Trial Outcomes & Findings for A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate (NCT NCT00847613)

Last Updated: 2024-05-16

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). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

800 participants

Primary outcome timeframe

Month 6

Results posted on

2024-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Study STARTED	321	319	81	79
Overall Study Treated	321	316	81	79
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	321	319	81	79

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 5 mg CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 5 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Overall Study Ongoing at cut-off date	250	265	64	64
Overall Study Death	1	1	0	0
Overall Study Adverse Event	36	26	5	6
Overall Study Lack of Efficacy	7	3	3	1
Overall Study Study terminated by Sponsor	1	0	2	1
Overall Study Lost to Follow-up	5	0	0	3
Overall Study Protocol Violation	6	6	3	1
Overall Study Pregnancy	1	1	0	0
Overall Study Site closure	1	0	0	1
Overall Study Withdrawal by Subject	8	11	2	2
Overall Study Participant moved	4	1	0	0
Overall Study Sponsor request	0	1	0	0
Overall Study Randomized, but not treated	0	3	0	0
Overall Study Other	1	1	2	0

Baseline Characteristics

A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 5 mg n=321 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=316 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 5 mg n=81 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.	Total n=797 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 11.6 • n=93 Participants	52.0 years STANDARD_DEVIATION 11.4 • n=4 Participants	53.2 years STANDARD_DEVIATION 11.5 • n=27 Participants	52.1 years STANDARD_DEVIATION 11.8 • n=483 Participants	52.8 years STANDARD_DEVIATION 11.5 • n=36 Participants
Sex: Female, Male Female	269 Participants n=93 Participants	273 Participants n=4 Participants	65 Participants n=27 Participants	72 Participants n=483 Participants	679 Participants n=36 Participants
Sex: Female, Male Male	52 Participants n=93 Participants	43 Participants n=4 Participants	16 Participants n=27 Participants	7 Participants n=483 Participants	118 Participants n=36 Participants

PRIMARY outcome

Timeframe: Month 6

Population: Full Analysis Set (FAS): all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using Non-responder Imputation (NRI) method.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6	51.46 percentage of participants	61.81 percentage of participants	25.32 percentage of participants	—

PRIMARY outcome

Timeframe: Baseline, Month 6

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=286 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=295 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=139 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 Baseline	28.66 units on a scale Standard Error 2.98	34.66 units on a scale Standard Error 2.95	29.53 units on a scale Standard Error 4.25	—
Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6 Change at Month 6	0.12 units on a scale Standard Error 0.12	0.06 units on a scale Standard Error 0.11	0.47 units on a scale Standard Error 0.16	—

PRIMARY outcome

Timeframe: Baseline, Month 3

Population: FAS included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities over past week. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty;2=much difficulty; 3=unable to do. Overall score was computed as sum of domain sc ores and divided by number of domains answered. Total possible score range 0-3: 0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=315 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 Baseline	1.41 units on a scale Standard Deviation 0.68	1.39 units on a scale Standard Deviation 0.66	1.31 units on a scale Standard Deviation 0.68	—
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Month 3 Change at Month 3	-0.3 units on a scale Standard Deviation 0.45	-0.4 units on a scale Standard Deviation 0.48	-0.1 units on a scale Standard Deviation 0.38	—

PRIMARY outcome

Timeframe: Month 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.

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. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=257 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=129 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
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 6	7.17 percentage of participants	15.95 percentage of participants	1.55 percentage of participants	—

SECONDARY outcome

Timeframe: Month 1, 3

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 HAQ); and CRP.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 Month 1	41.42 percentage of participants	52.10 percentage of participants	16.34 percentage of participants	—
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 1 and 3 Month 3	56.31 percentage of participants	66.34 percentage of participants	27.27 percentage of participants	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Population: FAS population. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 Month 9	47.90 percentage of participants	62.46 percentage of participants	32.91 percentage of participants	29.33 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9, 12, 15, 18, 21 and 24 Month 12	48.54 percentage of participants	56.96 percentage of participants	30.38 percentage of participants	33.33 percentage of participants

SECONDARY outcome

Timeframe: Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.

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

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 Month 1	16.83 percentage of participants	18.45 percentage of participants	1.31 percentage of participants	—
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 Month 3	28.80 percentage of participants	36.25 percentage of participants	7.79 percentage of participants	—
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 1, 3 and 6 Month 6	32.36 percentage of participants	43.69 percentage of participants	8.44 percentage of participants	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 Month 9	32.69 percentage of participants	44.01 percentage of participants	22.78 percentage of participants	20.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9, 12, 15, 18, 21 and 24 Month 12	32.69 percentage of participants	41.10 percentage of participants	21.52 percentage of participants	16.00 percentage of participants

SECONDARY outcome

Timeframe: Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method.

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

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 Month 1	3.88 percentage of participants	3.56 percentage of participants	0.00 percentage of participants	—
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 Month 3	10.68 percentage of participants	17.15 percentage of participants	2.60 percentage of participants	—
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 1, 3 and 6 Month 6	14.56 percentage of participants	22.33 percentage of participants	1.30 percentage of participants	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 Month 9	18.45 percentage of participants	28.48 percentage of participants	8.86 percentage of participants	12.00 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9, 12, 15, 18, 21 and 24 Month 12	18.77 percentage of participants	27.51 percentage of participants	10.13 percentage of participants	12.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 Month 3 (n=294,299,145)	3.62 units on a scale Standard Deviation 1.13	3.29 units on a scale Standard Deviation 1.14	4.54 units on a scale Standard Deviation 1.18	—
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 Baseline (n=316,309,156)	5.22 units on a scale Standard Deviation 0.88	5.20 units on a scale Standard Deviation 0.87	5.16 units on a scale Standard Deviation 0.87	—
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 Month 1 (n=309,308,152)	4.04 units on a scale Standard Deviation 1.14	3.84 units on a scale Standard Deviation 1.09	4.73 units on a scale Standard Deviation 1.10	—
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Month 1, 3 and 6 Month 6 (n=283,285,62)	3.33 units on a scale Standard Deviation 1.12	2.96 units on a scale Standard Deviation 1.09	3.79 units on a scale Standard Deviation 1.06	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=278 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=69 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 Month 9	3.11 units on a scale Standard Deviation 1.17	2.88 units on a scale Standard Deviation 1.20	2.99 units on a scale Standard Deviation 1.11	3.03 units on a scale Standard Deviation 1.06
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Month 9, 12, 15, 18, 21 and 24 Month 12	3.07 units on a scale Standard Deviation 1.23	2.75 units on a scale Standard Deviation 1.14	3.05 units on a scale Standard Deviation 1.18	2.91 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=306 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 Baseline (n=316,306,154)	6.34 units on a scale Standard Deviation 0.97	6.25 units on a scale Standard Deviation 0.99	6.27 units on a scale Standard Deviation 1.01	—
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 Month 1 (n=258,250,127)	5.12 units on a scale Standard Deviation 1.32	4.84 units on a scale Standard Deviation 1.28	5.83 units on a scale Standard Deviation 1.17	—
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 Month 3 (n=249,248,122)	4.58 units on a scale Standard Deviation 1.29	4.19 units on a scale Standard Deviation 1.34	5.57 units on a scale Standard Deviation 1.23	—
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 1, 3 and 6 Month 6 (n=239,236,49)	4.34 units on a scale Standard Deviation 1.24	3.90 units on a scale Standard Deviation 1.31	4.81 units on a scale Standard Deviation 1.21	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=227 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=229 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=54 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 Month 9	4.12 units on a scale Standard Deviation 1.26	3.84 units on a scale Standard Deviation 1.35	4.04 units on a scale Standard Deviation 1.33	3.87 units on a scale Standard Deviation 1.30
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 9, 12, 15, 18, 21 and 24 Month 12	4.09 units on a scale Standard Deviation 1.31	3.79 units on a scale Standard Deviation 1.34	4.20 units on a scale Standard Deviation 1.41	3.84 units on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24

Population: Since DAS28-4 (CRP) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-4 (CRP).

DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP \[mg/L\] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 \[CRP\] \<=3.2 implied low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 implied moderate to high disease activity and DAS28 \<2.6 implied remission.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24

Population: Since DAS28-3 (ESR) was determined to provide no new information over DAS28-4 (ESR) and DAS28-3 (CRP), there was a change in planned analysis and data was not analyzed for DAS28-3 (ESR).

DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=286 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=295 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=139 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Modified Total Sharp Scores (mTSS) at Baseline	31.1 units on a scale Standard Deviation 47.71	37.3 units on a scale Standard Deviation 54.10	32.6 units on a scale Standard Deviation 41.80	—

SECONDARY outcome

Timeframe: Month 12, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for Month 24 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=286 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=295 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=71 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=68 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Modified Total Sharp Scores (mTSS) at Month 12 and 24	31.4 units on a scale Standard Deviation 47.88	37.3 units on a scale Standard Deviation 54.03	36.1 units on a scale Standard Deviation 43.59	30.9 units on a scale Standard Deviation 41.18

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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 where 0=least difficulty and 3=extreme difficulty.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=315 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 Baseline (n=315,309,156)	1.41 units on a scale Standard Deviation 0.68	1.39 units on a scale Standard Deviation 0.66	1.31 units on a scale Standard Deviation 0.68	—
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 Month 1 (n=309,308,153)	1.16 units on a scale Standard Deviation 0.67	1.02 units on a scale Standard Deviation 0.65	1.25 units on a scale Standard Deviation 0.67	—
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 Month 3 (n=295,300,146)	1.00 units on a scale Standard Deviation 0.65	0.84 units on a scale Standard Deviation 0.65	1.19 units on a scale Standard Deviation 0.69	—
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Month 1, 3 and 6 Month 6 (n=283,285,62)	0.94 units on a scale Standard Deviation 0.62	0.79 units on a scale Standard Deviation 0.64	1.09 units on a scale Standard Deviation 0.62	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=278 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=69 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 Month 9	0.91 units on a scale Standard Deviation 0.65	0.75 units on a scale Standard Deviation 0.64	0.95 units on a scale Standard Deviation 0.66	0.74 units on a scale Standard Deviation 0.67
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9, 12, 15, 18, 21 and 24 Month 12	0.90 units on a scale Standard Deviation 0.65	0.76 units on a scale Standard Deviation 0.68	0.84 units on a scale Standard Deviation 0.66	0.74 units on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 Baseline (n=316,309,156)	58.39 mm Standard Deviation 23.08	57.62 mm Standard Deviation 24.10	55.01 mm Standard Deviation 23.87	—
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 Month 1 (n=309,308,153)	41.61 mm Standard Deviation 24.08	33.91 mm Standard Deviation 22.30	49.22 mm Standard Deviation 24.51	—
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 Month 3 (n=295,300,146)	34.47 mm Standard Deviation 23.49	29.23 mm Standard Deviation 21.95	46.96 mm Standard Deviation 24.02	—
Patient Assessment of Arthritis Pain at Baseline, Month 1, 3 and 6 Month 6 (n=283,285,62)	32.79 mm Standard Deviation 22.90	29.05 mm Standard Deviation 22.71	36.76 mm Standard Deviation 22.14	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Participants rated the severity of arthritis pain on a 0 to 100 mm visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=278 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=69 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 Month 9	31.59 mm Standard Deviation 23.13	27.14 mm Standard Deviation 23.10	31.74 mm Standard Deviation 23.26	27.54 mm Standard Deviation 23.12
Patient Assessment of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 Month 12	30.54 mm Standard Deviation 23.00	27.45 mm Standard Deviation 24.56	27.99 mm Standard Deviation 23.55	29.41 mm Standard Deviation 26.22

