Trial Outcomes & Findings for A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis (NCT NCT00550446)

Last Updated: 2013-01-03

Results Overview

ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

386 participants

Primary outcome timeframe

Week 12

Results posted on

2013-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Up To Week 12 STARTED	54	52	50	61	57	53	59	0	0	0	0
Up To Week 12 Treated	54	51	49	61	57	53	59	0	0	0	0
Up To Week 12 COMPLETED	44	47	46	58	54	45	46	0	0	0	0
Up To Week 12 NOT COMPLETED	10	5	4	3	3	8	13	0	0	0	0
Post Week 12 STARTED	27	30	46	58	54	1	21	17	17	44	25
Post Week 12 COMPLETED	24	28	43	55	52	0	19	16	15	37	24
Post Week 12 NOT COMPLETED	3	2	3	3	2	1	2	1	2	7	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Up To Week 12 Adverse Event	2	2	0	0	2	2	1	0	0	0	0
Up To Week 12 Lack of Efficacy	3	1	0	1	0	3	3	0	0	0	0
Up To Week 12 Lost to Follow-up	0	1	0	0	1	1	2	0	0	0	0
Up To Week 12 Withdrawal by Subject	2	0	3	2	0	1	3	0	0	0	0
Up To Week 12 Other	3	0	0	0	0	1	4	0	0	0	0
Up To Week 12 Randomized not treated	0	1	1	0	0	0	0	0	0	0	0
Post Week 12 Adverse Event	2	1	1	1	1	1	0	0	0	4	0
Post Week 12 Lack of Efficacy	0	0	1	0	0	0	0	1	1	2	1
Post Week 12 Lost to Follow-up	0	0	1	1	0	0	1	0	0	0	0
Post Week 12 Withdrawal by Subject	0	0	0	0	1	0	0	0	0	0	0
Post Week 12 Other	1	1	0	1	0	0	1	0	1	1	0

Baseline Characteristics

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=51 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=49 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=61 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=57 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Total n=384 Participants Total of all reporting groups
Age Continuous	55.1 years STANDARD_DEVIATION 13.3 • n=5 Participants	53.4 years STANDARD_DEVIATION 12.2 • n=7 Participants	53.7 years STANDARD_DEVIATION 13.5 • n=5 Participants	52.4 years STANDARD_DEVIATION 10.9 • n=4 Participants	53.2 years STANDARD_DEVIATION 13.0 • n=21 Participants	53.5 years STANDARD_DEVIATION 11.9 • n=8 Participants	52.5 years STANDARD_DEVIATION 13.7 • n=8 Participants	53.3 years STANDARD_DEVIATION 12.6 • n=24 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	44 Participants n=7 Participants	43 Participants n=5 Participants	53 Participants n=4 Participants	50 Participants n=21 Participants	45 Participants n=8 Participants	52 Participants n=8 Participants	333 Participants n=24 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=8 Participants	7 Participants n=8 Participants	51 Participants n=24 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. The analysis used Baseline Observation Carried Forward (BOCF) imputation for missing values.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=51 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=49 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=61 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=57 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	31.48 percentage of participants	45.10 percentage of participants	61.22 percentage of participants	72.13 percentage of participants	71.93 percentage of participants	39.62 percentage of participants	23.73 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Missing values were imputed using BOCF. n=number of participants evaluable at specific time points for each arm group, respectively.

ACR20 response: 20% improvement in TJC; \>=20% improvement in SJC; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)	22.22 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.25 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.82 percentage of participants	52.46 percentage of participants	63.16 percentage of participants	28.30 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.12 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)	16.67 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.37 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.65 percentage of participants	50.82 percentage of participants	38.60 percentage of participants	26.42 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.25 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)	38.89 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.06 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	63.27 percentage of participants	63.93 percentage of participants	66.67 percentage of participants	30.19 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	25.42 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)	37.04 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.06 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	63.27 percentage of participants	65.57 percentage of participants	71.93 percentage of participants	35.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.12 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)	35.19 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.25 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	57.14 percentage of participants	75.41 percentage of participants	75.44 percentage of participants	35.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.73 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)	51.4 percentage of participants	0.0 percentage of participants	58.8 percentage of participants	0.0 percentage of participants	67.3 percentage of participants	70.5 percentage of participants	71.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	35.3 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)	45.9 percentage of participants	0.0 percentage of participants	64.7 percentage of participants	0.0 percentage of participants	69.4 percentage of participants	73.8 percentage of participants	71.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	32.4 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)	35.1 percentage of participants	0.0 percentage of participants	58.8 percentage of participants	0.0 percentage of participants	57.1 percentage of participants	73.8 percentage of participants	68.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	47.1 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

ACR50 response: \>= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 12 (n=54,0,51,0,49,61,57,53,0,59,0)	11.11 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	25.49 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.78 percentage of participants	45.90 percentage of participants	50.88 percentage of participants	20.75 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.17 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)	1.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.84 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.16 percentage of participants	18.03 percentage of participants	17.54 percentage of participants	7.55 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.69 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)	9.26 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.73 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.20 percentage of participants	31.15 percentage of participants	40.35 percentage of participants	9.43 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.08 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)	14.81 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.69 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.29 percentage of participants	36.07 percentage of participants	42.11 percentage of participants	16.98 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.78 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)	12.96 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.57 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	24.49 percentage of participants	29.51 percentage of participants	49.12 percentage of participants	16.98 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.47 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)	12.96 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.65 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.69 percentage of participants	50.82 percentage of participants	43.86 percentage of participants	15.09 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.78 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)	18.9 percentage of participants	0.0 percentage of participants	38.2 percentage of participants	0.0 percentage of participants	34.7 percentage of participants	42.6 percentage of participants	56.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	20.6 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)	18.9 percentage of participants	0.0 percentage of participants	44.1 percentage of participants	0.0 percentage of participants	32.7 percentage of participants	42.6 percentage of participants	59.6 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	17.6 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)	10.8 percentage of participants	0.0 percentage of participants	44.1 percentage of participants	0.0 percentage of participants	36.7 percentage of participants	45.9 percentage of participants	54.4 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	17.6 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

ACR70 response: \>= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)	9.26 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.92 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.16 percentage of participants	18.03 percentage of participants	24.56 percentage of participants	5.66 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.69 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)	1.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.96 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.04 percentage of participants	3.28 percentage of participants	7.02 percentage of participants	1.89 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.88 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.04 percentage of participants	11.48 percentage of participants	8.77 percentage of participants	5.66 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.69 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)	3.70 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.96 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.08 percentage of participants	19.67 percentage of participants	17.54 percentage of participants	5.66 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.69 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)	3.70 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.84 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.33 percentage of participants	26.23 percentage of participants	21.05 percentage of participants	3.77 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.69 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 12 (n=54,0,51,0,49,61,57,53,0,59,0)	5.56 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.76 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.29 percentage of participants	24.59 percentage of participants	26.32 percentage of participants	3.77 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.39 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)	10.8 percentage of participants	0.0 percentage of participants	26.5 percentage of participants	0.0 percentage of participants	20.4 percentage of participants	29.5 percentage of participants	33.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)	10.8 percentage of participants	0.0 percentage of participants	17.6 percentage of participants	0.0 percentage of participants	18.4 percentage of participants	31.1 percentage of participants	31.6 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	8.8 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)	8.1 percentage of participants	0.0 percentage of participants	23.5 percentage of participants	0.0 percentage of participants	22.4 percentage of participants	37.7 percentage of participants	33.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	11.8 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

ACR90 response: \>= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 10 (n=54,0,51,0,49,61,57,53,0,59,0)	1.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.96 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.08 percentage of participants	9.84 percentage of participants	10.53 percentage of participants	1.89 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 2 (n=54,0,51,0,49,61,57,53,0,59,0)	1.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	1.64 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 4 (n=54,0,51,0,49,61,57,53,0,59,0)	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.04 percentage of participants	3.28 percentage of participants	1.75 percentage of participants	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 6 (n=54,0,51,0,49,61,57,53,0,59,0)	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.04 percentage of participants	6.56 percentage of participants	1.75 percentage of participants	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 8 (n=54,0,51,0,49,61,57,53,0,59,0)	1.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.04 percentage of participants	9.84 percentage of participants	1.75 percentage of participants	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 12 (n=54,0,51,0,49,61,57,53,0,59,0)	1.85 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.96 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.08 percentage of participants	11.48 percentage of participants	7.02 percentage of participants	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 16 (n=37,17,34,17,49,61,57,9,44,34,25)	2.7 percentage of participants	0.0 percentage of participants	5.9 percentage of participants	0.0 percentage of participants	8.2 percentage of participants	13.1 percentage of participants	8.8 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 20 (n=37,17,34,17,49,61,57,9,44,34,25)	2.7 percentage of participants	0.0 percentage of participants	2.9 percentage of participants	0.0 percentage of participants	6.1 percentage of participants	11.5 percentage of participants	10.5 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 24 (n=37,17,34,17,49,61,57,9,44,34,25)	2.7 percentage of participants	0.0 percentage of participants	5.9 percentage of participants	0.0 percentage of participants	6.1 percentage of participants	14.8 percentage of participants	12.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 2, 4, 6, 8, 10, 12

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. Missing values were imputed using Last Observation Carried Forward (LOCF).

ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=50 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=49 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=61 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=56 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 2	-99.17 units on a scale Standard Deviation 430.60	-21.41 units on a scale Standard Deviation 348.60	36.11 units on a scale Standard Deviation 254.60	117.91 units on a scale Standard Deviation 236.40	16.24 units on a scale Standard Deviation 507.70	-82.12 units on a scale Standard Deviation 436.48	-97.56 units on a scale Standard Deviation 362.62	—	—	—	—
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 6	-488.95 units on a scale Standard Deviation 2121.82	-7.91 units on a scale Standard Deviation 1840.80	416.04 units on a scale Standard Deviation 1117.60	839.12 units on a scale Standard Deviation 1219.16	584.69 units on a scale Standard Deviation 1864.04	-280.67 units on a scale Standard Deviation 1925.43	-430.41 units on a scale Standard Deviation 1471.10	—	—	—	—
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 4	-328.58 units on a scale Standard Deviation 1190.65	-31.17 units on a scale Standard Deviation 1068.34	165.07 units on a scale Standard Deviation 685.88	421.90 units on a scale Standard Deviation 700.43	184.76 units on a scale Standard Deviation 1317.14	-211.66 units on a scale Standard Deviation 1178.51	-268.25 units on a scale Standard Deviation 906.61	—	—	—	—
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 8	-545.16 units on a scale Standard Deviation 3121.09	30.98 units on a scale Standard Deviation 2675.04	761.40 units on a scale Standard Deviation 1552.54	1311.99 units on a scale Standard Deviation 1736.67	1077.41 units on a scale Standard Deviation 2543.43	-331.79 units on a scale Standard Deviation 2727.74	-531.80 units on a scale Standard Deviation 2095.50	—	—	—	—
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 10	-588.77 units on a scale Standard Deviation 4109.74	81.85 units on a scale Standard Deviation 3510.17	1163.37 units on a scale Standard Deviation 1985.69	1857.57 units on a scale Standard Deviation 2203.00	1539.51 units on a scale Standard Deviation 3768.28	-337.47 units on a scale Standard Deviation 3478.31	-642.56 units on a scale Standard Deviation 2805.90	—	—	—	—
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve Week 12	-675.05 units on a scale Standard Deviation 5160.91	145.08 units on a scale Standard Deviation 4380.78	1579.56 units on a scale Standard Deviation 2447.05	2443.62 units on a scale Standard Deviation 2701.93	2053.03 units on a scale Standard Deviation 4745.53	-242.83 units on a scale Standard Deviation 4111.62	-803.67 units on a scale Standard Deviation 3548.72	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Tender Joint Count (TJC) Baseline (n=54,0,51,0,49,61,57,53,0,59,0)	27.02 tender joints Standard Deviation 15.39	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	24.55 tender joints Standard Deviation 11.31	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.14 tender joints Standard Deviation 14.62	25.70 tender joints Standard Deviation 13.92	25.88 tender joints Standard Deviation 13.37	24.11 tender joints Standard Deviation 13.86	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	25.92 tender joints Standard Deviation 12.92	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)	21.98 tender joints Standard Deviation 14.45	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.94 tender joints Standard Deviation 10.75	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.79 tender joints Standard Deviation 12.42	15.33 tender joints Standard Deviation 12.74	17.42 tender joints Standard Deviation 14.33	19.40 tender joints Standard Deviation 14.76	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.00 tender joints Standard Deviation 11.82	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	20.54 tender joints Standard Deviation 17.43	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.83 tender joints Standard Deviation 11.80	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.43 tender joints Standard Deviation 13.01	12.84 tender joints Standard Deviation 12.55	13.16 tender joints Standard Deviation 14.95	16.78 tender joints Standard Deviation 14.79	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	18.94 tender joints Standard Deviation 13.30	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	15.13 tender joints Standard Deviation 13.52	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.67 tender joints Standard Deviation 12.06	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.33 tender joints Standard Deviation 11.06	10.95 tender joints Standard Deviation 11.95	11.27 tender joints Standard Deviation 14.89	15.73 tender joints Standard Deviation 13.94	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.77 tender joints Standard Deviation 14.45	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	16.30 tender joints Standard Deviation 14.14	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.40 tender joints Standard Deviation 12.74	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.68 tender joints Standard Deviation 12.57	10.00 tender joints Standard Deviation 11.81	9.15 tender joints Standard Deviation 12.18	14.87 tender joints Standard Deviation 13.11	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.93 tender joints Standard Deviation 12.33	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	17.15 tender joints Standard Deviation 17.32	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.65 tender joints Standard Deviation 11.89	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.87 tender joints Standard Deviation 11.17	7.68 tender joints Standard Deviation 10.94	9.23 tender joints Standard Deviation 12.88	14.47 tender joints Standard Deviation 15.20	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.22 tender joints Standard Deviation 14.38	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	18.32 tender joints Standard Deviation 16.77	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.33 tender joints Standard Deviation 12.88	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.52 tender joints Standard Deviation 12.35	8.09 tender joints Standard Deviation 12.02	8.44 tender joints Standard Deviation 11.26	14.74 tender joints Standard Deviation 14.73	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.50 tender joints Standard Deviation 13.14	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Tender Joint Count (TJC) Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	7.44 tender joints Standard Deviation 8.38	19.47 tender joints Standard Deviation 14.06	6.27 tender joints Standard Deviation 6.49	19.41 tender joints Standard Deviation 12.25	10.85 tender joints Standard Deviation 11.11	7.57 tender joints Standard Deviation 11.08	7.22 tender joints Standard Deviation 11.34	NA tender joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	8.70 tender joints Standard Deviation 9.47	8.30 tender joints Standard Deviation 9.07	12.40 tender joints Standard Deviation 12.24
Tender Joint Count (TJC) Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)	10.41 tender joints Standard Deviation 10.69	16.19 tender joints Standard Deviation 9.72	6.76 tender joints Standard Deviation 8.25	18.25 tender joints Standard Deviation 15.65	11.80 tender joints Standard Deviation 12.82	6.66 tender joints Standard Deviation 10.62	6.79 tender joints Standard Deviation 9.69	NA tender joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	8.95 tender joints Standard Deviation 10.56	8.16 tender joints Standard Deviation 8.74	12.60 tender joints Standard Deviation 13.28
Tender Joint Count (TJC) Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)	11.92 tender joints Standard Deviation 13.64	21.31 tender joints Standard Deviation 14.81	6.59 tender joints Standard Deviation 10.58	16.60 tender joints Standard Deviation 13.49	10.47 tender joints Standard Deviation 11.50	6.25 tender joints Standard Deviation 10.12	7.27 tender joints Standard Deviation 11.35	NA tender joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	10.44 tender joints Standard Deviation 9.97	8.75 tender joints Standard Deviation 8.59	10.54 tender joints Standard Deviation 13.09

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)	-5.04 tender joints Standard Deviation 12.12	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.61 tender joints Standard Deviation 9.31	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.23 tender joints Standard Deviation 12.61	-10.28 tender joints Standard Deviation 12.57	-8.46 tender joints Standard Deviation 12.87	-4.72 tender joints Standard Deviation 10.97	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.19 tender joints Standard Deviation 11.84	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	-6.56 tender joints Standard Deviation 14.49	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.43 tender joints Standard Deviation 10.53	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.33 tender joints Standard Deviation 10.76	-13.00 tender joints Standard Deviation 12.73	-12.85 tender joints Standard Deviation 14.91	-7.67 tender joints Standard Deviation 11.40	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.23 tender joints Standard Deviation 11.39	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	-11.96 tender joints Standard Deviation 15.35	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.38 tender joints Standard Deviation 11.02	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.40 tender joints Standard Deviation 13.50	-14.49 tender joints Standard Deviation 13.52	-14.38 tender joints Standard Deviation 14.86	-8.83 tender joints Standard Deviation 13.02	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.69 tender joints Standard Deviation 13.86	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	-11.83 tender joints Standard Deviation 13.56	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.65 tender joints Standard Deviation 11.06	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.70 tender joints Standard Deviation 13.86	-15.61 tender joints Standard Deviation 13.82	-15.57 tender joints Standard Deviation 13.80	-8.57 tender joints Standard Deviation 12.44	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.67 tender joints Standard Deviation 11.63	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	-11.07 tender joints Standard Deviation 16.23	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.65 tender joints Standard Deviation 10.87	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-15.93 tender joints Standard Deviation 13.92	-17.51 tender joints Standard Deviation 14.08	-15.77 tender joints Standard Deviation 12.77	-9.89 tender joints Standard Deviation 12.54	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.72 tender joints Standard Deviation 13.22	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	-9.57 tender joints Standard Deviation 15.80	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.04 tender joints Standard Deviation 11.42	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.24 tender joints Standard Deviation 13.32	-16.74 tender joints Standard Deviation 14.23	-16.28 tender joints Standard Deviation 12.25	-9.30 tender joints Standard Deviation 11.96	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.43 tender joints Standard Deviation 14.72	NA tender joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	-19.11 tender joints Standard Deviation 13.88	-10.53 tender joints Standard Deviation 12.43	-15.03 tender joints Standard Deviation 9.88	-8.47 tender joints Standard Deviation 12.51	-16.91 tender joints Standard Deviation 13.06	-17.48 tender joints Standard Deviation 13.24	-17.50 tender joints Standard Deviation 13.29	NA tender joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-15.09 tender joints Standard Deviation 12.35	-19.55 tender joints Standard Deviation 13.02	-12.40 tender joints Standard Deviation 10.17
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)	-16.15 tender joints Standard Deviation 16.26	-13.38 tender joints Standard Deviation 11.59	-15.28 tender joints Standard Deviation 11.11	-10.00 tender joints Standard Deviation 13.23	-15.98 tender joints Standard Deviation 13.20	-17.53 tender joints Standard Deviation 12.86	-17.57 tender joints Standard Deviation 13.62	NA tender joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-15.18 tender joints Standard Deviation 11.25	-18.16 tender joints Standard Deviation 13.00	-12.20 tender joints Standard Deviation 12.02
Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)	-12.63 tender joints Standard Deviation 14.37	-8.25 tender joints Standard Deviation 13.75	-15.45 tender joints Standard Deviation 13.03	-10.47 tender joints Standard Deviation 13.60	-17.58 tender joints Standard Deviation 15.22	-18.42 tender joints Standard Deviation 13.64	-17.02 tender joints Standard Deviation 14.14	NA tender joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-13.10 tender joints Standard Deviation 12.94	-19.10 tender joints Standard Deviation 14.88	-14.21 tender joints Standard Deviation 12.25

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Swollen Joint Counts (SJC) Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	11.11 swollen joints Standard Deviation 11.67	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.88 swollen joints Standard Deviation 10.87	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.15 swollen joints Standard Deviation 7.46	7.02 swollen joints Standard Deviation 8.63	5.91 swollen joints Standard Deviation 7.65	8.89 swollen joints Standard Deviation 10.84	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.37 swollen joints Standard Deviation 9.64	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	11.39 swollen joints Standard Deviation 11.23	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.26 swollen joints Standard Deviation 10.74	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.33 swollen joints Standard Deviation 7.15	5.58 swollen joints Standard Deviation 7.84	5.11 swollen joints Standard Deviation 7.15	7.41 swollen joints Standard Deviation 7.83	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.85 swollen joints Standard Deviation 9.64	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Baseline (n=54,0,51,0,49,61,57,53,0,59,0)	16.70 swollen joints Standard Deviation 8.89	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.90 swollen joints Standard Deviation 8.50	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	17.35 swollen joints Standard Deviation 10.26	16.33 swollen joints Standard Deviation 8.28	16.93 swollen joints Standard Deviation 9.03	14.91 swollen joints Standard Deviation 8.12	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.90 swollen joints Standard Deviation 9.77	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)	11.87 swollen joints Standard Deviation 7.69	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.82 swollen joints Standard Deviation 10.23	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.27 swollen joints Standard Deviation 8.90	10.55 swollen joints Standard Deviation 9.13	11.25 swollen joints Standard Deviation 8.91	11.58 swollen joints Standard Deviation 9.96	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.25 swollen joints Standard Deviation 8.95	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	12.78 swollen joints Standard Deviation 13.24	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.98 swollen joints Standard Deviation 10.67	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.43 swollen joints Standard Deviation 9.15	8.50 swollen joints Standard Deviation 7.60	7.55 swollen joints Standard Deviation 8.89	10.08 swollen joints Standard Deviation 8.75	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.11 swollen joints Standard Deviation 9.10	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	9.58 swollen joints Standard Deviation 9.11	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.08 swollen joints Standard Deviation 9.55	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.29 swollen joints Standard Deviation 5.77	7.03 swollen joints Standard Deviation 7.24	6.55 swollen joints Standard Deviation 8.02	9.27 swollen joints Standard Deviation 9.52	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.44 swollen joints Standard Deviation 11.47	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	10.63 swollen joints Standard Deviation 10.89	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.35 swollen joints Standard Deviation 9.52	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.93 swollen joints Standard Deviation 7.11	5.39 swollen joints Standard Deviation 7.47	5.68 swollen joints Standard Deviation 7.96	9.11 swollen joints Standard Deviation 11.81	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.76 swollen joints Standard Deviation 11.21	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Swollen Joint Counts (SJC) Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	6.44 swollen joints Standard Deviation 7.29	10.82 swollen joints Standard Deviation 7.63	4.50 swollen joints Standard Deviation 5.48	14.88 swollen joints Standard Deviation 13.15	5.96 swollen joints Standard Deviation 6.54	5.34 swollen joints Standard Deviation 7.91	4.46 swollen joints Standard Deviation 7.64	NA swollen joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	4.56 swollen joints Standard Deviation 5.59	5.90 swollen joints Standard Deviation 6.02	9.76 swollen joints Standard Deviation 8.53
Swollen Joint Counts (SJC) Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)	7.89 swollen joints Standard Deviation 7.95	10.31 swollen joints Standard Deviation 8.55	5.03 swollen joints Standard Deviation 7.59	14.38 swollen joints Standard Deviation 13.99	6.71 swollen joints Standard Deviation 6.96	4.60 swollen joints Standard Deviation 7.82	4.36 swollen joints Standard Deviation 7.17	NA swollen joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	5.52 swollen joints Standard Deviation 7.68	5.21 swollen joints Standard Deviation 4.50	7.92 swollen joints Standard Deviation 6.95
Swollen Joint Counts (SJC) Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)	8.92 swollen joints Standard Deviation 11.01	10.94 swollen joints Standard Deviation 9.04	4.86 swollen joints Standard Deviation 7.81	13.27 swollen joints Standard Deviation 13.01	5.88 swollen joints Standard Deviation 6.38	4.44 swollen joints Standard Deviation 7.78	4.10 swollen joints Standard Deviation 6.83	NA swollen joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	5.67 swollen joints Standard Deviation 7.46	5.95 swollen joints Standard Deviation 6.26	6.04 swollen joints Standard Deviation 6.40

