 percentage of participants
|
36.78 percentage of participants
|
12.50 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
ACR50 response: greater than or equal to \>=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 HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=60 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=60 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6
Month 4
|
37.34 percentage of participants
|
42.98 percentage of participants
|
28.33 percentage of participants
|
28.33 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6
Month 5
|
39.42 percentage of participants
|
45.45 percentage of participants
|
36.67 percentage of participants
|
35.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 4, 5 and 6
Month 6
|
41.91 percentage of participants
|
46.69 percentage of participants
|
33.33 percentage of participants
|
33.33 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, Month 1, 2, 3Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
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 HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
Week 2
|
2.08 percentage of participants
|
4.58 percentage of participants
|
0.00 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
Month 1
|
4.98 percentage of participants
|
9.09 percentage of participants
|
1.67 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
Month 2
|
9.96 percentage of participants
|
19.01 percentage of participants
|
3.33 percentage of participants
|
—
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, Month 1, 2 and 3
Month 3
|
15.35 percentage of participants
|
20.25 percentage of participants
|
5.83 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
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 HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550 5 mg
n=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=60 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=60 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6
Month 6
|
21.99 percentage of participants
|
29.34 percentage of participants
|
20.00 percentage of participants
|
21.67 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6
Month 4
|
19.92 percentage of participants
|
26.03 percentage of participants
|
13.33 percentage of participants
|
15.00 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 4, 5 and 6
Month 5
|
21.16 percentage of participants
|
28.51 percentage of participants
|
18.33 percentage of participants
|
18.33 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed)=participants evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and 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) =\<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=236 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=234 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=115 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline and Month 3
Baseline (n= 236, 234, 115)
|
6.71 units on a scale
Standard Deviation 0.93
|
6.70 units on a scale
Standard Deviation 0.94
|
6.65 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 and Month 3
Month 3 (n= 229, 219, 104)
|
4.78 units on a scale
Standard Deviation 1.37
|
4.55 units on a scale
Standard Deviation 1.39
|
5.54 units on a scale
Standard Deviation 1.46
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (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, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.
Outcome measures
| Measure |
CP-690,550 5 mg
n=221 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=209 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=52 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=47 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 6
|
4.33 units on a scale
Standard Deviation 1.39
|
4.01 units on a scale
Standard Deviation 1.38
|
4.31 units on a scale
Standard Deviation 1.34
|
3.98 units on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 2, 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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=239 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=121 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
Baseline (n= 239, 242, 121)
|
5.68 units on a scale
Standard Deviation 0.90
|
5.60 units on a scale
Standard Deviation 0.91
|
5.56 units on a scale
Standard Deviation 0.85
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
Week 2 (n= 234, 231, 118)
|
4.79 units on a scale
Standard Deviation 1.12
|
4.42 units on a scale
Standard Deviation 1.11
|
5.30 units on a scale
Standard Deviation 1.13
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
Month 1 (n= 237, 236, 115)
|
4.41 units on a scale
Standard Deviation 1.12
|
3.99 units on a scale
Standard Deviation 1.26
|
4.98 units on a scale
Standard Deviation 1.25
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
Month 2 (n= 238, 233, 109)
|
4.02 units on a scale
Standard Deviation 1.26
|
3.64 units on a scale
Standard Deviation 1.27
|
4.85 units on a scale
Standard Deviation 1.36
|
—
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2 and 3
Month 3 (n= 238, 229, 109)
|
3.89 units on a scale
Standard Deviation 1.27
|
3.59 units on a scale
Standard Deviation 1.27
|
4.68 units on a scale
Standard Deviation 1.27
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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=235 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=222 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=55 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
Month 4 (n= 235, 222, 54, 48)
|
3.65 units on a scale
Standard Deviation 1.24
|
3.26 units on a scale
Standard Deviation 1.22
|
3.89 units on a scale
Standard Deviation 1.19
|
3.50 units on a scale
Standard Deviation 1.28
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
Month 5 (n= 231, 219, 55, 50)
|
3.54 units on a scale
Standard Deviation 1.26
|
3.12 units on a scale
Standard Deviation 1.24
|
3.53 units on a scale
Standard Deviation 1.25
|
3.34 units on a scale
Standard Deviation 1.26
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 4, 5 and 6
Month 6 (n= 228, 215, 53, 50)
|
3.48 units on a scale
Standard Deviation 1.23
|
3.11 units on a scale
Standard Deviation 1.26
|
3.56 units on a scale
Standard Deviation 1.32
|
3.12 units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 2, 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=240 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=241 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Baseline (n= 240, 241, 122)
|
1.53 units on a scale
Standard Deviation 0.66
|
1.50 units on a scale
Standard Deviation 0.64
|
1.53 units on a scale
Standard Deviation 0.65
|
—
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Week 2 (n= 240, 239, 119)
|
1.27 units on a scale
Standard Deviation 0.62
|
1.21 units on a scale
Standard Deviation 0.65
|
1.43 units on a scale
Standard Deviation 0.64
|
—
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Month 1 (n= 237, 240, 116)
|
1.18 units on a scale
Standard Deviation 0.68
|
1.09 units on a scale
Standard Deviation 0.66
|
1.40 units on a scale
Standard Deviation 0.64
|
—
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Month 2 (n= 240, 233, 110)
|
1.05 units on a scale
Standard Deviation 0.66
|
0.97 units on a scale
Standard Deviation 0.68
|
1.40 units on a scale
Standard Deviation 0.68
|
—
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2 and 3
Month 3 (n= 238, 229, 109)
|
1.05 units on a scale
Standard Deviation 0.70
|
0.97 units on a scale
Standard Deviation 0.69
|
1.35 units on a scale
Standard Deviation 0.73
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Outcome measures
| Measure |
CP-690,550 5 mg
n=235 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=223 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=55 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6
Month 4 (n= 235, 223, 55, 49)
|
0.97 units on a scale
Standard Deviation 0.66
|
0.88 units on a scale
Standard Deviation 0.68
|
1.08 units on a scale
Standard Deviation 0.70
|
1.09 units on a scale
Standard Deviation 0.65
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6
Month 5 (n= 231, 221, 55, 50)
|
0.95 units on a scale
Standard Deviation 0.69
|
0.87 units on a scale
Standard Deviation 0.69
|
1.04 units on a scale
Standard Deviation 0.59
|
1.03 units on a scale
Standard Deviation 0.64
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 4, 5 and 6
Month 6 (n= 229, 216, 54, 50)
|
0.94 units on a scale
Standard Deviation 0.68
|
0.86 units on a scale
Standard Deviation 0.67
|
1.05 units on a scale
Standard Deviation 0.63
|
1.00 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 2, 3Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each group respectively.
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Outcome measures
| Measure |
CP-690,550 5 mg
n=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Baseline (n= 241, 243, 122)
|
61.35 mm
Standard Deviation 22.27
|
62.03 mm
Standard Deviation 23.63
|
61.79 mm
Standard Deviation 21.27
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Week 2 (n= 239, 239, 119)
|
45.92 mm
Standard Deviation 22.87
|
42.13 mm
Standard Deviation 25.06
|
55.61 mm
Standard Deviation 23.63
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 1 (n= 237, 240, 116)
|
40.68 mm
Standard Deviation 23.04
|
36.86 mm
Standard Deviation 24.46
|
52.47 mm
Standard Deviation 24.59
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 2 (n= 240, 233, 110)
|
36.39 mm
Standard Deviation 23.29
|
31.66 mm
Standard Deviation 24.38
|
52.38 mm
Standard Deviation 26.09
|
—
|
|
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 3 (n= 237, 228, 108)
|
34.93 mm
Standard Deviation 23.73
|
31.37 mm
Standard Deviation 24.35
|
49.84 mm
Standard Deviation 25.10
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Outcome measures
| Measure |
CP-690,550 5 mg
n=235 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=223 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=55 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Patient Assessment of Arthritis Pain at Month 4, 5 and 6
Month 4 (n= 235, 223, 55, 49)
|
33.18 mm
Standard Deviation 23.02
|
29.70 mm
Standard Deviation 23.21
|
34.27 mm
Standard Deviation 24.53
|
35.47 mm
Standard Deviation 25.28
|
|
Patient Assessment of Arthritis Pain at Month 4, 5 and 6
Month 5 (n= 231, 221, 55, 50)
|
32.63 mm
Standard Deviation 23.07
|
29.10 mm
Standard Deviation 22.24
|
34.05 mm
Standard Deviation 23.48
|
35.06 mm
Standard Deviation 24.82
|
|
Patient Assessment of Arthritis Pain at Month 4, 5 and 6
Month 6 (n= 228, 216, 54, 50)
|
32.60 mm
Standard Deviation 23.55
|
27.89 mm
Standard Deviation 23.17
|
33.96 mm
Standard Deviation 24.62
|
32.28 mm
Standard Deviation 23.79
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 2, 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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 Visual Analog Scale where 0 = very well and 100 = very poorly.