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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 VAS where 0 = very well and 100 = very poorly.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=308 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 Baseline (n=316,308,156)	58.06 mm Standard Deviation 23.62	56.45 mm Standard Deviation 22.96	54.11 mm Standard Deviation 22.87	—
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 Month 1 (n=309,308,153)	41.26 mm Standard Deviation 23.69	34.95 mm Standard Deviation 21.43	48.30 mm Standard Deviation 24.47	—
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 Month 3 (n=295,300,146)	35.07 mm Standard Deviation 22.68	29.11 mm Standard Deviation 20.54	46.96 mm Standard Deviation 24.09	—
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Month 1, 3, and 6 Month 6 (n=283,285,62)	33.48 mm Standard Deviation 22.39	29.03 mm Standard Deviation 22.68	38.87 mm Standard Deviation 23.17	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=278 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=69 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 Month 9	31.19 mm Standard Deviation 22.10	28.05 mm Standard Deviation 22.46	31.46 mm Standard Deviation 23.22	27.41 mm Standard Deviation 23.22
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9, 12, 15, 18, 21 and 24 Month 12	31.77 mm Standard Deviation 22.55	29.12 mm Standard Deviation 24.06	29.60 mm Standard Deviation 23.15	28.11 mm Standard Deviation 24.09

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

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

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 Baseline (n=316,309,156)	59.44 mm Standard Deviation 15.87	58.42 mm Standard Deviation 17.08	55.90 mm Standard Deviation 17.37	—
Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 Month 1 (n=309,308,152)	37.97 mm Standard Deviation 18.58	35.19 mm Standard Deviation 19.29	45.50 mm Standard Deviation 19.57	—
Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 Month 3 (n=294,300,146)	30.12 mm Standard Deviation 18.61	24.47 mm Standard Deviation 17.51	43.29 mm Standard Deviation 22.25	—
Physician Global Assessment (PGA) of Arthritis at Baseline, Month 1, 3 and 6 Month 6 (n=283,284,61)	25.47 mm Standard Deviation 18.62	20.44 mm Standard Deviation 15.75	26.61 mm Standard Deviation 17.73	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

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

Outcome measures
Measure	CP-690,550 5 mg n=264 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=278 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=69 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=62 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 Month 9	21.68 mm Standard Deviation 16.14	18.90 mm Standard Deviation 15.89	19.92 mm Standard Deviation 17.59	19.29 mm Standard Deviation 15.53
Physician Global Assessment (PGA) of Arthritis at Month 9, 12, 15, 18, 21 and 24 Month 12	20.40 mm Standard Deviation 15.71	17.97 mm Standard Deviation 15.08	20.42 mm Standard Deviation 16.63	18.79 mm Standard Deviation 15.42

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=315 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:physical component(n=307,308,153)	36.99 units on a scale Standard Deviation 8.24	38.96 units on a scale Standard Deviation 8.07	36.25 units on a scale Standard Deviation 8.24	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:mental health(n=295,300,146)	43.84 units on a scale Standard Deviation 11.82	45.52 units on a scale Standard Deviation 10.50	42.80 units on a scale Standard Deviation 11.47	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:role emotional(n=295,300,146)	39.52 units on a scale Standard Deviation 12.64	43.12 units on a scale Standard Deviation 11.97	38.20 units on a scale Standard Deviation 13.46	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:vitality(n=295,300,146)	46.72 units on a scale Standard Deviation 10.31	48.60 units on a scale Standard Deviation 9.52	44.24 units on a scale Standard Deviation 10.15	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:general health(n=294,300,146)	39.76 units on a scale Standard Deviation 9.31	41.20 units on a scale Standard Deviation 8.84	38.24 units on a scale Standard Deviation 8.79	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:mental component(n=294,300,146)	45.22 units on a scale Standard Deviation 11.69	47.05 units on a scale Standard Deviation 10.27	43.70 units on a scale Standard Deviation 11.68	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:physical component(n=294,300,146)	38.65 units on a scale Standard Deviation 8.62	41.30 units on a scale Standard Deviation 8.49	36.79 units on a scale Standard Deviation 8.39	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:physical functioning(n=283,284,62)	37.33 units on a scale Standard Deviation 10.51	39.76 units on a scale Standard Deviation 10.71	37.60 units on a scale Standard Deviation 8.70	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:role physical(n=282,284,62)	41.46 units on a scale Standard Deviation 10.16	43.37 units on a scale Standard Deviation 9.62	41.38 units on a scale Standard Deviation 8.78	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:social functioning(n=283,285,62)	42.99 units on a scale Standard Deviation 10.58	44.87 units on a scale Standard Deviation 10.53	42.79 units on a scale Standard Deviation 9.48	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:bodily pain(n=283,285,62)	41.90 units on a scale Standard Deviation 8.81	44.18 units on a scale Standard Deviation 9.37	40.70 units on a scale Standard Deviation 8.06	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:mental health(n=283,285,62)	44.46 units on a scale Standard Deviation 11.86	45.60 units on a scale Standard Deviation 11.34	43.37 units on a scale Standard Deviation 8.46	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:role emotional(n=282,284,62)	40.58 units on a scale Standard Deviation 12.54	42.71 units on a scale Standard Deviation 11.69	41.88 units on a scale Standard Deviation 10.80	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:role physical(n=295,300,146)	39.83 units on a scale Standard Deviation 10.11	42.82 units on a scale Standard Deviation 9.98	38.37 units on a scale Standard Deviation 10.65	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:physical functioning(n=295,300,146)	36.40 units on a scale Standard Deviation 10.51	39.34 units on a scale Standard Deviation 10.66	35.39 units on a scale Standard Deviation 10.66	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:social functioning(n=295,300,146)	42.73 units on a scale Standard Deviation 10.60	44.50 units on a scale Standard Deviation 10.27	40.86 units on a scale Standard Deviation 11.23	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:general health(n=315,309,156)	35.16 units on a scale Standard Deviation 9.07	36.03 units on a scale Standard Deviation 8.79	36.82 units on a scale Standard Deviation 8.11	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:physical functioning(n=315,309,156)	32.16 units on a scale Standard Deviation 9.98	32.61 units on a scale Standard Deviation 9.86	33.50 units on a scale Standard Deviation 10.70	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:role physical(n=315,309,156)	34.61 units on a scale Standard Deviation 9.40	35.41 units on a scale Standard Deviation 9.73	36.69 units on a scale Standard Deviation 10.54	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:social functioning(n=315,309,156)	37.16 units on a scale Standard Deviation 11.05	39.17 units on a scale Standard Deviation 11.42	39.37 units on a scale Standard Deviation 11.54	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:bodily pain(n=315,309,156)	34.01 units on a scale Standard Deviation 7.52	34.64 units on a scale Standard Deviation 7.89	35.57 units on a scale Standard Deviation 8.05	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:mental health(n=315,309,156)	39.94 units on a scale Standard Deviation 11.30	40.45 units on a scale Standard Deviation 11.15	42.03 units on a scale Standard Deviation 11.28	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:role emotional(n=315,309,156)	35.64 units on a scale Standard Deviation 12.67	36.25 units on a scale Standard Deviation 13.37	37.43 units on a scale Standard Deviation 13.82	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:vitality(n=315,309,156)	40.62 units on a scale Standard Deviation 9.90	42.53 units on a scale Standard Deviation 9.67	42.97 units on a scale Standard Deviation 9.95	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:mental component(n=315,309,156)	41.01 units on a scale Standard Deviation 11.54	42.24 units on a scale Standard Deviation 11.52	43.21 units on a scale Standard Deviation 11.90	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Baseline:physical component(n=315,309,156)	33.05 units on a scale Standard Deviation 7.94	33.75 units on a scale Standard Deviation 7.77	34.51 units on a scale Standard Deviation 8.03	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:physical functioning(n=308,308,153)	34.61 units on a scale Standard Deviation 9.96	36.72 units on a scale Standard Deviation 10.01	35.27 units on a scale Standard Deviation 10.48	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:role physical(n=307,308,153)	39.21 units on a scale Standard Deviation 10.04	41.02 units on a scale Standard Deviation 9.81	38.30 units on a scale Standard Deviation 10.24	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:social functioning(n=308,308,153)	41.70 units on a scale Standard Deviation 10.44	43.54 units on a scale Standard Deviation 10.06	41.01 units on a scale Standard Deviation 11.57	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:bodily pain(n=308,308,153)	39.75 units on a scale Standard Deviation 8.08	42.02 units on a scale Standard Deviation 8.41	37.31 units on a scale Standard Deviation 8.93	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:mental health(n=308,308,153)	43.70 units on a scale Standard Deviation 11.76	44.88 units on a scale Standard Deviation 10.82	42.70 units on a scale Standard Deviation 11.98	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:role emotional(n=307,308,153)	39.06 units on a scale Standard Deviation 12.34	41.13 units on a scale Standard Deviation 12.03	38.53 units on a scale Standard Deviation 12.47	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:vitality(n=308,308,153)	45.33 units on a scale Standard Deviation 10.33	46.84 units on a scale Standard Deviation 9.77	43.82 units on a scale Standard Deviation 10.40	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:general health(n=308,308,153)	38.49 units on a scale Standard Deviation 9.28	39.91 units on a scale Standard Deviation 9.00	37.70 units on a scale Standard Deviation 8.85	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 1:mental component(n=307,308,153)	44.90 units on a scale Standard Deviation 11.74	46.28 units on a scale Standard Deviation 10.70	43.86 units on a scale Standard Deviation 11.90	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 3:bodily pain(n=295,300,146)	41.30 units on a scale Standard Deviation 9.23	44.43 units on a scale Standard Deviation 9.02	38.17 units on a scale Standard Deviation 9.16	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:vitality(n=283,285,62)	46.58 units on a scale Standard Deviation 10.11	48.52 units on a scale Standard Deviation 9.42	46.31 units on a scale Standard Deviation 9.14	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:general health(n=283,285,62)	40.40 units on a scale Standard Deviation 9.14	41.78 units on a scale Standard Deviation 9.24	39.90 units on a scale Standard Deviation 7.03	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:mental component(n=282,284,62)	45.39 units on a scale Standard Deviation 11.86	46.82 units on a scale Standard Deviation 10.85	45.42 units on a scale Standard Deviation 9.35	—
36-Item Short-Form Health Survey (SF-36) at Baseline, Month 1, 3 and 6 Month 6:physical component(n=282,284,62)	39.69 units on a scale Standard Deviation 8.39	41.78 units on a scale Standard Deviation 8.56	39.21 units on a scale Standard Deviation 6.99	—