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)	-4.83 swollen joints Standard Deviation 7.04	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.08 swollen joints Standard Deviation 8.86	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.85 swollen joints Standard Deviation 9.65	-5.67 swollen joints Standard Deviation 6.94	-5.68 swollen joints Standard Deviation 9.98	-3.32 swollen joints Standard Deviation 9.25	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.74 swollen joints Standard Deviation 8.33	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	-4.08 swollen joints Standard Deviation 10.31	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.66 swollen joints Standard Deviation 9.88	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.63 swollen joints Standard Deviation 9.01	-8.02 swollen joints Standard Deviation 7.03	-9.55 swollen joints Standard Deviation 11.00	-4.57 swollen joints Standard Deviation 8.52	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.06 swollen joints Standard Deviation 8.76	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	-7.88 swollen joints Standard Deviation 9.28	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.54 swollen joints Standard Deviation 9.76	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.69 swollen joints Standard Deviation 9.13	-9.36 swollen joints Standard Deviation 7.60	-10.51 swollen joints Standard Deviation 10.61	-5.75 swollen joints Standard Deviation 8.32	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.87 swollen joints Standard Deviation 10.53	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	-6.36 swollen joints Standard Deviation 10.05	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.75 swollen joints Standard Deviation 9.94	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.70 swollen joints Standard Deviation 9.60	-9.19 swollen joints Standard Deviation 7.70	-10.85 swollen joints Standard Deviation 10.60	-6.17 swollen joints Standard Deviation 8.50	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.33 swollen joints Standard Deviation 9.12	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	-6.70 swollen joints Standard Deviation 8.60	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.33 swollen joints Standard Deviation 9.40	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.89 swollen joints Standard Deviation 9.78	-11.11 swollen joints Standard Deviation 7.99	-11.28 swollen joints Standard Deviation 10.79	-6.00 swollen joints Standard Deviation 9.66	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.50 swollen joints Standard Deviation 11.31	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	-6.07 swollen joints Standard Deviation 9.67	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.85 swollen joints Standard Deviation 10.70	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.74 swollen joints Standard Deviation 10.28	-10.91 swollen joints Standard Deviation 8.48	-11.65 swollen joints Standard Deviation 10.26	-7.83 swollen joints Standard Deviation 7.52	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.41 swollen joints Standard Deviation 9.89	NA swollen joints Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	-11.00 swollen joints Standard Deviation 8.75	-6.65 swollen joints Standard Deviation 9.84	-9.97 swollen joints Standard Deviation 6.98	-1.24 swollen joints Standard Deviation 13.15	-11.11 swollen joints Standard Deviation 9.87	-11.27 swollen joints Standard Deviation 8.86	-12.30 swollen joints Standard Deviation 10.98	NA swollen joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-10.86 swollen joints Standard Deviation 8.03	-10.25 swollen joints Standard Deviation 6.77	-7.00 swollen joints Standard Deviation 11.08
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)	-9.56 swollen joints Standard Deviation 9.21	-6.06 swollen joints Standard Deviation 9.70	-9.90 swollen joints Standard Deviation 9.32	-2.19 swollen joints Standard Deviation 14.28	-10.40 swollen joints Standard Deviation 10.40	-11.17 swollen joints Standard Deviation 7.92	-12.68 swollen joints Standard Deviation 10.65	NA swollen joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-9.91 swollen joints Standard Deviation 7.50	-11.47 swollen joints Standard Deviation 7.46	-8.84 swollen joints Standard Deviation 9.92
Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 Week 24 (n=24,16,29,15,43,55,52,0,39,20,24)	-8.58 swollen joints Standard Deviation 8.98	-5.44 swollen joints Standard Deviation 9.33	-10.07 swollen joints Standard Deviation 9.70	-1.60 swollen joints Standard Deviation 14.34	-11.60 swollen joints Standard Deviation 11.55	-11.75 swollen joints Standard Deviation 7.82	-13.10 swollen joints Standard Deviation 10.44	NA swollen joints Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-9.46 swollen joints Standard Deviation 9.37	-10.20 swollen joints Standard Deviation 7.78	-11.00 swollen joints Standard Deviation 11.16

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Patient Assessment of Arthritis Pain Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	51.72 mm Standard Deviation 24.91	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.91 mm Standard Deviation 23.80	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.65 mm Standard Deviation 22.56	33.28 mm Standard Deviation 22.37	32.69 mm Standard Deviation 23.77	46.78 mm Standard Deviation 23.85	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.89 mm Standard Deviation 23.50	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Baseline (n=54,0,51,0,49,61,56,53,0,59,0)	59.74 mm Standard Deviation 23.56	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	61.25 mm Standard Deviation 23.93	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	64.14 mm Standard Deviation 23.55	62.92 mm Standard Deviation 18.74	63.46 mm Standard Deviation 25.26	64.36 mm Standard Deviation 21.46	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	60.29 mm Standard Deviation 23.23	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Week 2 (n=54,0,51,0,48,60,57,53,0,57,0)	53.76 mm Standard Deviation 24.49	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.25 mm Standard Deviation 24.19	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.10 mm Standard Deviation 24.48	43.90 mm Standard Deviation 23.43	41.28 mm Standard Deviation 28.06	48.00 mm Standard Deviation 25.09	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	55.26 mm Standard Deviation 26.70	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	47.31 mm Standard Deviation 24.21	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.75 mm Standard Deviation 22.17	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.24 mm Standard Deviation 22.73	33.68 mm Standard Deviation 22.52	30.24 mm Standard Deviation 25.46	46.27 mm Standard Deviation 28.16	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.63 mm Standard Deviation 24.08	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	47.28 mm Standard Deviation 25.46	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.21 mm Standard Deviation 22.19	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.91 mm Standard Deviation 23.56	33.05 mm Standard Deviation 22.34	26.74 mm Standard Deviation 26.01	43.17 mm Standard Deviation 25.22	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.26 mm Standard Deviation 23.25	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	45.70 mm Standard Deviation 26.30	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.24 mm Standard Deviation 23.23	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.67 mm Standard Deviation 24.34	28.11 mm Standard Deviation 21.80	23.38 mm Standard Deviation 22.03	48.73 mm Standard Deviation 27.32	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.96 mm Standard Deviation 24.72	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	47.25 mm Standard Deviation 25.81	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.30 mm Standard Deviation 26.89	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.70 mm Standard Deviation 25.23	28.14 mm Standard Deviation 22.79	27.26 mm Standard Deviation 25.88	42.87 mm Standard Deviation 25.76	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.93 mm Standard Deviation 24.16	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Assessment of Arthritis Pain Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	35.00 mm Standard Deviation 26.63	49.29 mm Standard Deviation 29.81	34.97 mm Standard Deviation 29.16	47.88 mm Standard Deviation 25.87	31.39 mm Standard Deviation 23.72	29.05 mm Standard Deviation 26.23	24.24 mm Standard Deviation 23.60	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	30.16 mm Standard Deviation 21.52	37.55 mm Standard Deviation 22.42	28.16 mm Standard Deviation 22.28
Patient Assessment of Arthritis Pain Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)	39.67 mm Standard Deviation 27.28	43.38 mm Standard Deviation 24.69	34.66 mm Standard Deviation 29.75	38.81 mm Standard Deviation 25.45	33.13 mm Standard Deviation 24.57	27.43 mm Standard Deviation 23.98	23.21 mm Standard Deviation 22.60	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	31.68 mm Standard Deviation 22.68	36.95 mm Standard Deviation 25.80	31.64 mm Standard Deviation 20.22
Patient Assessment of Arthritis Pain Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)	44.13 mm Standard Deviation 24.32	44.00 mm Standard Deviation 28.63	30.62 mm Standard Deviation 28.36	31.87 mm Standard Deviation 20.47	31.81 mm Standard Deviation 27.72	22.85 mm Standard Deviation 22.04	25.31 mm Standard Deviation 22.28	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	34.33 mm Standard Deviation 24.87	31.35 mm Standard Deviation 22.51	29.83 mm Standard Deviation 18.37

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	-11.61 mm Standard Deviation 31.51	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.04 mm Standard Deviation 22.11	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-31.24 mm Standard Deviation 24.72	-34.47 mm Standard Deviation 25.63	-35.31 mm Standard Deviation 31.92	-23.15 mm Standard Deviation 27.70	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.65 mm Standard Deviation 24.40	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 2 (n=54,0,51,0,48,60,56,53,0,57,0)	-5.98 mm Standard Deviation 25.77	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.00 mm Standard Deviation 17.89	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.33 mm Standard Deviation 20.70	-19.33 mm Standard Deviation 22.50	-23.11 mm Standard Deviation 29.72	-16.36 mm Standard Deviation 23.18	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.14 mm Standard Deviation 25.64	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 4 (n=50,0,47,0,46,58,54,49,0,53,0)	-6.78 mm Standard Deviation 30.17	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-19.04 mm Standard Deviation 19.15	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.28 mm Standard Deviation 21.33	-28.60 mm Standard Deviation 24.09	-32.41 mm Standard Deviation 29.39	-16.96 mm Standard Deviation 28.05	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.89 mm Standard Deviation 23.27	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 6 (n=48,0,48,0,45,59,54,48,0,52,0)	-11.42 mm Standard Deviation 28.68	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.23 mm Standard Deviation 23.04	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-25.04 mm Standard Deviation 22.63	-28.80 mm Standard Deviation 22.13	-33.50 mm Standard Deviation 29.39	-18.35 mm Standard Deviation 26.77	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.08 mm Standard Deviation 22.68	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	-11.68 mm Standard Deviation 29.48	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-18.77 mm Standard Deviation 20.45	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-30.02 mm Standard Deviation 25.59	-29.07 mm Standard Deviation 23.84	-35.83 mm Standard Deviation 30.52	-20.83 mm Standard Deviation 27.49	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.28 mm Standard Deviation 23.46	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	-13.98 mm Standard Deviation 27.46	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.39 mm Standard Deviation 22.24	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-29.30 mm Standard Deviation 26.46	-34.77 mm Standard Deviation 25.60	-38.94 mm Standard Deviation 29.33	-16.80 mm Standard Deviation 26.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.63 mm Standard Deviation 21.45	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	-19.00 mm Standard Deviation 33.30	-17.29 mm Standard Deviation 29.71	-18.73 mm Standard Deviation 25.91	-21.00 mm Standard Deviation 22.29	-32.54 mm Standard Deviation 23.55	-33.77 mm Standard Deviation 27.27	-38.33 mm Standard Deviation 30.31	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-36.37 mm Standard Deviation 22.95	-16.05 mm Standard Deviation 24.30	-33.40 mm Standard Deviation 25.97
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 20 (n=27,16,29,16,45,53,53,0,44,19,25)	-14.33 mm Standard Deviation 28.92	-22.19 mm Standard Deviation 29.73	-19.66 mm Standard Deviation 25.00	-29.50 mm Standard Deviation 25.80	-31.67 mm Standard Deviation 20.98	-34.66 mm Standard Deviation 23.72	-39.55 mm Standard Deviation 31.04	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-35.09 mm Standard Deviation 27.62	-15.58 mm Standard Deviation 25.51	-29.92 mm Standard Deviation 23.24
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)	-9.83 mm Standard Deviation 29.65	-21.56 mm Standard Deviation 35.86	-23.69 mm Standard Deviation 24.12	-36.00 mm Standard Deviation 18.57	-32.84 mm Standard Deviation 25.37	-39.69 mm Standard Deviation 22.62	-37.83 mm Standard Deviation 28.84	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-31.48 mm Standard Deviation 28.90	-22.25 mm Standard Deviation 25.21	-31.63 mm Standard Deviation 24.22

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Patient Global Assessment (PtGA) of Arthritis Pain Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	52.96 mm Standard Deviation 23.69	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.68 mm Standard Deviation 23.55	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.54 mm Standard Deviation 23.10	34.86 mm Standard Deviation 23.15	34.73 mm Standard Deviation 25.05	46.24 mm Standard Deviation 23.10	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.40 mm Standard Deviation 23.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	45.80 mm Standard Deviation 27.90	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.57 mm Standard Deviation 24.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.04 mm Standard Deviation 24.26	29.09 mm Standard Deviation 21.52	22.72 mm Standard Deviation 23.36	46.11 mm Standard Deviation 25.71	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.24 mm Standard Deviation 24.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	45.39 mm Standard Deviation 26.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.78 mm Standard Deviation 26.08	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.52 mm Standard Deviation 24.26	29.02 mm Standard Deviation 23.09	26.39 mm Standard Deviation 26.55	44.04 mm Standard Deviation 25.24	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.85 mm Standard Deviation 23.59	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	36.07 mm Standard Deviation 25.88	52.00 mm Standard Deviation 28.93	35.03 mm Standard Deviation 29.52	44.24 mm Standard Deviation 25.78	30.37 mm Standard Deviation 23.58	30.71 mm Standard Deviation 25.69	24.72 mm Standard Deviation 23.11	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	31.33 mm Standard Deviation 18.80	38.65 mm Standard Deviation 22.37	32.48 mm Standard Deviation 20.69
Patient Global Assessment (PtGA) of Arthritis Pain Baseline (n=54,0,51,0,49,61,57,53,0,59,0)	60.74 mm Standard Deviation 24.83	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	59.76 mm Standard Deviation 22.75	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	67.55 mm Standard Deviation 22.44	62.41 mm Standard Deviation 19.94	62.77 mm Standard Deviation 27.24	62.15 mm Standard Deviation 21.87	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	61.41 mm Standard Deviation 21.32	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 2 (n=53,0,51,0,48,60,57,53,0,57,0)	54.36 mm Standard Deviation 23.84	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	48.49 mm Standard Deviation 24.49	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.58 mm Standard Deviation 24.55	41.82 mm Standard Deviation 24.09	42.02 mm Standard Deviation 25.77	48.00 mm Standard Deviation 24.15	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	58.93 mm Standard Deviation 25.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	47.08 mm Standard Deviation 23.11	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.52 mm Standard Deviation 21.65	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.07 mm Standard Deviation 22.47	33.63 mm Standard Deviation 22.01	31.09 mm Standard Deviation 25.20	43.46 mm Standard Deviation 25.41	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.71 mm Standard Deviation 22.73	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	46.57 mm Standard Deviation 27.58	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.02 mm Standard Deviation 23.13	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.81 mm Standard Deviation 23.95	33.42 mm Standard Deviation 23.39	28.07 mm Standard Deviation 26.86	43.85 mm Standard Deviation 23.60	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.74 mm Standard Deviation 23.66	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Patient Global Assessment (PtGA) of Arthritis Pain Week 20 (n=27,16,29,16,45,53,52,0,44,19,25)	39.74 mm Standard Deviation 27.72	47.19 mm Standard Deviation 24.36	35.41 mm Standard Deviation 29.13	41.44 mm Standard Deviation 24.86	33.91 mm Standard Deviation 24.90	28.06 mm Standard Deviation 23.26	23.90 mm Standard Deviation 22.38	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	30.95 mm Standard Deviation 21.47	35.84 mm Standard Deviation 26.21	36.20 mm Standard Deviation 21.44
Patient Global Assessment (PtGA) of Arthritis Pain Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)	43.08 mm Standard Deviation 23.92	45.69 mm Standard Deviation 26.15	33.07 mm Standard Deviation 27.90	33.20 mm Standard Deviation 19.77	33.77 mm Standard Deviation 28.44	24.85 mm Standard Deviation 22.29	26.58 mm Standard Deviation 23.04	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	34.45 mm Standard Deviation 23.60	32.05 mm Standard Deviation 22.63	28.13 mm Standard Deviation 17.42

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 2 (n=53,0,51,0,48,60,57,53,0,57,0)	-5.72 mm Standard Deviation 22.55	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.27 mm Standard Deviation 18.57	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.33 mm Standard Deviation 26.14	-21.48 mm Standard Deviation 25.18	-20.75 mm Standard Deviation 28.26	-14.15 mm Standard Deviation 25.21	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.84 mm Standard Deviation 26.71	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	-6.62 mm Standard Deviation 28.20	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-15.51 mm Standard Deviation 22.14	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-23.15 mm Standard Deviation 24.65	-26.52 mm Standard Deviation 25.06	-28.29 mm Standard Deviation 28.34	-15.35 mm Standard Deviation 25.66	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.64 mm Standard Deviation 22.16	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 6 (n=48,0,48,0,45,59,55,48,0,52,0)	-13.58 mm Standard Deviation 29.19	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.77 mm Standard Deviation 25.31	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-28.89 mm Standard Deviation 24.62	-28.39 mm Standard Deviation 25.53	-31.49 mm Standard Deviation 29.39	-18.69 mm Standard Deviation 24.71	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-11.27 mm Standard Deviation 18.60	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	-13.79 mm Standard Deviation 27.05	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.27 mm Standard Deviation 21.81	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-32.91 mm Standard Deviation 28.68	-28.18 mm Standard Deviation 26.81	-34.11 mm Standard Deviation 29.33	-18.23 mm Standard Deviation 29.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.24 mm Standard Deviation 19.77	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	-14.70 mm Standard Deviation 26.43	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.21 mm Standard Deviation 21.93	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-32.93 mm Standard Deviation 28.11	-33.21 mm Standard Deviation 27.96	-39.25 mm Standard Deviation 28.87	-17.42 mm Standard Deviation 26.53	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.93 mm Standard Deviation 22.30	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	-15.05 mm Standard Deviation 29.31	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.96 mm Standard Deviation 22.92	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-34.17 mm Standard Deviation 25.62	-33.09 mm Standard Deviation 28.82	-35.80 mm Standard Deviation 30.90	-19.80 mm Standard Deviation 29.70	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-15.33 mm Standard Deviation 22.06	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 16 (n=27,17,30,17,46,56,54,0,43,20,25)	-19.81 mm Standard Deviation 29.62	-15.65 mm Standard Deviation 29.98	-20.60 mm Standard Deviation 24.26	-19.35 mm Standard Deviation 22.34	-37.33 mm Standard Deviation 25.23	-31.50 mm Standard Deviation 28.85	-37.46 mm Standard Deviation 29.80	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-33.19 mm Standard Deviation 25.10	-16.75 mm Standard Deviation 24.67	-32.44 mm Standard Deviation 22.40
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 20 (n=27,16,29,16,45,53,52,0,44,19,25)	-16.15 mm Standard Deviation 30.54	-19.69 mm Standard Deviation 31.12	-20.38 mm Standard Deviation 23.79	-21.00 mm Standard Deviation 17.74	-34.73 mm Standard Deviation 24.52	-32.87 mm Standard Deviation 24.10	-37.65 mm Standard Deviation 32.14	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-33.64 mm Standard Deviation 28.30	-18.74 mm Standard Deviation 20.40	-28.72 mm Standard Deviation 22.80
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)	-12.96 mm Standard Deviation 26.46	-21.19 mm Standard Deviation 33.96	-22.72 mm Standard Deviation 25.10	-27.93 mm Standard Deviation 15.08	-34.72 mm Standard Deviation 26.19	-37.31 mm Standard Deviation 25.58	-36.10 mm Standard Deviation 29.30	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-29.33 mm Standard Deviation 34.25	-23.35 mm Standard Deviation 16.74	-36.75 mm Standard Deviation 21.95