Outcome measures
| Measure |
CP-690,550 5 mg
n=240 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Baseline (n= 240, 243, 122)
|
61.66 mm
Standard Deviation 22.00
|
63.46 mm
Standard Deviation 23.23
|
62.63 mm
Standard Deviation 21.91
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Week 2 (n= 240, 239, 119)
|
46.34 mm
Standard Deviation 22.36
|
41.32 mm
Standard Deviation 24.90
|
55.95 mm
Standard Deviation 23.79
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 1 (n= 237, 240, 116)
|
39.63 mm
Standard Deviation 22.36
|
37.69 mm
Standard Deviation 23.94
|
53.23 mm
Standard Deviation 24.01
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 2 (n= 240, 233, 110)
|
36.29 mm
Standard Deviation 22.20
|
32.56 mm
Standard Deviation 23.47
|
53.05 mm
Standard Deviation 26.04
|
—
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 3 (n= 238, 229, 108)
|
35.90 mm
Standard Deviation 23.61
|
32.78 mm
Standard Deviation 23.75
|
50.48 mm
Standard Deviation 25.82
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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 Visual Analog Scale where 0 = very well and 100 = very poorly.
Outcome measures
| Measure |
CP-690,550 5 mg
n=235 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=223 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=55 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6
Month 4 (n= 235, 223, 55, 49)
|
33.59 mm
Standard Deviation 22.44
|
29.69 mm
Standard Deviation 22.25
|
35.27 mm
Standard Deviation 23.77
|
36.45 mm
Standard Deviation 25.92
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6
Month 5 (n= 231, 221, 55, 50)
|
34.59 mm
Standard Deviation 23.37
|
29.37 mm
Standard Deviation 22.13
|
32.88 mm
Standard Deviation 21.43
|
33.96 mm
Standard Deviation 25.02
|
|
Patient Global Assessment (PtGA) of Arthritis Pain at Month 4, 5 and 6
Month 6 (n= 228, 216, 54, 50)
|
32.56 mm
Standard Deviation 23.09
|
29.52 mm
Standard Deviation 22.89
|
33.51 mm
Standard Deviation 24.00
|
32.89 mm
Standard Deviation 23.78
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, 2, 3Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'n'=participants evaluable at given time point for each 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=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Baseline (n= 241, 243, 122)
|
61.46 mm
Standard Deviation 16.93
|
60.84 mm
Standard Deviation 16.84
|
62.22 mm
Standard Deviation 16.85
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Week 2 (n= 239, 240, 119)
|
43.43 mm
Standard Deviation 17.69
|
40.47 mm
Standard Deviation 19.73
|
52.15 mm
Standard Deviation 19.25
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 1 (n= 237, 240, 116)
|
35.89 mm
Standard Deviation 18.91
|
33.99 mm
Standard Deviation 20.37
|
46.98 mm
Standard Deviation 22.29
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 2 (n= 240, 232, 110)
|
32.06 mm
Standard Deviation 20.81
|
26.75 mm
Standard Deviation 19.23
|
44.45 mm
Standard Deviation 23.62
|
—
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2 and 3
Month 3 (n= 238, 229, 109)
|
29.20 mm
Standard Deviation 19.98
|
24.47 mm
Standard Deviation 18.42
|
42.05 mm
Standard Deviation 23.58
|
—
|
SECONDARY outcome
Timeframe: Month 4, 5, 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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=235 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=221 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=55 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6
Month 4 (n= 235, 221, 54, 49)
|
25.30 mm
Standard Deviation 18.56
|
21.21 mm
Standard Deviation 16.46
|
27.48 mm
Standard Deviation 19.80
|
25.86 mm
Standard Deviation 20.32
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6
Month 5 (n= 231, 221, 55, 50)
|
23.60 mm
Standard Deviation 17.63
|
20.99 mm
Standard Deviation 16.13
|
24.74 mm
Standard Deviation 17.93
|
25.90 mm
Standard Deviation 19.85
|
|
Physician Global Assessment (PGA) of Arthritis Pain at Month 4, 5 and 6
Month 6 (n= 229, 216, 54, 50)
|
23.26 mm
Standard Deviation 18.12
|
20.61 mm
Standard Deviation 16.27
|
26.16 mm
Standard Deviation 19.55
|
21.54 mm
Standard Deviation 17.51
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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 is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Outcome measures
| Measure |
CP-690,550 5 mg
n=239 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Physical functioning (n=239,243,122)
|
30.09 units on a scale
Standard Deviation 9.31
|
30.51 units on a scale
Standard Deviation 8.76
|
31.41 units on a scale
Standard Deviation 9.66
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Role Physical (n=239,243,122)
|
32.84 units on a scale
Standard Deviation 8.87
|
33.45 units on a scale
Standard Deviation 8.69
|
33.33 units on a scale
Standard Deviation 8.97
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Social Functioning (n=239,243,122)
|
36.78 units on a scale
Standard Deviation 11.04
|
36.07 units on a scale
Standard Deviation 11.27
|
35.16 units on a scale
Standard Deviation 10.34
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Bodily Pain (n=239,243,122)
|
32.41 units on a scale
Standard Deviation 7.57
|
32.74 units on a scale
Standard Deviation 7.55
|
32.77 units on a scale
Standard Deviation 7.67
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Mental Health (n=239,243,122)
|
40.05 units on a scale
Standard Deviation 11.49
|
40.50 units on a scale
Standard Deviation 12.57
|
38.43 units on a scale
Standard Deviation 12.36
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Role Emotional (n=239,243,122)
|
34.26 units on a scale
Standard Deviation 12.63
|
36.70 units on a scale
Standard Deviation 13.03
|
35.17 units on a scale
Standard Deviation 13.11
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Vitality (n=239,243,122)
|
41.22 units on a scale
Standard Deviation 10.06
|
41.04 units on a scale
Standard Deviation 10.27
|
40.13 units on a scale
Standard Deviation 9.82
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:General health perception(n=239,243,122)
|
34.86 units on a scale
Standard Deviation 8.72
|
35.71 units on a scale
Standard Deviation 8.86
|
34.70 units on a scale
Standard Deviation 9.00
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Mental Component (n=239,243,122)
|
41.36 units on a scale
Standard Deviation 11.68
|
42.19 units on a scale
Standard Deviation 12.44
|
39.87 units on a scale
Standard Deviation 11.62
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Baseline:Physical Component (n=239,243,122)
|
31.23 units on a scale
Standard Deviation 8.03
|
31.37 units on a scale
Standard Deviation 7.39
|
32.21 units on a scale
Standard Deviation 8.35
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Physical functioning(n=235,224,108)
|
36.13 units on a scale
Standard Deviation 10.44
|
37.05 units on a scale
Standard Deviation 10.58
|
32.93 units on a scale
Standard Deviation 10.63
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Role Physical (n=233,224,107)
|
38.90 units on a scale
Standard Deviation 9.41
|
40.45 units on a scale
Standard Deviation 9.90
|
35.19 units on a scale
Standard Deviation 9.72
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Social Functioning(n=235,224,108)
|
41.62 units on a scale
Standard Deviation 10.90
|
43.25 units on a scale
Standard Deviation 9.95
|
36.14 units on a scale
Standard Deviation 10.04
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Bodily Pain (n=235,224,108)
|
40.56 units on a scale
Standard Deviation 9.38
|
43.08 units on a scale
Standard Deviation 9.50
|
36.35 units on a scale
Standard Deviation 8.81
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Mental Health (n=235,224,108)
|
44.33 units on a scale
Standard Deviation 11.50
|
45.13 units on a scale
Standard Deviation 11.25
|
40.73 units on a scale
Standard Deviation 10.73
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Role Emotional (n=233,224,107)
|
38.76 units on a scale
Standard Deviation 12.13
|
40.84 units on a scale
Standard Deviation 11.57
|
36.08 units on a scale
Standard Deviation 12.66
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Vitality (n=235,224,108)
|
47.36 units on a scale
Standard Deviation 10.69
|
49.03 units on a scale
Standard Deviation 9.86
|
42.23 units on a scale
Standard Deviation 9.75
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:General health perception(n=235,224,108)
|
39.52 units on a scale
Standard Deviation 9.37
|
41.50 units on a scale
Standard Deviation 9.78
|
37.22 units on a scale
Standard Deviation 8.75
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Mental Component (n=233,224,107)
|
45.21 units on a scale
Standard Deviation 11.65
|
46.58 units on a scale
Standard Deviation 10.81
|
41.13 units on a scale
Standard Deviation 10.90
|
—
|
|
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 3
Month 3:Physical Component (n=233,224,107)
|
38.03 units on a scale
Standard Deviation 9.18
|
39.69 units on a scale
Standard Deviation 9.31
|
34.58 units on a scale
Standard Deviation 8.94
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
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 is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning.