SECONDARY outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=264 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=278 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=69 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:physical functioning	37.94 units on a scale Standard Deviation 10.38	40.66 units on a scale Standard Deviation 10.70	38.31 units on a scale Standard Deviation 10.62	41.29 units on a scale Standard Deviation 11.80
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:role physical	41.41 units on a scale Standard Deviation 10.30	43.96 units on a scale Standard Deviation 9.86	41.48 units on a scale Standard Deviation 9.87	44.96 units on a scale Standard Deviation 10.21
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:social functioning	44.16 units on a scale Standard Deviation 10.13	45.20 units on a scale Standard Deviation 10.67	43.70 units on a scale Standard Deviation 10.10	45.90 units on a scale Standard Deviation 11.40
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:bodily pain	42.24 units on a scale Standard Deviation 8.90	44.17 units on a scale Standard Deviation 9.45	43.88 units on a scale Standard Deviation 8.56	47.17 units on a scale Standard Deviation 9.99
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:mental health	45.02 units on a scale Standard Deviation 11.18	45.05 units on a scale Standard Deviation 11.75	44.52 units on a scale Standard Deviation 11.29	48.35 units on a scale Standard Deviation 11.68
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:role emotional	41.66 units on a scale Standard Deviation 12.56	43.01 units on a scale Standard Deviation 11.72	41.85 units on a scale Standard Deviation 11.43	45.28 units on a scale Standard Deviation 11.54
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:vitality	47.50 units on a scale Standard Deviation 10.28	47.94 units on a scale Standard Deviation 9.81	46.23 units on a scale Standard Deviation 10.02	50.10 units on a scale Standard Deviation 9.83
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:general health	40.61 units on a scale Standard Deviation 9.16	42.02 units on a scale Standard Deviation 9.57	40.79 units on a scale Standard Deviation 8.64	43.98 units on a scale Standard Deviation 9.96
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:mental component	46.53 units on a scale Standard Deviation 11.50	46.38 units on a scale Standard Deviation 11.16	45.70 units on a scale Standard Deviation 11.01	49.07 units on a scale Standard Deviation 10.98
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 9:physical component	39.79 units on a scale Standard Deviation 8.38	42.49 units on a scale Standard Deviation 8.75	40.52 units on a scale Standard Deviation 8.47	43.44 units on a scale Standard Deviation 10.11
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:physical functioning	38.42 units on a scale Standard Deviation 10.83	40.01 units on a scale Standard Deviation 11.03	39.43 units on a scale Standard Deviation 10.51	42.27 units on a scale Standard Deviation 11.02
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:role physical	41.37 units on a scale Standard Deviation 10.19	43.59 units on a scale Standard Deviation 9.93	42.31 units on a scale Standard Deviation 10.62	45.15 units on a scale Standard Deviation 10.12
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:social functioning	43.48 units on a scale Standard Deviation 10.56	45.18 units on a scale Standard Deviation 10.54	44.28 units on a scale Standard Deviation 10.48	47.18 units on a scale Standard Deviation 10.29
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:bodily pain	42.83 units on a scale Standard Deviation 8.85	44.18 units on a scale Standard Deviation 9.59	43.60 units on a scale Standard Deviation 8.21	45.78 units on a scale Standard Deviation 9.89
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:mental health	44.73 units on a scale Standard Deviation 10.78	45.07 units on a scale Standard Deviation 11.22	44.66 units on a scale Standard Deviation 12.07	46.81 units on a scale Standard Deviation 11.48
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:role emotional	41.09 units on a scale Standard Deviation 12.73	42.80 units on a scale Standard Deviation 11.44	41.27 units on a scale Standard Deviation 12.59	44.38 units on a scale Standard Deviation 12.34
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:vitality	47.54 units on a scale Standard Deviation 10.15	48.12 units on a scale Standard Deviation 9.96	47.08 units on a scale Standard Deviation 11.04	49.20 units on a scale Standard Deviation 10.33
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:general health	40.35 units on a scale Standard Deviation 9.31	41.65 units on a scale Standard Deviation 9.38	40.48 units on a scale Standard Deviation 9.38	43.83 units on a scale Standard Deviation 9.53
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:mental component	45.82 units on a scale Standard Deviation 11.23	46.49 units on a scale Standard Deviation 10.61	45.55 units on a scale Standard Deviation 12.12	47.95 units on a scale Standard Deviation 10.79
36-Item Short-Form Health Survey (SF-36) at Month 9, 12, 15, 18, 21 and 24 Month 12:physical component	40.23 units on a scale Standard Deviation 8.61	42.02 units on a scale Standard Deviation 8.82	41.22 units on a scale Standard Deviation 8.29	43.92 units on a scale Standard Deviation 9.20

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively.

Participant-rated 12 item questionnaire to 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(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100,higher score=more intensity of attribute.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=314 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:sleep problem summary(n=307,307,151)	33.55 units on a scale Standard Deviation 20.86	33.33 units on a scale Standard Deviation 18.97	35.36 units on a scale Standard Deviation 19.46	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:somnolence(n=307,307,151)	32.18 units on a scale Standard Deviation 21.27	30.38 units on a scale Standard Deviation 20.22	32.80 units on a scale Standard Deviation 23.78	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:snoring(n=308,306,151)	31.36 units on a scale Standard Deviation 31.13	30.20 units on a scale Standard Deviation 31.25	29.80 units on a scale Standard Deviation 28.92	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:quantity(n=307,306,153)	6.60 units on a scale Standard Deviation 1.51	6.69 units on a scale Standard Deviation 1.31	6.38 units on a scale Standard Deviation 1.46	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:sleep disturbance(n=308,307,151)	34.04 units on a scale Standard Deviation 27.26	33.07 units on a scale Standard Deviation 24.86	33.73 units on a scale Standard Deviation 26.06	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:awaken short of breath(n=308,307,151)	15.26 units on a scale Standard Deviation 24.95	11.60 units on a scale Standard Deviation 19.70	14.97 units on a scale Standard Deviation 23.80	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:adequacy(n=308,307,151)	51.23 units on a scale Standard Deviation 28.31	49.61 units on a scale Standard Deviation 27.28	47.48 units on a scale Standard Deviation 26.79	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:overall sleep problem(n=295,300,146)	34.67 units on a scale Standard Deviation 20.37	34.10 units on a scale Standard Deviation 19.56	35.45 units on a scale Standard Deviation 18.16	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:snoring(n=295,299,146)	33.49 units on a scale Standard Deviation 31.36	28.90 units on a scale Standard Deviation 29.81	30.27 units on a scale Standard Deviation 30.01	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:sleep problem summary(n=295,300,146)	33.49 units on a scale Standard Deviation 20.90	33.30 units on a scale Standard Deviation 19.97	35.16 units on a scale Standard Deviation 19.04	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:somnolence(n=295,300,146)	31.86 units on a scale Standard Deviation 21.52	28.64 units on a scale Standard Deviation 20.43	32.65 units on a scale Standard Deviation 22.57	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:quantity(n=295,300,146)	6.69 units on a scale Standard Deviation 1.51	6.67 units on a scale Standard Deviation 1.34	6.59 units on a scale Standard Deviation 1.43	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:sleep disturbance(n=295,300,146)	34.43 units on a scale Standard Deviation 26.15	34.32 units on a scale Standard Deviation 26.81	33.15 units on a scale Standard Deviation 25.49	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:awaken short of breath(n=295,300,146)	16.61 units on a scale Standard Deviation 24.68	14.13 units on a scale Standard Deviation 21.52	15.75 units on a scale Standard Deviation 22.56	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3:adequacy(n=295,300,146)	52.88 units on a scale Standard Deviation 29.21	50.93 units on a scale Standard Deviation 27.31	48.84 units on a scale Standard Deviation 25.74	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:overall sleep problem(n=282,285,62)	33.10 units on a scale Standard Deviation 19.14	32.67 units on a scale Standard Deviation 18.56	32.40 units on a scale Standard Deviation 13.97	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:awaken short of breath(n=283,285,62)	15.90 units on a scale Standard Deviation 25.21	13.47 units on a scale Standard Deviation 21.19	13.23 units on a scale Standard Deviation 20.47	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:sleep problem summary(n=282,285,62)	32.67 units on a scale Standard Deviation 20.38	32.07 units on a scale Standard Deviation 18.84	31.56 units on a scale Standard Deviation 15.05	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:overall sleep problem(n=314,309,156)	40.19 units on a scale Standard Deviation 20.12	39.70 units on a scale Standard Deviation 19.48	37.30 units on a scale Standard Deviation 18.32	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:somnolence(n=283,285,62)	30.60 units on a scale Standard Deviation 21.25	28.16 units on a scale Standard Deviation 20.17	27.74 units on a scale Standard Deviation 18.31	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:sleep problem summary(n=314,309,156)	38.65 units on a scale Standard Deviation 20.70	38.47 units on a scale Standard Deviation 19.62	36.39 units on a scale Standard Deviation 18.50	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:snoring(n=283,285,62)	31.87 units on a scale Standard Deviation 29.85	31.51 units on a scale Standard Deviation 30.29	29.03 units on a scale Standard Deviation 29.12	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:somnolence(n=314,309,156)	36.75 units on a scale Standard Deviation 22.74	34.63 units on a scale Standard Deviation 22.05	33.72 units on a scale Standard Deviation 21.13	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:quantity(n=283,285,62)	6.66 units on a scale Standard Deviation 1.46	6.66 units on a scale Standard Deviation 1.41	6.65 units on a scale Standard Deviation 1.32	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:sleep disturbance(n=282,285,62)	31.76 units on a scale Standard Deviation 23.72	32.10 units on a scale Standard Deviation 24.14	31.61 units on a scale Standard Deviation 21.56	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:snoring(n=312,309,156)	34.36 units on a scale Standard Deviation 32.74	29.71 units on a scale Standard Deviation 31.28	29.36 units on a scale Standard Deviation 27.02	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6:adequacy(n=283,285,62)	53.14 units on a scale Standard Deviation 27.54	52.32 units on a scale Standard Deviation 26.99	51.77 units on a scale Standard Deviation 26.64	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:quantity(n=315,308,155)	6.46 units on a scale Standard Deviation 1.44	6.42 units on a scale Standard Deviation 1.41	6.46 units on a scale Standard Deviation 1.39	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:sleep disturbance(n=314,309,156)	41.04 units on a scale Standard Deviation 27.04	40.60 units on a scale Standard Deviation 26.64	36.49 units on a scale Standard Deviation 26.76	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:awaken short of breath(n=314,309,156)	17.90 units on a scale Standard Deviation 25.82	15.15 units on a scale Standard Deviation 23.60	14.74 units on a scale Standard Deviation 21.80	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline:adequacy(n=314,309,156)	46.66 units on a scale Standard Deviation 28.23	45.83 units on a scale Standard Deviation 27.37	46.92 units on a scale Standard Deviation 26.14	—
Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1:overall sleep problem(n=307,307,151)	34.74 units on a scale Standard Deviation 20.68	33.90 units on a scale Standard Deviation 18.55	35.80 units on a scale Standard Deviation 19.12	—

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=315 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Baseline (n=315,309,156)	140 participants	132 participants	70 participants	—
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 1 (n=309,309,153)	144 participants	156 participants	67 participants	—
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 3 (n=295,300,146)	140 participants	150 participants	71 participants	—
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Baseline, Month 1, 3 and 6 Month 6 (n=283,285,139)	132 participants	140 participants	64 participants	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=248 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=264 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=67 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:overall sleep problem	32.50 units on a scale Standard Deviation 18.21	32.68 units on a scale Standard Deviation 19.05	30.92 units on a scale Standard Deviation 17.24	28.34 units on a scale Standard Deviation 17.87
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:sleep problem summary	31.69 units on a scale Standard Deviation 18.69	31.97 units on a scale Standard Deviation 19.21	31.69 units on a scale Standard Deviation 18.18	28.73 units on a scale Standard Deviation 17.96
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:somnolence	30.53 units on a scale Standard Deviation 20.71	29.75 units on a scale Standard Deviation 21.78	28.96 units on a scale Standard Deviation 20.81	25.40 units on a scale Standard Deviation 18.62
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:snoring	31.77 units on a scale Standard Deviation 30.75	30.91 units on a scale Standard Deviation 31.14	31.64 units on a scale Standard Deviation 30.18	25.71 units on a scale Standard Deviation 25.25
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:quantity	6.73 units on a scale Standard Deviation 1.20	6.67 units on a scale Standard Deviation 1.26	6.73 units on a scale Standard Deviation 1.46	6.71 units on a scale Standard Deviation 1.52
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:sleep disturbance	30.72 units on a scale Standard Deviation 23.45	31.43 units on a scale Standard Deviation 24.09	29.35 units on a scale Standard Deviation 23.07	24.01 units on a scale Standard Deviation 24.02
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:awaken short of breath	14.19 units on a scale Standard Deviation 22.23	13.48 units on a scale Standard Deviation 20.86	15.82 units on a scale Standard Deviation 20.16	13.33 units on a scale Standard Deviation 22.14
Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24 Month 12:adequacy	53.35 units on a scale Standard Deviation 27.11	52.16 units on a scale Standard Deviation 26.33	55.37 units on a scale Standard Deviation 25.66	53.02 units on a scale Standard Deviation 28.77