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Physician Global Assessment (PGA) of Arthritis Baseline (n=54,0,50,0,48,60,57,53,0,59,0)	62.13 mm Standard Deviation 16.69	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	62.10 mm Standard Deviation 18.37	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	65.85 mm Standard Deviation 14.36	61.05 mm Standard Deviation 15.78	67.19 mm Standard Deviation 17.93	62.77 mm Standard Deviation 15.18	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	63.02 mm Standard Deviation 18.74	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 24 (n=24,15,28,15,43,55,51,0,40,20,24)	35.21 mm Standard Deviation 23.91	41.20 mm Standard Deviation 19.27	22.50 mm Standard Deviation 23.37	32.00 mm Standard Deviation 19.13	30.26 mm Standard Deviation 20.91	20.13 mm Standard Deviation 16.50	19.06 mm Standard Deviation 16.73	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	27.05 mm Standard Deviation 17.55	24.05 mm Standard Deviation 17.75	29.42 mm Standard Deviation 21.01
Physician Global Assessment (PGA) of Arthritis Week 2 (n=54,0,51,0,46,60,57,53,0,57,0)	52.30 mm Standard Deviation 21.90	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.88 mm Standard Deviation 20.86	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.37 mm Standard Deviation 21.90	39.85 mm Standard Deviation 18.69	44.98 mm Standard Deviation 21.61	47.58 mm Standard Deviation 20.95	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	55.19 mm Standard Deviation 19.98	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 4 (n=50,0,47,0,46,58,55,49,0,53,0)	47.30 mm Standard Deviation 20.40	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.23 mm Standard Deviation 20.80	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.3 mm Standard Deviation 19.49	34.55 mm Standard Deviation 20.68	31.89 mm Standard Deviation 20.38	44.02 mm Standard Deviation 20.06	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	50.15 mm Standard Deviation 20.92	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 6 (n=48,0,47,0,45,59,55,48,0,52,0)	39.75 mm Standard Deviation 21.73	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.98 mm Standard Deviation 21.30	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.40 mm Standard Deviation 20.40	31.22 mm Standard Deviation 19.51	28.56 mm Standard Deviation 21.47	39.83 mm Standard Deviation 22.75	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.12 mm Standard Deviation 24.57	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 8 (n=47,0,48,0,47,57,54,47,0,46,0)	40.06 mm Standard Deviation 22.39	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.54 mm Standard Deviation 23.22	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.79 mm Standard Deviation 19.94	29.56 mm Standard Deviation 18.60	25.20 mm Standard Deviation 21.85	38.34 mm Standard Deviation 21.38	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.91 mm Standard Deviation 20.78	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	41.65 mm Standard Deviation 23.12	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.78 mm Standard Deviation 24.18	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.70 mm Standard Deviation 20.03	24.72 mm Standard Deviation 18.83	23.68 mm Standard Deviation 18.76	40.69 mm Standard Deviation 25.21	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.83 mm Standard Deviation 21.34	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 12 (n=43,0,46,0,46,57,54,46,0,46,0)	41.72 mm Standard Deviation 23.11	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.65 mm Standard Deviation 23.47	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.80 mm Standard Deviation 19.13	25.37 mm Standard Deviation 20.01	24.20 mm Standard Deviation 18.74	38.22 mm Standard Deviation 23.33	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.76 mm Standard Deviation 24.90	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Physician Global Assessment (PGA) of Arthritis Week 16 (n=27,17,30,17,46,56,53,0,43,20,25)	29.93 mm Standard Deviation 19.58	48.59 mm Standard Deviation 20.92	26.97 mm Standard Deviation 23.53	44.59 mm Standard Deviation 21.99	29.74 mm Standard Deviation 20.31	24.39 mm Standard Deviation 19.14	21.09 mm Standard Deviation 19.71	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	25.74 mm Standard Deviation 15.96	28.70 mm Standard Deviation 22.76	34.00 mm Standard Deviation 20.65
Physician Global Assessment (PGA) of Arthritis Week 20 (n=27,16,29,16,45,52,53,0,44,19,25)	32.59 mm Standard Deviation 20.17	45.69 mm Standard Deviation 15.98	23.86 mm Standard Deviation 20.45	41.25 mm Standard Deviation 23.77	27.04 mm Standard Deviation 17.16	19.35 mm Standard Deviation 14.10	19.42 mm Standard Deviation 17.92	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	26.36 mm Standard Deviation 17.76	29.95 mm Standard Deviation 21.31	32.40 mm Standard Deviation 19.24

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=50 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=46 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=59 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 20 (n=27,16,28,16,44,51,53,0,44,19,25)	-25.44 mm Standard Deviation 17.89	-20.38 mm Standard Deviation 20.91	-33.29 mm Standard Deviation 28.80	-25.19 mm Standard Deviation 18.46	-38.55 mm Standard Deviation 21.77	-41.49 mm Standard Deviation 18.87	-47.11 mm Standard Deviation 23.87	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-36.86 mm Standard Deviation 20.07	-32.89 mm Standard Deviation 19.37	-31.56 mm Standard Deviation 24.08
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 24 (n=24,15,27,15,42,54,51,0,40,20,24)	-24.38 mm Standard Deviation 13.92	-24.87 mm Standard Deviation 25.37	-34.78 mm Standard Deviation 32.39	-33.73 mm Standard Deviation 17.12	-35.55 mm Standard Deviation 24.81	-41.59 mm Standard Deviation 18.94	-47.12 mm Standard Deviation 23.42	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-35.83 mm Standard Deviation 22.06	-39.80 mm Standard Deviation 24.35	-35.13 mm Standard Deviation 23.70
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 16 (n=27,17,29,17,45,55,53,0,43,20,25)	-28.11 mm Standard Deviation 19.93	-18.59 mm Standard Deviation 24.63	-31.24 mm Standard Deviation 31.83	-23.59 mm Standard Deviation 17.14	-35.60 mm Standard Deviation 22.92	-37.87 mm Standard Deviation 21.09	-44.66 mm Standard Deviation 26.28	NA mm Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-37.28 mm Standard Deviation 19.72	-35.15 mm Standard Deviation 25.29	-29.96 mm Standard Deviation 23.75
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 2 (n=54,0,50,0,46,59,57,53,0,57,0)	-9.83 mm Standard Deviation 18.32	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-14.24 mm Standard Deviation 19.94	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-14.93 mm Standard Deviation 22.19	-21.14 mm Standard Deviation 20.74	-22.21 mm Standard Deviation 26.01	-15.19 mm Standard Deviation 19.07	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.00 mm Standard Deviation 21.96	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 4 (n=50,0,46,0,45,57,55,49,0,53,0)	-14.24 mm Standard Deviation 18.08	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-21.93 mm Standard Deviation 22.49	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-22.24 mm Standard Deviation 21.63	-26.61 mm Standard Deviation 23.51	-36.24 mm Standard Deviation 26.36	-18.65 mm Standard Deviation 23.07	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-12.47 mm Standard Deviation 25.24	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 6 (n=48,0,47,0,44,58,55,48,0,52,0)	-22.10 mm Standard Deviation 22.45	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-26.70 mm Standard Deviation 23.32	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-26.36 mm Standard Deviation 21.04	-30.48 mm Standard Deviation 22.57	-38.24 mm Standard Deviation 27.62	-23.44 mm Standard Deviation 21.38	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.38 mm Standard Deviation 27.00	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 8 (n=47,0,47,0,46,56,54,47,0,46,0)	-21.72 mm Standard Deviation 21.14	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-25.53 mm Standard Deviation 24.00	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-33.48 mm Standard Deviation 22.13	-31.88 mm Standard Deviation 21.14	-41.04 mm Standard Deviation 26.88	-24.45 mm Standard Deviation 21.70	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-20.22 mm Standard Deviation 25.40	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 10 (n=46,0,48,0,45,56,53,45,0,46,0)	-20.04 mm Standard Deviation 22.75	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-23.31 mm Standard Deviation 24.67	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-32.20 mm Standard Deviation 23.25	-36.93 mm Standard Deviation 23.90	-42.70 mm Standard Deviation 25.85	-23.31 mm Standard Deviation 24.37	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-19.41 mm Standard Deviation 24.91	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 12 (n=43,0,46,0,45,56,54,46,0,46,0)	-19.33 mm Standard Deviation 20.91	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-24.57 mm Standard Deviation 23.98	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-35.84 mm Standard Deviation 20.73	-36.50 mm Standard Deviation 22.13	-42.04 mm Standard Deviation 24.60	-25.74 mm Standard Deviation 23.17	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-19.48 mm Standard Deviation 27.84	NA mm Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
C-Reactive Protein (CRP) Week 2 (n=53,0,51,0,48,60,57,52,0,56,0)	16.09 mg/L Standard Deviation 17.96	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.63 mg/L Standard Deviation 16.13	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.33 mg/L Standard Deviation 17.71	4.37 mg/L Standard Deviation 5.98	6.18 mg/L Standard Deviation 9.45	9.54 mg/L Standard Deviation 13.93	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.14 mg/L Standard Deviation 36.74	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Week 4 (n=50,0,48,0,45,57,53,49,0,53,0)	16.81 mg/L Standard Deviation 19.66	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.33 mg/L Standard Deviation 13.20	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.32 mg/L Standard Deviation 10.20	3.15 mg/L Standard Deviation 5.93	5.04 mg/L Standard Deviation 7.15	13.74 mg/L Standard Deviation 19.51	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.69 mg/L Standard Deviation 35.34	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Baseline (n=54,0,51,0,49,61,57,53,0,59,0)	21.39 mg/L Standard Deviation 22.17	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.22 mg/L Standard Deviation 19.53	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	24.51 mg/L Standard Deviation 30.39	16.66 mg/L Standard Deviation 16.85	21.70 mg/L Standard Deviation 33.01	20.09 mg/L Standard Deviation 23.47	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.53 mg/L Standard Deviation 27.07	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Week 6 (n=47,0,48,0,45,58,55,48,0,52,0)	15.47 mg/L Standard Deviation 16.19	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.76 mg/L Standard Deviation 12.52	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.73 mg/L Standard Deviation 9.80	4.00 mg/L Standard Deviation 7.25	4.43 mg/L Standard Deviation 6.21	15.47 mg/L Standard Deviation 21.75	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.13 mg/L Standard Deviation 33.02	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Week 8 (n=47,0,48,0,47,56,53,47,0,45,0)	21.80 mg/L Standard Deviation 33.09	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.61 mg/L Standard Deviation 26.98	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.22 mg/L Standard Deviation 11.35	3.52 mg/L Standard Deviation 5.82	4.50 mg/L Standard Deviation 7.80	13.60 mg/L Standard Deviation 18.86	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.06 mg/L Standard Deviation 33.94	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Week 10 (n=46,0,48,0,46,57,52,45,0,46,0)	15.89 mg/L Standard Deviation 21.85	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.20 mg/L Standard Deviation 12.04	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.49 mg/L Standard Deviation 10.77	2.34 mg/L Standard Deviation 1.90	3.14 mg/L Standard Deviation 4.45	14.31 mg/L Standard Deviation 18.37	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.87 mg/L Standard Deviation 36.82	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Week 12 (n=43,0,46,0,45,54,52,45,0,45,0)	16.89 mg/L Standard Deviation 21.34	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.23 mg/L Standard Deviation 12.64	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.13 mg/L Standard Deviation 12.01	3.12 mg/L Standard Deviation 3.48	3.62 mg/L Standard Deviation 3.88	14.53 mg/L Standard Deviation 20.30	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.00 mg/L Standard Deviation 52.65	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
C-Reactive Protein (CRP) Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)	11.64 mg/L Standard Deviation 15.98	9.86 mg/L Standard Deviation 18.85	7.64 mg/L Standard Deviation 11.06	9.21 mg/L Standard Deviation 12.03	8.03 mg/L Standard Deviation 16.57	4.65 mg/L Standard Deviation 7.38	4.50 mg/L Standard Deviation 7.05	NA mg/L Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	5.73 mg/L Standard Deviation 7.66	21.98 mg/L Standard Deviation 28.43	6.04 mg/L Standard Deviation 7.33
C-Reactive Protein (CRP) Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)	8.90 mg/L Standard Deviation 7.91	4.02 mg/L Standard Deviation 3.32	7.32 mg/L Standard Deviation 8.75	7.20 mg/L Standard Deviation 12.14	4.72 mg/L Standard Deviation 4.57	2.85 mg/L Standard Deviation 3.81	5.34 mg/L Standard Deviation 9.65	NA mg/L Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	6.82 mg/L Standard Deviation 9.21	17.89 mg/L Standard Deviation 15.34	4.65 mg/L Standard Deviation 5.85
C-Reactive Protein (CRP) Week 24 (n=24,16,28,15,41,55,52,0,40,20,24)	12.41 mg/L Standard Deviation 13.51	10.51 mg/L Standard Deviation 18.33	10.02 mg/L Standard Deviation 15.12	5.74 mg/L Standard Deviation 6.42	6.31 mg/L Standard Deviation 7.79	5.65 mg/L Standard Deviation 10.51	2.51 mg/L Standard Deviation 2.50	NA mg/L Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	6.01 mg/L Standard Deviation 9.02	18.35 mg/L Standard Deviation 17.49	5.39 mg/L Standard Deviation 8.57

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=52 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 10 (n=46,0,48,0,46,57,52,45,0,46,0)	-7.41 mg/L Standard Deviation 17.95	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.97 mg/L Standard Deviation 16.96	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.80 mg/L Standard Deviation 30.17	-14.46 mg/L Standard Deviation 17.28	-19.68 mg/L Standard Deviation 33.41	-7.02 mg/L Standard Deviation 21.73	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.60 mg/L Standard Deviation 26.07	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 24 (n=24,16,28,15,41,55,52,0,40,20,24)	-4.19 mg/L Standard Deviation 14.90	-18.87 mg/L Standard Deviation 31.77	-2.25 mg/L Standard Deviation 20.44	-17.13 mg/L Standard Deviation 26.10	-19.43 mg/L Standard Deviation 29.21	-10.50 mg/L Standard Deviation 19.53	-20.43 mg/L Standard Deviation 33.71	NA mg/L Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-16.00 mg/L Standard Deviation 25.94	-4.18 mg/L Standard Deviation 21.73	-19.77 mg/L Standard Deviation 30.92
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 2 (n=53,0,51,0,48,60,57,52,0,56,0)	-5.59 mg/L Standard Deviation 12.00	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.59 mg/L Standard Deviation 11.53	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-15.32 mg/L Standard Deviation 25.84	-11.77 mg/L Standard Deviation 16.87	-15.53 mg/L Standard Deviation 28.18	-10.82 mg/L Standard Deviation 17.70	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.63 mg/L Standard Deviation 20.15	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 4 (n=50,0,48,0,45,57,53,49,0,53,0)	-5.35 mg/L Standard Deviation 15.23	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.84 mg/L Standard Deviation 13.87	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-16.47 mg/L Standard Deviation 27.76	-13.88 mg/L Standard Deviation 15.71	-16.29 mg/L Standard Deviation 32.42	-6.73 mg/L Standard Deviation 19.31	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.68 mg/L Standard Deviation 30.09	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 6 (n=47,0,48,0,45,58,55,48,0,52,0)	-7.04 mg/L Standard Deviation 17.82	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.46 mg/L Standard Deviation 15.68	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-18.20 mg/L Standard Deviation 25.77	-13.09 mg/L Standard Deviation 18.13	-17.78 mg/L Standard Deviation 31.72	-5.64 mg/L Standard Deviation 21.52	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.13 mg/L Standard Deviation 24.29	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 8 (n=47,0,48,0,47,56,53,47,0,45,0)	-0.88 mg/L Standard Deviation 34.23	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.61 mg/L Standard Deviation 29.34	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-17.68 mg/L Standard Deviation 26.27	-12.70 mg/L Standard Deviation 16.84	-18.12 mg/L Standard Deviation 33.97	-7.65 mg/L Standard Deviation 22.81	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.68 mg/L Standard Deviation 25.86	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 12 (n=43,0,46,0,45,54,52,45,0,45,0)	-5.62 mg/L Standard Deviation 19.89	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.79 mg/L Standard Deviation 18.44	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-15.67 mg/L Standard Deviation 27.63	-13.28 mg/L Standard Deviation 16.77	-17.12 mg/L Standard Deviation 29.92	-7.29 mg/L Standard Deviation 23.48	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	13.27 mg/L Standard Deviation 45.76	NA mg/L Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)	-5.08 mg/L Standard Deviation 21.05	-21.54 mg/L Standard Deviation 34.58	-4.63 mg/L Standard Deviation 17.15	-12.89 mg/L Standard Deviation 23.41	-15.57 mg/L Standard Deviation 28.20	-12.54 mg/L Standard Deviation 19.07	-18.41 mg/L Standard Deviation 33.75	NA mg/L Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-16.19 mg/L Standard Deviation 25.25	-0.54 mg/L Standard Deviation 19.76	-18.29 mg/L Standard Deviation 27.14
Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)	-8.39 mg/L Standard Deviation 13.06	-25.36 mg/L Standard Deviation 28.34	-5.33 mg/L Standard Deviation 17.10	-14.73 mg/L Standard Deviation 25.04	-19.21 mg/L Standard Deviation 28.52	-14.08 mg/L Standard Deviation 17.85	-17.67 mg/L Standard Deviation 35.23	NA mg/L Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-15.09 mg/L Standard Deviation 25.59	-6.87 mg/L Standard Deviation 17.01	-19.68 mg/L Standard Deviation 30.10

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; 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 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=58 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 2 (n=54,0,51,0,48,60,57,53,0,56,0)	1.45 units on a scale Standard Deviation 0.66	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.28 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.22 units on a scale Standard Deviation 0.73	1.22 units on a scale Standard Deviation 0.68	1.26 units on a scale Standard Deviation 0.66	1.23 units on a scale Standard Deviation 0.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.49 units on a scale Standard Deviation 0.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline (n=54,0,51,0,49,60,57,53,0,58,0)	1.57 units on a scale Standard Deviation 0.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.53 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.40 units on a scale Standard Deviation 0.73	1.49 units on a scale Standard Deviation 0.74	1.62 units on a scale Standard Deviation 0.70	1.44 units on a scale Standard Deviation 0.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.54 units on a scale Standard Deviation 0.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 4 (n=50,0,46,0,45,57,55,49,0,53,0)	1.45 units on a scale Standard Deviation 0.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.23 units on a scale Standard Deviation 0.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.14 units on a scale Standard Deviation 0.67	1.04 units on a scale Standard Deviation 0.74	1.08 units on a scale Standard Deviation 0.68	1.31 units on a scale Standard Deviation 0.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.38 units on a scale Standard Deviation 0.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 6 (n=48,0,48,0,44,59,54,48,0,52,0)	1.30 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.24 units on a scale Standard Deviation 0.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.14 units on a scale Standard Deviation 0.71	1.00 units on a scale Standard Deviation 0.72	0.93 units on a scale Standard Deviation 0.71	1.19 units on a scale Standard Deviation 0.83	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.31 units on a scale Standard Deviation 0.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 8 (n=47,0,48,0,46,57,54,47,0,46,0)	1.29 units on a scale Standard Deviation 0.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.12 units on a scale Standard Deviation 0.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.99 units on a scale Standard Deviation 0.65	0.97 units on a scale Standard Deviation 0.75	0.86 units on a scale Standard Deviation 0.68	1.12 units on a scale Standard Deviation 0.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.24 units on a scale Standard Deviation 0.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 10 (n=46,0,49,0,46,57,53,45,0,46,0)	1.25 units on a scale Standard Deviation 0.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.20 units on a scale Standard Deviation 0.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.94 units on a scale Standard Deviation 0.75	0.86 units on a scale Standard Deviation 0.68	0.81 units on a scale Standard Deviation 0.71	1.18 units on a scale Standard Deviation 0.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.24 units on a scale Standard Deviation 0.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 12 (n=44,0,46,0,46,57,54,46,0,46,0)	1.28 units on a scale Standard Deviation 0.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.09 units on a scale Standard Deviation 0.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.94 units on a scale Standard Deviation 0.73	0.81 units on a scale Standard Deviation 0.68	0.78 units on a scale Standard Deviation 0.66	1.13 units on a scale Standard Deviation 0.74	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.24 units on a scale Standard Deviation 0.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 16 (n=27,17,29,17,46,56,54,0,43,20,25)	1.02 units on a scale Standard Deviation 0.72	1.34 units on a scale Standard Deviation 0.81	1.04 units on a scale Standard Deviation 0.79	1.31 units on a scale Standard Deviation 0.72	0.91 units on a scale Standard Deviation 0.74	0.85 units on a scale Standard Deviation 0.72	0.73 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.95 units on a scale Standard Deviation 0.67	1.28 units on a scale Standard Deviation 0.66	0.86 units on a scale Standard Deviation 0.82
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 20 (n=27,16,29,15,45,53,52,0,44,19,25)	1.05 units on a scale Standard Deviation 0.71	1.20 units on a scale Standard Deviation 0.65	1.00 units on a scale Standard Deviation 0.78	1.04 units on a scale Standard Deviation 0.67	0.96 units on a scale Standard Deviation 0.76	0.80 units on a scale Standard Deviation 0.75	0.71 units on a scale Standard Deviation 0.65	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.95 units on a scale Standard Deviation 0.71	1.30 units on a scale Standard Deviation 0.69	0.82 units on a scale Standard Deviation 0.78
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 24 (n=24,16,29,15,43,55,52,0,40,20,24)	1.02 units on a scale Standard Deviation 0.65	1.29 units on a scale Standard Deviation 0.66	0.96 units on a scale Standard Deviation 0.83	1.00 units on a scale Standard Deviation 0.74	0.95 units on a scale Standard Deviation 0.81	0.81 units on a scale Standard Deviation 0.73	0.79 units on a scale Standard Deviation 0.67	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.93 units on a scale Standard Deviation 0.65	1.20 units on a scale Standard Deviation 0.81	0.69 units on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=59 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 4 (n=50,0,46,0,45,56,55,49,0,52,0)	-0.14 units on a scale Standard Deviation 0.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.30 units on a scale Standard Deviation 0.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.26 units on a scale Standard Deviation 0.51	-0.44 units on a scale Standard Deviation 0.60	-0.55 units on a scale Standard Deviation 0.61	-0.14 units on a scale Standard Deviation 0.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.09 units on a scale Standard Deviation 0.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 2 (n=54,0,51,0,48,59,57,53,0,56,0)	-0.13 units on a scale Standard Deviation 0.41	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.25 units on a scale Standard Deviation 0.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.16 units on a scale Standard Deviation 0.47	-0.27 units on a scale Standard Deviation 0.37	-0.36 units on a scale Standard Deviation 0.63	-0.21 units on a scale Standard Deviation 0.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.04 units on a scale Standard Deviation 0.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 6 (n=48,0,48,0,44,58,54,48,0,51,0)	-0.31 units on a scale Standard Deviation 0.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.28 units on a scale Standard Deviation 0.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.30 units on a scale Standard Deviation 0.56	-0.49 units on a scale Standard Deviation 0.49	-0.68 units on a scale Standard Deviation 0.73	-0.25 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.17 units on a scale Standard Deviation 0.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 8 (n=47,0,48,0,46,56,54,47,0,45,0)	-0.34 units on a scale Standard Deviation 0.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.40 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.37 units on a scale Standard Deviation 0.61	-0.54 units on a scale Standard Deviation 0.60	-0.73 units on a scale Standard Deviation 0.66	-0.32 units on a scale Standard Deviation 0.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.24 units on a scale Standard Deviation 0.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 10 (n=46,0,49,0,46,56,53,45,0,45,0)	-0.36 units on a scale Standard Deviation 0.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.34 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.45 units on a scale Standard Deviation 0.68	-0.59 units on a scale Standard Deviation 0.56	-0.78 units on a scale Standard Deviation 0.67	-0.29 units on a scale Standard Deviation 0.66	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.24 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 12 (n=44,0,46,0,46,56,54,46,0,45,0)	-0.30 units on a scale Standard Deviation 0.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.42 units on a scale Standard Deviation 0.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.43 units on a scale Standard Deviation 0.65	-0.63 units on a scale Standard Deviation 0.58	-0.81 units on a scale Standard Deviation 0.71	-0.32 units on a scale Standard Deviation 0.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.24 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 16 (n=27,17,29,17,46,55,54,0,43,20,24)	-0.54 units on a scale Standard Deviation 0.63	-0.29 units on a scale Standard Deviation 0.58	-0.46 units on a scale Standard Deviation 0.55	-0.31 units on a scale Standard Deviation 0.54	-0.47 units on a scale Standard Deviation 0.66	-0.60 units on a scale Standard Deviation 0.68	-0.86 units on a scale Standard Deviation 0.67	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-0.49 units on a scale Standard Deviation 0.56	-0.33 units on a scale Standard Deviation 0.52	-0.55 units on a scale Standard Deviation 0.65
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 20 (n=27,16,29,15,45,52,52,0,44,19,24)	-0.51 units on a scale Standard Deviation 0.73	-0.35 units on a scale Standard Deviation 0.57	-0.49 units on a scale Standard Deviation 0.56	-0.51 units on a scale Standard Deviation 0.69	-0.42 units on a scale Standard Deviation 0.66	-0.62 units on a scale Standard Deviation 0.67	-0.87 units on a scale Standard Deviation 0.68	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-0.50 units on a scale Standard Deviation 0.66	-0.28 units on a scale Standard Deviation 0.39	-0.59 units on a scale Standard Deviation 0.62
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 24 (n=24,16,29,15,43,54,52,0,40,20,23)	-0.58 units on a scale Standard Deviation 0.67	-0.26 units on a scale Standard Deviation 0.62	-0.53 units on a scale Standard Deviation 0.59	-0.56 units on a scale Standard Deviation 0.75	-0.45 units on a scale Standard Deviation 0.75	-0.63 units on a scale Standard Deviation 0.66	-0.82 units on a scale Standard Deviation 0.67	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-0.53 units on a scale Standard Deviation 0.66	-0.41 units on a scale Standard Deviation 0.60	-0.72 units on a scale Standard Deviation 0.55