Outcome measures
| Measure |
CP-690,550 5 mg
n=229 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=216 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=54 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Mental component
|
45.43 units on a scale
Standard Deviation 11.58
|
46.08 units on a scale
Standard Deviation 10.44
|
43.29 units on a scale
Standard Deviation 12.37
|
48.76 units on a scale
Standard Deviation 11.06
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Physical functioning
|
36.99 units on a scale
Standard Deviation 10.07
|
38.43 units on a scale
Standard Deviation 10.67
|
35.74 units on a scale
Standard Deviation 10.23
|
35.26 units on a scale
Standard Deviation 9.98
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Role Physical
|
39.85 units on a scale
Standard Deviation 9.57
|
40.93 units on a scale
Standard Deviation 9.50
|
38.25 units on a scale
Standard Deviation 9.73
|
38.97 units on a scale
Standard Deviation 9.06
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Social Functioning
|
42.36 units on a scale
Standard Deviation 10.60
|
42.98 units on a scale
Standard Deviation 10.15
|
39.57 units on a scale
Standard Deviation 11.45
|
43.39 units on a scale
Standard Deviation 9.78
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Bodily Pain
|
41.80 units on a scale
Standard Deviation 9.55
|
43.67 units on a scale
Standard Deviation 9.54
|
40.80 units on a scale
Standard Deviation 9.36
|
42.19 units on a scale
Standard Deviation 9.46
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Mental Health
|
43.98 units on a scale
Standard Deviation 12.18
|
45.05 units on a scale
Standard Deviation 11.01
|
42.14 units on a scale
Standard Deviation 11.90
|
47.03 units on a scale
Standard Deviation 10.62
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Role Emotional
|
40.37 units on a scale
Standard Deviation 11.32
|
41.03 units on a scale
Standard Deviation 11.47
|
39.04 units on a scale
Standard Deviation 12.93
|
42.66 units on a scale
Standard Deviation 12.10
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Vitality
|
47.47 units on a scale
Standard Deviation 10.58
|
48.89 units on a scale
Standard Deviation 10.29
|
45.08 units on a scale
Standard Deviation 9.50
|
47.88 units on a scale
Standard Deviation 9.19
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
General health perception
|
41.05 units on a scale
Standard Deviation 9.24
|
42.58 units on a scale
Standard Deviation 9.84
|
38.99 units on a scale
Standard Deviation 8.73
|
40.42 units on a scale
Standard Deviation 10.83
|
|
36-Item Short-Form Health Survey (SF-36) at Month 6
Physical component
|
39.24 units on a scale
Standard Deviation 8.42
|
40.89 units on a scale
Standard Deviation 9.04
|
37.89 units on a scale
Standard Deviation 9.56
|
37.06 units on a scale
Standard Deviation 9.14
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute.
Outcome measures
| Measure |
CP-690,550 5 mg
n=239 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=242 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:overall sleep problem(n=236,228,109)
|
35.53 units on a scale
Standard Deviation 19.30
|
33.29 units on a scale
Standard Deviation 19.96
|
41.13 units on a scale
Standard Deviation 21.31
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:sleep problem summary(n=236,228,109)
|
34.46 units on a scale
Standard Deviation 19.89
|
33.25 units on a scale
Standard Deviation 20.16
|
40.55 units on a scale
Standard Deviation 22.02
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:somnolence(n=236,229,109)
|
30.28 units on a scale
Standard Deviation 21.28
|
30.45 units on a scale
Standard Deviation 21.26
|
35.66 units on a scale
Standard Deviation 23.01
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:snoring(n=236,229,109)
|
32.63 units on a scale
Standard Deviation 29.61
|
25.85 units on a scale
Standard Deviation 27.57
|
27.52 units on a scale
Standard Deviation 29.79
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:quantity(n=237,228,109)
|
6.77 units on a scale
Standard Deviation 1.63
|
6.89 units on a scale
Standard Deviation 1.45
|
6.78 units on a scale
Standard Deviation 1.47
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:sleep disturbance(n=236,229,109)
|
36.58 units on a scale
Standard Deviation 24.67
|
32.58 units on a scale
Standard Deviation 24.27
|
41.16 units on a scale
Standard Deviation 27.40
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:awaken short of breath(n=236,228,109)
|
15.93 units on a scale
Standard Deviation 21.29
|
16.23 units on a scale
Standard Deviation 21.69
|
22.20 units on a scale
Standard Deviation 24.99
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3:adequacy(n=236,229,109)
|
51.69 units on a scale
Standard Deviation 28.77
|
52.93 units on a scale
Standard Deviation 27.75
|
44.40 units on a scale
Standard Deviation 27.67
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:overall sleep problem(n=238,242,122)
|
42.45 units on a scale
Standard Deviation 18.38
|
43.09 units on a scale
Standard Deviation 20.41
|
47.32 units on a scale
Standard Deviation 21.24
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:sleep problem summary(n=239,242,122)
|
40.59 units on a scale
Standard Deviation 18.98
|
42.38 units on a scale
Standard Deviation 21.01
|
45.98 units on a scale
Standard Deviation 21.85
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:snoring(n=238,243,121)
|
35.71 units on a scale
Standard Deviation 31.07
|
30.29 units on a scale
Standard Deviation 30.50
|
30.25 units on a scale
Standard Deviation 31.42
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:somnolence(n=239,243,122)
|
37.21 units on a scale
Standard Deviation 22.47
|
37.64 units on a scale
Standard Deviation 21.76
|
36.56 units on a scale
Standard Deviation 21.29
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:quantity(n=240,243,122)
|
6.53 units on a scale
Standard Deviation 1.56
|
6.38 units on a scale
Standard Deviation 1.63
|
6.37 units on a scale
Standard Deviation 1.74
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:sleep disturbance(n=238,242,122)
|
44.44 units on a scale
Standard Deviation 24.11
|
43.33 units on a scale
Standard Deviation 26.18
|
51.27 units on a scale
Standard Deviation 25.89
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:awaken short of breath(n=239,243,122)
|
18.16 units on a scale
Standard Deviation 23.76
|
20.91 units on a scale
Standard Deviation 25.47
|
24.92 units on a scale
Standard Deviation 29.35
|
—
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline:adequacy(n=239,243,122)
|
45.44 units on a scale
Standard Deviation 27.25
|
42.63 units on a scale
Standard Deviation 27.37
|
40.08 units on a scale
Standard Deviation 28.36
|
—
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'n'=participants evaluable at given time point for each 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=241 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3
Baseline(n=241,243,122)
|
96 participants
|
98 participants
|
45 participants
|
—
|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline and Month 3
Month 3(n=238,229,109)
|
113 participants
|
117 participants
|
52 participants
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no). 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range\*100);total score range:0-100,higher score=more intensity of attribute.