SECONDARY outcome

Timeframe: Month 12, 18, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data reported for Month 12. For time points after Month 12, data will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=251 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=265 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=67 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12, 18 and 24	131 participants	134 participants	36 participants	28 participants

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=315 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=307 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=155 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 Baseline (n=315,307,155)	28.59 units on a scale Standard Deviation 10.62	29.49 units on a scale Standard Deviation 10.62	31.07 units on a scale Standard Deviation 11.06	—
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 Month 1 (n=309,306,150)	33.13 units on a scale Standard Deviation 10.47	34.31 units on a scale Standard Deviation 10.19	31.52 units on a scale Standard Deviation 10.63	—
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 Month 3 (n=295,300,146)	34.19 units on a scale Standard Deviation 10.29	36.14 units on a scale Standard Deviation 9.53	31.51 units on a scale Standard Deviation 11.10	—
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Baseline, Month 1, 3, and 6 Month 6 (n=283,284,61)	34.36 units on a scale Standard Deviation 9.95	36.47 units on a scale Standard Deviation 9.76	33.69 units on a scale Standard Deviation 9.06	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=250 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=265 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=67 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=62 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12, 18 and 24	35.06 units on a scale Standard Deviation 10.00	35.88 units on a scale Standard Deviation 10.04	35.58 units on a scale Standard Deviation 10.65	37.29 units on a scale Standard Deviation 9.98

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=313 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=153 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 Month 3 (n=261,262,125)	0.60 units on a scale Standard Deviation 0.27	0.67 units on a scale Standard Deviation 0.22	0.52 units on a scale Standard Deviation 0.30	—
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 Baseline (n=313,309,153)	0.43 units on a scale Standard Deviation 0.31	0.47 units on a scale Standard Deviation 0.31	0.47 units on a scale Standard Deviation 0.30	—
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Baseline, Month 3 and 6 Month 6 (n=283,285,62)	0.62 units on a scale Standard Deviation 0.25	0.69 units on a scale Standard Deviation 0.23	0.59 units on a scale Standard Deviation 0.24	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=251 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=265 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=67 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=63 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12, 18 and 24	0.64 units on a scale Standard Deviation 0.25	0.69 units on a scale Standard Deviation 0.26	0.63 units on a scale Standard Deviation 0.30	0.74 units on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=155 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=157 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=87 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Baseline:physical demands(n=149,152,86)	50.17 units on a scale Standard Deviation 24.18	50.11 units on a scale Standard Deviation 24.19	49.96 units on a scale Standard Deviation 26.67	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Baseline:time management(n=147,146,81)	49.74 units on a scale Standard Deviation 25.59	41.93 units on a scale Standard Deviation 26.90	44.02 units on a scale Standard Deviation 28.39	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Baseline:mental demands(n=151,151,86)	33.91 units on a scale Standard Deviation 25.41	29.28 units on a scale Standard Deviation 24.47	33.13 units on a scale Standard Deviation 27.93	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Baseline:output demands(n=149,147,83)	38.81 units on a scale Standard Deviation 26.66	36.85 units on a scale Standard Deviation 25.95	40.57 units on a scale Standard Deviation 29.38	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Baseline:work loss index(n=155,157,87)	11.13 units on a scale Standard Deviation 5.71	9.98 units on a scale Standard Deviation 5.66	10.99 units on a scale Standard Deviation 6.78	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 3:time management(n=107,116,52)	45.18 units on a scale Standard Deviation 31.06	35.87 units on a scale Standard Deviation 33.78	41.11 units on a scale Standard Deviation 27.36	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 3:physical demands(n=106,124,55)	47.11 units on a scale Standard Deviation 29.37	44.06 units on a scale Standard Deviation 32.26	46.02 units on a scale Standard Deviation 25.36	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 3:mental demands(n=111,124,55	27.92 units on a scale Standard Deviation 27.18	23.52 units on a scale Standard Deviation 27.09	34.24 units on a scale Standard Deviation 27.87	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 3:output demands(n=108,119,54)	32.71 units on a scale Standard Deviation 27.67	25.48 units on a scale Standard Deviation 28.69	39.23 units on a scale Standard Deviation 28.44	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 3:work loss index(n=111,127,55)	9.77 units on a scale Standard Deviation 6.29	7.86 units on a scale Standard Deviation 6.44	10.89 units on a scale Standard Deviation 6.40	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 6:time management(n=97,116,19)	37.90 units on a scale Standard Deviation 30.57	34.33 units on a scale Standard Deviation 33.47	40.53 units on a scale Standard Deviation 32.70	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 6:physical demands(n=104,116,19)	48.00 units on a scale Standard Deviation 29.47	43.01 units on a scale Standard Deviation 34.57	43.90 units on a scale Standard Deviation 31.26	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 6:mental demands(n=103,117,18)	25.30 units on a scale Standard Deviation 29.75	21.95 units on a scale Standard Deviation 28.40	32.43 units on a scale Standard Deviation 30.69	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 6:output demands(n=101,117,18)	29.43 units on a scale Standard Deviation 29.61	24.26 units on a scale Standard Deviation 29.30	35.56 units on a scale Standard Deviation 26.78	—
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6 Month 6:work loss index(n=105,123,19)	8.78 units on a scale Standard Deviation 6.75	7.47 units on a scale Standard Deviation 6.57	10.05 units on a scale Standard Deviation 6.54	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=94 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=118 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=23 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=33 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 Month 12:physical demands(n=91,110,22,33)	45.64 units on a scale Standard Deviation 33.67	46.16 units on a scale Standard Deviation 33.53	47.01 units on a scale Standard Deviation 32.96	41.10 units on a scale Standard Deviation 35.89
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 Month 12:time management(n=92,108,22,32)	35.82 units on a scale Standard Deviation 31.75	31.30 units on a scale Standard Deviation 31.68	43.69 units on a scale Standard Deviation 32.76	37.58 units on a scale Standard Deviation 36.88
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 Month 12:mental demands(n=93,115,23,33)	21.24 units on a scale Standard Deviation 25.05	20.42 units on a scale Standard Deviation 25.99	39.29 units on a scale Standard Deviation 35.39	27.70 units on a scale Standard Deviation 33.57
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 Month 12:output demands(n=93,107,23,31)	23.71 units on a scale Standard Deviation 26.59	21.18 units on a scale Standard Deviation 26.52	37.12 units on a scale Standard Deviation 34.59	33.67 units on a scale Standard Deviation 34.78
Work Limitations Questionnaire (WLQ) Score at Month 12, 18 and 24 Month 12:work loss index(n=94,118,23,33)	7.78 units on a scale Standard Deviation 5.94	6.88 units on a scale Standard Deviation 5.98	11.33 units on a scale Standard Deviation 7.64	9.24 units on a scale Standard Deviation 7.91