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 = remission.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=59 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=52 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=58 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 4 (n=50,0,47,0,45,57,53,49,0,53,0)	4.77 units on a scale Standard Deviation 1.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.16 units on a scale Standard Deviation 1.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.36 units on a scale Standard Deviation 1.00	3.71 units on a scale Standard Deviation 1.15	3.71 units on a scale Standard Deviation 1.09	4.40 units on a scale Standard Deviation 1.45	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.01 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 8 (n=47,0,48,0,47,56,53,47,0,45,0)	4.52 units on a scale Standard Deviation 1.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.00 units on a scale Standard Deviation 1.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.01 units on a scale Standard Deviation 1.25	3.37 units on a scale Standard Deviation 1.06	3.13 units on a scale Standard Deviation 1.21	4.23 units on a scale Standard Deviation 1.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.84 units on a scale Standard Deviation 1.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Baseline (n=54,0,51,0,47,59,57,52,0,58,0)	5.51 units on a scale Standard Deviation 0.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.37 units on a scale Standard Deviation 0.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.58 units on a scale Standard Deviation 0.88	5.46 units on a scale Standard Deviation 0.82	5.46 units on a scale Standard Deviation 0.96	5.35 units on a scale Standard Deviation 0.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.62 units on a scale Standard Deviation 0.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)	3.63 units on a scale Standard Deviation 1.35	4.47 units on a scale Standard Deviation 1.13	3.30 units on a scale Standard Deviation 1.07	4.75 units on a scale Standard Deviation 1.16	3.55 units on a scale Standard Deviation 1.41	3.06 units on a scale Standard Deviation 1.13	2.92 units on a scale Standard Deviation 1.14	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	3.32 units on a scale Standard Deviation 1.13	3.93 units on a scale Standard Deviation 1.22	4.01 units on a scale Standard Deviation 1.08
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 2 (n=53,0,51,0,48,60,57,52,0,56,0)	4.96 units on a scale Standard Deviation 1.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.60 units on a scale Standard Deviation 1.23	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.63 units on a scale Standard Deviation 1.15	4.16 units on a scale Standard Deviation 0.96	4.32 units on a scale Standard Deviation 1.09	4.59 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.24 units on a scale Standard Deviation 1.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 6 (n=47,0,48,0,45,58,55,48,0,52,0)	4.42 units on a scale Standard Deviation 1.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.02 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.16 units on a scale Standard Deviation 1.06	3.45 units on a scale Standard Deviation 1.11	3.34 units on a scale Standard Deviation 1.29	4.19 units on a scale Standard Deviation 1.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.92 units on a scale Standard Deviation 1.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)	3.94 units on a scale Standard Deviation 1.40	4.14 units on a scale Standard Deviation 0.92	3.26 units on a scale Standard Deviation 1.00	4.44 units on a scale Standard Deviation 1.32	3.68 units on a scale Standard Deviation 1.38	2.85 units on a scale Standard Deviation 1.10	2.93 units on a scale Standard Deviation 1.20	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	3.33 units on a scale Standard Deviation 1.17	3.97 units on a scale Standard Deviation 1.08	3.78 units on a scale Standard Deviation 1.11
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 10 (n=46,0,48,0,46,57,52,45,0,46,0)	4.37 units on a scale Standard Deviation 1.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.92 units on a scale Standard Deviation 1.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.80 units on a scale Standard Deviation 1.21	3.06 units on a scale Standard Deviation 0.98	3.05 units on a scale Standard Deviation 1.18	4.12 units on a scale Standard Deviation 1.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.83 units on a scale Standard Deviation 1.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 12 (n=43,0,46,0,45,54,52,45,0,45,0)	4.57 units on a scale Standard Deviation 1.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.96 units on a scale Standard Deviation 1.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.76 units on a scale Standard Deviation 1.38	3.11 units on a scale Standard Deviation 1.18	3.06 units on a scale Standard Deviation 1.13	4.13 units on a scale Standard Deviation 1.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.83 units on a scale Standard Deviation 1.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 24 (n=24,16,28,15,41,55,52,0,39,20,24)	4.11 units on a scale Standard Deviation 1.26	4.42 units on a scale Standard Deviation 1.12	3.11 units on a scale Standard Deviation 1.25	4.33 units on a scale Standard Deviation 1.28	3.64 units on a scale Standard Deviation 1.22	2.92 units on a scale Standard Deviation 1.03	2.82 units on a scale Standard Deviation 1.17	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	3.40 units on a scale Standard Deviation 1.17	3.96 units on a scale Standard Deviation 1.36	3.61 units on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints 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 and \> 3.2 to 5.1 implied moderate to high disease activity, and \< 2.6 = remission.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=46 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=58 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=51 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=55 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 2 (n=53,0,51,0,46,58,57,51,0,55,0)	-0.55 units on a scale Standard Deviation 0.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.77 units on a scale Standard Deviation 0.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.95 units on a scale Standard Deviation 0.85	-1.28 units on a scale Standard Deviation 0.99	-1.14 units on a scale Standard Deviation 1.03	-0.73 units on a scale Standard Deviation 0.90	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.37 units on a scale Standard Deviation 0.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 6 (n=47,0,48,0,43,56,55,47,0,51,0)	-1.17 units on a scale Standard Deviation 1.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.31 units on a scale Standard Deviation 1.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.50 units on a scale Standard Deviation 0.95	-1.99 units on a scale Standard Deviation 1.25	-2.14 units on a scale Standard Deviation 1.44	-1.12 units on a scale Standard Deviation 1.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.73 units on a scale Standard Deviation 1.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 4 (n=50,0,47,0,43,56,53,48,0,52,0)	-0.75 units on a scale Standard Deviation 1.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.17 units on a scale Standard Deviation 1.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.26 units on a scale Standard Deviation 0.95	-1.75 units on a scale Standard Deviation 1.23	-1.72 units on a scale Standard Deviation 1.27	-0.91 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.63 units on a scale Standard Deviation 0.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 12 (n=43,0,46,0,43,53,52,44,0,44,0)	-1.04 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.36 units on a scale Standard Deviation 1.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.87 units on a scale Standard Deviation 1.29	-2.29 units on a scale Standard Deviation 1.25	-2.37 units on a scale Standard Deviation 1.26	-1.18 units on a scale Standard Deviation 1.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.80 units on a scale Standard Deviation 1.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 16 (n=27,17,30,17,44,54,51,0,43,20,24)	-1.83 units on a scale Standard Deviation 1.25	-1.36 units on a scale Standard Deviation 1.07	-1.80 units on a scale Standard Deviation 1.19	-0.95 units on a scale Standard Deviation 0.96	-2.05 units on a scale Standard Deviation 1.33	-2.41 units on a scale Standard Deviation 1.20	-2.49 units on a scale Standard Deviation 1.31	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-2.01 units on a scale Standard Deviation 1.12	-1.73 units on a scale Standard Deviation 1.19	-1.54 units on a scale Standard Deviation 1.16
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 8 (n=47,0,48,0,45,54,53,46,0,44,0)	-1.09 units on a scale Standard Deviation 1.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.34 units on a scale Standard Deviation 1.23	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.60 units on a scale Standard Deviation 1.09	-2.05 units on a scale Standard Deviation 1.13	-2.31 units on a scale Standard Deviation 1.44	-1.08 units on a scale Standard Deviation 1.23	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.84 units on a scale Standard Deviation 1.14	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 10 (n=46,0,48,0,44,56,52,44,0,45,0)	-1.24 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.43 units on a scale Standard Deviation 1.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.87 units on a scale Standard Deviation 1.18	-2.40 units on a scale Standard Deviation 1.12	-2.41 units on a scale Standard Deviation 1.25	-1.23 units on a scale Standard Deviation 1.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.76 units on a scale Standard Deviation 1.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 20 (n=26,16,29,16,43,52,52,0,43,18,24)	-1.52 units on a scale Standard Deviation 1.39	-1.61 units on a scale Standard Deviation 1.23	-1.96 units on a scale Standard Deviation 1.18	-1.25 units on a scale Standard Deviation 1.13	-1.96 units on a scale Standard Deviation 1.33	-2.54 units on a scale Standard Deviation 1.17	-2.52 units on a scale Standard Deviation 1.40	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-2.01 units on a scale Standard Deviation 1.07	-1.77 units on a scale Standard Deviation 0.91	-1.76 units on a scale Standard Deviation 1.27
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET Week 24 (n=24,16,28,15,39,54,52,0,39,20,23)	-1.27 units on a scale Standard Deviation 1.22	-1.33 units on a scale Standard Deviation 1.36	-2.08 units on a scale Standard Deviation 1.34	-1.28 units on a scale Standard Deviation 1.02	-2.07 units on a scale Standard Deviation 1.24	-2.51 units on a scale Standard Deviation 1.20	-2.62 units on a scale Standard Deviation 1.47	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-1.94 units on a scale Standard Deviation 1.29	-1.71 units on a scale Standard Deviation 1.26	-2.04 units on a scale Standard Deviation 1.43

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implies low disease activity and \> 3.2 to 5.1 implies moderate to high disease activity, and \< 2.6 = remission.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=50 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=47 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=54 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=51 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Baseline (n=49,0,49,0,47,59,54,51,0,56,0)	6.51 units on a scale Standard Deviation 0.90	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.35 units on a scale Standard Deviation 0.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.57 units on a scale Standard Deviation 0.87	6.46 units on a scale Standard Deviation 0.85	6.46 units on a scale Standard Deviation 0.95	6.30 units on a scale Standard Deviation 0.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.56 units on a scale Standard Deviation 0.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 2 (n=51,0,50,0,47,60,54,51,0,53,0)	5.92 units on a scale Standard Deviation 1.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.57 units on a scale Standard Deviation 1.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.61 units on a scale Standard Deviation 1.34	5.20 units on a scale Standard Deviation 1.07	5.20 units on a scale Standard Deviation 1.29	5.53 units on a scale Standard Deviation 1.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.04 units on a scale Standard Deviation 1.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 4 (n=49,0,46,0,46,57,53,46,0,51,0)	5.73 units on a scale Standard Deviation 1.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.10 units on a scale Standard Deviation 1.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.23 units on a scale Standard Deviation 1.09	4.69 units on a scale Standard Deviation 1.31	4.46 units on a scale Standard Deviation 1.43	5.22 units on a scale Standard Deviation 1.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.70 units on a scale Standard Deviation 1.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 6 (n=46,0,47,0,45,58,54,47,0,51,0)	5.36 units on a scale Standard Deviation 1.10	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.91 units on a scale Standard Deviation 1.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.90 units on a scale Standard Deviation 1.19	4.33 units on a scale Standard Deviation 1.32	4.02 units on a scale Standard Deviation 1.57	4.99 units on a scale Standard Deviation 1.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.64 units on a scale Standard Deviation 1.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 8 (n=47,0,48,0,47,56,54,46,0,44,0)	5.31 units on a scale Standard Deviation 1.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.89 units on a scale Standard Deviation 1.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.70 units on a scale Standard Deviation 1.24	4.22 units on a scale Standard Deviation 1.18	3.80 units on a scale Standard Deviation 1.45	5.01 units on a scale Standard Deviation 1.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.56 units on a scale Standard Deviation 1.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 10 (n=46,0,49,0,45,56,53,43,0,44,0)	5.22 units on a scale Standard Deviation 1.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.81 units on a scale Standard Deviation 1.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.50 units on a scale Standard Deviation 1.31	3.93 units on a scale Standard Deviation 1.17	3.71 units on a scale Standard Deviation 1.31	4.98 units on a scale Standard Deviation 1.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.54 units on a scale Standard Deviation 1.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 12 (n=44,0,46,0,46,56,53,45,0,45,0)	5.41 units on a scale Standard Deviation 1.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.78 units on a scale Standard Deviation 1.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.37 units on a scale Standard Deviation 1.43	3.95 units on a scale Standard Deviation 1.38	3.77 units on a scale Standard Deviation 1.32	5.00 units on a scale Standard Deviation 1.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.39 units on a scale Standard Deviation 1.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 16 (n=27,17,30,17,45,55,54,0,42,20,24)	4.39 units on a scale Standard Deviation 1.33	5.36 units on a scale Standard Deviation 1.23	3.96 units on a scale Standard Deviation 1.31	5.70 units on a scale Standard Deviation 1.22	4.25 units on a scale Standard Deviation 1.47	3.86 units on a scale Standard Deviation 1.36	3.63 units on a scale Standard Deviation 1.39	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	4.08 units on a scale Standard Deviation 1.19	4.53 units on a scale Standard Deviation 1.34	4.95 units on a scale Standard Deviation 1.30
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 20 (n=26,16,29,16,45,51,52,0,43,19,24)	4.76 units on a scale Standard Deviation 1.50	5.22 units on a scale Standard Deviation 0.93	4.08 units on a scale Standard Deviation 1.30	5.31 units on a scale Standard Deviation 1.37	4.47 units on a scale Standard Deviation 1.47	3.67 units on a scale Standard Deviation 1.39	3.54 units on a scale Standard Deviation 1.29	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	4.04 units on a scale Standard Deviation 1.35	4.47 units on a scale Standard Deviation 1.50	4.62 units on a scale Standard Deviation 1.27
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 24 (n=24,16,29,15,43,54,51,0,38,20,23)	4.87 units on a scale Standard Deviation 1.43	5.27 units on a scale Standard Deviation 1.42	3.72 units on a scale Standard Deviation 1.58	5.19 units on a scale Standard Deviation 1.23	4.33 units on a scale Standard Deviation 1.40	3.62 units on a scale Standard Deviation 1.26	3.61 units on a scale Standard Deviation 1.31	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	4.22 units on a scale Standard Deviation 1.26	4.51 units on a scale Standard Deviation 1.41	4.28 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR \[mm/hour\] and 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 implies low disease activity and \> 3.2 to 5.1 implies moderate to high disease activity, and \< 2.6 = remission.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=48 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=49 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=16 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=45 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=58 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=52 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=50 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=42 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=53 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=22 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 2 (n=48,0,49,0,45,58,52,50,0,53,0)	-0.56 units on a scale Standard Deviation 1.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.81 units on a scale Standard Deviation 1.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.98 units on a scale Standard Deviation 0.88	-1.32 units on a scale Standard Deviation 1.05	-1.27 units on a scale Standard Deviation 1.28	-0.82 units on a scale Standard Deviation 1.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.53 units on a scale Standard Deviation 1.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 4 (n=46,0,45,0,44,55,51,45,0,50,0)	-0.82 units on a scale Standard Deviation 1.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.29 units on a scale Standard Deviation 1.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.31 units on a scale Standard Deviation 0.89	-1.81 units on a scale Standard Deviation 1.32	-1.95 units on a scale Standard Deviation 1.50	-1.14 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.87 units on a scale Standard Deviation 1.09	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 6 (n=43,0,46,0,43,56,52,46,0,49,0)	-1.26 units on a scale Standard Deviation 1.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.41 units on a scale Standard Deviation 1.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.67 units on a scale Standard Deviation 0.97	-2.16 units on a scale Standard Deviation 1.40	-2.39 units on a scale Standard Deviation 1.58	-1.29 units on a scale Standard Deviation 1.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.97 units on a scale Standard Deviation 1.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 8 (n=43,0,46,0,45,54,52,45,0,42,0)	-1.30 units on a scale Standard Deviation 1.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.40 units on a scale Standard Deviation 1.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.84 units on a scale Standard Deviation 0.99	-2.28 units on a scale Standard Deviation 1.21	-2.63 units on a scale Standard Deviation 1.56	-1.29 units on a scale Standard Deviation 1.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.00 units on a scale Standard Deviation 1.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 10 (n=42,0,47,0,43,54,51,42,0,42,0)	-1.37 units on a scale Standard Deviation 1.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.48 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.05 units on a scale Standard Deviation 1.28	-2.55 units on a scale Standard Deviation 1.30	-2.78 units on a scale Standard Deviation 1.42	-1.37 units on a scale Standard Deviation 1.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.00 units on a scale Standard Deviation 1.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 12 (n=40,0,44,0,44,54,51,44,0,43,0)	-1.16 units on a scale Standard Deviation 1.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.52 units on a scale Standard Deviation 1.43	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.16 units on a scale Standard Deviation 1.32	-2.55 units on a scale Standard Deviation 1.46	-2.65 units on a scale Standard Deviation 1.41	-1.35 units on a scale Standard Deviation 1.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.17 units on a scale Standard Deviation 1.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 16 (n=25,15,29,16,43,53,52,0,41,20,22)	-1.97 units on a scale Standard Deviation 1.42	-1.51 units on a scale Standard Deviation 1.08	-2.06 units on a scale Standard Deviation 1.38	-1.18 units on a scale Standard Deviation 0.93	-2.30 units on a scale Standard Deviation 1.29	-2.63 units on a scale Standard Deviation 1.37	-2.83 units on a scale Standard Deviation 1.53	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-2.29 units on a scale Standard Deviation 1.15	-1.97 units on a scale Standard Deviation 1.28	-1.63 units on a scale Standard Deviation 0.93
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 20 (n=24,15,28,15,43,49,50,0,42,19,22)	-1.54 units on a scale Standard Deviation 1.58	-1.58 units on a scale Standard Deviation 1.34	-2.02 units on a scale Standard Deviation 1.37	-1.47 units on a scale Standard Deviation 1.15	-2.02 units on a scale Standard Deviation 1.34	-2.68 units on a scale Standard Deviation 1.29	-2.88 units on a scale Standard Deviation 1.46	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-2.33 units on a scale Standard Deviation 1.28	-2.03 units on a scale Standard Deviation 1.11	-1.91 units on a scale Standard Deviation 1.03
Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET Week 24 (n=22,15,28,14,41,52,49,0,37,20,21)	-1.33 units on a scale Standard Deviation 1.46	-1.58 units on a scale Standard Deviation 1.58	-2.38 units on a scale Standard Deviation 1.50	-1.51 units on a scale Standard Deviation 1.04	-2.24 units on a scale Standard Deviation 1.31	-2.79 units on a scale Standard Deviation 1.37	-2.78 units on a scale Standard Deviation 1.52	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-2.08 units on a scale Standard Deviation 1.32	-1.99 units on a scale Standard Deviation 1.27	-2.30 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of \>1.2 and a present score of \<=3.2; none: an improvement of \<=0.6 or \>0.6 to \<=1.2 with a present score of \>5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=51 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=50 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=47 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=54 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=51 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=53 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 4: None (n=49,0,46,0,46,57,53,46,0,51,0)	63.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.0 percentage of participants	29.8 percentage of participants	28.3 percentage of participants	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 6: Good (n=46,0,47,0,45,58,54,47,0,51,0)	2.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.2 percentage of participants	22.4 percentage of participants	29.6 percentage of participants	14.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 2: Good (n=51,0,50,0,47,60,54,51,0,53,0)	3.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.3 percentage of participants	3.3 percentage of participants	7.4 percentage of participants	3.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 2: Mod (n=51,0,50,0,47,60,54,51,0,53,0)	13.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.9 percentage of participants	53.3 percentage of participants	42.6 percentage of participants	39.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 2: None (n=51,0,50,0,47,60,54,51,0,53,0)	76.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	68.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	59.6 percentage of participants	40.0 percentage of participants	46.3 percentage of participants	54.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	73.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 4: Good (n=49,0,46,0,46,57,53,46,0,51,0)	2.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.2 percentage of participants	14.0 percentage of participants	17.0 percentage of participants	10.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 4: Mod (n=49,0,46,0,46,57,53,46,0,51,0)	28.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	56.5 percentage of participants	52.6 percentage of participants	50.9 percentage of participants	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 6: Mod (n=46,0,47,0,45,58,54,47,0,51,0)	47.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	66.7 percentage of participants	53.4 percentage of participants	50.0 percentage of participants	42.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 6: None (n=46,0,47,0,45,58,54,47,0,51,0)	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.7 percentage of participants	20.7 percentage of participants	16.7 percentage of participants	40.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 8: Good (n=47,0,48,0,47,56,54,46,0,44,0)	6.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.5 percentage of participants	17.9 percentage of participants	37.0 percentage of participants	10.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 8: Mod (n=47,0,48,0,47,56,54,46,0,44,0)	44.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	68.1 percentage of participants	64.3 percentage of participants	40.7 percentage of participants	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 8: None (n=47,0,48,0,47,56,54,46,0,44,0)	40.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	19.1 percentage of participants	14.3 percentage of participants	18.5 percentage of participants	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	52.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 10: Good (n=46,0,49,0,45,56,53,43,0,44,0)	8.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.6 percentage of participants	25.0 percentage of participants	41.5 percentage of participants	9.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.3 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 10: Mod (n=46,0,49,0,45,56,53,43,0,44,0)	45.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	55.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	57.8 percentage of participants	60.7 percentage of participants	45.3 percentage of participants	46.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 10: None (n=46,0,49,0,45,56,53,43,0,44,0)	37.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.6 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.2 percentage of participants	10.7 percentage of participants	9.4 percentage of participants	41.9 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	47.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 12: Good (n=44,0,46,0,46,56,53,45,0,45,0)	9.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	15.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.7 percentage of participants	32.1 percentage of participants	37.7 percentage of participants	11.1 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 12: Mod (n=44,0,46,0,46,56,53,45,0,45,0)	31.8 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.5 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	54.3 percentage of participants	50.0 percentage of participants	47.2 percentage of participants	42.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.2 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 12: None (n=44,0,46,0,46,56,53,45,0,45,0)	50.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.0 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	19.6 percentage of participants	14.3 percentage of participants	11.3 percentage of participants	44.4 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.7 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 16: Good (n=27,17,30,17,45,55,54,0,42,20,24)	18.5 percentage of participants	5.9 percentage of participants	26.7 percentage of participants	5.9 percentage of participants	22.2 percentage of participants	32.7 percentage of participants	44.4 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	23.8 percentage of participants	20.0 percentage of participants	8.3 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 16: Mod (n=27,17,30,17,45,55,54,0,42,20,24)	44.4 percentage of participants	52.9 percentage of participants	50.0 percentage of participants	35.3 percentage of participants	60.0 percentage of participants	52.7 percentage of participants	40.7 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	61.9 percentage of participants	50.0 percentage of participants	54.2 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 16: None (n=27,17,30,17,45,55,54,0,42,20,24)	29.6 percentage of participants	29.4 percentage of participants	20.0 percentage of participants	52.9 percentage of participants	13.3 percentage of participants	10.9 percentage of participants	11.1 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	11.9 percentage of participants	30.0 percentage of participants	29.2 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 20: Good (n=26,16,29,16,45,51,52,0,43,19,24)	11.5 percentage of participants	0.0 percentage of participants	27.6 percentage of participants	0.0 percentage of participants	20.0 percentage of participants	37.3 percentage of participants	38.5 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	27.9 percentage of participants	26.3 percentage of participants	12.5 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 20: Mod (n=26,16,29,16,45,51,52,0,43,19,24)	42.3 percentage of participants	56.3 percentage of participants	55.2 percentage of participants	62.5 percentage of participants	48.9 percentage of participants	52.9 percentage of participants	48.1 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	60.5 percentage of participants	47.4 percentage of participants	62.5 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 20: None (n=26,16,29,16,45,51,52,0,43,19,24)	38.5 percentage of participants	37.5 percentage of participants	13.8 percentage of participants	31.3 percentage of participants	26.7 percentage of participants	5.9 percentage of participants	9.6 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	9.3 percentage of participants	26.3 percentage of participants	16.7 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 24: Good (n=24,16,29,15,43,54,51,0,38,20,23)	12.5 percentage of participants	12.5 percentage of participants	41.4 percentage of participants	6.7 percentage of participants	20.9 percentage of participants	38.9 percentage of participants	43.1 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	23.7 percentage of participants	20.0 percentage of participants	8.7 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 24: Mod (n=24,16,29,15,43,54,51,0,38,20,23)	37.5 percentage of participants	43.8 percentage of participants	41.4 percentage of participants	60.0 percentage of participants	58.1 percentage of participants	48.1 percentage of participants	45.1 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	57.9 percentage of participants	60.0 percentage of participants	65.2 percentage of participants
Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR) Week 24: None (n=24,16,29,15,43,54,51,0,38,20,23)	41.7 percentage of participants	37.5 percentage of participants	13.8 percentage of participants	26.7 percentage of participants	16.3 percentage of participants	9.3 percentage of participants	7.8 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	15.8 percentage of participants	20.0 percentage of participants	17.4 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=43 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=33 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=40 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=45 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=39 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=40 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=37 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 2 (n=43,0,33,0,40,45,39,40,0,37,0)	25.58 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.33 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	62.50 percentage of participants	71.11 percentage of participants	66.67 percentage of participants	40.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.70 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 4 (n=40,0,30,0,37,43,37,37,0,35,0)	30.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.33 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	62.16 percentage of participants	83.72 percentage of participants	62.16 percentage of participants	35.14 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.71 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 6 (n=39,0,30,0,39,44,37,36,0,34,0)	20.51 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.33 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	56.41 percentage of participants	79.55 percentage of participants	67.57 percentage of participants	30.56 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.88 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 8 (n=39,0,30,0,39,42,36,35,0,31,0)	25.64 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.67 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	66.67 percentage of participants	78.57 percentage of participants	75.00 percentage of participants	25.71 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.68 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 10 (n=38,0,30,0,38,43,34,33,0,30,0)	26.32 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	53.33 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	65.79 percentage of participants	90.70 percentage of participants	79.41 percentage of participants	21.21 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.33 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 12 (n=36,0,28,0,37,41,35,33,0,30,0)	22.22 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.86 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	62.16 percentage of participants	75.61 percentage of participants	68.57 percentage of participants	30.30 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.67 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)	48.1 percentage of participants	41.2 percentage of participants	53.3 percentage of participants	64.7 percentage of participants	69.6 percentage of participants	78.2 percentage of participants	82.4 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	67.4 percentage of participants	35.0 percentage of participants	68.0 percentage of participants
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)	46.2 percentage of participants	75.0 percentage of participants	58.6 percentage of participants	75.0 percentage of participants	68.9 percentage of participants	88.7 percentage of participants	76.9 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	67.4 percentage of participants	16.7 percentage of participants	72.0 percentage of participants
Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP) Week 24 (n=24,16,28,15,41,55,52,0,40,20,24)	33.3 percentage of participants	75.0 percentage of participants	46.4 percentage of participants	60.0 percentage of participants	65.9 percentage of participants	72.7 percentage of participants	84.6 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	72.5 percentage of participants	30.0 percentage of participants	66.7 percentage of participants