Outcome measures
| Measure |
CP-690,550 5 mg
n=229 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=214 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=54 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Overall sleep problem
|
35.68 units on a scale
Standard Deviation 18.80
|
33.33 units on a scale
Standard Deviation 19.19
|
37.29 units on a scale
Standard Deviation 19.26
|
35.64 units on a scale
Standard Deviation 21.20
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Snoring
|
35.28 units on a scale
Standard Deviation 31.04
|
27.79 units on a scale
Standard Deviation 28.24
|
26.30 units on a scale
Standard Deviation 28.50
|
29.20 units on a scale
Standard Deviation 27.47
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Quantity
|
6.64 units on a scale
Standard Deviation 1.45
|
6.87 units on a scale
Standard Deviation 1.71
|
6.65 units on a scale
Standard Deviation 1.52
|
6.64 units on a scale
Standard Deviation 1.27
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Sleep problem summary
|
35.17 units on a scale
Standard Deviation 18.81
|
33.33 units on a scale
Standard Deviation 19.66
|
37.41 units on a scale
Standard Deviation 20.30
|
35.87 units on a scale
Standard Deviation 20.80
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Somnolence
|
30.26 units on a scale
Standard Deviation 21.01
|
29.42 units on a scale
Standard Deviation 20.64
|
31.36 units on a scale
Standard Deviation 19.75
|
29.60 units on a scale
Standard Deviation 21.56
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Sleep disturbance
|
35.75 units on a scale
Standard Deviation 25.11
|
33.38 units on a scale
Standard Deviation 23.91
|
37.80 units on a scale
Standard Deviation 23.96
|
33.80 units on a scale
Standard Deviation 25.83
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Awaken short of breath
|
15.55 units on a scale
Standard Deviation 21.67
|
15.70 units on a scale
Standard Deviation 21.41
|
21.11 units on a scale
Standard Deviation 21.43
|
23.20 units on a scale
Standard Deviation 25.67
|
|
Medical Outcome Study Sleep Scale (MOS-SS) at Month 6
Adequacy(n=229,214,54,50)
|
48.52 units on a scale
Standard Deviation 27.41
|
53.04 units on a scale
Standard Deviation 29.14
|
49.44 units on a scale
Standard Deviation 29.36
|
49.00 units on a scale
Standard Deviation 27.94
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were 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=229 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=216 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=54 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 6
|
105 participants
|
107 participants
|
23 participants
|
25 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
FACIT-Fatigue 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=240 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Baseline (n= 240, 243, 122)
|
27.90 units on a scale
Standard Deviation 10.70
|
27.72 units on a scale
Standard Deviation 11.15
|
27.17 units on a scale
Standard Deviation 10.88
|
—
|
|
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline and Month 3
Month 3 (n= 237, 227, 109)
|
34.40 units on a scale
Standard Deviation 10.65
|
35.42 units on a scale
Standard Deviation 9.75
|
30.06 units on a scale
Standard Deviation 10.87
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
FACIT-Fatigue 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=229 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=216 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=54 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 6
|
34.58 units on a scale
Standard Deviation 10.69
|
36.30 units on a scale
Standard Deviation 10.10
|
33.63 units on a scale
Standard Deviation 9.29
|
36.46 units on a scale
Standard Deviation 9.27
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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=240 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=243 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=122 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3
Baseline (n= 240, 243, 122)
|
0.41 units on a scale
Standard Deviation 0.32
|
0.39 units on a scale
Standard Deviation 0.32
|
0.42 units on a scale
Standard Deviation 0.31
|
—
|
|
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline and Month 3
Month 3 (n= 237, 227, 108)
|
0.60 units on a scale
Standard Deviation 0.25
|
0.66 units on a scale
Standard Deviation 0.23
|
0.51 units on a scale
Standard Deviation 0.31
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were 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=227 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=214 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=54 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=49 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 6
|
0.63 units on a scale
Standard Deviation 0.23
|
0.68 units on a scale
Standard Deviation 0.22
|
0.58 units on a scale
Standard Deviation 0.29
|
0.65 units on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. Participants with at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint were included. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare 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=higher medical cost.
Outcome measures
| Measure |
CP-690,550 5 mg
n=236 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=239 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=120 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Outpatient surgery(n=236,239,120
|
1.97 units on a scale
Standard Deviation 0.16
|
1.95 units on a scale
Standard Deviation 0.21
|
1.98 units on a scale
Standard Deviation 0.16
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Non-study diagnostic test(n=235,239,120)
|
1.83 units on a scale
Standard Deviation 0.38
|
1.78 units on a scale
Standard Deviation 0.41
|
1.83 units on a scale
Standard Deviation 0.37
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:In nursing home(n=236,239,120)
|
1.98 units on a scale
Standard Deviation 0.13
|
1.99 units on a scale
Standard Deviation 0.09
|
1.99 units on a scale
Standard Deviation 0.09
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Home healthcare services(n=235,239,119)
|
1.99 units on a scale
Standard Deviation 0.09
|
1.98 units on a scale
Standard Deviation 0.13
|
1.99 units on a scale
Standard Deviation 0.09
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Required aids/devices(n=236,239,119)
|
1.84 units on a scale
Standard Deviation 0.37
|
1.87 units on a scale
Standard Deviation 0.34
|
1.83 units on a scale
Standard Deviation 0.38
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Non-medical practitioner(n=236,239,120)
|
1.97 units on a scale
Standard Deviation 0.18
|
1.99 units on a scale
Standard Deviation 0.09
|
1.98 units on a scale
Standard Deviation 0.13
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Currently employed(n=236,239,120)
|
1.69 units on a scale
Standard Deviation 0.46
|
1.64 units on a scale
Standard Deviation 0.48
|
1.64 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Feel well enough to work(n=111,90,57)
|
1.86 units on a scale
Standard Deviation 0.35
|
1.83 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 Baseline and Month 3
Baseline:Unable to work due to RA(n=111,93,59)
|
1.37 units on a scale
Standard Deviation 0.48
|
1.29 units on a scale
Standard Deviation 0.46
|
1.41 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Lost job/retired early(n=110,92,58)
|
1.61 units on a scale
Standard Deviation 0.49
|
1.55 units on a scale
Standard Deviation 0.50
|
1.55 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Work disabled due to RA(n=111,91,58)
|
1.54 units on a scale
Standard Deviation 0.50
|
1.48 units on a scale
Standard Deviation 0.50
|
1.52 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Retired(n=116,99,59)
|
1.57 units on a scale
Standard Deviation 0.50
|
1.57 units on a scale
Standard Deviation 0.50
|
1.49 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Sick leave due to RA(n=191,202,99)
|
1.82 units on a scale
Standard Deviation 0.38
|
1.83 units on a scale
Standard Deviation 0.38
|
1.74 units on a scale
Standard Deviation 0.44
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Performed part time work(n=192,202,98)
|
1.89 units on a scale
Standard Deviation 0.31
|
1.87 units on a scale
Standard Deviation 0.34
|
1.88 units on a scale
Standard Deviation 0.33
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Performed paid work(n=191,204,99)
|
1.64 units on a scale
Standard Deviation 0.48
|
1.66 units on a scale
Standard Deviation 0.48
|
1.62 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Unable to do chores(n=235,238,118)
|
1.36 units on a scale
Standard Deviation 0.48
|
1.32 units on a scale
Standard Deviation 0.47
|
1.30 units on a scale
Standard Deviation 0.46
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Seen any doctor(n=236,239,119)
|
1.19 units on a scale
Standard Deviation 0.39
|
1.15 units on a scale
Standard Deviation 0.36
|
1.17 units on a scale
Standard Deviation 0.38
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Treated in emergency room(n=236,239,120)
|
1.94 units on a scale
Standard Deviation 0.23
|
1.92 units on a scale
Standard Deviation 0.26
|
1.92 units on a scale
Standard Deviation 0.28
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Admitted for overnight stay (n=13,18,10)
|
0.15 units on a scale
Standard Deviation 0.55
|
0.17 units on a scale
Standard Deviation 0.51
|
0.20 units on a scale
Standard Deviation 0.63
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Hospitalization(n=236,239,120)
|
1.94 units on a scale
Standard Deviation 0.24
|
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 and Month 3
Baseline:Chores by housekeeper(n=235,239,119)
|
1.86 units on a scale
Standard Deviation 0.35
|
1.82 units on a scale
Standard Deviation 0.39
|
1.81 units on a scale
Standard Deviation 0.40
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Baseline:Chores by family/friends(n=235,239,118)
|
1.40 units on a scale
Standard Deviation 0.49
|
1.44 units on a scale
Standard Deviation 0.50
|
1.29 units on a scale
Standard Deviation 0.45
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3:Seen any doctor(n=235,228,109)
|
1.42 units on a scale