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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 or housekeeper. Assessment was based on 0 to 2-point scale; higher score=higher medical cost.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=315 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=306 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=155 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Treated in emergency room(n=259,260,121)	1.95 units on a scale Standard Deviation 0.23	1.95 units on a scale Standard Deviation 0.22	1.97 units on a scale Standard Deviation 0.18	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Non-study diagnostic test(n=259,260,121)	1.86 units on a scale Standard Deviation 0.35	1.83 units on a scale Standard Deviation 0.37	1.88 units on a scale Standard Deviation 0.32	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:In nursing home(n=259,260,121)	2.00 units on a scale Standard Deviation 0.00	2.00 units on a scale Standard Deviation 0.06	2.00 units on a scale Standard Deviation 0.00	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Home healthcare services(n=257,260,121)	1.98 units on a scale Standard Deviation 0.14	2.00 units on a scale Standard Deviation 0.06	2.00 units on a scale Standard Deviation 0.00	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Required aids/devices(n=259,260,121)	1.91 units on a scale Standard Deviation 0.29	1.91 units on a scale Standard Deviation 0.29	1.89 units on a scale Standard Deviation 0.31	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Unable to work due to RA(n=148,139,67)	1.44 units on a scale Standard Deviation 0.50	1.50 units on a scale Standard Deviation 0.50	1.39 units on a scale Standard Deviation 0.49	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Lost job/retired early(n=148,139,67)	1.64 units on a scale Standard Deviation 0.48	1.63 units on a scale Standard Deviation 0.49	1.57 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Work disabled due to RA(n=150,140,68)	1.53 units on a scale Standard Deviation 0.50	1.64 units on a scale Standard Deviation 0.48	1.57 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Retired(n=150,142,70)	1.51 units on a scale Standard Deviation 0.50	1.42 units on a scale Standard Deviation 0.50	1.63 units on a scale Standard Deviation 0.49	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Sick leave due to RA(n=175,200,89)	1.89 units on a scale Standard Deviation 0.31	1.93 units on a scale Standard Deviation 0.26	1.82 units on a scale Standard Deviation 0.39	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Performed paid work(n=174,197,88)	1.70 units on a scale Standard Deviation 0.46	1.76 units on a scale Standard Deviation 0.43	1.69 units on a scale Standard Deviation 0.46	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Unable to do chores(n=257,256,121)	1.60 units on a scale Standard Deviation 0.49	1.70 units on a scale Standard Deviation 0.46	1.52 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Chores by housekeeper(n=257,259,121)	1.90 units on a scale Standard Deviation 0.30	1.92 units on a scale Standard Deviation 0.27	1.90 units on a scale Standard Deviation 0.30	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Chores by family/friends(n=257,259,121)	1.67 units on a scale Standard Deviation 0.47	1.73 units on a scale Standard Deviation 0.44	1.53 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Seen any doctor(n=282,285,61)	1.21 units on a scale Standard Deviation 0.41	1.21 units on a scale Standard Deviation 0.41	1.31 units on a scale Standard Deviation 0.47	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Treated in emergency room(n=283,285,61)	1.94 units on a scale Standard Deviation 0.23	1.96 units on a scale Standard Deviation 0.20	1.93 units on a scale Standard Deviation 0.25	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Admitted for overnight stay (n=17,12,4)	0.12 units on a scale Standard Deviation 0.33	0.00 units on a scale Standard Deviation 0.00	1.00 units on a scale Standard Deviation 0.15	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Hospitalization(n=283,285,61)	1.99 units on a scale Standard Deviation 0.10	1.99 units on a scale Standard Deviation 0.10	1.93 units on a scale Standard Deviation 0.25	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Outpatient surgery(n=283,285,61)	1.96 units on a scale Standard Deviation 0.20	1.99 units on a scale Standard Deviation 0.10	1.95 units on a scale Standard Deviation 0.22	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Non-study diagnostic test(n=282,284,61)	1.79 units on a scale Standard Deviation 0.41	1.85 units on a scale Standard Deviation 0.36	1.82 units on a scale Standard Deviation 0.39	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:In nursing home(n=283,285,61)	1.99 units on a scale Standard Deviation 0.10	2.00 units on a scale Standard Deviation 0.00	2.00 units on a scale Standard Deviation 0.00	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Home healthcare services(n=282,284,61)	1.98 units on a scale Standard Deviation 0.13	1.99 units on a scale Standard Deviation 0.08	1.98 units on a scale Standard Deviation 0.13	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Required aids/devices(n=283,285,61)	1.90 units on a scale Standard Deviation 0.30	1.94 units on a scale Standard Deviation 0.24	1.97 units on a scale Standard Deviation 0.18	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Lost job/retired early(n=173,158,38)	1.69 units on a scale Standard Deviation 0.46	1.63 units on a scale Standard Deviation 0.49	1.79 units on a scale Standard Deviation 0.41	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Performed part time work(n=193,215,37)	1.96 units on a scale Standard Deviation 0.20	1.94 units on a scale Standard Deviation 0.23	1.92 units on a scale Standard Deviation 0.28	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Performed paid work(n=193,216,37)	1.76 units on a scale Standard Deviation 0.43	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, Month 3 and 6 Month 6:Chores by family/friends(n=281,285,61)	1.70 units on a scale Standard Deviation 0.46	1.76 units on a scale Standard Deviation 0.42	1.75 units on a scale Standard Deviation 0.43	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Hospitalization(n=259,260,121)	1.97 units on a scale Standard Deviation 0.18	1.98 units on a scale Standard Deviation 0.12	1.99 units on a scale Standard Deviation 0.09	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Outpatient surgery(n=259,260,121)	1.97 units on a scale Standard Deviation 0.17	1.98 units on a scale Standard Deviation 0.12	1.99 units on a scale Standard Deviation 0.09	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Non-medical practitioner(n=259,260,121)	1.98 units on a scale Standard Deviation 0.14	1.97 units on a scale Standard Deviation 0.17	1.98 units on a scale Standard Deviation 0.16	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline: Seen any doctor (n=315, 305, 154)	1.14 units on a scale Standard Deviation 0.34	1.15 units on a scale Standard Deviation 0.36	1.16 units on a scale Standard Deviation 0.36	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Treated in emergency room(n=315,306,155)	1.93 units on a scale Standard Deviation 0.26	1.96 units on a scale Standard Deviation 0.19	1.94 units on a scale Standard Deviation 0.23	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Admitted for overnight stay (n=22,12,9)	0.27 units on a scale Standard Deviation 0.63	0.25 units on a scale Standard Deviation 0.45	0.00 units on a scale Standard Deviation 0.00	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Hospitalization(n=315,306,155)	1.94 units on a scale Standard Deviation 0.23	1.94 units on a scale Standard Deviation 0.24	1.97 units on a scale Standard Deviation 0.18	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Outpatient surgery(n=315,305,155)	1.97 units on a scale Standard Deviation 0.16	1.96 units on a scale Standard Deviation 0.20	1.97 units on a scale Standard Deviation 0.18	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Non-study diagnostic test(n=315,306,155)	1.82 units on a scale Standard Deviation 0.39	1.83 units on a scale Standard Deviation 0.37	1.85 units on a scale Standard Deviation 0.36	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:In nursing home(n=315,306,155)	1.99 units on a scale Standard Deviation 0.10	1.99 units on a scale Standard Deviation 0.10	1.99 units on a scale Standard Deviation 0.11	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Home healthcare services(n=315,306,154)	1.97 units on a scale Standard Deviation 0.16	1.99 units on a scale Standard Deviation 0.10	1.98 units on a scale Standard Deviation 0.14	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Required aids/devices(n=315,306,155)	1.87 units on a scale Standard Deviation 0.34	1.91 units on a scale Standard Deviation 0.29	1.90 units on a scale Standard Deviation 0.30	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Non-medical practitioner(n=315,306,155)	1.97 units on a scale Standard Deviation 0.18	1.94 units on a scale Standard Deviation 0.23	1.95 units on a scale Standard Deviation 0.21	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Currently employed(n=314,306,155)	1.65 units on a scale Standard Deviation 0.48	1.60 units on a scale Standard Deviation 0.49	1.62 units on a scale Standard Deviation 0.49	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Feel well enough to work(n=182,166,89)	1.87 units on a scale Standard Deviation 0.33	1.86 units on a scale Standard Deviation 0.35	1.82 units on a scale Standard Deviation 0.39	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Unable to work due to RA(n=185,169,88)	1.37 units on a scale Standard Deviation 0.48	1.37 units on a scale Standard Deviation 0.48	1.32 units on a scale Standard Deviation 0.47	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Lost job/retired early(n=184,169,86)	1.61 units on a scale Standard Deviation 0.49	1.61 units on a scale Standard Deviation 0.49	1.67 units on a scale Standard Deviation 0.47	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Work disabled due to RA(n=186,168,88)	1.52 units on a scale Standard Deviation 0.50	1.61 units on a scale Standard Deviation 0.49	1.52 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Retired(n=193,171,92)	1.51 units on a scale Standard Deviation 0.50	1.51 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, Month 3 and 6 Baseline:Sick leave due to RA(n=236,236,123)	1.83 units on a scale Standard Deviation 0.38	1.81 units on a scale Standard Deviation 0.39	1.76 units on a scale Standard Deviation 0.43	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Performed part time work(n=235,236,121)	1.87 units on a scale Standard Deviation 0.34	1.87 units on a scale Standard Deviation 0.33	1.90 units on a scale Standard Deviation 0.30	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Performed paid work(n=235,235,122)	1.60 units on a scale Standard Deviation 0.49	1.62 units on a scale Standard Deviation 0.49	1.61 units on a scale Standard Deviation 0.49	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Unable to do chores(n=312,302,152)	1.38 units on a scale Standard Deviation 0.48	1.43 units on a scale Standard Deviation 0.50	1.43 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Chores by housekeeper(n=315,305,155)	1.83 units on a scale Standard Deviation 0.37	1.85 units on a scale Standard Deviation 0.36	1.90 units on a scale Standard Deviation 0.30	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Baseline:Chores by family/friends(n=315,305,155)	1.49 units on a scale Standard Deviation 0.50	1.50 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, Month 3 and 6 Month 3:Seen any doctor(n=259,260,121)	1.31 units on a scale Standard Deviation 0.46	1.31 units on a scale Standard Deviation 0.46	1.28 units on a scale Standard Deviation 0.45	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Admitted for overnight stay (n=14,12,4)	0.64 units on a scale Standard Deviation 0.84	0.08 units on a scale Standard Deviation 0.29	0.00 units on a scale Standard Deviation 0.00	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Currently employed(n=259,260,121)	1.63 units on a scale Standard Deviation 0.48	1.57 units on a scale Standard Deviation 0.50	1.60 units on a scale Standard Deviation 0.49	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Non-medical practitioner(n=283,285,61)	1.98 units on a scale Standard Deviation 0.14	1.97 units on a scale Standard Deviation 0.17	1.97 units on a scale Standard Deviation 0.18	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Currently employed(n=283,285,61)	1.65 units on a scale Standard Deviation 0.48	1.59 units on a scale Standard Deviation 0.49	1.70 units on a scale Standard Deviation 0.46	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Feel well enough to work(n=176,154,38)	1.77 units on a scale Standard Deviation 0.42	1.73 units on a scale Standard Deviation 0.44	1.79 units on a scale Standard Deviation 0.41	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Unable to work due to RA(n=177,155,40)	1.47 units on a scale Standard Deviation 0.50	1.55 units on a scale Standard Deviation 0.50	1.43 units on a scale Standard Deviation 0.50	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Work disabled due to RA(n=174,154,38)	1.52 units on a scale Standard Deviation 0.50	1.66 units on a scale Standard Deviation 0.48	1.66 units on a scale Standard Deviation 0.48	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Retired(n=178,157,41)	1.49 units on a scale Standard Deviation 0.50	1.48 units on a scale Standard Deviation 0.50	1.61 units on a scale Standard Deviation 0.49	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Sick leave due to RA(n=195,216,37)	1.92 units on a scale Standard Deviation 0.27	1.95 units on a scale Standard Deviation 0.22	1.89 units on a scale Standard Deviation 0.31	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Unable to do chores(n=281,284,61)	1.63 units on a scale Standard Deviation 0.48	1.80 units on a scale Standard Deviation 0.40	1.64 units on a scale Standard Deviation 0.48	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 6:Chores by housekeeper(n=281,285,61)	1.89 units on a scale Standard Deviation 0.31	1.92 units on a scale Standard Deviation 0.28	1.90 units on a scale Standard Deviation 0.30	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Feel well enough to work(n=147,140,68)	1.78 units on a scale Standard Deviation 0.41	1.73 units on a scale Standard Deviation 0.45	1.82 units on a scale Standard Deviation 0.38	—
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6 Month 3:Performed part time work(n=176,196,89)	1.91 units on a scale Standard Deviation 0.29	1.94 units on a scale Standard Deviation 0.24	1.87 units on a scale Standard Deviation 0.34	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.