SECONDARY outcome

Timeframe: Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

DAS28-3 (CRP) defined remission was classified as a score of \<2.6.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=53 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=17 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=50 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=17 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=52 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=43 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 16 (n=27,17,30,17,46,55,51,0,43,20,25)	22.2 percentage of participants	5.9 percentage of participants	30.0 percentage of participants	5.9 percentage of participants	28.3 percentage of participants	36.4 percentage of participants	43.1 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	25.6 percentage of participants	15.0 percentage of participants	12.0 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 20 (n=26,16,29,16,45,53,52,0,43,18,25)	19.2 percentage of participants	6.3 percentage of participants	20.7 percentage of participants	6.3 percentage of participants	20.0 percentage of participants	43.4 percentage of participants	42.3 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	25.6 percentage of participants	5.6 percentage of participants	12.0 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 24 (n=24,16,28,15,41,55,52,0,39,20,24)	16.7 percentage of participants	6.3 percentage of participants	39.3 percentage of participants	6.7 percentage of participants	22.0 percentage of participants	36.4 percentage of participants	50.0 percentage of participants	NA percentage of participants Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	23.1 percentage of participants	15.0 percentage of participants	25.0 percentage of participants
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 2 (n=53,0,50,0,48,60,57,52,0,56,0)	1.89 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.17 percentage of participants	5.00 percentage of participants	7.02 percentage of participants	1.92 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 4 (n=50,0,46,0,45,57,53,49,0,53,0)	6.00 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.52 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.44 percentage of participants	17.54 percentage of participants	15.09 percentage of participants	12.24 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.89 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 6 (n=47,0,47,0,45,58,55,48,0,52,0)	8.51 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.77 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.89 percentage of participants	24.14 percentage of participants	32.73 percentage of participants	12.50 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.92 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 8 (n=47,0,47,0,47,56,53,47,0,45,0)	2.13 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.77 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	14.89 percentage of participants	21.43 percentage of participants	41.51 percentage of participants	12.77 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.44 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 10 (n=46,0,47,0,46,57,52,45,0,46,0)	10.87 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.51 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	21.74 percentage of participants	31.58 percentage of participants	38.46 percentage of participants	15.56 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.35 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) Week 12 (n=43,0,45,0,45,54,52,45,0,45,0)	9.30 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	8.89 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	24.44 percentage of participants	33.33 percentage of participants	40.38 percentage of participants	4.44 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.67 percentage of participants	NA percentage of participants Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

SF-36 is a standardized survey evaluating 8 domains (of 2 components \[C\]; physical \[Ph\] and mental \[Mn\]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical \[R-P\], role-emotional \[R-E\]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=15 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
36-Item Short-Form Health Survey (SF-36) Baseline: BP (n=54,0,51,0,49,61,57,53,0,59,0)	32.60 units on a scale Standard Deviation 7.89	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.41 units on a scale Standard Deviation 8.54	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.21 units on a scale Standard Deviation 7.30	33.48 units on a scale Standard Deviation 6.48	32.54 units on a scale Standard Deviation 7.25	32.23 units on a scale Standard Deviation 6.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.19 units on a scale Standard Deviation 8.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: Vit (n=54,0,51,0,49,61,57,53,0,59,0)	40.30 units on a scale Standard Deviation 10.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.46 units on a scale Standard Deviation 11.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.28 units on a scale Standard Deviation 10.95	38.94 units on a scale Standard Deviation 10.43	38.34 units on a scale Standard Deviation 10.70	36.42 units on a scale Standard Deviation 10.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.87 units on a scale Standard Deviation 9.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: Vit (n=44,0,46,0,45,57,54,45,0,46,0)	45.92 units on a scale Standard Deviation 10.27	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.37 units on a scale Standard Deviation 10.41	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.22 units on a scale Standard Deviation 10.15	48.59 units on a scale Standard Deviation 11.74	49.20 units on a scale Standard Deviation 11.73	44.88 units on a scale Standard Deviation 10.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.20 units on a scale Standard Deviation 11.23	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: R-E (n=44,0,46,0,45,57,53,45,0,46,0)	37.86 units on a scale Standard Deviation 10.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.03 units on a scale Standard Deviation 13.74	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.98 units on a scale Standard Deviation 10.35	39.72 units on a scale Standard Deviation 12.80	39.23 units on a scale Standard Deviation 13.39	39.98 units on a scale Standard Deviation 12.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.23 units on a scale Standard Deviation 12.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: MnH (n=44,0,46,0,45,57,54,45,0,46,0)	43.61 units on a scale Standard Deviation 11.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.50 units on a scale Standard Deviation 11.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.44 units on a scale Standard Deviation 10.86	43.29 units on a scale Standard Deviation 12.68	43.91 units on a scale Standard Deviation 13.60	42.94 units on a scale Standard Deviation 12.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.89 units on a scale Standard Deviation 10.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: Ph Fn (n=54,0,51,0,49,61,57,53,0,59,0)	29.75 units on a scale Standard Deviation 10.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.88 units on a scale Standard Deviation 11.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.93 units on a scale Standard Deviation 11.75	30.30 units on a scale Standard Deviation 10.65	30.08 units on a scale Standard Deviation 9.66	30.55 units on a scale Standard Deviation 8.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.25 units on a scale Standard Deviation 9.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: R-P (n=54,0,51,0,49,61,57,53,0,59,0)	32.82 units on a scale Standard Deviation 9.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.21 units on a scale Standard Deviation 9.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.31 units on a scale Standard Deviation 10.46	31.44 units on a scale Standard Deviation 9.32	31.63 units on a scale Standard Deviation 8.07	32.87 units on a scale Standard Deviation 10.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.20 units on a scale Standard Deviation 8.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: GH (n=54,0,51,0,49,61,56,53,0,59,0)	34.80 units on a scale Standard Deviation 8.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.60 units on a scale Standard Deviation 8.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.89 units on a scale Standard Deviation 8.57	34.24 units on a scale Standard Deviation 8.23	34.58 units on a scale Standard Deviation 8.81	35.55 units on a scale Standard Deviation 9.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.35 units on a scale Standard Deviation 7.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: So Fn (n=54,0,51,0,49,61,57,53,0,59,0)	36.35 units on a scale Standard Deviation 11.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.17 units on a scale Standard Deviation 11.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.14 units on a scale Standard Deviation 10.88	35.93 units on a scale Standard Deviation 10.73	36.28 units on a scale Standard Deviation 12.11	33.28 units on a scale Standard Deviation 10.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.50 units on a scale Standard Deviation 10.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: R-E (n=54,0,51,0,49,61,57,53,0,59,0)	33.28 units on a scale Standard Deviation 11.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.09 units on a scale Standard Deviation 12.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.14 units on a scale Standard Deviation 11.74	34.40 units on a scale Standard Deviation 14.35	32.21 units on a scale Standard Deviation 12.92	32.26 units on a scale Standard Deviation 12.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.21 units on a scale Standard Deviation 14.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: MnH (n=54,0,51,0,49,61,57,53,0,59,0)	39.16 units on a scale Standard Deviation 11.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.58 units on a scale Standard Deviation 11.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.94 units on a scale Standard Deviation 12.02	37.73 units on a scale Standard Deviation 12.10	37.80 units on a scale Standard Deviation 12.62	36.22 units on a scale Standard Deviation 12.78	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.45 units on a scale Standard Deviation 11.66	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: Ph C (n=54,0,51,0,49,61,56,53,0,59,0)	31.49 units on a scale Standard Deviation 7.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.52 units on a scale Standard Deviation 9.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.12 units on a scale Standard Deviation 9.52	31.44 units on a scale Standard Deviation 8.16	31.82 units on a scale Standard Deviation 7.59	32.67 units on a scale Standard Deviation 7.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.94 units on a scale Standard Deviation 6.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Baseline: Mn C (n=54,0,51,0,49,61,56,53,0,59,0)	40.23 units on a scale Standard Deviation 11.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.47 units on a scale Standard Deviation 11.11	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.52 units on a scale Standard Deviation 11.82	39.56 units on a scale Standard Deviation 12.17	38.64 units on a scale Standard Deviation 12.45	36.46 units on a scale Standard Deviation 12.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.96 units on a scale Standard Deviation 12.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: Ph Fn (n=44,0,46,0,45,57,54,45,0,46,0)	32.59 units on a scale Standard Deviation 11.82	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.48 units on a scale Standard Deviation 11.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.36 units on a scale Standard Deviation 10.74	39.42 units on a scale Standard Deviation 11.99	38.44 units on a scale Standard Deviation 11.65	35.61 units on a scale Standard Deviation 10.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.11 units on a scale Standard Deviation 11.43	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: R-P (n=44,0,46,0,45,57,54,45,0,46,0)	37.60 units on a scale Standard Deviation 8.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.27 units on a scale Standard Deviation 10.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.00 units on a scale Standard Deviation 9.31	40.78 units on a scale Standard Deviation 10.67	41.75 units on a scale Standard Deviation 11.45	36.83 units on a scale Standard Deviation 10.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.21 units on a scale Standard Deviation 9.84	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: BP (n=44,0,46,0,45,57,54,45,0,46,0)	39.14 units on a scale Standard Deviation 7.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.87 units on a scale Standard Deviation 9.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.26 units on a scale Standard Deviation 9.13	45.65 units on a scale Standard Deviation 9.40	46.24 units on a scale Standard Deviation 10.30	37.67 units on a scale Standard Deviation 9.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.50 units on a scale Standard Deviation 9.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: GH (n=44,0,46,0,45,57,54,45,0,46,0)	38.99 units on a scale Standard Deviation 7.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.45 units on a scale Standard Deviation 9.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.00 units on a scale Standard Deviation 7.90	40.11 units on a scale Standard Deviation 11.10	40.80 units on a scale Standard Deviation 11.07	38.42 units on a scale Standard Deviation 11.41	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.05 units on a scale Standard Deviation 8.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: So Fn (n=44,0,46,0,45,57,54,45,0,46,0)	41.11 units on a scale Standard Deviation 11.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.55 units on a scale Standard Deviation 11.76	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.15 units on a scale Standard Deviation 9.20	43.93 units on a scale Standard Deviation 11.78	44.43 units on a scale Standard Deviation 12.15	38.43 units on a scale Standard Deviation 12.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.44 units on a scale Standard Deviation 11.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: Ph C (n=44,0,46,0,45,57,53,45,0,46,0)	35.76 units on a scale Standard Deviation 7.89	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.17 units on a scale Standard Deviation 8.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.15 units on a scale Standard Deviation 9.30	41.89 units on a scale Standard Deviation 9.70	42.44 units on a scale Standard Deviation 9.71	35.89 units on a scale Standard Deviation 10.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.00 units on a scale Standard Deviation 9.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 12: Mn C (n=44,0,46,0,45,57,53,45,0,46,0)	45.03 units on a scale Standard Deviation 11.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.82 units on a scale Standard Deviation 11.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.49 units on a scale Standard Deviation 9.96	44.46 units on a scale Standard Deviation 12.89	44.91 units on a scale Standard Deviation 14.05	44.22 units on a scale Standard Deviation 12.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.22 units on a scale Standard Deviation 10.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
36-Item Short-Form Health Survey (SF-36) Week 24: Ph Fn (n=24,15,29,15,43,55,52,0,40,20,24)	35.64 units on a scale Standard Deviation 10.40	35.57 units on a scale Standard Deviation 11.72	37.66 units on a scale Standard Deviation 12.25	33.32 units on a scale Standard Deviation 12.79	36.23 units on a scale Standard Deviation 12.04	40.43 units on a scale Standard Deviation 11.67	39.67 units on a scale Standard Deviation 10.91	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	38.36 units on a scale Standard Deviation 10.74	34.94 units on a scale Standard Deviation 10.76	41.60 units on a scale Standard Deviation 10.62
36-Item Short-Form Health Survey (SF-36) Week 24: R-P (n=24,15,29,15,43,55,52,0,40,20,24)	37.06 units on a scale Standard Deviation 9.13	39.38 units on a scale Standard Deviation 10.26	42.33 units on a scale Standard Deviation 9.00	34.98 units on a scale Standard Deviation 9.64	39.82 units on a scale Standard Deviation 11.02	41.80 units on a scale Standard Deviation 10.75	41.17 units on a scale Standard Deviation 9.61	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	38.98 units on a scale Standard Deviation 9.51	37.14 units on a scale Standard Deviation 9.88	43.38 units on a scale Standard Deviation 9.50
36-Item Short-Form Health Survey (SF-36) Week 24: BP (n=24,15,29,15,43,55,52,0,40,20,24)	39.26 units on a scale Standard Deviation 8.99	38.11 units on a scale Standard Deviation 9.41	42.15 units on a scale Standard Deviation 10.95	41.89 units on a scale Standard Deviation 9.03	42.05 units on a scale Standard Deviation 10.07	46.73 units on a scale Standard Deviation 10.09	45.37 units on a scale Standard Deviation 9.66	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	42.66 units on a scale Standard Deviation 9.22	39.91 units on a scale Standard Deviation 7.67	43.96 units on a scale Standard Deviation 10.01
36-Item Short-Form Health Survey (SF-36) Week 24: GH (n=24,15,29,15,43,55,52,0,40,20,24)	41.20 units on a scale Standard Deviation 10.49	38.47 units on a scale Standard Deviation 8.43	42.53 units on a scale Standard Deviation 10.23	37.11 units on a scale Standard Deviation 7.14	39.56 units on a scale Standard Deviation 8.79	41.46 units on a scale Standard Deviation 11.85	39.63 units on a scale Standard Deviation 10.19	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	39.62 units on a scale Standard Deviation 9.20	38.16 units on a scale Standard Deviation 8.74	42.84 units on a scale Standard Deviation 9.18
36-Item Short-Form Health Survey (SF-36) Week 24: Vit (n=24,15,29,15,43,55,52,0,40,20,24)	45.85 units on a scale Standard Deviation 12.21	44.18 units on a scale Standard Deviation 8.74	49.29 units on a scale Standard Deviation 9.71	45.78 units on a scale Standard Deviation 9.47	46.28 units on a scale Standard Deviation 10.00	47.61 units on a scale Standard Deviation 11.24	46.51 units on a scale Standard Deviation 10.98	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	46.24 units on a scale Standard Deviation 9.33	46.47 units on a scale Standard Deviation 10.70	49.10 units on a scale Standard Deviation 9.72
36-Item Short-Form Health Survey (SF-36) Week 24: So Fn (n=24,15,29,15,43,55,52,0,40,20,24)	42.08 units on a scale Standard Deviation 11.31	39.40 units on a scale Standard Deviation 9.26	44.25 units on a scale Standard Deviation 9.46	40.12 units on a scale Standard Deviation 8.86	41.76 units on a scale Standard Deviation 10.16	44.26 units on a scale Standard Deviation 12.32	42.69 units on a scale Standard Deviation 11.39	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	41.71 units on a scale Standard Deviation 9.99	41.85 units on a scale Standard Deviation 8.28	47.08 units on a scale Standard Deviation 9.37
36-Item Short-Form Health Survey (SF-36) Week 24: R-E (n=24,15,29,15,43,55,52,0,40,20,24)	36.12 units on a scale Standard Deviation 13.51	39.03 units on a scale Standard Deviation 13.44	43.14 units on a scale Standard Deviation 10.38	32.81 units on a scale Standard Deviation 13.42	38.97 units on a scale Standard Deviation 12.29	40.82 units on a scale Standard Deviation 12.85	40.33 units on a scale Standard Deviation 11.52	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	41.20 units on a scale Standard Deviation 11.66	38.39 units on a scale Standard Deviation 10.81	42.27 units on a scale Standard Deviation 10.38
36-Item Short-Form Health Survey (SF-36) Week 24: MnH (n=24,15,29,15,43,55,52,0,40,20,24)	45.55 units on a scale Standard Deviation 10.60	41.00 units on a scale Standard Deviation 8.92	44.76 units on a scale Standard Deviation 11.28	39.87 units on a scale Standard Deviation 8.37	43.20 units on a scale Standard Deviation 11.53	44.63 units on a scale Standard Deviation 12.75	43.08 units on a scale Standard Deviation 13.13	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	44.94 units on a scale Standard Deviation 10.13	43.53 units on a scale Standard Deviation 11.34	45.55 units on a scale Standard Deviation 11.08
36-Item Short-Form Health Survey (SF-36) Week 24: Ph C (n=24,15,29,15,43,55,52,0,40,20,24)	37.35 units on a scale Standard Deviation 8.62	37.51 units on a scale Standard Deviation 9.25	40.21 units on a scale Standard Deviation 10.21	37.35 units on a scale Standard Deviation 9.07	39.03 units on a scale Standard Deviation 9.96	42.81 units on a scale Standard Deviation 9.89	41.80 units on a scale Standard Deviation 10.03	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	39.03 units on a scale Standard Deviation 9.50	36.55 units on a scale Standard Deviation 9.64	42.87 units on a scale Standard Deviation 9.13
36-Item Short-Form Health Survey (SF-36) Week 24: Mn C (n=24,15,29,15,43,55,52,0,40,20,24)	44.79 units on a scale Standard Deviation 12.57	42.61 units on a scale Standard Deviation 9.01	47.43 units on a scale Standard Deviation 9.51	40.65 units on a scale Standard Deviation 8.04	44.18 units on a scale Standard Deviation 10.91	44.97 units on a scale Standard Deviation 12.87	43.73 units on a scale Standard Deviation 12.76	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	45.53 units on a scale Standard Deviation 10.29	45.01 units on a scale Standard Deviation 10.13	46.93 units on a scale Standard Deviation 10.63