Standard Deviation 0.49
|
1.41 units on a scale
Standard Deviation 0.49
|
1.39 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3:Treated in emergency room(n=236,229,109)
|
1.94 units on a scale
Standard Deviation 0.24
|
1.94 units on a scale
Standard Deviation 0.24
|
1.93 units on a scale
Standard Deviation 0.26
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3:Admitted for overnight stay (n=14,14,8)
|
0.29 units on a scale
Standard Deviation 0.61
|
0.43 units on a scale
Standard Deviation 0.65
|
0.50 units on a scale
Standard Deviation 0.93
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3:Hospitalization(n=236,228,109)
|
1.99 units on a scale
Standard Deviation 0.09
|
1.97 units on a scale
Standard Deviation 0.16
|
1.98 units on a scale
Standard Deviation 0.13
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3:Outpatient surgery(n=236,229,109)
|
1.97 units on a scale
Standard Deviation 0.17
|
1.98 units on a scale
Standard Deviation 0.15
|
1.98 units on a scale
Standard Deviation 0.13
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Non-study diagnostic test(n=236,228,109)
|
1.87 units on a scale
Standard Deviation 0.33
|
1.88 units on a scale
Standard Deviation 0.32
|
1.87 units on a scale
Standard Deviation 0.34
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: In nursing home(n=236,229,109)
|
2.00 units on a scale
Standard Deviation 0.00
|
2.00 units on a scale
Standard Deviation 0.07
|
1.99 units on a scale
Standard Deviation 0.10
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Home healthcare services(n=236,228,108)
|
1.99 units on a scale
Standard Deviation 0.09
|
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 and Month 3
Month 3: Required aids/devices(n=235,228,109)
|
1.89 units on a scale
Standard Deviation 0.32
|
1.91 units on a scale
Standard Deviation 0.28
|
1.87 units on a scale
Standard Deviation 0.34
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Non-medical practitioner(n=236,229,109)
|
1.98 units on a scale
Standard Deviation 0.13
|
2.00 units on a scale
Standard Deviation 0.07
|
2.00 units on a scale
Standard Deviation 0.00
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Currently employed(n=236,228,109)
|
1.71 units on a scale
Standard Deviation 0.45
|
1.65 units on a scale
Standard Deviation 0.48
|
1.62 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Feel well enough to work(n=108,93,50)
|
1.72 units on a scale
Standard Deviation 0.45
|
1.69 units on a scale
Standard Deviation 0.47
|
1.86 units on a scale
Standard Deviation 0.35
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Unable to work due to RA(n=107,98,52)
|
1.51 units on a scale
Standard Deviation 0.50
|
1.48 units on a scale
Standard Deviation 0.50
|
1.35 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Lost job/retired early(n=107,92,49)
|
1.68 units on a scale
Standard Deviation 0.47
|
1.70 units on a scale
Standard Deviation 0.46
|
1.59 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Work disabled due to RA(n=109,92,49)
|
1.57 units on a scale
Standard Deviation 0.50
|
1.62 units on a scale
Standard Deviation 0.49
|
1.47 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Retired(n=115,107,51)
|
1.52 units on a scale
Standard Deviation 0.50
|
1.51 units on a scale
Standard Deviation 0.50
|
1.53 units on a scale
Standard Deviation 0.50
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Sick leave due to RA(n=180,183,88)
|
1.93 units on a scale
Standard Deviation 0.26
|
1.91 units on a scale
Standard Deviation 0.29
|
1.89 units on a scale
Standard Deviation 0.32
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Performed part time work(n=181,180,88)
|
1.94 units on a scale
Standard Deviation 0.23
|
1.94 units on a scale
Standard Deviation 0.24
|
1.90 units on a scale
Standard Deviation 0.30
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Performed paid work(n=179,184,88)
|
1.75 units on a scale
Standard Deviation 0.44
|
1.76 units on a scale
Standard Deviation 0.43
|
1.65 units on a scale
Standard Deviation 0.48
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Unable to do chores(n=231,227,107)
|
1.60 units on a scale
Standard Deviation 0.49
|
1.63 units on a scale
Standard Deviation 0.49
|
1.39 units on a scale
Standard Deviation 0.49
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Chores by housekeeper(n=235,229,108)
|
1.88 units on a scale
Standard Deviation 0.32
|
1.92 units on a scale
Standard Deviation 0.28
|
1.79 units on a scale
Standard Deviation 0.41
|
—
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline and Month 3
Month 3: Chores by family/friends(n=234,229,108)
|
1.65 units on a scale
Standard Deviation 0.48
|
1.64 units on a scale
Standard Deviation 0.48
|
1.49 units on a scale
Standard Deviation 0.50
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains. Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare 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=higher medical cost.
Outcome measures
| Measure |
CP-690,550 5 mg
n=229 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=216 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=54 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=50 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Lost job/retired early(n=126,102,24,23)
|
1.73 units on a scale
Standard Deviation 0.45
|
1.63 units on a scale
Standard Deviation 0.49
|
1.54 units on a scale
Standard Deviation 0.51
|
1.57 units on a scale
Standard Deviation 0.51
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Work disabled due to RA(n=125,103,24,23)
|
1.62 units on a scale
Standard Deviation 0.49
|
1.54 units on a scale
Standard Deviation 0.50
|
1.54 units on a scale
Standard Deviation 0.51
|
1.43 units on a scale
Standard Deviation 0.51
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Retired(n=126,110,25,23)
|
1.51 units on a scale
Standard Deviation 0.50
|
1.45 units on a scale
Standard Deviation 0.50
|
1.56 units on a scale
Standard Deviation 0.51
|
1.48 units on a scale
Standard Deviation 0.51
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Seen any doctor(n=227,216,54,50)
|
1.30 units on a scale
Standard Deviation 0.46
|
1.30 units on a scale
Standard Deviation 0.46
|
1.28 units on a scale
Standard Deviation 0.45
|
1.28 units on a scale
Standard Deviation 0.45
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Treated in emergency room(n=229,216,54,50)
|
1.93 units on a scale
Standard Deviation 0.26
|
1.94 units on a scale
Standard Deviation 0.24
|
1.94 units on a scale
Standard Deviation 0.23
|
1.96 units on a scale
Standard Deviation 0.20
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Admitted for overnight stay (n=16,13,3,2)
|
0.25 units on a scale
Standard Deviation 0.58
|
0.23 units on a scale
Standard Deviation 0.44
|
1.33 units on a scale
Standard Deviation 2.31
|
1.00 units on a scale
Standard Deviation 1.41
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Hospitalization(n=229,216,54,50)
|
1.98 units on a scale
Standard Deviation 1.15
|
1.99 units on a scale
Standard Deviation 1.12
|
1.96 units on a scale
Standard Deviation 1.19
|
1.96 units on a scale
Standard Deviation 0.20
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Outpatient surgery(n=229,216,54,50)
|
1.99 units on a scale
Standard Deviation 0.11
|
1.94 units on a scale
Standard Deviation 0.23
|
2.00 units on a scale
Standard Deviation 0.00
|
1.96 units on a scale
Standard Deviation 0.20
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Diagnostic test(n=229,216,54,50)
|
1.87 units on a scale
Standard Deviation 0.34
|
1.84 units on a scale
Standard Deviation 0.37
|
1.87 units on a scale
Standard Deviation 0.34
|
1.88 units on a scale
Standard Deviation 0.33
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:In nursing home(n=229,216,54,50)
|
2.00 units on a scale
Standard Deviation 0.07
|
2.00 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
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Home healthcare services(n=229,216,54,49)
|
1.99 units on a scale
Standard Deviation 0.11
|
2.00 units on a scale
Standard Deviation 0.07
|
1.96 units on a scale
Standard Deviation 0.19
|
1.98 units on a scale
Standard Deviation 0.14
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Required aids/devices(n=229,216,54,50)
|
1.89 units on a scale
Standard Deviation 0.31
|
1.94 units on a scale
Standard Deviation 0.24
|
1.89 units on a scale
Standard Deviation 0.32
|
1.92 units on a scale
Standard Deviation 0.27
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Non-medical practitioner(n=229,216,54,50)
|
2.00 units on a scale
Standard Deviation 0.00
|
1.99 units on a scale
Standard Deviation 0.10
|
1.98 units on a scale
Standard Deviation 0.14
|
2.00 units on a scale
Standard Deviation 0.00
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Currently employed(n=229,216,54,50)
|
1.71 units on a scale
Standard Deviation 0.46
|
1.65 units on a scale
Standard Deviation 0.48
|
1.59 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 Month 6
Month 6:Feel well enough to work(n=124,101,24,22)
|
1.73 units on a scale
Standard Deviation 0.45
|
1.66 units on a scale
Standard Deviation 0.47
|
1.71 units on a scale
Standard Deviation 0.46
|
1.73 units on a scale
Standard Deviation 0.46
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Unable to work due to RA(n=123,105,24,24)
|
1.50 units on a scale
Standard Deviation 0.50
|
1.46 units on a scale
Standard Deviation 0.50
|
1.54 units on a scale
Standard Deviation 0.51
|
1.42 units on a scale
Standard Deviation 0.50
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Sick leave due to RA(n=175,169,41,41)
|
1.94 units on a scale
Standard Deviation 0.23
|
1.94 units on a scale
Standard Deviation 0.24
|
1.93 units on a scale
Standard Deviation 0.26
|
1.95 units on a scale
Standard Deviation 0.22
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Performed part time work(n=173,170,40,41)
|
1.93 units on a scale
Standard Deviation 0.25
|
1.96 units on a scale
Standard Deviation 0.19
|
1.93 units on a scale
Standard Deviation 0.27
|
1.95 units on a scale
Standard Deviation 0.22
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Performed paid work(n=172,169,39,41)
|
1.80 units on a scale
Standard Deviation 0.40
|
1.80 units on a scale