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

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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 events including visits to doctor, non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=273 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=262 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=132 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related ER visit(n=23,12,9)	0.74 events Standard Deviation 0.81	0.83 events Standard Deviation 1.34	0.56 events Standard Deviation 0.73	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Doctor visit(n=273,262,132)	3.78 events Standard Deviation 4.24	4.00 events Standard Deviation 5.07	4.80 events Standard Deviation 5.61	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related doctor visit(n=271,262,131)	1.16 events Standard Deviation 0.70	1.20 events Standard Deviation 0.80	1.25 events Standard Deviation 0.67	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Hospital ER visit(n=19,11,9)	1.42 events Standard Deviation 0.77	1.73 events Standard Deviation 1.27	1.22 events Standard Deviation 0.67	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Hospitalization(n=18,18,5)	1.17 events Standard Deviation 0.51	1.17 events Standard Deviation 0.38	1.00 events Standard Deviation 0.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related hospitalization(n=18,19,5)	1.11 events Standard Deviation 0.58	1.32 events Standard Deviation 1.34	1.40 events Standard Deviation 0.55	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Outpatient surgery(n=8,13,5)	1.13 events Standard Deviation 0.35	1.85 events Standard Deviation 2.76	1.00 events Standard Deviation 0.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related outpatient surgery(n=8,14,5)	0.38 events Standard Deviation 0.52	0.43 events Standard Deviation 0.85	0.40 events Standard Deviation 0.55	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Non-study diagnostic test(n=56,51,22)	1.80 events Standard Deviation 1.18	1.67 events Standard Deviation 1.16	1.73 events Standard Deviation 1.12	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related diagnostic test(n=57,53,23)	0.74 events Standard Deviation 1.09	0.77 events Standard Deviation 1.19	0.83 events Standard Deviation 1.15	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Non-medical practitioner visit(n=10,17,7)	12.50 events Standard Deviation 12.29	10.88 events Standard Deviation 13.09	12.57 events Standard Deviation 13.23	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related non-medical visit(n=11,18,7)	1.00 events Standard Deviation 0.77	1.00 events Standard Deviation 0.84	1.57 events Standard Deviation 1.27	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Doctor visit(n=181,181,89)	2.85 events Standard Deviation 1.79	3.08 events Standard Deviation 2.76	3.27 events Standard Deviation 3.73	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related doctor visit(n=181,180,89)	0.92 events Standard Deviation 0.63	0.79 events Standard Deviation 0.54	0.87 events Standard Deviation 0.61	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Hospital ER visit(n=14,11,4)	1.29 events Standard Deviation 0.61	1.45 events Standard Deviation 0.93	1.00 events Standard Deviation 0.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related ER visit(n=14,13,4)	0.29 events Standard Deviation 0.73	0.15 events Standard Deviation 0.55	0.00 events Standard Deviation 0.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Hospitalization(n=9,4,1)	1.00 events Standard Deviation 0.00	1.25 events Standard Deviation 0.50	2.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related hospitalization(n=9,4,1)	0.11 events Standard Deviation 0.33	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Outpatient surgery(n=8,5,1)	1.25 events Standard Deviation 0.46	1.20 events Standard Deviation 0.45	1.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related outpatient surgery(n=8,5,1)	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Non-study diagnostic test(n=32,43,13)	1.41 events Standard Deviation 0.71	1.56 events Standard Deviation 1.35	1.46 events Standard Deviation 0.97	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related diagnostic test(n=37,44,14)	0.14 events Standard Deviation 0.35	0.07 events Standard Deviation 0.25	0.14 events Standard Deviation 0.36	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Non-medical practitioner visit(n=4,8,3)	7.50 events Standard Deviation 11.03	3.63 events Standard Deviation 1.51	22.33 events Standard Deviation 11.24	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related non-medical visit(n=4,8,3)	0.50 events Standard Deviation 1.00	0.38 events Standard Deviation 0.52	0.67 events Standard Deviation 0.58	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Doctor visit(n=226,225,43)	3.00 events Standard Deviation 2.89	2.72 events Standard Deviation 2.28	4.51 events Standard Deviation 6.05	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:RA related doctor visit(n=225,224,43)	0.87 events Standard Deviation 0.56	0.86 events Standard Deviation 0.56	0.91 events Standard Deviation 0.61	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Hospital ER visit(n=15,12,4)	1.27 events Standard Deviation 0.59	1.33 events Standard Deviation 0.49	2.25 events Standard Deviation 2.50	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:RA related ER visit(n=16,12,4)	0.25 events Standard Deviation 0.58	0.33 events Standard Deviation 0.78	0.50 events Standard Deviation 1.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Hospitalization(n=3,3,4)	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation 0.00	1.25 events Standard Deviation 0.50	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Non-study diagnostic test(n=58,41,11)	1.78 events Standard Deviation 1.83	1.73 events Standard Deviation 1.40	2.00 events Standard Deviation 1.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:RA related diagnostic test(n=60,44,11)	0.25 events Standard Deviation 0.68	0.25 events Standard Deviation 0.69	0.09 events Standard Deviation 0.30	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Non-medical practitioner visit(n=6,8,2)	15.00 events Standard Deviation 17.34	6.13 events Standard Deviation 4.55	25.00 events Standard Deviation 7.07	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:RA related non-medical visit(n=6,8,3)	1.50 events Standard Deviation 1.52	0.25 events Standard Deviation 0.46	1.67 events Standard Deviation 0.58	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:RA related hospitalization(n=3,3,4)	0.33 events Standard Deviation 0.58	0.33 events Standard Deviation 0.58	0.50 events Standard Deviation 1.00	—
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Outpatient surgery(n=12,2,3)	1.33 events Standard Deviation 0.89	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, Month 3 and 6 Month 6:RA related outpatient surgery(n=12,3,3)	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Population: FAS. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=197 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=221 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=52 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Doctor visit(n=197,221,56,52)	2.70 events Standard Deviation 2.74	2.43 events Standard Deviation 2.26	3.27 events Standard Deviation 4.02	2.81 events Standard Deviation 3.91
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:RA related doctor visit (n=197,220,56,52)	0.92 events Standard Deviation 0.52	0.89 events Standard Deviation 0.43	0.93 events Standard Deviation 0.60	0.88 events Standard Deviation 0.47
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Hospital ER visit(n=18,11,4,3)	1.61 events Standard Deviation 1.58	1.00 events Standard Deviation 0.00	1.25 events Standard Deviation 0.50	1.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:RA related ER visit(n=18,11,4,3)	0.11 events Standard Deviation 0.32	0.09 events Standard Deviation 0.30	0.25 events Standard Deviation 0.50	0.00 events Standard Deviation 0.00
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:RA related outpatient surgery(n=13,4,1,1)	0.46 events Standard Deviation 0.66	0.25 events Standard Deviation 0.50	2.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	0.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Non-study diagnostic test(n=50,47,9,8)	1.98 events Standard Deviation 1.49	1.55 events Standard Deviation 1.14	2.00 events Standard Deviation 1.00	1.88 events Standard Deviation 0.83
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:RA related diagnostic test(n=52,50,9,9)	0.27 events Standard Deviation 0.56	0.24 events Standard Deviation 0.48	0.22 events Standard Deviation 0.67	0.11 events Standard Deviation 0.33
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Non-medical practitioner visit(n=4,6,4,1)	12.00 events Standard Deviation 5.86	9.83 events Standard Deviation 15.03	10.00 events Standard Deviation 7.12	9.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:RA related non-medical visit(n=4,6,4,1)	1.25 events Standard Deviation 0.96	0.17 events Standard Deviation 0.41	0.75 events Standard Deviation 0.96	0.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Hospitalization(n=8,4,2,1)	1.00 events Standard Deviation 0.00	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 12, 18 and 24 Month 12:RA related hospitalization(n=8,4,2,1)	0.50 events Standard Deviation 0.76	0.50 events Standard Deviation 0.58	0.00 events Standard Deviation 0.00	0.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Outpatient surgery(n=13,4,1,1)	2.31 events Standard Deviation 2.39	1.00 events Standard Deviation 0.00	1.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	2.00 events Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=158 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=152 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=73 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Days of work per week(n=109,121,59)	5.01 days Standard Deviation 1.14	5.14 days Standard Deviation 0.92	4.93 days Standard Deviation 1.39	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Days on sick leave due to RA(n=41,44,29)	13.17 days Standard Deviation 21.61	16.84 days Standard Deviation 27.67	15.45 days Standard Deviation 25.69	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Days of part time work(n=30,29,12)	9.07 days Standard Deviation 12.62	12.07 days Standard Deviation 16.50	26.92 days Standard Deviation 32.20	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Paid work, bothered by RA(n=92,88,48)	29.13 days Standard Deviation 30.81	31.59 days Standard Deviation 30.12	31.90 days Standard Deviation 31.61	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Chores by housekeeper(n=50,44,15)	19.06 days Standard Deviation 23.91	20.89 days Standard Deviation 33.69	17.87 days Standard Deviation 18.71	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Chores by family(n=158,152,73)	36.28 days Standard Deviation 34.40	30.39 days Standard Deviation 34.00	37.11 days Standard Deviation 34.99	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Days aids/devices used(n=23,22,13)	107.22 days Standard Deviation 102.77	69.36 days Standard Deviation 60.36	85.00 days Standard Deviation 57.64	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related aids used(n=23,24,14)	1.78 days Standard Deviation 1.04	1.21 days Standard Deviation 0.51	1.21 days Standard Deviation 0.70	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Days of work per week(n=97,113,48)	5.03 days Standard Deviation 1.03	5.25 days Standard Deviation 0.92	4.88 days Standard Deviation 1.21	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Days on sick leave due to RA(n=19,15,16)	12.16 days Standard Deviation 20.51	8.20 days Standard Deviation 19.95	11.13 days Standard Deviation 21.56	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Chores by housekeeper(n=25,21,12)	17.00 days Standard Deviation 20.88	6.05 days Standard Deviation 33.69	21.75 days Standard Deviation 18.71	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Chores by family(n=84,70,57)	31.37 days Standard Deviation 34.32	21.46 days Standard Deviation 29.48	27.53 days Standard Deviation 33.51	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Days aids/devices used(n=27,17,2)	93.44 days Standard Deviation 104.39	87.12 days Standard Deviation 61.54	110.00 days Standard Deviation 98.99	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:RA related aids used(n=28,18,2)	1.36 days Standard Deviation 1.06	1.56 days Standard Deviation 1.20	2.00 days Standard Deviation 0.00	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Days of work per week(n=98,117,18)	5.02 days Standard Deviation 1.16	5.29 days Standard Deviation 0.78	4.94 days Standard Deviation 1.00	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Days on sick leave due to RA(n=15,11,4)	14.93 days Standard Deviation 24.05	14.18 days Standard Deviation 25.86	24.25 days Standard Deviation 43.84	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Days of part time work(n=8,12,3)	11.88 days Standard Deviation 14.99	11.33 days Standard Deviation 11.44	4.33 days Standard Deviation 1.15	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Paid work, bothered by RA(n=46,52,13)	18.87 days Standard Deviation 25.75	18.67 days Standard Deviation 19.85	12.85 days Standard Deviation 15.66	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Chores by housekeeper(n=30,24,6)	15.90 days Standard Deviation 22.43	18.08 days Standard Deviation 26.29	44.00 days Standard Deviation 40.99	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Chores by family(n=85,66,15)	29.41 days Standard Deviation 33.22	29.65 days Standard Deviation 33.02	34.87 days Standard Deviation 40.65	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Hospital length of stay(n=18,18,5)	10.94 days Standard Deviation 9.12	20.22 days Standard Deviation 19.70	22.20 days Standard Deviation 15.37	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Days in nursing home(n=3,3,2)	14.33 days Standard Deviation 12.10	17.67 days Standard Deviation 3.51	15.50 days Standard Deviation 7.78	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:Days aids/devices used(n=41,25,14)	109.63 days Standard Deviation 108.88	74.08 days Standard Deviation 66.11	102.21 days Standard Deviation 75.87	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related aids used(n=42,29,14)	1.93 days Standard Deviation 1.24	1.59 days Standard Deviation 1.02	1.64 days Standard Deviation 0.50	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Hospital length of stay(n=9,4,1)	5.67 days Standard Deviation 4.95	16.25 days Standard Deviation 26.51	32.00 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, Month 3 and 6 Month 3:Days in nursing home(n=0,1,0)	NA days Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	28.00 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.	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Days of part time work(n=16,12,12)	9.44 days Standard Deviation 11.51	9.42 days Standard Deviation 13.17	15.67 days Standard Deviation 26.60	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3:Paid work, bothered by RA(n=52,48,27)	20.60 days Standard Deviation 27.99	17.42 days Standard Deviation 21.52	34.59 days Standard Deviation 33.28	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Hospital length of stay(n=3,3,4)	12.67 days Standard Deviation 9.07	8.33 days Standard Deviation 6.66	9.25 days Standard Deviation 2.50	—
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6:Days in nursing home(n=3,0,0)	24.00 days Standard Deviation 3.61	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.	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=94 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=114 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=23 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=31 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Days aids/devices used(n=25,14,4,1)	85.68 days Standard Deviation 95.83	138.21 days Standard Deviation 110.42	100.50 days Standard Deviation 57.63	180.00 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 12, 18 and 24 Month 12:Paid work, bothered by RA(n=38,38,10,12)	20.89 days Standard Deviation 24.78	18.58 days Standard Deviation 24.28	23.80 days Standard Deviation 28.35	28.17 days Standard Deviation 35.51
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Chores by housekeeper(n=18,18,4,0)	14.06 days Standard Deviation 20.23	10.11 days Standard Deviation 11.20	24.50 days Standard Deviation 43.68	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 12, 18 and 24 Month 12:Chores by family(n=62,56,16,13)	30.15 days Standard Deviation 33.03	23.77 days Standard Deviation 31.80	38.38 days Standard Deviation 39.32	16.77 days Standard Deviation 24.59
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Hospital length of stay(n=8,4,2,1)	10.13 days Standard Deviation 6.58	7.00 days Standard Deviation 5.35	2.50 days Standard Deviation 2.12	3.00 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 12, 18 and 24 Month 12:Days in nursing home(n=2,0,0,0)	11.50 days Standard Deviation 2.12	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.	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 12, 18 and 24 Month 12:RA related aids used(n=26,16,4,1)	1.62 days Standard Deviation 1.06	1.94 days Standard Deviation 1.69	1.00 days Standard Deviation 0.82	2.00 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 12, 18 and 24 Month 12:Days of work per week(n=94,114,23,31)	5.01 days Standard Deviation 1.15	5.20 days Standard Deviation 0.75	4.65 days Standard Deviation 1.15	4.87 days Standard Deviation 1.26
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Days on sick leave due to RA(n=11,15,1,5)	32.27 days Standard Deviation 39.24	5.13 days Standard Deviation 4.42	1.00 days Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	5.60 days Standard Deviation 4.51
Number of Days as Assessed Using RA-HCRU at Month 12, 18 and 24 Month 12:Days of part time work(n=3,7,0,3)	16.33 days Standard Deviation 17.90	15.57 days Standard Deviation 21.19	NA days Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	31.67 days Standard Deviation 51.39