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.n=number of participants evaluable at specific time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=44 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=46 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=15 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=45 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=57 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=54 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=45 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=46 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: So Fn (n=24,15,29,15,43,55,52,0,40,20,24)	4.54 units on a scale Standard Deviation 11.10	7.27 units on a scale Standard Deviation 12.82	2.07 units on a scale Standard Deviation 11.61	7.64 units on a scale Standard Deviation 7.38	6.21 units on a scale Standard Deviation 11.51	7.93 units on a scale Standard Deviation 12.46	6.61 units on a scale Standard Deviation 13.46	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	7.77 units on a scale Standard Deviation 13.47	10.36 units on a scale Standard Deviation 10.15	10.23 units on a scale Standard Deviation 9.69
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: R-E (n=24,15,29,15,43,55,52,0,40,20,24)	2.75 units on a scale Standard Deviation 16.15	7.77 units on a scale Standard Deviation 14.09	6.43 units on a scale Standard Deviation 9.13	3.11 units on a scale Standard Deviation 13.72	4.70 units on a scale Standard Deviation 10.37	7.07 units on a scale Standard Deviation 14.41	7.55 units on a scale Standard Deviation 11.09	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	7.77 units on a scale Standard Deviation 16.06	6.22 units on a scale Standard Deviation 16.32	7.45 units on a scale Standard Deviation 12.18
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: MnH (n=24,15,29,15,43,55,52,0,40,20,24)	5.28 units on a scale Standard Deviation 8.92	7.51 units on a scale Standard Deviation 10.73	3.50 units on a scale Standard Deviation 9.18	5.44 units on a scale Standard Deviation 7.33	5.37 units on a scale Standard Deviation 13.10	7.68 units on a scale Standard Deviation 8.32	4.55 units on a scale Standard Deviation 13.22	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	9.19 units on a scale Standard Deviation 12.03	5.63 units on a scale Standard Deviation 10.81	7.86 units on a scale Standard Deviation 10.14
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Ph C (n=24,15,29,15,43,55,51,0,40,20,24)	4.78 units on a scale Standard Deviation 7.89	6.50 units on a scale Standard Deviation 7.44	6.40 units on a scale Standard Deviation 9.31	6.05 units on a scale Standard Deviation 10.51	7.72 units on a scale Standard Deviation 9.12	10.77 units on a scale Standard Deviation 9.80	10.58 units on a scale Standard Deviation 10.83	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	6.32 units on a scale Standard Deviation 9.21	6.18 units on a scale Standard Deviation 6.21	8.73 units on a scale Standard Deviation 9.45
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Mn C (n=24,15,29,15,43,55,51,0,40,20,24)	3.45 units on a scale Standard Deviation 9.84	7.51 units on a scale Standard Deviation 11.20	3.50 units on a scale Standard Deviation 7.24	5.10 units on a scale Standard Deviation 8.70	4.57 units on a scale Standard Deviation 11.28	6.25 units on a scale Standard Deviation 10.22	4.23 units on a scale Standard Deviation 12.36	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	8.67 units on a scale Standard Deviation 12.28	7.03 units on a scale Standard Deviation 12.02	7.91 units on a scale Standard Deviation 10.04
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Ph Fn (n=44,0,46,0,45,57,54,45,0,46,0)	3.11 units on a scale Standard Deviation 11.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.90 units on a scale Standard Deviation 8.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.64 units on a scale Standard Deviation 10.60	8.90 units on a scale Standard Deviation 9.85	8.18 units on a scale Standard Deviation 10.11	5.05 units on a scale Standard Deviation 8.09	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.83 units on a scale Standard Deviation 9.89	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: R-P (n=44,0,46,0,45,57,54,45,0,46,0)	4.34 units on a scale Standard Deviation 10.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.01 units on a scale Standard Deviation 9.01	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.64 units on a scale Standard Deviation 9.87	8.98 units on a scale Standard Deviation 9.94	9.71 units on a scale Standard Deviation 11.64	3.43 units on a scale Standard Deviation 12.06	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.84 units on a scale Standard Deviation 9.88	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: BP (n=44,0,46,0,45,57,54,45,0,46,0)	6.36 units on a scale Standard Deviation 8.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.37 units on a scale Standard Deviation 9.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	9.15 units on a scale Standard Deviation 8.40	12.06 units on a scale Standard Deviation 9.21	13.73 units on a scale Standard Deviation 10.95	5.91 units on a scale Standard Deviation 8.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.91 units on a scale Standard Deviation 8.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: GH (n=44,0,46,0,45,57,53,45,0,46,0)	3.46 units on a scale Standard Deviation 7.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.59 units on a scale Standard Deviation 8.51	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.21 units on a scale Standard Deviation 7.48	6.00 units on a scale Standard Deviation 8.92	6.63 units on a scale Standard Deviation 9.64	4.05 units on a scale Standard Deviation 9.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.41 units on a scale Standard Deviation 6.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Vit (n=44,0,46,0,45,57,54,45,0,46,0)	5.25 units on a scale Standard Deviation 9.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.87 units on a scale Standard Deviation 9.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.76 units on a scale Standard Deviation 8.93	9.75 units on a scale Standard Deviation 11.53	10.75 units on a scale Standard Deviation 12.76	8.12 units on a scale Standard Deviation 10.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.73 units on a scale Standard Deviation 10.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: So Fn (n=44,0,46,0,45,57,54,45,0,46,0)	12.71 units on a scale Standard Deviation 1.92	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.31 units on a scale Standard Deviation 1.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	10.03 units on a scale Standard Deviation 1.50	11.91 units on a scale Standard Deviation 1.58	13.88 units on a scale Standard Deviation 1.89	14.01 units on a scale Standard Deviation 2.09	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	12.71 units on a scale Standard Deviation 1.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: R-E (n=44,0,46,0,45,57,53,45,0,46,0)	5.12 units on a scale Standard Deviation 12.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.70 units on a scale Standard Deviation 12.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.53 units on a scale Standard Deviation 13.45	5.86 units on a scale Standard Deviation 11.48	5.94 units on a scale Standard Deviation 14.19	6.82 units on a scale Standard Deviation 15.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.17 units on a scale Standard Deviation 13.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: MnH (n=44,0,46,0,45,57,54,45,0,46,0)	4.86 units on a scale Standard Deviation 11.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.12 units on a scale Standard Deviation 9.92	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.13 units on a scale Standard Deviation 11.63	6.08 units on a scale Standard Deviation 8.39	5.42 units on a scale Standard Deviation 14.02	7.48 units on a scale Standard Deviation 10.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.00 units on a scale Standard Deviation 10.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Ph C (n=44,0,46,0,45,57,52,45,0,46,0)	3.78 units on a scale Standard Deviation 7.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	4.96 units on a scale Standard Deviation 8.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.29 units on a scale Standard Deviation 7.95	10.01 units on a scale Standard Deviation 9.31	10.70 units on a scale Standard Deviation 9.83	3.47 units on a scale Standard Deviation 8.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.43 units on a scale Standard Deviation 9.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 12: Mn C (n=44,0,46,0,45,57,52,45,0,46,0)	5.23 units on a scale Standard Deviation 10.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	2.33 units on a scale Standard Deviation 9.78	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.45 units on a scale Standard Deviation 11.77	5.38 units on a scale Standard Deviation 9.61	6.12 units on a scale Standard Deviation 13.57	7.59 units on a scale Standard Deviation 11.64	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.74 units on a scale Standard Deviation 9.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Ph Fn (n=24,15,29,15,43,55,52,0,40,20,24)	5.52 units on a scale Standard Deviation 8.28	7.30 units on a scale Standard Deviation 10.84	5.01 units on a scale Standard Deviation 10.60	6.87 units on a scale Standard Deviation 9.85	6.12 units on a scale Standard Deviation 11.54	9.60 units on a scale Standard Deviation 9.63	9.67 units on a scale Standard Deviation 11.58	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	7.21 units on a scale Standard Deviation 9.80	6.63 units on a scale Standard Deviation 7.01	7.80 units on a scale Standard Deviation 11.06
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: R-P (n=24,15,29,15,43,55,52,0,40,20,24)	4.39 units on a scale Standard Deviation 12.06	6.86 units on a scale Standard Deviation 9.49	7.18 units on a scale Standard Deviation 9.00	3.65 units on a scale Standard Deviation 11.91	7.18 units on a scale Standard Deviation 9.19	10.02 units on a scale Standard Deviation 11.19	9.37 units on a scale Standard Deviation 9.78	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	5.14 units on a scale Standard Deviation 12.41	6.61 units on a scale Standard Deviation 7.95	8.98 units on a scale Standard Deviation 9.30
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: BP (n=24,15,29,15,43,55,52,0,40,20,24)	4.65 units on a scale Standard Deviation 10.48	7.86 units on a scale Standard Deviation 11.86	7.40 units on a scale Standard Deviation 9.78	8.93 units on a scale Standard Deviation 9.70	9.89 units on a scale Standard Deviation 9.07	13.19 units on a scale Standard Deviation 9.64	13.13 units on a scale Standard Deviation 10.51	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	10.51 units on a scale Standard Deviation 9.55	6.23 units on a scale Standard Deviation 7.24	11.11 units on a scale Standard Deviation 10.03
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: GH (n=24,15,29,15,43,55,51,0,40,20,24)	4.23 units on a scale Standard Deviation 11.06	5.91 units on a scale Standard Deviation 8.60	5.10 units on a scale Standard Deviation 8.04	2.51 units on a scale Standard Deviation 7.65	5.64 units on a scale Standard Deviation 7.18	7.37 units on a scale Standard Deviation 9.15	5.44 units on a scale Standard Deviation 9.03	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	5.77 units on a scale Standard Deviation 8.35	5.46 units on a scale Standard Deviation 6.54	6.87 units on a scale Standard Deviation 10.73
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET Week 24: Vit (n=24,15,29,15,43,55,52,0,40,20,24)	3.38 units on a scale Standard Deviation 9.20	8.12 units on a scale Standard Deviation 10.00	5.49 units on a scale Standard Deviation 9.01	8.46 units on a scale Standard Deviation 12.53	6.75 units on a scale Standard Deviation 8.31	9.20 units on a scale Standard Deviation 10.89	8.17 units on a scale Standard Deviation 12.01	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	9.13 units on a scale Standard Deviation 10.13	7.80 units on a scale Standard Deviation 10.10	9.37 units on a scale Standard Deviation 7.92

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=14 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score Baseline (n=54,0,51,0,49,61,57,53,0,59,0)	0.41 units on a scale Standard Deviation 0.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.33 units on a scale Standard Deviation 0.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.39 units on a scale Standard Deviation 0.37	0.41 units on a scale Standard Deviation 0.30	0.34 units on a scale Standard Deviation 0.35	0.36 units on a scale Standard Deviation 0.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.38 units on a scale Standard Deviation 0.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score Week 12 (n=43,0,46,0,45,56,54,45,0,45,0)	0.56 units on a scale Standard Deviation 0.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.50 units on a scale Standard Deviation 0.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.60 units on a scale Standard Deviation 0.27	0.68 units on a scale Standard Deviation 0.25	0.66 units on a scale Standard Deviation 0.27	0.51 units on a scale Standard Deviation 0.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.53 units on a scale Standard Deviation 0.32	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score Week 24 (n=24,15,29,14,43,55,52,0,40,20,24)	0.64 units on a scale Standard Deviation 0.23	0.55 units on a scale Standard Deviation 0.30	0.67 units on a scale Standard Deviation 0.22	0.58 units on a scale Standard Deviation 0.25	0.61 units on a scale Standard Deviation 0.30	0.68 units on a scale Standard Deviation 0.26	0.67 units on a scale Standard Deviation 0.26	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.60 units on a scale Standard Deviation 0.24	0.63 units on a scale Standard Deviation 0.22	0.73 units on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline, Week 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=43 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=46 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=14 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=45 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=56 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=54 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=45 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=45 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET Week 12 (n=43,0,46,0,45,56,54,45,0,45,0)	0.15 units on a scale Standard Deviation 0.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.14 units on a scale Standard Deviation 0.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.21 units on a scale Standard Deviation 0.33	0.27 units on a scale Standard Deviation 0.29	0.30 units on a scale Standard Deviation 0.37	0.16 units on a scale Standard Deviation 0.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.11 units on a scale Standard Deviation 0.37	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET Week 24 (n=24,15,29,14,43,55,52,0,40,20,24)	0.23 units on a scale Standard Deviation 0.33	0.15 units on a scale Standard Deviation 0.34	0.23 units on a scale Standard Deviation 0.28	0.36 units on a scale Standard Deviation 0.36	0.23 units on a scale Standard Deviation 0.32	0.27 units on a scale Standard Deviation 0.31	0.32 units on a scale Standard Deviation 0.40	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.24 units on a scale Standard Deviation 0.36	0.21 units on a scale Standard Deviation 0.28	0.32 units on a scale Standard Deviation 0.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=50 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=47 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=12 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=45 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=58 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=53 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=49 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=34 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=54 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=22 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels Baseline: IgG (n=50,0,47,0,45,58,53,49,0,54,0)	1261.68 milligram per deciliter (mg/dL) Standard Deviation 331.53	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1157.79 milligram per deciliter (mg/dL) Standard Deviation 290.29	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1219.31 milligram per deciliter (mg/dL) Standard Deviation 326.92	1219.38 milligram per deciliter (mg/dL) Standard Deviation 397.93	1157.57 milligram per deciliter (mg/dL) Standard Deviation 271.58	1143.78 milligram per deciliter (mg/dL) Standard Deviation 359.41	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1221.28 milligram per deciliter (mg/dL) Standard Deviation 402.84	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels Baseline: IgM (n=50,0,47,0,45,58,53,49,0,54,0)	154.20 milligram per deciliter (mg/dL) Standard Deviation 77.36	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	172.81 milligram per deciliter (mg/dL) Standard Deviation 72.41	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	115.04 milligram per deciliter (mg/dL) Standard Deviation 48.12	160.69 milligram per deciliter (mg/dL) Standard Deviation 75.04	156.04 milligram per deciliter (mg/dL) Standard Deviation 73.34	144.27 milligram per deciliter (mg/dL) Standard Deviation 103.26	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	169.78 milligram per deciliter (mg/dL) Standard Deviation 83.80	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels Baseline: IgA (n=50,0,47,0,45,58,51,49,0,54,0)	356.76 milligram per deciliter (mg/dL) Standard Deviation 242.48	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	285.34 milligram per deciliter (mg/dL) Standard Deviation 121.73	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	321.58 milligram per deciliter (mg/dL) Standard Deviation 171.12	316.60 milligram per deciliter (mg/dL) Standard Deviation 140.26	304.14 milligram per deciliter (mg/dL) Standard Deviation 164.97	323.49 milligram per deciliter (mg/dL) Standard Deviation 134.21	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	327.00 milligram per deciliter (mg/dL) Standard Deviation 177.70	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels Week 24: IgG (n=21,15,24,12,35,48,44,0,34,17,22)	1207.57 milligram per deciliter (mg/dL) Standard Deviation 330.54	1148.07 milligram per deciliter (mg/dL) Standard Deviation 439.24	1068.08 milligram per deciliter (mg/dL) Standard Deviation 266.71	1142.75 milligram per deciliter (mg/dL) Standard Deviation 315.33	1169.97 milligram per deciliter (mg/dL) Standard Deviation 280.16	1111.42 milligram per deciliter (mg/dL) Standard Deviation 286.08	1073.66 milligram per deciliter (mg/dL) Standard Deviation 274.31	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	1143.91 milligram per deciliter (mg/dL) Standard Deviation 290.22	1153.76 milligram per deciliter (mg/dL) Standard Deviation 350.08	1213.86 milligram per deciliter (mg/dL) Standard Deviation 379.24
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels Week 24: IgM (n=21,15,24,12,35,48,44,0,34,17,22)	145.71 milligram per deciliter (mg/dL) Standard Deviation 86.21	144.73 milligram per deciliter (mg/dL) Standard Deviation 73.08	161.96 milligram per deciliter (mg/dL) Standard Deviation 62.54	153.08 milligram per deciliter (mg/dL) Standard Deviation 69.05	122.46 milligram per deciliter (mg/dL) Standard Deviation 46.08	140.06 milligram per deciliter (mg/dL) Standard Deviation 59.51	128.25 milligram per deciliter (mg/dL) Standard Deviation 56.26	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	143.29 milligram per deciliter (mg/dL) Standard Deviation 73.11	153.24 milligram per deciliter (mg/dL) Standard Deviation 80.78	167.95 milligram per deciliter (mg/dL) Standard Deviation 82.86
Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels Week 24: IgA (n=21,15,24,12,35,48,43,0,34,17,22)	305.62 milligram per deciliter (mg/dL) Standard Deviation 160.91	435.00 milligram per deciliter (mg/dL) Standard Deviation 405.07	237.00 milligram per deciliter (mg/dL) Standard Deviation 87.21	287.50 milligram per deciliter (mg/dL) Standard Deviation 107.94	294.97 milligram per deciliter (mg/dL) Standard Deviation 136.28	280.65 milligram per deciliter (mg/dL) Standard Deviation 118.50	232.51 milligram per deciliter (mg/dL) Standard Deviation 100.39	NA milligram per deciliter (mg/dL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	294.35 milligram per deciliter (mg/dL) Standard Deviation 131.76	329.65 milligram per deciliter (mg/dL) Standard Deviation 152.74	305.18 milligram per deciliter (mg/dL) Standard Deviation 150.23

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 24/ ET

Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=18 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=22 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=11 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=32 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=46 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=41 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=32 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=15 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=20 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24 IgA	6.28 mg/dL Standard Deviation 44.81	7.07 mg/dL Standard Deviation 164.76	-38.50 mg/dL Standard Deviation 55.58	-45.36 mg/dL Standard Deviation 59.51	-24.53 mg/dL Standard Deviation 48.01	-42.50 mg/dL Standard Deviation 72.55	-68.41 mg/dL Standard Deviation 104.16	-26.03 mg/dL Standard Deviation 82.04	8.60 mg/dL Standard Deviation 45.09	-18.15 mg/dL Standard Deviation 52.51	—
Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24 IgG	-13.50 mg/dL Standard Deviation 159.02	-114.27 mg/dL Standard Deviation 321.37	-71.55 mg/dL Standard Deviation 152.89	-145.36 mg/dL Standard Deviation 267.20	-53.81 mg/dL Standard Deviation 164.31	-131.50 mg/dL Standard Deviation 183.76	-86.44 mg/dL Standard Deviation 175.79	-49.81 mg/dL Standard Deviation 192.28	31.00 mg/dL Standard Deviation 129.17	-59.75 mg/dL Standard Deviation 163.33	—
Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24 IgM	7.83 mg/dL Standard Deviation 21.88	-9.73 mg/dL Standard Deviation 35.26	-11.86 mg/dL Standard Deviation 25.02	-3.73 mg/dL Standard Deviation 27.32	4.25 mg/dL Standard Deviation 16.41	-17.02 mg/dL Standard Deviation 41.65	-22.73 mg/dL Standard Deviation 33.64	-3.69 mg/dL Standard Deviation 46.72	3.00 mg/dL Standard Deviation 30.44	-2.50 mg/dL Standard Deviation 37.27	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=30 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=6 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=35 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=7 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=29 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=37 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=34 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=32 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=19 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=40 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=12 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Baseline: CD3 (n=30,0,35,0,29,37,34,32,0,40,0)	1.29 cells per micro liter (cells/mcL) Standard Deviation 0.59	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.31 cells per micro liter (cells/mcL) Standard Deviation 0.46	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.31 cells per micro liter (cells/mcL) Standard Deviation 0.73	1.24 cells per micro liter (cells/mcL) Standard Deviation 0.61	1.30 cells per micro liter (cells/mcL) Standard Deviation 0.51	1.36 cells per micro liter (cells/mcL) Standard Deviation 0.52	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.17 cells per micro liter (cells/mcL) Standard Deviation 0.49	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Baseline: CD4 (n=30,0,35,0,29,37,34,32,0,40,0)	0.84 cells per micro liter (cells/mcL) Standard Deviation 0.41	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.93 cells per micro liter (cells/mcL) Standard Deviation 0.35	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.93 cells per micro liter (cells/mcL) Standard Deviation 0.56	0.85 cells per micro liter (cells/mcL) Standard Deviation 0.49	0.89 cells per micro liter (cells/mcL) Standard Deviation 0.35	0.91 cells per micro liter (cells/mcL) Standard Deviation 0.40	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.80 cells per micro liter (cells/mcL) Standard Deviation 0.34	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Baseline: CD8 (n=30,0,35,0,29,37,34,32,0,40,0)	0.44 cells per micro liter (cells/mcL) Standard Deviation 0.29	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.37 cells per micro liter (cells/mcL) Standard Deviation 0.20	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.37 cells per micro liter (cells/mcL) Standard Deviation 0.26	0.37 cells per micro liter (cells/mcL) Standard Deviation 0.19	0.40 cells per micro liter (cells/mcL) Standard Deviation 0.21	0.43 cells per micro liter (cells/mcL) Standard Deviation 0.23	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.35 cells per micro liter (cells/mcL) Standard Deviation 0.21	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Baseline: CD19 (n=30,0,34,0,29,37,34,32,0,40,0)	0.21 cells per micro liter (cells/mcL) Standard Deviation 0.16	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.20 cells per micro liter (cells/mcL) Standard Deviation 0.11	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.22 cells per micro liter (cells/mcL) Standard Deviation 0.23	0.19 cells per micro liter (cells/mcL) Standard Deviation 0.09	0.20 cells per micro liter (cells/mcL) Standard Deviation 0.12	0.18 cells per micro liter (cells/mcL) Standard Deviation 0.10	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.16 cells per micro liter (cells/mcL) Standard Deviation 0.10	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Baseline: CD56 (n=30,0,34,0,29,37,34,32,0,40,0)	0.15 cells per micro liter (cells/mcL) Standard Deviation 0.09	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.14 cells per micro liter (cells/mcL) Standard Deviation 0.10	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.14 cells per micro liter (cells/mcL) Standard Deviation 0.10	0.14 cells per micro liter (cells/mcL) Standard Deviation 0.12	0.14 cells per micro liter (cells/mcL) Standard Deviation 0.10	0.14 cells per micro liter (cells/mcL) Standard Deviation 0.12	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.12 cells per micro liter (cells/mcL) Standard Deviation 0.09	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Week 24: CD3 (n=16,6,17,7,22,29,26,0,19,9,12)	1.16 cells per micro liter (cells/mcL) Standard Deviation 0.67	1.45 cells per micro liter (cells/mcL) Standard Deviation 0.57	1.45 cells per micro liter (cells/mcL) Standard Deviation 0.82	1.20 cells per micro liter (cells/mcL) Standard Deviation 0.46	1.10 cells per micro liter (cells/mcL) Standard Deviation 0.43	1.27 cells per micro liter (cells/mcL) Standard Deviation 0.61	1.14 cells per micro liter (cells/mcL) Standard Deviation 0.36	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	1.46 cells per micro liter (cells/mcL) Standard Deviation 0.48	1.63 cells per micro liter (cells/mcL) Standard Deviation 0.69	1.26 cells per micro liter (cells/mcL) Standard Deviation 0.57
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Week 24: CD4 (n=16,6,17,7,22,29,26,0,19,9,12)	0.75 cells per micro liter (cells/mcL) Standard Deviation 0.42	0.87 cells per micro liter (cells/mcL) Standard Deviation 0.33	1.01 cells per micro liter (cells/mcL) Standard Deviation 0.65	0.86 cells per micro liter (cells/mcL) Standard Deviation 0.35	0.77 cells per micro liter (cells/mcL) Standard Deviation 0.30	0.92 cells per micro liter (cells/mcL) Standard Deviation 0.51	0.82 cells per micro liter (cells/mcL) Standard Deviation 0.26	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.98 cells per micro liter (cells/mcL) Standard Deviation 0.35	1.01 cells per micro liter (cells/mcL) Standard Deviation 0.52	0.91 cells per micro liter (cells/mcL) Standard Deviation 0.45
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Week 24: CD8 (n=16,6,17,7,22,29,26,0,19,9,12)	0.38 cells per micro liter (cells/mcL) Standard Deviation 0.26	0.58 cells per micro liter (cells/mcL) Standard Deviation 0.43	0.42 cells per micro liter (cells/mcL) Standard Deviation 0.25	0.30 cells per micro liter (cells/mcL) Standard Deviation 0.13	0.31 cells per micro liter (cells/mcL) Standard Deviation 0.18	0.33 cells per micro liter (cells/mcL) Standard Deviation 0.15	0.32 cells per micro liter (cells/mcL) Standard Deviation 0.14	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.45 cells per micro liter (cells/mcL) Standard Deviation 0.34	0.58 cells per micro liter (cells/mcL) Standard Deviation 0.34	0.33 cells per micro liter (cells/mcL) Standard Deviation 0.14
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Week 24: CD19 (n=16,6,17,7,22,29,25,0,19,9,12)	0.23 cells per micro liter (cells/mcL) Standard Deviation 0.18	0.27 cells per micro liter (cells/mcL) Standard Deviation 0.14	0.22 cells per micro liter (cells/mcL) Standard Deviation 0.11	0.27 cells per micro liter (cells/mcL) Standard Deviation 0.15	0.17 cells per micro liter (cells/mcL) Standard Deviation 0.11	0.31 cells per micro liter (cells/mcL) Standard Deviation 0.16	0.24 cells per micro liter (cells/mcL) Standard Deviation 0.09	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.29 cells per micro liter (cells/mcL) Standard Deviation 0.15	0.12 cells per micro liter (cells/mcL) Standard Deviation 0.05	0.31 cells per micro liter (cells/mcL) Standard Deviation 0.21
Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers Week 24: CD56 (n=16,6,17,7,22,29,26,0,19,9,12)	0.10 cells per micro liter (cells/mcL) Standard Deviation 0.06	0.12 cells per micro liter (cells/mcL) Standard Deviation 0.09	0.11 cells per micro liter (cells/mcL) Standard Deviation 0.08	0.08 cells per micro liter (cells/mcL) Standard Deviation 0.10	0.07 cells per micro liter (cells/mcL) Standard Deviation 0.05	0.05 cells per micro liter (cells/mcL) Standard Deviation 0.05	0.04 cells per micro liter (cells/mcL) Standard Deviation 0.03	NA cells per micro liter (cells/mcL) Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.09 cells per micro liter (cells/mcL) Standard Deviation 0.09	0.15 cells per micro liter (cells/mcL) Standard Deviation 0.12	0.07 cells per micro liter (cells/mcL) Standard Deviation 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 24/ ET