Standard Deviation 0.40
|
1.64 units on a scale
Standard Deviation 0.49
|
1.73 units on a scale
Standard Deviation 0.45
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Unable to do chores(n=229,214,52,50)
|
1.62 units on a scale
Standard Deviation 0.49
|
1.69 units on a scale
Standard Deviation 0.46
|
1.54 units on a scale
Standard Deviation 0.50
|
1.70 units on a scale
Standard Deviation 0.46
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Chores by housekeeper(n=229,216,54,50)
|
1.89 units on a scale
Standard Deviation 0.31
|
1.94 units on a scale
Standard Deviation 0.25
|
1.85 units on a scale
Standard Deviation 0.36
|
1.98 units on a scale
Standard Deviation 0.14
|
|
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 6
Month 6:Chores by family/friends(n=229,216,54,50)
|
1.67 units on a scale
Standard Deviation 0.47
|
1.70 units on a scale
Standard Deviation 0.46
|
1.54 units on a scale
Standard Deviation 0.50
|
1.74 units on a scale
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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 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=193 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=205 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=102 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Hospital ER visit(n=14,14,8)
|
1.21 events
Standard Deviation 0.80
|
1.29 events
Standard Deviation 0.47
|
1.50 events
Standard Deviation 0.76
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related ER visit(n=14,13,8)
|
0.14 events
Standard Deviation 0.53
|
0.15 events
Standard Deviation 0.55
|
0.25 events
Standard Deviation 0.46
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Hospitalization(n=2,6,2)
|
1.00 events
Standard Deviation 0.00
|
1.17 events
Standard Deviation 0.41
|
1.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related hospitalization(n=2,7,2)
|
0.50 events
Standard Deviation 0.71
|
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 and Month 3
Month 3:Outpatient surgery(n=7,5,2)
|
1.14 events
Standard Deviation 0.38
|
1.60 events
Standard Deviation 0.89
|
1.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related outpatient surgery(n=7,5,2)
|
0.29 events
Standard Deviation 0.76
|
0.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 1.41
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Non-study diagnostic test(n=27,25,13)
|
1.26 events
Standard Deviation 0.81
|
1.60 events
Standard Deviation 0.82
|
1.54 events
Standard Deviation 0.78
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related diagnostic test(n=30,26,14)
|
0.13 events
Standard Deviation 0.35
|
0.15 events
Standard Deviation 0.37
|
0.21 events
Standard Deviation 0.43
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Non-medical practitioner visit(n=4,1,0)
|
10.75 events
Standard Deviation 6.99
|
7.00 events
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related non-medical visit(n=4,1,0)
|
0.25 events
Standard Deviation 0.50
|
2.00 events
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Doctor visit(n=193,204,102)
|
4.38 events
Standard Deviation 4.50
|
3.85 events
Standard Deviation 4.07
|
3.56 events
Standard Deviation 2.73
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related doctor visit (n=192,205,100)
|
1.26 events
Standard Deviation 0.81
|
1.18 events
Standard Deviation 0.85
|
1.33 events
Standard Deviation 0.89
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Hospital ER visit(n=13,18,10)
|
1.15 events
Standard Deviation 0.38
|
1.61 events
Standard Deviation 1.29
|
1.40 events
Standard Deviation 0.70
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related ER visit(n=12,18,10)
|
0.75 events
Standard Deviation 0.75
|
0.50 events
Standard Deviation 0.62
|
0.80 events
Standard Deviation 0.92
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Hospitalization(n=14,19,7)
|
1.07 events
Standard Deviation 0.27
|
1.11 events
Standard Deviation 0.32
|
1.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related hospitalization(n=14,19,8)
|
1.00 events
Standard Deviation 0.55
|
0.84 events
Standard Deviation 0.60
|
0.88 events
Standard Deviation 0.64
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Outpatient surgery(n=6,11,2)
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
1.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related outpatient surgery(n=6,11,3)
|
0.00 events
Standard Deviation 0.00
|
0.55 events
Standard Deviation 0.82
|
0.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Non-study diagnostic test(n=39,51,17)
|
1.69 events
Standard Deviation 1.22
|
1.94 events
Standard Deviation 1.22
|
1.59 events
Standard Deviation 1.06
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related diagnostic test(n=41,52,19)
|
0.61 events
Standard Deviation 0.67
|
0.83 events
Standard Deviation 0.94
|
0.95 events
Standard Deviation 0.97
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Non-medical practitioner visit(n=8,2,2)
|
12.00 events
Standard Deviation 12.99
|
7.00 events
Standard Deviation 7.07
|
1.00 events
Standard Deviation 0.00
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related non-medical visit(n=8,2,2)
|
1.13 events
Standard Deviation 0.64
|
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 and Month 3
Month 3:Doctor visit(n=141,137,66)
|
3.60 events
Standard Deviation 2.40
|
3.64 events
Standard Deviation 3.44
|
4.00 events
Standard Deviation 3.12
|
—
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related doctor visit(n=142,138,66)
|
0.83 events
Standard Deviation 0.67
|
0.81 events
Standard Deviation 0.81
|
0.92 events
Standard Deviation 0.81
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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 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=159 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=152 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=39 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=36 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Non-medical practitioner visit(n=0,2,0,0)
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
3.00 events
Standard Deviation 1.41
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Doctor visit(n=159,152,39,36)
|
3.22 events
Standard Deviation 2.54
|
3.69 events
Standard Deviation 3.18
|
3.00 events
Standard Deviation 2.29
|
3.69 events
Standard Deviation 2.25
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA related doctor visit(n=159,152,39,36)
|
0.92 events
Standard Deviation 0.70
|
0.83 events
Standard Deviation 0.73
|
1.05 events
Standard Deviation 0.60
|
0.92 events
Standard Deviation 0.69
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Hospital ER visit(n=16,13,3,2)
|
1.06 events
Standard Deviation 0.25
|
1.25 events
Standard Deviation 0.45
|
3.00 events
Standard Deviation 1.73
|
1.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA related ER visit(n=16,12,3,2)
|
0.13 events
Standard Deviation 0.34
|
0.08 events
Standard Deviation 0.28
|
1.67 events
Standard Deviation 2.08
|
0.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Hospitalization(n=5,3,2,2)
|
1.20 events
Standard Deviation 0.45
|
1.00 events
Standard Deviation 0.00
|
1.50 events
Standard Deviation 0.71
|
1.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA related hospitalization(n=5,3,2,2)
|
0.20 events
Standard Deviation 0.45
|
0.33 events
Standard Deviation 0.58
|
0.50 events
Standard Deviation 0.71
|
0.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Outpatient surgery(n=3,10,0,2)
|
1.00 events
Standard Deviation 0.00
|
1.50 events
Standard Deviation 1.58
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
1.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA related outpatient surgery(n=3,12,0,2)
|
0.00 events
Standard Deviation 0.00
|
0.00 events
Standard Deviation 0.00
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
0.00 events
Standard Deviation 0.00
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
Non-study diagnostic test(n=24,33,7,5)
|
2.04 events
Standard Deviation 1.55
|
1.39 events
Standard Deviation 0.75
|
2.57 events
Standard Deviation 1.62
|
1.20 events
Standard Deviation 0.45
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA related diagnostic test(n=29,34,6,6)
|
0.45 events
Standard Deviation 0.87
|
0.29 events
Standard Deviation 0.52
|
0.67 events
Standard Deviation 0.82
|
0.33 events
Standard Deviation 0.52
|
|
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 6
RA related non-medical visit(n=0,2,0,0)
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
0.50 events
Standard Deviation 0.71
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
NA events
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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=139 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=131 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=84 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Hospital length of stay(n=14,19,7)
|
15.43 days
Standard Deviation 12.33
|
9.63 days
Standard Deviation 7.27
|
4.29 days
Standard Deviation 2.81
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Hospital length of stay(n=2,6,2)
|
7.50 days
Standard Deviation 6.36
|
6.33 days
Standard Deviation 7.12
|
12.00 days
Standard Deviation 2.83
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Chores by family(n=81,82,55)
|
25.72 days
Standard Deviation 31.12
|
27.29 days
Standard Deviation 33.02
|
27.00 days
Standard Deviation 30.37
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Days in nursing home(n=4,2,1)
|
23.25 days
Standard Deviation 2.63
|
16.50 days
Standard Deviation 6.36
|
10.00 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Days devices/aids used(n=37,31,20)
|
118.95 days
Standard Deviation 134.74
|
85.52 days
Standard Deviation 95.38
|
55.90 days
Standard Deviation 56.66
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:RA related aids used(n=38,31,20)
|
2.21 days
Standard Deviation 1.47
|
1.90 days
Standard Deviation 1.33
|
1.45 days
Standard Deviation 0.69
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Days of work per week(n=72,84,43)
|
5.08 days
Standard Deviation 1.04
|
4.92 days
Standard Deviation 1.17
|
5.02 days
Standard Deviation 0.96
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Days on sick leave(n=33,34,25)