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=158 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=152 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=71 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Baseline:Chores by family(n=158,152,71)	3.95 hours per day Standard Deviation 4.33	3.66 hours per day Standard Deviation 3.87	3.49 hours per day Standard Deviation 4.16	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Baseline:Chores by housekeeper(n=51,44,14)	4.27 hours per day Standard Deviation 2.19	4.98 hours per day Standard Deviation 2.76	4.21 hours per day Standard Deviation 2.22	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Baseline:Home healthcare services(n=6,2,3)	1.50 hours per day Standard Deviation 0.84	3.00 hours per day Standard Deviation 1.41	1.33 hours per day Standard Deviation 0.58	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Baseline:RA related home HC services(n=8,4,3)	1.00 hours per day Standard Deviation 0.76	1.50 hours per day Standard Deviation 1.00	0.67 hours per day Standard Deviation 1.15	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Baseline:Work done(n=108,121,59)	8.01 hours per day Standard Deviation 4.05	8.22 hours per day Standard Deviation 4.41	8.12 hours per day Standard Deviation 5.25	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Baseline:Missed work due to RA(n=30,30,12)	7.03 hours per day Standard Deviation 9.98	5.33 hours per day Standard Deviation 4.47	4.33 hours per day Standard Deviation 6.29	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 3:Home healthcare services(n=5,1,0)	1.20 hours per day Standard Deviation 0.45	4.00 hours per day Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 3:RA related home HC services(n=5,1,0)	0.80 hours per day Standard Deviation 0.84	3.00 hours per day Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 3:Work done(n=97,113,48)	7.71 hours per day Standard Deviation 4.83	8.25 hours per day Standard Deviation 3.60	7.42 hours per day Standard Deviation 2.47	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 3:Missed work due to RA(n=16,12,12)	9.94 hours per day Standard Deviation 16.85	3.17 hours per day Standard Deviation 2.92	5.42 hours per day Standard Deviation 6.16	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 3:Chores by housekeeper(n=25,21,12)	4.84 hours per day Standard Deviation 4.59	4.48 hours per day Standard Deviation 2.18	4.83 hours per day Standard Deviation 2.62	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 3:Chores by family(n=83,70,56)	4.31 hours per day Standard Deviation 9.29	3.64 hours per day Standard Deviation 4.73	4.04 hours per day Standard Deviation 4.45	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 6:Home healthcare services(n=5,2,1)	2.20 hours per day Standard Deviation 2.17	3.00 hours per day Standard Deviation 2.83	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, Month 3 and 6 Month 6:RA related home HC services(n=5,2,1)	1.20 hours per day Standard Deviation 0.84	1.50 hours per day Standard Deviation 2.12	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, Month 3 and 6 Month 6:Work done(n=98,117,18)	8.15 hours per day Standard Deviation 4.15	7.90 hours per day Standard Deviation 1.85	7.56 hours per day Standard Deviation 3.05	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 6:Missed work due to RA(n=8,12,3)	2.38 hours per day Standard Deviation 1.60	2.50 hours per day Standard Deviation 1.62	1.00 hours per day Standard Deviation 1.73	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 6:Chores by housekeeper(n=30,23,6)	4.97 hours per day Standard Deviation 3.00	4.87 hours per day Standard Deviation 2.32	2.67 hours per day Standard Deviation 1.21	—
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6 Month 6:Chores by family(n=83,67,15)	3.13 hours per day Standard Deviation 2.39	3.25 hours per day Standard Deviation 4.09	2.93 hours per day Standard Deviation 1.79	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=95 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=114 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=23 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=31 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 Month 12:Home healthcare services(n=2,1,0,0)	20.50 hours per day Standard Deviation 27.58	4.00 hours per day Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 Month 12:RA related home HC services(n=2,1,0,0)	0.50 hours per day Standard Deviation 0.71	3.00 hours per day Standard Deviation NA Standard deviation was not estimable as only 1 participant was evaluable.	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 Month 12:Work done(n=95,114,23,31)	7.78 hours per day Standard Deviation 3.81	7.92 hours per day Standard Deviation 1.88	7.48 hours per day Standard Deviation 2.02	8.03 hours per day Standard Deviation 2.09
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 Month 12:Missed work due to RA(n=3,7,0,3)	1.33 hours per day Standard Deviation 1.15	8.71 hours per day Standard Deviation 12.42	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.	2.67 hours per day Standard Deviation 1.53
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 Month 12:Chores by housekeeper(n=17,17,4,0)	4.47 hours per day Standard Deviation 2.27	4.53 hours per day Standard Deviation 1.70	5.25 hours per day Standard Deviation 3.40	NA hours per day Standard Deviation NA Data was not analyzed as no participant was evaluable for this parameter.
Number of Hours Per Day as Assessed RA-HCRU at Month 12, 18 and 24 Month 12:Chores by family(n=62,56,16,13)	3.31 hours per day Standard Deviation 2.36	3.20 hours per day Standard Deviation 2.16	3.75 hours per day Standard Deviation 2.38	2.31 hours per day Standard Deviation 0.95

SECONDARY outcome

Timeframe: Baseline, Month 1, 3, 6

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points 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

Outcome measures
Measure	CP-690,550 5 mg n=204 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=202 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=104 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Baseline (n=204,202,104)	5.29 units on a scale Standard Deviation 3.09	4.88 units on a scale Standard Deviation 3.03	4.68 units on a scale Standard Deviation 3.03	—
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 3 (n=151,176,81)	3.81 units on a scale Standard Deviation 3.11	3.11 units on a scale Standard Deviation 2.67	4.40 units on a scale Standard Deviation 2.87	—
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6 Month 6 (n=160,185,29)	3.73 units on a scale Standard Deviation 3.18	2.99 units on a scale Standard Deviation 2.94	3.41 units on a scale Standard Deviation 2.85	—

SECONDARY outcome

Timeframe: Month 12, 18, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data for time points after Month 12 shall be reported after completion of the end-of-study analysis.

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

Outcome measures
Measure	CP-690,550 5 mg n=144 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=163 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=39 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=44 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12, 18 and 24	3.19 units on a scale Standard Deviation 3.13	2.66 units on a scale Standard Deviation 2.80	2.51 units on a scale Standard Deviation 2.54	2.66 units on a scale Standard Deviation 2.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Month 12, Month 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response 5 consecutive visits	18.7 percentage of participants	33.7 percentage of participants	7.6 percentage of participants	3.9 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response 2 consecutive visits	16.8 percentage of participants	13.9 percentage of participants	21.5 percentage of participants	16.9 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response 3 consecutive visits	13.0 percentage of participants	14.2 percentage of participants	27.8 percentage of participants	28.6 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 20% (ACR20) Response 4 consecutive visits	16.5 percentage of participants	16.2 percentage of participants	11.4 percentage of participants	10.4 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Month 12, Month 24

Population: FAS population: all randomized participants who received at least 1 dose of study medication. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.

ACR50 response: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP. Participants with sustained ACR50 response for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=77 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response 2 consecutive visits	12.0 percentage of participants	16.5 percentage of participants	21.5 percentage of participants	19.5 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response 3 consecutive visits	7.9 percentage of participants	11.3 percentage of participants	13.9 percentage of participants	13.0 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response 4 consecutive visits	8.2 percentage of participants	12.3 percentage of participants	0.0 percentage of participants	2.6 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 50% (ACR50) Response 5 consecutive visits	7.3 percentage of participants	9.4 percentage of participants	1.3 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Month 12, Month 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=77 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response 2 consecutive visits	6.6 percentage of participants	10.4 percentage of participants	8.9 percentage of participants	18.2 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response 3 consecutive visits	4.1 percentage of participants	6.8 percentage of participants	5.1 percentage of participants	2.6 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response 4 consecutive visits	2.8 percentage of participants	7.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Sustained American College of Rheumatology 70% (ACR70) Response 5 consecutive visits	1.3 percentage of participants	2.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Month 12, Month 24

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. Participants with sustained DAS28-3 (CRP) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 2 consecutive visits	13.0 percentage of participants	12.6 percentage of participants	19.0 percentage of participants	18.2 percentage of participants
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 3 consecutive visits	7.9 percentage of participants	11.7 percentage of participants	5.1 percentage of participants	7.8 percentage of participants
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 4 consecutive visits	5.7 percentage of participants	13.3 percentage of participants	3.8 percentage of participants	0.0 percentage of participants
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 5 consecutive visits	2.2 percentage of participants	3.2 percentage of participants	1.3 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline through Month 12, Month 24

Population: FAS population. Data up to Month 12 reported. For time period after Month 12, data will be reported after completion of the end-of-study analysis.