The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=9 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=5 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=11 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=7 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=18 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=21 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=20 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=17 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=7 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=11 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24 CD3	0.01 cells/mcL Standard Deviation 0.77	0.00 cells/mcL Standard Deviation 0.44	0.07 cells/mcL Standard Deviation 0.62	0.07 cells/mcL Standard Deviation 0.39	-0.19 cells/mcL Standard Deviation 0.52	0.01 cells/mcL Standard Deviation 0.45	-0.13 cells/mcL Standard Deviation 0.44	0.12 cells/mcL Standard Deviation 0.60	0.36 cells/mcL Standard Deviation 0.38	0.20 cells/mcL Standard Deviation 0.50	—
Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24 CD4	-0.03 cells/mcL Standard Deviation 0.50	-0.05 cells/mcL Standard Deviation 0.31	0.06 cells/mcL Standard Deviation 0.48	0.07 cells/mcL Standard Deviation 0.30	-0.16 cells/mcL Standard Deviation 0.41	0.03 cells/mcL Standard Deviation 0.32	-0.11 cells/mcL Standard Deviation 0.31	0.08 cells/mcL Standard Deviation 0.49	0.20 cells/mcL Standard Deviation 0.33	0.18 cells/mcL Standard Deviation 0.37	—
Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24 CD8	0.01 cells/mcL Standard Deviation 0.28	0.04 cells/mcL Standard Deviation 0.14	0.01 cells/mcL Standard Deviation 0.17	-0.01 cells/mcL Standard Deviation 0.14	-0.03 cells/mcL Standard Deviation 0.18	-0.02 cells/mcL Standard Deviation 0.15	-0.03 cells/mcL Standard Deviation 0.14	0.04 cells/mcL Standard Deviation 0.19	0.11 cells/mcL Standard Deviation 0.11	0.03 cells/mcL Standard Deviation 0.14	—
Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24 CD19	0.03 cells/mcL Standard Deviation 0.24	0.01 cells/mcL Standard Deviation 0.10	-0.00 cells/mcL Standard Deviation 0.17	0.07 cells/mcL Standard Deviation 0.07	-0.03 cells/mcL Standard Deviation 0.21	0.12 cells/mcL Standard Deviation 0.14	0.06 cells/mcL Standard Deviation 0.10	0.09 cells/mcL Standard Deviation 0.13	0.02 cells/mcL Standard Deviation 0.03	0.13 cells/mcL Standard Deviation 0.12	—
Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24 CD56	-0.05 cells/mcL Standard Deviation 0.05	0.03 cells/mcL Standard Deviation 0.08	-0.03 cells/mcL Standard Deviation 0.05	-0.06 cells/mcL Standard Deviation 0.15	-0.06 cells/mcL Standard Deviation 0.09	-0.06 cells/mcL Standard Deviation 0.07	-0.08 cells/mcL Standard Deviation 0.04	-0.03 cells/mcL Standard Deviation 0.08	0.01 cells/mcL Standard Deviation 0.07	-0.05 cells/mcL Standard Deviation 0.08	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 2, 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=15 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=61 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Ade (n=54,0,51,0,49,61,57,53,0,58,0)	40.74 units on a scale Standard Deviation 27.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.31 units on a scale Standard Deviation 27.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.10 units on a scale Standard Deviation 23.73	41.31 units on a scale Standard Deviation 24.93	40.18 units on a scale Standard Deviation 27.87	39.81 units on a scale Standard Deviation 27.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.62 units on a scale Standard Deviation 23.28	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: SPS (n=54,0,51,0,49,61,57,53,0,58,0)	45.06 units on a scale Standard Deviation 22.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	45.56 units on a scale Standard Deviation 19.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	39.86 units on a scale Standard Deviation 17.35	44.86 units on a scale Standard Deviation 17.60	44.39 units on a scale Standard Deviation 23.35	44.72 units on a scale Standard Deviation 22.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.77 units on a scale Standard Deviation 18.83	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: OSP (n=54,0,51,0,49,61,57,53,0,58,0)	44.87 units on a scale Standard Deviation 22.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	48.34 units on a scale Standard Deviation 19.98	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	42.51 units on a scale Standard Deviation 18.35	45.82 units on a scale Standard Deviation 15.79	45.77 units on a scale Standard Deviation 22.68	45.94 units on a scale Standard Deviation 22.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	46.12 units on a scale Standard Deviation 18.54	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: A SOB (n=54,0,51,0,49,61,57,53,0,58,0)	22.96 units on a scale Standard Deviation 22.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	29.41 units on a scale Standard Deviation 30.03	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	20.82 units on a scale Standard Deviation 22.35	23.61 units on a scale Standard Deviation 27.69	27.72 units on a scale Standard Deviation 30.18	21.51 units on a scale Standard Deviation 28.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.10 units on a scale Standard Deviation 27.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: SD (n=54,0,51,0,49,61,57,53,0,58,0)	46.60 units on a scale Standard Deviation 28.00	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	52.40 units on a scale Standard Deviation 25.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.52 units on a scale Standard Deviation 25.73	48.34 units on a scale Standard Deviation 22.61	45.09 units on a scale Standard Deviation 28.53	47.90 units on a scale Standard Deviation 28.81	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	49.72 units on a scale Standard Deviation 24.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Opt (n=54,0,51,0,49,61,57,53,0,59,0)	0.31 units on a scale Standard Deviation 0.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.45 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.51 units on a scale Standard Deviation 0.51	0.31 units on a scale Standard Deviation 0.47	0.42 units on a scale Standard Deviation 0.50	0.57 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.47 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Qua (n=54,0,51,0,49,61,57,53,0,59,0)	6.11 units on a scale Standard Deviation 1.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.51 units on a scale Standard Deviation 1.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.76 units on a scale Standard Deviation 1.39	6.59 units on a scale Standard Deviation 1.76	6.33 units on a scale Standard Deviation 1.38	6.72 units on a scale Standard Deviation 2.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.63 units on a scale Standard Deviation 1.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Sno (n=54,0,51,0,49,61,57,53,0,58,0)	30.00 units on a scale Standard Deviation 34.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.39 units on a scale Standard Deviation 36.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.84 units on a scale Standard Deviation 34.14	33.11 units on a scale Standard Deviation 31.60	32.28 units on a scale Standard Deviation 32.02	42.26 units on a scale Standard Deviation 32.02	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.24 units on a scale Standard Deviation 31.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Som (n=54,0,51,0,49,61,57,53,0,58,0)	36.05 units on a scale Standard Deviation 22.60	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.69 units on a scale Standard Deviation 21.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.05 units on a scale Standard Deviation 22.27	38.91 units on a scale Standard Deviation 25.57	38.36 units on a scale Standard Deviation 18.78	38.74 units on a scale Standard Deviation 25.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.68 units on a scale Standard Deviation 21.13	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: SPS (n=54,0,50,0,48,59,57,52,0,56,0)	41.79 units on a scale Standard Deviation 21.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.73 units on a scale Standard Deviation 19.87	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.22 units on a scale Standard Deviation 17.41	37.57 units on a scale Standard Deviation 17.68	35.50 units on a scale Standard Deviation 21.27	38.46 units on a scale Standard Deviation 21.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.18 units on a scale Standard Deviation 19.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: OSP (n=54,0,50,0,48,59,57,52,0,56,0)	41.64 units on a scale Standard Deviation 20.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.19 units on a scale Standard Deviation 19.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.61 units on a scale Standard Deviation 17.17	37.75 units on a scale Standard Deviation 16.80	36.15 units on a scale Standard Deviation 21.04	39.24 units on a scale Standard Deviation 21.81	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	40.35 units on a scale Standard Deviation 18.90	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Ade (n=54,0,51,0,48,59,57,52,0,56,0)	46.11 units on a scale Standard Deviation 27.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.14 units on a scale Standard Deviation 26.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.04 units on a scale Standard Deviation 25.54	47.80 units on a scale Standard Deviation 26.40	52.63 units on a scale Standard Deviation 29.00	48.65 units on a scale Standard Deviation 30.74	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	43.21 units on a scale Standard Deviation 25.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: A SOB (n=54,0,50,0,48,59,57,52,0,56,0)	23.33 units on a scale Standard Deviation 24.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.80 units on a scale Standard Deviation 28.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.25 units on a scale Standard Deviation 28.03	19.32 units on a scale Standard Deviation 23.18	23.16 units on a scale Standard Deviation 28.98	19.23 units on a scale Standard Deviation 25.35	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.79 units on a scale Standard Deviation 22.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: SD (n=54,0,50,0,48,59,57,52,0,56,0)	42.01 units on a scale Standard Deviation 25.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	44.48 units on a scale Standard Deviation 25.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.81 units on a scale Standard Deviation 23.40	38.24 units on a scale Standard Deviation 23.34	36.69 units on a scale Standard Deviation 26.47	39.16 units on a scale Standard Deviation 27.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.32 units on a scale Standard Deviation 24.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Opt (n=54,0,51,0,48,60,57,53,0,58,0)	0.39 units on a scale Standard Deviation 0.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.35 units on a scale Standard Deviation 0.48	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.60 units on a scale Standard Deviation 0.49	0.45 units on a scale Standard Deviation 0.50	0.47 units on a scale Standard Deviation 0.50	0.43 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.48 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Qua (n=54,0,51,0,48,60,57,52,0,57,0)	6.31 units on a scale Standard Deviation 1.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.41 units on a scale Standard Deviation 1.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.98 units on a scale Standard Deviation 1.23	6.85 units on a scale Standard Deviation 1.69	6.72 units on a scale Standard Deviation 1.26	6.71 units on a scale Standard Deviation 2.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.74 units on a scale Standard Deviation 1.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Sno (n=54,0,51,0,48,59,57,52,0,56,0)	27.04 units on a scale Standard Deviation 28.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.16 units on a scale Standard Deviation 30.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.83 units on a scale Standard Deviation 30.02	30.85 units on a scale Standard Deviation 29.79	32.28 units on a scale Standard Deviation 28.97	40.38 units on a scale Standard Deviation 31.31	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.43 units on a scale Standard Deviation 29.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Som (n=54,0,51,0,48,59,57,52,0,56,0)	36.05 units on a scale Standard Deviation 21.34	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.20 units on a scale Standard Deviation 18.40	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.69 units on a scale Standard Deviation 22.20	31.75 units on a scale Standard Deviation 22.57	30.53 units on a scale Standard Deviation 18.17	38.33 units on a scale Standard Deviation 28.59	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	32.86 units on a scale Standard Deviation 21.34	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: SPS (n=44,0,46,0,45,57,53,45,0,45,0)	35.61 units on a scale Standard Deviation 22.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.48 units on a scale Standard Deviation 21.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.85 units on a scale Standard Deviation 16.91	35.09 units on a scale Standard Deviation 18.32	31.26 units on a scale Standard Deviation 22.84	36.37 units on a scale Standard Deviation 20.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.56 units on a scale Standard Deviation 18.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: OSP (n=44,0,46,0,45,57,53,45,0,45,0)	36.44 units on a scale Standard Deviation 22.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	38.93 units on a scale Standard Deviation 21.68	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.51 units on a scale Standard Deviation 17.81	35.19 units on a scale Standard Deviation 17.56	32.11 units on a scale Standard Deviation 22.33	37.09 units on a scale Standard Deviation 20.82	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.26 units on a scale Standard Deviation 18.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Ade (n=44,0,46,0,45,57,53,45,0,45,0)	58.18 units on a scale Standard Deviation 27.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	51.30 units on a scale Standard Deviation 28.17	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	48.67 units on a scale Standard Deviation 24.36	49.82 units on a scale Standard Deviation 28.06	57.55 units on a scale Standard Deviation 31.06	49.56 units on a scale Standard Deviation 24.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	53.11 units on a scale Standard Deviation 24.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: A SOB (n=44,0,46,0,45,57,53,45,0,45,0)	19.09 units on a scale Standard Deviation 21.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	22.17 units on a scale Standard Deviation 26.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.00 units on a scale Standard Deviation 22.40	17.19 units on a scale Standard Deviation 19.80	23.02 units on a scale Standard Deviation 27.00	19.11 units on a scale Standard Deviation 24.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	16.44 units on a scale Standard Deviation 23.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: SD (n=44,0,46,0,45,57,53,45,0,45,0)	38.58 units on a scale Standard Deviation 27.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	41.39 units on a scale Standard Deviation 26.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	37.94 units on a scale Standard Deviation 25.31	36.47 units on a scale Standard Deviation 25.90	31.30 units on a scale Standard Deviation 25.45	37.22 units on a scale Standard Deviation 28.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	35.08 units on a scale Standard Deviation 21.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Opt (n=44,0,46,0,45,57,54,45,0,46,0)	0.45 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.43 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.47 units on a scale Standard Deviation 0.50	0.51 units on a scale Standard Deviation 0.50	0.52 units on a scale Standard Deviation 0.50	0.58 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.61 units on a scale Standard Deviation 0.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Qua (n=44,0,46,0,45,56,53,45,0,46,0)	6.77 units on a scale Standard Deviation 1.71	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.65 units on a scale Standard Deviation 1.61	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.91 units on a scale Standard Deviation 1.28	6.80 units on a scale Standard Deviation 1.55	6.68 units on a scale Standard Deviation 1.25	6.78 units on a scale Standard Deviation 1.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.09 units on a scale Standard Deviation 1.24	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Sno (n=44,0,46,0,45,57,53,45,0,45,0)	30.45 units on a scale Standard Deviation 30.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	36.96 units on a scale Standard Deviation 33.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.67 units on a scale Standard Deviation 32.59	30.53 units on a scale Standard Deviation 25.10	28.68 units on a scale Standard Deviation 29.49	36.89 units on a scale Standard Deviation 32.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	23.56 units on a scale Standard Deviation 25.69	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Som (n=44,0,46,0,45,57,53,45,0,45,0)	34.70 units on a scale Standard Deviation 22.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.59 units on a scale Standard Deviation 21.84	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.19 units on a scale Standard Deviation 24.39	29.12 units on a scale Standard Deviation 21.44	27.80 units on a scale Standard Deviation 19.42	35.26 units on a scale Standard Deviation 26.92	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.37 units on a scale Standard Deviation 19.67	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: SPS (n=24,15,29,15,43,55,52,0,40,20,24)	30.83 units on a scale Standard Deviation 18.55	45.56 units on a scale Standard Deviation 20.77	32.07 units on a scale Standard Deviation 18.22	39.33 units on a scale Standard Deviation 22.54	33.72 units on a scale Standard Deviation 18.42	34.18 units on a scale Standard Deviation 18.66	33.85 units on a scale Standard Deviation 21.69	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	32.75 units on a scale Standard Deviation 19.48	31.17 units on a scale Standard Deviation 21.20	33.19 units on a scale Standard Deviation 17.54
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: OSP (n=24,15,29,15,43,55,52,0,40,20,24)	30.93 units on a scale Standard Deviation 18.06	43.37 units on a scale Standard Deviation 19.86	32.32 units on a scale Standard Deviation 18.93	39.67 units on a scale Standard Deviation 21.03	34.30 units on a scale Standard Deviation 18.69	34.18 units on a scale Standard Deviation 17.79	33.57 units on a scale Standard Deviation 19.91	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	33.14 units on a scale Standard Deviation 19.80	31.39 units on a scale Standard Deviation 19.85	33.89 units on a scale Standard Deviation 15.61
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Ade (n=24,15,29,15,43,55,52,0,40,20,24)	60.00 units on a scale Standard Deviation 28.89	40.67 units on a scale Standard Deviation 29.39	59.66 units on a scale Standard Deviation 26.52	45.33 units on a scale Standard Deviation 26.96	53.26 units on a scale Standard Deviation 24.08	50.00 units on a scale Standard Deviation 28.41	51.73 units on a scale Standard Deviation 30.53	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	59.50 units on a scale Standard Deviation 25.31	60.50 units on a scale Standard Deviation 25.64	54.58 units on a scale Standard Deviation 22.06
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: A SOB (n=24,15,29,15,43,55,52,0,40,20,24)	25.00 units on a scale Standard Deviation 27.82	36.00 units on a scale Standard Deviation 21.65	24.14 units on a scale Standard Deviation 27.97	30.67 units on a scale Standard Deviation 33.69	22.79 units on a scale Standard Deviation 29.79	21.45 units on a scale Standard Deviation 21.72	23.46 units on a scale Standard Deviation 26.78	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	25.50 units on a scale Standard Deviation 30.38	17.00 units on a scale Standard Deviation 23.64	13.33 units on a scale Standard Deviation 18.34
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: SD (n=24,15,29,15,43,55,52,0,40,20,24)	29.79 units on a scale Standard Deviation 21.33	41.58 units on a scale Standard Deviation 23.29	34.27 units on a scale Standard Deviation 24.80	38.58 units on a scale Standard Deviation 24.30	33.58 units on a scale Standard Deviation 22.98	33.09 units on a scale Standard Deviation 23.23	31.59 units on a scale Standard Deviation 23.31	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	33.81 units on a scale Standard Deviation 27.14	33.13 units on a scale Standard Deviation 24.58	36.46 units on a scale Standard Deviation 21.42
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Opt (n=24,15,29,15,43,55,52,0,40,20,24)	0.58 units on a scale Standard Deviation 0.50	0.31 units on a scale Standard Deviation 0.48	0.55 units on a scale Standard Deviation 0.51	0.33 units on a scale Standard Deviation 0.49	0.72 units on a scale Standard Deviation 0.45	0.38 units on a scale Standard Deviation 0.49	0.50 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.55 units on a scale Standard Deviation 0.50	0.75 units on a scale Standard Deviation 0.44	0.50 units on a scale Standard Deviation 0.51
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Qua (n=24,14,29,15,43,55,52,0,40,20,24)	7.04 units on a scale Standard Deviation 1.63	7.00 units on a scale Standard Deviation 1.41	6.83 units on a scale Standard Deviation 1.42	6.60 units on a scale Standard Deviation 1.35	7.14 units on a scale Standard Deviation 1.06	6.73 units on a scale Standard Deviation 1.60	6.92 units on a scale Standard Deviation 1.44	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	6.95 units on a scale Standard Deviation 1.41	7.20 units on a scale Standard Deviation 1.06	7.00 units on a scale Standard Deviation 1.25
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Sno (n=24,15,29,15,43,55,52,0,40,20,24)	23.33 units on a scale Standard Deviation 20.14	33.33 units on a scale Standard Deviation 36.77	38.62 units on a scale Standard Deviation 32.04	36.00 units on a scale Standard Deviation 33.97	34.42 units on a scale Standard Deviation 31.27	28.73 units on a scale Standard Deviation 27.96	31.54 units on a scale Standard Deviation 29.73	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	40.50 units on a scale Standard Deviation 32.18	34.00 units on a scale Standard Deviation 31.19	32.50 units on a scale Standard Deviation 24.18
Medical Outcome Study- Sleep Scale (MOS-SS) Week 24: Som (n=24,15,29,15,43,55,52,0,40,20,24)	29.44 units on a scale Standard Deviation 20.80	30.67 units on a scale Standard Deviation 18.14	26.44 units on a scale Standard Deviation 19.48	31.11 units on a scale Standard Deviation 22.21	30.39 units on a scale Standard Deviation 17.54	27.39 units on a scale Standard Deviation 20.47	26.54 units on a scale Standard Deviation 17.83	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	30.17 units on a scale Standard Deviation 22.80	28.00 units on a scale Standard Deviation 18.17	28.33 units on a scale Standard Deviation 17.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 2, 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\*100); total score range: 0 to 100; higher score = greater intensity of attribute.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=16 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=15 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=58 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Ade (n=54,0,51,0,48,59,57,52,0,55,0)	5.37 units on a scale Standard Deviation 20.62	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.18 units on a scale Standard Deviation 20.65	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.83 units on a scale Standard Deviation 23.95	7.29 units on a scale Standard Deviation 23.33	12.46 units on a scale Standard Deviation 25.44	10.00 units on a scale Standard Deviation 24.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.82 units on a scale Standard Deviation 19.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: A SOB (n=54,0,50,0,48,59,57,52,0,55,0)	0.37 units on a scale Standard Deviation 21.80	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.20 units on a scale Standard Deviation 26.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	5.83 units on a scale Standard Deviation 25.75	-4.07 units on a scale Standard Deviation 30.80	-4.56 units on a scale Standard Deviation 21.39	-1.92 units on a scale Standard Deviation 23.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.18 units on a scale Standard Deviation 18.81	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Sno (n=54,0,51,0,48,59,57,52,0,55,0)	-2.96 units on a scale Standard Deviation 19.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.24 units on a scale Standard Deviation 22.33	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.67 units on a scale Standard Deviation 15.34	-1.69 units on a scale Standard Deviation 19.75	0.00 units on a scale Standard Deviation 27.26	-1.15 units on a scale Standard Deviation 16.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.36 units on a scale Standard Deviation 18.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: SPS (n=54,0,50,0,48,59,57,52,0,55,0)	-3.27 units on a scale Standard Deviation 14.06	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.13 units on a scale Standard Deviation 12.63	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-2.50 units on a scale Standard Deviation 18.09	-7.12 units on a scale Standard Deviation 15.14	-8.89 units on a scale Standard Deviation 17.59	-6.99 units on a scale Standard Deviation 16.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.85 units on a scale Standard Deviation 15.95	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: OSP (n=54,0,50,0,48,59,57,52,0,55,0)	-3.23 units on a scale Standard Deviation 13.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.36 units on a scale Standard Deviation 11.58	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.62 units on a scale Standard Deviation 17.59	-7.95 units on a scale Standard Deviation 15.26	-9.62 units on a scale Standard Deviation 16.95	-7.41 units on a scale Standard Deviation 15.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.89 units on a scale Standard Deviation 16.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: SD (n=54,0,50,0,48,59,57,52,0,55,0)	-4.58 units on a scale Standard Deviation 18.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.25 units on a scale Standard Deviation 14.46	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.38 units on a scale Standard Deviation 22.80	-9.83 units on a scale Standard Deviation 19.04	-8.40 units on a scale Standard Deviation 23.32	-9.66 units on a scale Standard Deviation 18.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.89 units on a scale Standard Deviation 23.77	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Opt (n=54,0,51,0,48,60,57,53,0,58,0)	0.07 units on a scale Standard Deviation 0.43	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.10 units on a scale Standard Deviation 0.50	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.08 units on a scale Standard Deviation 0.50	0.13 units on a scale Standard Deviation 0.50	0.05 units on a scale Standard Deviation 0.61	-0.13 units on a scale Standard Deviation 0.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.00 units on a scale Standard Deviation 0.56	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Qua (n=54,0,51,0,48,60,57,52,0,57,0)	0.20 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.10 units on a scale Standard Deviation 1.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.19 units on a scale Standard Deviation 1.16	0.20 units on a scale Standard Deviation 1.22	0.39 units on a scale Standard Deviation 1.06	0.02 units on a scale Standard Deviation 1.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.11 units on a scale Standard Deviation 1.19	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 2: Som (n=54,0,51,0,48,59,57,52,0,55,0)	-0.00 units on a scale Standard Deviation 19.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.49 units on a scale Standard Deviation 17.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.14 units on a scale Standard Deviation 18.63	-6.33 units on a scale Standard Deviation 19.20	-7.84 units on a scale Standard Deviation 17.05	-0.90 units on a scale Standard Deviation 16.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.21 units on a scale Standard Deviation 14.75	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: SPS (n=44,0,46,0,45,57,53,45,0,44,0)	-8.56 units on a scale Standard Deviation 19.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.59 units on a scale Standard Deviation 17.72	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.74 units on a scale Standard Deviation 17.05	-9.82 units on a scale Standard Deviation 18.09	-11.70 units on a scale Standard Deviation 18.44	-6.96 units on a scale Standard Deviation 16.30	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-9.32 units on a scale Standard Deviation 18.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: OSP (n=44,0,46,0,45,57,53,45,0,44,0)	-7.16 units on a scale Standard Deviation 18.36	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-8.85 units on a scale Standard Deviation 16.99	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-5.73 units on a scale Standard Deviation 16.87	-10.75 units on a scale Standard Deviation 17.25	-12.16 units on a scale Standard Deviation 17.51	-7.36 units on a scale Standard Deviation 15.12	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.19 units on a scale Standard Deviation 18.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Ade (n=44,0,46,0,45,57,53,45,0,44,0)	15.45 units on a scale Standard Deviation 28.73	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.52 units on a scale Standard Deviation 26.52	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.56 units on a scale Standard Deviation 25.33	9.30 units on a scale Standard Deviation 27.38	15.28 units on a scale Standard Deviation 26.79	9.33 units on a scale Standard Deviation 27.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	11.14 units on a scale Standard Deviation 21.15	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: A SOB (n=44,0,46,0,45,57,53,45,0,44,0)	-6.36 units on a scale Standard Deviation 19.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.83 units on a scale Standard Deviation 31.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-4.89 units on a scale Standard Deviation 20.96	-6.67 units on a scale Standard Deviation 25.45	-3.40 units on a scale Standard Deviation 24.72	-0.89 units on a scale Standard Deviation 27.29	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.82 units on a scale Standard Deviation 23.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: SD (n=44,0,46,0,45,57,53,45,0,44,0)	-6.56 units on a scale Standard Deviation 21.22	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-10.24 units on a scale Standard Deviation 22.44	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-7.89 units on a scale Standard Deviation 25.34	-12.52 units on a scale Standard Deviation 22.44	-12.08 units on a scale Standard Deviation 23.49	-9.11 units on a scale Standard Deviation 21.04	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-13.04 units on a scale Standard Deviation 25.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Opt (n=44,0,46,0,45,57,54,45,0,46,0)	0.09 units on a scale Standard Deviation 0.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.02 units on a scale Standard Deviation 0.54	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-0.02 units on a scale Standard Deviation 0.54	0.19 units on a scale Standard Deviation 0.52	0.07 units on a scale Standard Deviation 0.64	-0.04 units on a scale Standard Deviation 0.47	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.11 units on a scale Standard Deviation 0.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Qua (n=44,0,46,0,45,56,53,45,0,46,0)	0.52 units on a scale Standard Deviation 1.49	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.15 units on a scale Standard Deviation 1.26	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.16 units on a scale Standard Deviation 1.11	0.27 units on a scale Standard Deviation 1.36	0.30 units on a scale Standard Deviation 1.34	0.07 units on a scale Standard Deviation 2.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.35 units on a scale Standard Deviation 1.57	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Sno (n=44,0,46,0,45,57,53,45,0,44,0)	1.82 units on a scale Standard Deviation 29.83	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.91 units on a scale Standard Deviation 28.16	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	1.78 units on a scale Standard Deviation 20.37	-1.40 units on a scale Standard Deviation 25.60	-1.51 units on a scale Standard Deviation 19.55	-3.11 units on a scale Standard Deviation 25.21	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.36 units on a scale Standard Deviation 23.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 12: Som (n=44,0,46,0,45,57,53,45,0,44,0)	0.30 units on a scale Standard Deviation 22.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-6.96 units on a scale Standard Deviation 17.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-3.41 units on a scale Standard Deviation 21.63	-8.30 units on a scale Standard Deviation 22.37	-9.43 units on a scale Standard Deviation 18.65	-1.04 units on a scale Standard Deviation 21.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	-1.67 units on a scale Standard Deviation 18.53	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: SPS (n=24,15,29,15,43,55,52,0,40,19,24)	-8.89 units on a scale Standard Deviation 16.32	-11.78 units on a scale Standard Deviation 25.66	-12.18 units on a scale Standard Deviation 17.21	-5.11 units on a scale Standard Deviation 21.34	-6.90 units on a scale Standard Deviation 18.39	-11.09 units on a scale Standard Deviation 18.31	-10.00 units on a scale Standard Deviation 20.69	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-11.50 units on a scale Standard Deviation 22.93	-8.60 units on a scale Standard Deviation 13.21	-11.94 units on a scale Standard Deviation 22.76
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: OSP (n=24,15,29,15,43,55,52,0,40,19,24)	-8.43 units on a scale Standard Deviation 14.30	-12.48 units on a scale Standard Deviation 24.26	-14.44 units on a scale Standard Deviation 17.70	-8.52 units on a scale Standard Deviation 19.53	-9.10 units on a scale Standard Deviation 18.33	-12.14 units on a scale Standard Deviation 17.76	-11.68 units on a scale Standard Deviation 17.94	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-12.25 units on a scale Standard Deviation 20.59	-10.35 units on a scale Standard Deviation 13.71	-12.64 units on a scale Standard Deviation 19.16
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Ade (n=24,15,29,15,43,55,52,0,40,19,24)	12.92 units on a scale Standard Deviation 30.29	11.33 units on a scale Standard Deviation 32.04	9.66 units on a scale Standard Deviation 26.39	4.67 units on a scale Standard Deviation 27.74	7.21 units on a scale Standard Deviation 26.76	10.00 units on a scale Standard Deviation 29.19	10.77 units on a scale Standard Deviation 26.33	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	21.00 units on a scale Standard Deviation 26.68	13.16 units on a scale Standard Deviation 16.68	17.50 units on a scale Standard Deviation 28.93
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: A SOB (n=24,15,29,15,43,55,52,0,40,19,24)	4.17 units on a scale Standard Deviation 25.01	1.33 units on a scale Standard Deviation 34.20	-8.97 units on a scale Standard Deviation 32.33	6.67 units on a scale Standard Deviation 31.77	0.93 units on a scale Standard Deviation 27.59	-2.91 units on a scale Standard Deviation 27.60	-3.08 units on a scale Standard Deviation 29.48	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	5.00 units on a scale Standard Deviation 29.26	-5.26 units on a scale Standard Deviation 16.11	-5.83 units on a scale Standard Deviation 27.96
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: SD (n=24,15,29,15,43,55,52,0,40,19,24)	-11.88 units on a scale Standard Deviation 20.92	-16.42 units on a scale Standard Deviation 30.92	-16.98 units on a scale Standard Deviation 24.82	-11.50 units on a scale Standard Deviation 23.66	-12.33 units on a scale Standard Deviation 24.35	-16.14 units on a scale Standard Deviation 22.21	-13.20 units on a scale Standard Deviation 23.25	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-13.44 units on a scale Standard Deviation 26.54	-10.92 units on a scale Standard Deviation 20.62	-16.15 units on a scale Standard Deviation 23.75
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Opt (n=24,16,29,15,43,55,52,0,40,20,24)	0.17 units on a scale Standard Deviation 0.56	0.00 units on a scale Standard Deviation 0.52	0.07 units on a scale Standard Deviation 0.53	-0.13 units on a scale Standard Deviation 0.64	0.23 units on a scale Standard Deviation 0.53	0.05 units on a scale Standard Deviation 0.52	0.08 units on a scale Standard Deviation 0.52	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-0.08 units on a scale Standard Deviation 0.62	0.20 units on a scale Standard Deviation 0.62	0.08 units on a scale Standard Deviation 0.50
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Qua (n=24,14,29,15,43,55,52,0,40,20,24)	0.83 units on a scale Standard Deviation 0.92	0.57 units on a scale Standard Deviation 1.02	0.45 units on a scale Standard Deviation 1.50	-0.27 units on a scale Standard Deviation 1.53	0.37 units on a scale Standard Deviation 1.20	0.18 units on a scale Standard Deviation 1.59	0.62 units on a scale Standard Deviation 1.24	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	0.23 units on a scale Standard Deviation 2.39	0.50 units on a scale Standard Deviation 1.19	0.33 units on a scale Standard Deviation 1.31
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Sno (n=24,15,29,15,43,55,52,0,40,19,24)	0.00 units on a scale Standard Deviation 26.38	-4.00 units on a scale Standard Deviation 18.82	-4.83 units on a scale Standard Deviation 27.60	-2.67 units on a scale Standard Deviation 19.81	2.33 units on a scale Standard Deviation 26.26	-2.18 units on a scale Standard Deviation 24.55	0.77 units on a scale Standard Deviation 27.99	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	2.50 units on a scale Standard Deviation 22.27	-2.11 units on a scale Standard Deviation 39.38	5.83 units on a scale Standard Deviation 18.16
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET Week 24: Som (n=24,15,29,15,43,55,52,0,40,19,24)	0.00 units on a scale Standard Deviation 19.66	-13.33 units on a scale Standard Deviation 20.00	-11.95 units on a scale Standard Deviation 21.04	-9.78 units on a scale Standard Deviation 19.33	-7.29 units on a scale Standard Deviation 18.56	-10.42 units on a scale Standard Deviation 23.40	-11.03 units on a scale Standard Deviation 22.05	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	-5.50 units on a scale Standard Deviation 23.24	-5.26 units on a scale Standard Deviation 16.27	-2.50 units on a scale Standard Deviation 13.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 2, 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm 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 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=15 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=49 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=60 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=53 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=59 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline (n=54,0,51,0,49,60,57,53,0,59,0)	28.39 units on a scale Standard Deviation 11.55	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.90 units on a scale Standard Deviation 9.66	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	26.84 units on a scale Standard Deviation 11.85	26.75 units on a scale Standard Deviation 12.19	25.74 units on a scale Standard Deviation 11.32	25.87 units on a scale Standard Deviation 11.93	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	27.49 units on a scale Standard Deviation 9.96	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 2 (n=54,0,51,0,48,60,56,52,0,57,0)	29.06 units on a scale Standard Deviation 10.94	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.52 units on a scale Standard Deviation 9.70	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	30.31 units on a scale Standard Deviation 11.84	31.80 units on a scale Standard Deviation 11.57	31.66 units on a scale Standard Deviation 10.99	29.15 units on a scale Standard Deviation 12.08	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	28.23 units on a scale Standard Deviation 10.38	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 12 (n=44,0,46,0,45,56,54,45,0,46,0)	34.57 units on a scale Standard Deviation 10.82	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	33.37 units on a scale Standard Deviation 10.05	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	34.11 units on a scale Standard Deviation 11.29	37.11 units on a scale Standard Deviation 11.50	35.30 units on a scale Standard Deviation 11.63	30.58 units on a scale Standard Deviation 10.85	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	31.09 units on a scale Standard Deviation 10.91	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 24 (n=24,15,29,15,43,55,52,0,40,20,24)	35.21 units on a scale Standard Deviation 12.24	31.53 units on a scale Standard Deviation 9.98	37.48 units on a scale Standard Deviation 10.08	31.80 units on a scale Standard Deviation 8.79	35.00 units on a scale Standard Deviation 10.34	35.82 units on a scale Standard Deviation 11.59	34.03 units on a scale Standard Deviation 10.87	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	34.90 units on a scale Standard Deviation 10.47	35.45 units on a scale Standard Deviation 7.27	37.25 units on a scale Standard Deviation 8.52