|
25.12 days
Standard Deviation 33.23
|
10.91 days
Standard Deviation 18.15
|
22.40 days
Standard Deviation 29.72
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Days of part time work(n=20,25,12)
|
15.65 days
Standard Deviation 22.74
|
20.44 days
Standard Deviation 26.71
|
12.42 days
Standard Deviation 10.57
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Paid work, bothered by RA(n=69,68,37)
|
33.87 days
Standard Deviation 31.01
|
28.15 days
Standard Deviation 29.06
|
38.30 days
Standard Deviation 27.52
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Chores by housekeeper(n=33,43,22)
|
17.30 days
Standard Deviation 24.67
|
16.63 days
Standard Deviation 25.99
|
14.55 days
Standard Deviation 22.32
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Baseline:Chores by family(n=139,131,84)
|
29.54 days
Standard Deviation 31.72
|
27.85 days
Standard Deviation 34.80
|
22.12 days
Standard Deviation 27.36
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Days in nursing home(n=0,1,1)
|
NA days
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
2.0 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
10.0 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Days devices/aids used(n=27,20,14)
|
109.93 days
Standard Deviation 107.85
|
89.50 days
Standard Deviation 89.98
|
94.68 days
Standard Deviation 111.05
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:RA related aids used(n=27,20,14)
|
1.81 days
Standard Deviation 1.36
|
1.50 days
Standard Deviation 0.95
|
1.93 days
Standard Deviation 1.21
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Days of work per week(n=68,79,41)
|
5.00 days
Standard Deviation 0.93
|
5.05 days
Standard Deviation 1.19
|
4.88 days
Standard Deviation 1.17
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Days on sick leave(n=13,17,10)
|
15.00 days
Standard Deviation 23.59
|
14.82 days
Standard Deviation 23.32
|
19.60 days
Standard Deviation 27.68
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Days of part time work(n=10,11,9)
|
12.70 days
Standard Deviation 20.97
|
19.09 days
Standard Deviation 25.07
|
6.22 days
Standard Deviation 5.70
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Paid work, bothered by RA(n=44,44,30)
|
21.70 days
Standard Deviation 26.22
|
19.39 days
Standard Deviation 23.10
|
26.50 days
Standard Deviation 27.03
|
—
|
|
Number of Days as Assessed Using RA-HCRU at Baseline and Month 3
Month 3:Chores by housekeeper(n=26,19,23)
|
7.73 days
Standard Deviation 8.43
|
6.32 days
Standard Deviation 5.73
|
18.13 days
Standard Deviation 25.19
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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=74 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=75 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=24 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=21 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Hospital length of stay(n=5,3,2,2)
|
13.60 days
Standard Deviation 18.28
|
7.67 days
Standard Deviation 5.86
|
13.50 days
Standard Deviation 14.85
|
1.50 days
Standard Deviation 0.71
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Days in nursing home(n=1,1,0,0)
|
24.00 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
15.00 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
NA days
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
NA days
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Days devices/aids used(n=24,13,6,4)
|
97.17 days
Standard Deviation 116.84
|
53.85 days
Standard Deviation 52.29
|
101.50 days
Standard Deviation 106.85
|
72.25 days
Standard Deviation 113.10
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
RA related aids used(n=25,12,6,4)
|
1.48 days
Standard Deviation 1.23
|
1.67 days
Standard Deviation 0.98
|
2.17 days
Standard Deviation 1.83
|
1.75 days
Standard Deviation 0.96
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Days of work per week(n=65,75,22,21)
|
4.95 days
Standard Deviation 0.84
|
5.16 days
Standard Deviation 0.99
|
5.09 days
Standard Deviation 1.15
|
4.71 days
Standard Deviation 1.19
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Days on sick leave(n=10,10,3,2)
|
21.10 days
Standard Deviation 27.23
|
15.50 days
Standard Deviation 27.71
|
9.00 days
Standard Deviation 5.20
|
47.50 days
Standard Deviation 60.10
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Days of part time work(n=11,6,3,2)
|
15.00 days
Standard Deviation 25.46
|
8.50 days
Standard Deviation 5.68
|
5.00 days
Standard Deviation 3.00
|
4.00 days
Standard Deviation 4.24
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Paid work, bothered by RA(n=34,32,14,12)
|
21.09 days
Standard Deviation 25.89
|
12.72 days
Standard Deviation 17.50
|
26.14 days
Standard Deviation 29.98
|
15.92 days
Standard Deviation 18.80
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Chores by housekeeper(n=25,13,8,1)
|
16.32 days
Standard Deviation 24.40
|
20.23 days
Standard Deviation 31.76
|
8.50 days
Standard Deviation 11.78
|
90.00 days
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
|
Number of Days as Assessed Using RA-HCRU at Month 6
Chores by family(n=74,64,24,13)
|
20.38 days
Standard Deviation 27.42
|
28.09 days
Standard Deviation 32.55
|
11.58 days
Standard Deviation 18.35
|
27.38 days
Standard Deviation 30.61
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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, work done and work missed were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=139 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=131 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=82 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline:Home healthcare services(n=1,4,1)
|
2.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
3.75 hours per day
Standard Deviation 5.50
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline:RA related home HC services(n=2,4,1)
|
1.50 hours per day
Standard Deviation 0.71
|
2.25 hours per day
Standard Deviation 2.50
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline:Work done(n=71,85,43)
|
7.66 hours per day
Standard Deviation 1.87
|
8.60 hours per day
Standard Deviation 6.12
|
8.95 hours per day
Standard Deviation 5.20
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline:Missed work due to RA(n=19,25,12)
|
3.47 hours per day
Standard Deviation 2.67
|
10.84 hours per day
Standard Deviation 24.54
|
6.17 hours per day
Standard Deviation 12.29
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline:Chores by housekeeper(n=33,43,22)
|
5.64 hours per day
Standard Deviation 4.06
|
4.67 hours per day
Standard Deviation 2.07
|
5.86 hours per day
Standard Deviation 3.06
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Baseline:Chores by family(n=139,131,82)
|
3.99 hours per day
Standard Deviation 4.02
|
3.32 hours per day
Standard Deviation 2.89
|
4.85 hours per day
Standard Deviation 6.88
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3:Home healthcare services(n=2,0,1)
|
2.50 hours per day
Standard Deviation 2.12
|
NA hours per day
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3:RA related home HC services(n=2,0,1)
|
0.50 hours per day
Standard Deviation 0.71
|
NA hours per day
Standard Deviation NA
Data was not analyzed as no participant was evaluable for this parameter.
|
0.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3:Work done(n=66,79,41)
|
8.20 hours per day
Standard Deviation 7.28
|
7.68 hours per day
Standard Deviation 2.37
|
8.85 hours per day
Standard Deviation 5.34
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3:Missed work due to RA(n=10,9,9)
|
2.20 hours per day
Standard Deviation 1.55
|
3.67 hours per day
Standard Deviation 1.41
|
9.56 hours per day
Standard Deviation 19.04
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3:Chores by housekeeper(n=27,19,23)
|
5.74 hours per day
Standard Deviation 4.70
|
5.21 hours per day
Standard Deviation 4.89
|
5.91 hours per day
Standard Deviation 4.75
|
—
|
|
Number of Hours Per Day as Assessed RA-HCRU at Baseline and Month 3
Month 3:Chores by family(n=79,82,54)
|
3.09 hours per day
Standard Deviation 1.96
|
3.82 hours per day
Standard Deviation 6.91
|
3.69 hours per day
Standard Deviation 3.82
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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, work done and work missed were reported.
Outcome measures
| Measure |
CP-690,550 5 mg
n=74 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=75 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=24 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=21 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
Home healthcare services(n=3,1,1,1)
|
4.00 hours per day
Standard Deviation 1.00
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
0.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
|
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
RA related home healthcare services(3,1,2,1)
|
1.00 hours per day
Standard Deviation 1.00
|
1.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
0.00 hours per day
Standard Deviation 0.00
|
0.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
|
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
Work done(n=65,75,22,21)
|
8.38 hours per day
Standard Deviation 5.53
|
8.43 hours per day
Standard Deviation 4.16
|
7.23 hours per day
Standard Deviation 2.11
|
8.29 hours per day
Standard Deviation 1.79
|
|
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
Missed work due to RA(n=11,7,3,2)
|
2.73 hours per day
Standard Deviation 2.53
|
2.57 hours per day
Standard Deviation 1.72
|
2.67 hours per day
Standard Deviation 2.31
|
1.50 hours per day
Standard Deviation 2.12
|
|
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
Chores by housekeeper(n=24,14,8,1)
|
5.13 hours per day
Standard Deviation 2.49
|
10.57 hours per day
Standard Deviation 22.97
|
5.00 hours per day
Standard Deviation 2.45
|
8.00 hours per day
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was evaluable.
|
|
Number of Hours Per Days as Assessed Using RA-HCRU at Month 6
Chores by family(n=74,64,24,13)
|
3.11 hours per day
Standard Deviation 2.18
|
2.86 hours per day
Standard Deviation 1.80
|
3.29 hours per day
Standard Deviation 2.84
|
4.69 hours per day
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each group respectively.