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. Participants with sustained DAS28-4 (ESR) response less than 2.6 for 2, 3, 4 and 5 consecutive visits were analyzed up to Month 12.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=77 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 2 consecutive visits	4.4 percentage of participants	5.5 percentage of participants	3.8 percentage of participants	7.8 percentage of participants
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 3 consecutive visits	1.0 percentage of participants	3.6 percentage of participants	1.3 percentage of participants	1.3 percentage of participants
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 4 consecutive visits	1.9 percentage of participants	3.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With Sustained Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 5 consecutive visits	0.0 percentage of participants	1.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 1, 3, 6

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joint count, ESR (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) =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=257 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=129 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 Month 1	6.98 percentage of participants	10.40 percentage of participants	3.15 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 Month 3	13.96 percentage of participants	25.29 percentage of participants	3.88 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 1, 3 and 6 Month 6	14.34 percentage of participants	28.40 percentage of participants	3.10 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=257 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=65 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=64 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 Month 9	18.87 percentage of participants	33.46 percentage of participants	10.77 percentage of participants	12.50 percentage of participants
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 Month 12	21.13 percentage of participants	28.79 percentage of participants	9.23 percentage of participants	17.19 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 1, 3, 6

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=257 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=129 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6 Month 1	1.55 percentage of participants	2.80 percentage of participants	0.00 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6 Month 3	5.28 percentage of participants	11.28 percentage of participants	1.55 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 1, 3 and 6 Month 6	7.17 percentage of participants	15.95 percentage of participants	1.55 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=265 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=257 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=65 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=64 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 Month 9	10.57 percentage of participants	14.01 percentage of participants	4.62 percentage of participants	3.13 percentage of participants
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 Month 12	9.81 percentage of participants	14.40 percentage of participants	3.08 percentage of participants	7.81 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 1, 3, 6

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=308 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 Month 1	23.62 percentage of participants	31.49 percentage of participants	6.58 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 Month 3	35.28 percentage of participants	44.48 percentage of participants	11.69 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 1, 3 and 6 Month 6	37.86 percentage of participants	50.97 percentage of participants	10.39 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=308 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 Month 9	38.51 percentage of participants	52.27 percentage of participants	25.32 percentage of participants	24.00 percentage of participants
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than or Equal to 3.2 at Month 9, 12, 15, 18, 21 and 24 Month 12	40.13 percentage of participants	51.95 percentage of participants	24.05 percentage of participants	24.00 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 1, 3, 6

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=308 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=154 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 Month 1	11.33 percentage of participants	9.09 percentage of participants	1.97 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 Month 3	20.39 percentage of participants	26.95 percentage of participants	5.19 percentage of participants	—
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 1, 3 and 6 Month 6	22.98 percentage of participants	36.36 percentage of participants	5.19 percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 9, 12, 15, 18, 21, 24

Population: FAS population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Missing values due to withdrawal or advancement to active treatment before Month 6 were imputed using NRI method. Data for time points after Month 12 will be reported after completion of the end-of-study analysis.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=309 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=308 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=75 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 Month 9	26.86 percentage of participants	38.31 percentage of participants	22.78 percentage of participants	14.67 percentage of participants
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Less Than 2.6 at Month 9, 12, 15, 18, 21 and 24 Month 12	28.80 percentage of participants	39.61 percentage of participants	17.72 percentage of participants	18.67 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 24

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 1, 3, 6

Population: Safety analysis set: all randomized participants who received at least 1 dose of study medication. 'N' (number of participants analyzed)=participants evaluable for the measure. 'n'=participants evaluable at given time points for each group respectively. Data for time points after Month 12 will be reported after completion of end-of-study analysis.

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=156 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Baseline:systolic BP(n=316,309,156)	125.85 millimeters of mercury (mmHg) Standard Deviation 13.23	123.95 millimeters of mercury (mmHg) Standard Deviation 15.05	123.87 millimeters of mercury (mmHg) Standard Deviation 14.32	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Baseline:diastolic BP(n=316,309,156)	77.27 millimeters of mercury (mmHg) Standard Deviation 8.41	77.25 millimeters of mercury (mmHg) Standard Deviation 9.34	76.81 millimeters of mercury (mmHg) Standard Deviation 8.70	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Change at Month 1:systolic BP(n=309,308,153)	-1.6 millimeters of mercury (mmHg) Standard Deviation 11.87	0.5 millimeters of mercury (mmHg) Standard Deviation 12.40	0.5 millimeters of mercury (mmHg) Standard Deviation 11.96	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Change at Month 1:diastolic BP(n=309,308,153)	-0.1 millimeters of mercury (mmHg) Standard Deviation 8.06	0.1 millimeters of mercury (mmHg) Standard Deviation 7.99	0.5 millimeters of mercury (mmHg) Standard Deviation 7.19	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Change at Month 3:systolic BP(n=295,299,146)	-1.2 millimeters of mercury (mmHg) Standard Deviation 12.33	0.6 millimeters of mercury (mmHg) Standard Deviation 13.55	0.7 millimeters of mercury (mmHg) Standard Deviation 11.75	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Change at Month 3:diastolic BP(n=295,299,146)	1.0 millimeters of mercury (mmHg) Standard Deviation 8.76	0.5 millimeters of mercury (mmHg) Standard Deviation 8.61	-0.0 millimeters of mercury (mmHg) Standard Deviation 8.63	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Change at Month 6:systolic BP(n=283,285,62)	-0.5 millimeters of mercury (mmHg) Standard Deviation 13.57	1.1 millimeters of mercury (mmHg) Standard Deviation 13.15	-0.6 millimeters of mercury (mmHg) Standard Deviation 11.63	—
Change From Baseline in Blood Pressure (BP) at Month 1, 3 and 6 Change at Month 6:diastolic BP(n=283,285,62)	0.2 millimeters of mercury (mmHg) Standard Deviation 8.63	0.8 millimeters of mercury (mmHg) Standard Deviation 8.45	-0.4 millimeters of mercury (mmHg) Standard Deviation 7.74	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 9, 12, 15, 18, 21, 24

Outcome measures

Outcome measures
Measure	CP-690,550 5 mg n=316 Participants CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.	CP-690,550 10 mg n=309 Participants CP-690,550 10 mg tablet orally twice daily up to Month 24.	Placebo n=79 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.	Placebo, Then CP-690,550 10 mg n=77 Participants Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 Baseline:systolic BP(n=316,309,79,77)	125.83 mmHg Standard Deviation 13.23	123.95 mmHg Standard Deviation 15.05	124.37 mmHg Standard Deviation 14.78	123.35 mmHg Standard Deviation 13.90
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 Baseline:diastolic BP(n=316,309,79,77)	77.27 mmHg Standard Deviation 8.41	77.25 mmHg Standard Deviation 9.34	77.11 mmHg Standard Deviation 8.62	76.51 mmHg Standard Deviation 8.81
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 Change at Month 9:systolic BP(n=265,278,69,63)	-0.4 mmHg Standard Deviation 13.51	1.8 mmHg Standard Deviation 14.21	-1.1 mmHg Standard Deviation 12.44	0.3 mmHg Standard Deviation 13.09
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 Change at Month 9:diastolic BP(n=265,278,69,63)	0.1 mmHg Standard Deviation 8.92	1.3 mmHg Standard Deviation 8.78	-0.0 mmHg Standard Deviation 7.96	1.0 mmHg Standard Deviation 6.66
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 Change at Month 12:diastolic BP(n=251,265,67,63)	-0.9 mmHg Standard Deviation 9.37	0.6 mmHg Standard Deviation 8.94	1.8 mmHg Standard Deviation 7.50	0.7 mmHg Standard Deviation 9.32
Change From Baseline in Blood Pressure (BP) at Month 9, 12, 15, 18, 21 and 24 Change at Month 12:systolic BP(n=251,265,67,63)	-1.3 mmHg Standard Deviation 13.93	1.1 mmHg Standard Deviation 14.28	1.1 mmHg Standard Deviation 10.91	1.3 mmHg Standard Deviation 14.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24

Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Month 1, 3, 6, 9, 12, 15, 18, 21, 24

Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings as per planned analysis but not statistically summarized.

Outcome measures

Outcome data not reported

Adverse Events

CP-690,550 5 mg (Up To Month 3)

Serious events: 12 serious events

Other events: 70 other events

Deaths: 0 deaths

CP-690,550 10 mg (Up to Month 3)

Serious events: 10 serious events

Other events: 49 other events

Deaths: 0 deaths

Placebo (Up to Month 3)

Serious events: 5 serious events

Other events: 21 other events

Deaths: 0 deaths

CP-690,550 5 mg (Month 3 to 6)

Serious events: 18 serious events

Other events: 33 other events

Deaths: 0 deaths

CP-690,550 10 mg (Month 3 to 6)

Serious events: 8 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo (Month 3 to 6)

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

CP-690,550 5 mg (Post Month 6)

Serious events: 14 serious events

Other events: 66 other events

Deaths: 0 deaths

CP-690,550 10 mg (Post Month 6)

Serious events: 13 serious events

Other events: 79 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550 5 mg (Up To Month 3) n=321 participants at risk Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.	CP-690,550 10 mg (Up to Month 3) n=316 participants at risk Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.	Placebo (Up to Month 3) n=160 participants at risk Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.	CP-690,550 5 mg (Month 3 to 6) n=363 participants at risk Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.	CP-690,550 10 mg (Month 3 to 6) n=353 participants at risk Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.	Placebo (Month 3 to 6) n=81 participants at risk Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.	CP-690,550 5 mg (Post Month 6) n=402 participants at risk Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.	CP-690,550 10 mg (Post Month 6) n=395 participants at risk Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
Cardiac disorders Angina pectoris	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Coronary artery disease	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Angina unstable	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Bundle branch block right	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Leukocytosis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Necrotising retinitis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gastritis erosive	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematemesis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Enteritis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Device breakage	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Non-cardiac chest pain	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Drug ineffective	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Drug interaction	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.51% 2/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hepatosplenomegaly	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Cytomegalovirus viraemia	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dengue fever	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Pneumocystis jiroveci pneumonia	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.75% 3/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia viral	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sialoadenitis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Bacterial sepsis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Bronchiectasis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.55% 2/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Enterocolitis bacterial	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.55% 2/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia primary atypical	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 acute	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Sepsis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Diverticulitis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Ankle fracture	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Concussion	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Contusion	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Ligament sprain	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Muscle strain	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Road traffic accident	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Thoracic vertebral fracture	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Fracture	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Radius fracture	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Spinal fracture	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Subdural haematoma	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Upper limb fracture	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dislocation of vertebra	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Spinal compression fracture	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Transaminases increased	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Colonoscopy	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Fracture nonunion	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Inguinal mass	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Intervertebral disc protrusion	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Osteonecrosis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Lumbar spinal stenosis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Musculoskeletal chest pain	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Osteoarthritis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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) Basal cell carcinoma	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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) Breast cancer	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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) Squamous cell carcinoma of the cervix	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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) Lymphoma	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian granulosa-theca cell tumour	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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) Lung cancer metastatic	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Carotid artery disease	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Carotid artery stenosis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.32% 1/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Polyneuropathy	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Lacunar infarction	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Uraemic encephalopathy	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Sciatica	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Hydronephrosis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure acute	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Endometriosis	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 1/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Acute respiratory distress syndrome	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Aspiration	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Respiratory disorder	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.25% 1/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Infarction	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.28% 1/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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

Other adverse events
Measure	CP-690,550 5 mg (Up To Month 3) n=321 participants at risk Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.	CP-690,550 10 mg (Up to Month 3) n=316 participants at risk Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.	Placebo (Up to Month 3) n=160 participants at risk Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.	CP-690,550 5 mg (Month 3 to 6) n=363 participants at risk Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.	CP-690,550 10 mg (Month 3 to 6) n=353 participants at risk Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.	Placebo (Month 3 to 6) n=81 participants at risk Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.	CP-690,550 5 mg (Post Month 6) n=402 participants at risk Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.	CP-690,550 10 mg (Post Month 6) n=395 participants at risk Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
Gastrointestinal disorders Nausea	2.2% 7/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.95% 3/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 2/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	2.2% 7/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 8/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.2% 2/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	4.4% 14/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 13/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 13/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 9/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 4/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 22/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.6% 22/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	2.8% 9/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 7/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 5/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.7% 17/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 9/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.2% 13/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 15/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	2.8% 9/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.95% 3/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 4/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 10/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.3% 17/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.83% 3/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 9/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 9/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 10/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Herpes zoster	0.00% 0/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 10/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.5% 14/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	1.6% 5/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.95% 3/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.1% 5/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	5.6% 18/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 4/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.9% 3/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.31% 1/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 9/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.4% 11/321 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.3% 4/316 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.62% 1/160 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/363 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/353 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/81 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 8/402 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.5% 6/395 • Baseline up to Month 12 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

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