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 2, 12, 24/ ET

Population: FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline measure. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=54 Participants CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg n=15 Participants CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 5 mg n=51 Participants CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=15 Participants CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=48 Participants CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=59 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=56 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Adalimumab n=52 Participants Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=40 Participants Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=57 Participants Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=24 Participants Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET Week 2 (n=54,0,51,0,48,59,56,52,0,57,0)	0.67 units on a scale Standard Deviation 7.79	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.62 units on a scale Standard Deviation 7.07	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.38 units on a scale Standard Deviation 9.76	5.10 units on a scale Standard Deviation 9.32	6.07 units on a scale Standard Deviation 10.34	3.54 units on a scale Standard Deviation 9.18	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	0.70 units on a scale Standard Deviation 8.25	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET Week 12 (n=44,0,46,0,45,55,54,45,0,46,0)	5.14 units on a scale Standard Deviation 9.42	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	6.00 units on a scale Standard Deviation 8.20	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	7.47 units on a scale Standard Deviation 8.70	9.40 units on a scale Standard Deviation 11.52	8.85 units on a scale Standard Deviation 11.84	3.78 units on a scale Standard Deviation 11.39	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.	3.33 units on a scale Standard Deviation 9.97	NA units on a scale Standard Deviation NA Data not available at this time point since the reassignment to CP-690,550 5 mg was after Week 12.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET Week 24 (n=24,15,29,15,43,55,52,0,40,20,24)	4.96 units on a scale Standard Deviation 10.75	5.93 units on a scale Standard Deviation 9.93	6.97 units on a scale Standard Deviation 8.97	9.13 units on a scale Standard Deviation 6.83	8.81 units on a scale Standard Deviation 8.86	8.73 units on a scale Standard Deviation 11.87	7.59 units on a scale Standard Deviation 9.93	NA units on a scale Standard Deviation NA Data not available as all adalimumab participants received CP-690,550 5 mg after Week 12.	7.80 units on a scale Standard Deviation 12.39	8.90 units on a scale Standard Deviation 8.72	8.63 units on a scale Standard Deviation 6.01

Adverse Events

CP-690,550 1 mg

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

CP-690,550 1 mg to CP-690,550 5 mg (R)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

CP-690,550 3 mg

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

CP-690,550 3 mg to CP-690,550 5 mg (R)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

CP-690,550 5 mg

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

CP-690,550 10 mg

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

CP-690,550 15 mg

Serious events: 4 serious events

Other events: 31 other events

Deaths: 0 deaths

Adalimumab

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adalimumab to CP-690,550 5 mg (R)

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo to CP-690,550 5 mg (R)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550 1 mg n=37 participants at risk CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=17 participants at risk Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=34 participants at risk CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=17 participants at risk Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=49 participants at risk CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=61 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=57 participants at risk CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=9 participants at risk Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 participants at risk Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=34 participants at risk Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 participants at risk Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gastric ulcer	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Meningitis bacterial	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Pneumococcal sepsis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 pneumococcal	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Sinusitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Wound infection	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Meniscus lesion	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Cerebrovascular accident	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Panic attack	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Postmenopausal haemorrhage	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Knee arthroplasty	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 1 mg n=37 participants at risk CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 1 mg to CP-690,550 5 mg (R) n=17 participants at risk Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 3 mg n=34 participants at risk CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.	CP-690,550 3 mg to CP-690,550 5 mg (R) n=17 participants at risk Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	CP-690,550 5 mg n=49 participants at risk CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 10 mg n=61 participants at risk CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	CP-690,550 15 mg n=57 participants at risk CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.	Adalimumab n=9 participants at risk Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.	Adalimumab to CP-690,550 5 mg (R) n=44 participants at risk Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.	Placebo n=34 participants at risk Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.	Placebo to CP-690,550 5 mg (R) n=25 participants at risk Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
Infections and infestations Gastroenteritis	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gastrointestinal infection	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Leukopenia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Lymphadenopathy	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Sinus bradycardia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Tachycardia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ear discomfort	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Ear pain	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Vertigo	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Conjunctival haemorrhage	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Visual acuity reduced	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.0% 3/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dental caries	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.8% 3/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.1% 3/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 4/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Epigastric discomfort	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Eructation	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gastric ulcer	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gastrointestinal disorder	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gingival pain	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Glossodynia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Haemorrhoids	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Parotid gland enlargement	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Salivary gland enlargement	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Stomach discomfort	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Stomatitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 discomfort	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Chills	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Fatigue	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Influenza like illness	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Swelling	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Allergy to chemicals	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.0% 4/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 3/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Bronchopneumonia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Cystitis	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hordeolum	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 3/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Kidney infection	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Onychomycosis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Oral herpes	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Osteomyelitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis streptococcal	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Post procedural infection	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Rhinitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Sinusitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Subcutaneous abscess	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Tinea pedis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth infection	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	8.1% 3/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 5/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.5% 6/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Vulvovaginal mycotic infection	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Arthropod bite	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Epicondylitis	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Eye injury	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Rib fracture	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Aspartate aminotransferase increased	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood lactate dehydrogenase increased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood triglycerides increased	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Electrocardiogram RR interval prolonged	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Haematocrit decreased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Haemoglobin decreased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hepatic enzyme increased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Low density lipoprotein increased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Neutrophil count decreased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Platelet count decreased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Platelet count increased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 White blood cell count decreased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 White blood cell count increased	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Anorexia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Increased appetite	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Enthesopathy	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Fibromyalgia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Groin pain	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Muscle spasms	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 pain	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Myalgia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Myofascial pain syndrome	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Tenosynovitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Burning sensation	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Carpal tunnel syndrome	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 2/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.5% 2/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.8% 6/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 3/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hypoaesthesia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Migraine	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Psychomotor hyperactivity	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Somnolence	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 1/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dysuria	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Pyuria	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Amenorrhoea	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Erectile dysfunction	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Galactorrhoea	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Nipple disorder	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Bronchial obstruction	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dysphonia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dyspnoea	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Epistaxis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Oropharyngeal pain	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Rales	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Sinus congestion	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Alopecia	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.3% 1/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dermatitis	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dermatitis allergic	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.1% 1/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Erythema	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hyperhidrosis	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.9% 2/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Pruritus	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.6% 1/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 3/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.3% 3/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.1% 4/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash maculovesicular	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 hyperpigmentation	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 lesion	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Subcutaneous nodule	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Haematoma	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 1/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 2/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Hypotension	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.9% 1/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/17 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/49 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/61 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/57 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/9 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/44 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/34 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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