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Outcome measures
| Measure |
CP-690,550 5 mg
n=148 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=174 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=79 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Baseline (n=146, 174, 79)
|
5.59 units on a scale
Standard Deviation 3.17
|
5.61 units on a scale
Standard Deviation 6.42
|
5.41 units on a scale
Standard Deviation 2.94
|
—
|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline and Month 3
Month 3 (n=138, 148, 75)
|
3.39 units on a scale
Standard Deviation 2.85
|
3.43 units on a scale
Standard Deviation 2.88
|
4.57 units on a scale
Standard Deviation 2.94
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
Outcome measures
| Measure |
CP-690,550 5 mg
n=130 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=138 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=34 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=34 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 6
|
3.22 units on a scale
Standard Deviation 2.85
|
3.18 units on a scale
Standard Deviation 3.00
|
3.21 units on a scale
Standard Deviation 2.80
|
3.94 units on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given time point for each 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: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, 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=124 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=122 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=67 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline:Time management(n=118, 119, 62)
|
50.84 units on a scale
Standard Deviation 26.52
|
48.98 units on a scale
Standard Deviation 27.17
|
48.74 units on a scale
Standard Deviation 26.44
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline:Physical demands(n=117, 119, 66)
|
51.84 units on a scale
Standard Deviation 22.44
|
49.24 units on a scale
Standard Deviation 27.51
|
51.21 units on a scale
Standard Deviation 25.33
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline:Mental demands(n=119,120,66)
|
31.04 units on a scale
Standard Deviation 24.05
|
36.14 units on a scale
Standard Deviation 28.41
|
38.69 units on a scale
Standard Deviation 27.76
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline:Output demands(n=114, 116, 63)
|
39.70 units on a scale
Standard Deviation 24.76
|
44.85 units on a scale
Standard Deviation 30.23
|
45.30 units on a scale
Standard Deviation 28.11
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Baseline:Work loss index(n=124, 122, 67)
|
10.82 units on a scale
Standard Deviation 5.21
|
11.95 units on a scale
Standard Deviation 6.20
|
12.16 units on a scale
Standard Deviation 5.92
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3:Time management(n=94, 89, 45)
|
37.65 units on a scale
Standard Deviation 29.03
|
34.63 units on a scale
Standard Deviation 29.91
|
41.32 units on a scale
Standard Deviation 23.28
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3:Physical demands(n=98, 90, 46)
|
51.89 units on a scale
Standard Deviation 29.32
|
46.48 units on a scale
Standard Deviation 30.17
|
46.71 units on a scale
Standard Deviation 24.78
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3:Mental demands(n=100, 93, 47)
|
24.64 units on a scale
Standard Deviation 27.02
|
24.62 units on a scale
Standard Deviation 29.12
|
28.54 units on a scale
Standard Deviation 26.40
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3:Output demands(n=96, 90, 45)
|
27.03 units on a scale
Standard Deviation 24.44
|
28.31 units on a scale
Standard Deviation 29.37
|
33.41 units on a scale
Standard Deviation 23.28
|
—
|
|
Work Limitations Questionnaire (WLQ) Score at Baseline and Month 3
Month 3:Work loss index(n=102, 98, 49)
|
8.48 units on a scale
Standard Deviation 5.60
|
8.05 units on a scale
Standard Deviation 6.63
|
9.29 units on a scale
Standard Deviation 5.66
|
—
|
SECONDARY outcome
Timeframe: Month 6Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n'=participants evaluable at given parameter for each 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: Time Management scale (5-items); Physical Demands scale (6-item); Mental-Interpersonal Demands Scale (9-items); Output Demands scale (5-items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). Work Loss Index, 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 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=85 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=26 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
n=27 Participants
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Time management (n=80, 81, 25, 23)
|
36.27 units on a scale
Standard Deviation 29.22
|
30.42 units on a scale
Standard Deviation 28.39
|
34.40 units on a scale
Standard Deviation 25.59
|
39.86 units on a scale
Standard Deviation 30.64
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Physical demands (n=85, 81, 26, 25)
|
45.37 units on a scale
Standard Deviation 29.86
|
45.17 units on a scale
Standard Deviation 34.14
|
57.16 units on a scale
Standard Deviation 27.63
|
50.33 units on a scale
Standard Deviation 31.74
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Mental demands (n= 81, 82, 25, 26)
|
22.66 units on a scale
Standard Deviation 25.71
|
21.61 units on a scale
Standard Deviation 29.09
|
25.84 units on a scale
Standard Deviation 24.54
|
29.77 units on a scale
Standard Deviation 29.64
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Output demands (n= 80, 81, 26, 23)
|
25.04 units on a scale
Standard Deviation 24.29
|
26.30 units on a scale
Standard Deviation 29.40
|
28.65 units on a scale
Standard Deviation 23.90
|
35.05 units on a scale
Standard Deviation 29.32
|
|
Work Limitations Questionnaire (WLQ) Score at Month 6
Work loss index (n= 85, 85, 26, 27)
|
7.85 units on a scale
Standard Deviation 5.64
|
7.60 units on a scale
Standard Deviation 6.49
|
9.07 units on a scale
Standard Deviation 5.22
|
9.23 units on a scale
Standard Deviation 6.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksPopulation: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Outcome measures
| Measure |
CP-690,550 5 mg
n=59 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=61 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=31 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
|
3 days
|
3 days
|
3 days
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksPopulation: FAS: all participants who were randomized to study, received at least 1 dose of study drug (CP-690550/placebo), had at least 1 post-baseline measurement, and baseline measurement for change from baseline endpoint. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly.
Outcome measures
| Measure |
CP-690,550 5 mg
n=59 Participants
CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
|
CP-690,550 10 mg
n=61 Participants
CP-690,550 10 mg tablet orally twice daily up to Month 6.
|
Placebo
n=31 Participants
Matching placebo tablet orally twice daily up to Month 3.
|
Placebo, Then CP-690,550 10 mg
Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
|
|---|---|---|---|---|
|
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
|
3 days
|
3 days
|
3 days
|
—
|
Adverse Events
CP-690550 5 mg (Up To Month 3)
CP-690550 10 mg (Up To Month 3)
Placebo (Up To Month 3)
CP-690550 5 mg (Post Month 3)
CP-690550 10 mg (Post Month 3)
Serious adverse events
| Measure |
CP-690550 5 mg (Up To Month 3)
n=243 participants at risk
CP-690550 5 mg tablet orally twice daily up to Month 3.
|
CP-690550 10 mg (Up To Month 3)
n=245 participants at risk
CP-690550 10 mg tablet orally twice daily up to Month 3.
|
Placebo (Up To Month 3)
n=122 participants at risk
Matching placebo tablet orally twice daily up to Month 3.
|
CP-690550 5 mg (Post Month 3)
n=304 participants at risk
CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
|
CP-690550 10 mg (Post Month 3)
n=306 participants at risk
CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Liver abscess
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Hypoglycaemia
|
0.41%
1/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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)
Uterine leiomyoma
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Grand mal convulsion
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Transient ischaemic attack
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Uterine polyp
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 embolism
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Abdominoplasty
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Breast prosthesis implantation
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Deep vein thrombosis
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Atrial fibrillation
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.65%
2/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Asthenia
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Multi-organ failure
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.66%
2/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Pyelonephritis
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Tuberculous pleurisy
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Patella fracture
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Hyperkalaemia
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Hyponatraemia
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 fibrosis
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Sleep apnoea syndrome
|
0.00%
0/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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-690550 5 mg (Up To Month 3)
n=243 participants at risk
CP-690550 5 mg tablet orally twice daily up to Month 3.
|
CP-690550 10 mg (Up To Month 3)
n=245 participants at risk
CP-690550 10 mg tablet orally twice daily up to Month 3.
|
Placebo (Up To Month 3)
n=122 participants at risk
Matching placebo tablet orally twice daily up to Month 3.
|
CP-690550 5 mg (Post Month 3)
n=304 participants at risk
CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
|
CP-690550 10 mg (Post Month 3)
n=306 participants at risk
CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
1.2%
3/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
6/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Nausea
|
2.9%
7/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
9/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
4/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
6/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
2/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.99%
3/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
7/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 pain upper
|
2.5%
6/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
4/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Constipation
|
2.1%
5/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
4.5%
11/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.7%
9/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
2.1%
5/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
6/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
4/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
2.9%
7/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
7/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.82%
2/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Influenza
|
0.82%
2/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
4/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
4/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
6/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
1.6%
4/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
2/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
4.5%
11/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
8/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.9%
6/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.6%
14/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
8/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
1.6%
4/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.1%
10/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.99%
3/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.6%
11/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
1.2%
3/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.1%
10/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
1/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.82%
2/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
2/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
2.1%
5/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
2/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.6%
8/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
2.5%
6/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.82%
2/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Dizziness
|
1.2%
3/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.3%
4/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
5.3%
13/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.5%
11/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
3/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
9/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
2.3%
7/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
Paraesthesia
|
2.5%
6/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.41%
1/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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
|
0.82%
2/243
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
7/245
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
2/122
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
5/304
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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%
6/306
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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