Trial Outcomes & Findings for Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan (NCT NCT00603512)

Last Updated: 2013-01-25

Results Overview

ACR20 response: greater than or equal to (\>=) 20 percent (%) 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

140 participants

Primary outcome timeframe

Week 12

Results posted on

2013-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	CP-690,550 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Study STARTED	28	28	28	28	28
Overall Study Treated	28	27	27	26	28
Overall Study COMPLETED	26	23	23	21	23
Overall Study NOT COMPLETED	2	5	5	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-690,550 1 mg CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Overall Study Adverse Event	0	2	4	4	2
Overall Study Lack of Efficacy	0	1	0	0	1
Overall Study Other	2	1	0	1	1
Overall Study Withdrawal by Subject	0	0	0	0	1
Overall Study Randomized but not treated	0	1	1	2	0

Baseline Characteristics

Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.	Total n=136 Participants Total of all reporting groups
Age Continuous	52.0 Years STANDARD_DEVIATION 9.4 • n=5 Participants	53.3 Years STANDARD_DEVIATION 12.1 • n=7 Participants	50.0 Years STANDARD_DEVIATION 9.8 • n=5 Participants	50.6 Years STANDARD_DEVIATION 10.0 • n=4 Participants	50.6 Years STANDARD_DEVIATION 12.4 • n=21 Participants	51.3 Years STANDARD_DEVIATION 10.7 • n=10 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	24 Participants n=7 Participants	22 Participants n=5 Participants	25 Participants n=4 Participants	25 Participants n=21 Participants	117 Participants n=10 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	19 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using Last observation carried forward (LOCF) method.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	64.3 Percentage of Participants	77.8 Percentage of Participants	96.3 Percentage of Participants	80.8 Percentage of Participants	14.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 1	28.57 Percentage of Participants	14.81 Percentage of Participants	29.63 Percentage of Participants	38.46 Percentage of Participants	3.57 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 2	32.14 Percentage of Participants	40.74 Percentage of Participants	62.96 Percentage of Participants	50.00 Percentage of Participants	10.71 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 4	50.00 Percentage of Participants	55.56 Percentage of Participants	88.89 Percentage of Participants	76.92 Percentage of Participants	10.71 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 8	67.86 Percentage of Participants	66.67 Percentage of Participants	96.30 Percentage of Participants	80.77 Percentage of Participants	21.43 Percentage of Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12/End of Treatment (EOT)

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR50 response: \>= 50% improvement in tender or swollen joint counts 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 1	7.14 Percentage of Participants	3.70 Percentage of Participants	0.00 Percentage of Participants	7.69 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 2	7.14 Percentage of Participants	7.41 Percentage of Participants	25.93 Percentage of Participants	26.92 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 4	10.71 Percentage of Participants	22.22 Percentage of Participants	29.63 Percentage of Participants	34.62 Percentage of Participants	3.57 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 8	28.57 Percentage of Participants	29.63 Percentage of Participants	70.37 Percentage of Participants	50.00 Percentage of Participants	7.14 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 12	32.14 Percentage of Participants	44.44 Percentage of Participants	81.48 Percentage of Participants	57.69 Percentage of Participants	14.29 Percentage of Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR70 response: \>= 70% improvement in tender or swollen joint counts 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 1	0.00 Percentage of Participants	0.00 Percentage of Participants	0.00 Percentage of Participants	3.85 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 2	0.00 Percentage of Participants	3.70 Percentage of Participants	11.11 Percentage of Participants	3.85 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 4	3.57 Percentage of Participants	7.41 Percentage of Participants	14.81 Percentage of Participants	7.69 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 8	3.57 Percentage of Participants	7.41 Percentage of Participants	33.33 Percentage of Participants	26.92 Percentage of Participants	3.57 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 12	7.14 Percentage of Participants	14.81 Percentage of Participants	33.33 Percentage of Participants	34.62 Percentage of Participants	3.57 Percentage of Participants

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR90 response: \>= 90% improvement in tender or swollen joint counts 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 12	0.00 Percentage of Participants	11.11 Percentage of Participants	3.70 Percentage of Participants	11.54 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 1	0.00 Percentage of Participants	0.00 Percentage of Participants	0.00 Percentage of Participants	0.00 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 2	0.00 Percentage of Participants	0.00 Percentage of Participants	0.00 Percentage of Participants	3.85 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 4	0.00 Percentage of Participants	0.00 Percentage of Participants	3.70 Percentage of Participants	0.00 Percentage of Participants	0.00 Percentage of Participants
Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response Week 8	0.00 Percentage of Participants	3.70 Percentage of Participants	7.41 Percentage of Participants	3.85 Percentage of Participants	0.00 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. 'n' = number of participants who were 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Tender Joint Count (TJC) Baseline (n=28,27,27,26,28)	16.36 tender joints Standard Deviation 7.56	16.22 tender joints Standard Deviation 8.50	17.81 tender joints Standard Deviation 12.32	15.42 tender joints Standard Deviation 9.77	16.36 tender joints Standard Deviation 9.08
Tender Joint Count (TJC) Week 1 (n=28,26,27,26,28)	11.89 tender joints Standard Deviation 7.06	12.04 tender joints Standard Deviation 10.95	13.22 tender joints Standard Deviation 14.04	10.96 tender joints Standard Deviation 11.89	12.86 tender joints Standard Deviation 9.03
Tender Joint Count (TJC) Week 2 (n=27,27,27,25,26)	11.63 tender joints Standard Deviation 8.72	9.63 tender joints Standard Deviation 8.72	9.52 tender joints Standard Deviation 13.12	8.20 tender joints Standard Deviation 10.91	11.62 tender joints Standard Deviation 9.43
Tender Joint Count (TJC) Week 4 (n=27,26,27,24,25)	10.04 tender joints Standard Deviation 7.64	7.00 tender joints Standard Deviation 7.61	8.22 tender joints Standard Deviation 10.48	5.58 tender joints Standard Deviation 6.35	13.76 tender joints Standard Deviation 11.30
Tender Joint Count (TJC) Week 8 (n=26,25,26,23,24)	6.73 tender joints Standard Deviation 6.80	5.40 tender joints Standard Deviation 7.64	5.15 tender joints Standard Deviation 6.49	3.35 tender joints Standard Deviation 4.71	11.04 tender joints Standard Deviation 8.38
Tender Joint Count (TJC) Week 12 (n=26,24,24,21,24)	5.92 tender joints Standard Deviation 6.73	6.38 tender joints Standard Deviation 9.60	3.63 tender joints Standard Deviation 4.39	2.71 tender joints Standard Deviation 4.33	9.96 tender joints Standard Deviation 7.85

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-4.46 tender joints Standard Deviation 4.80	-4.19 tender joints Standard Deviation 6.92	-4.59 tender joints Standard Deviation 5.76	-4.46 tender joints Standard Deviation 7.61	-3.50 tender joints Standard Deviation 5.68
Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT Week 2 (n=27,27,27,25,26)	-4.70 tender joints Standard Deviation 7.37	-6.59 tender joints Standard Deviation 7.31	-8.30 tender joints Standard Deviation 6.36	-6.88 tender joints Standard Deviation 6.09	-4.54 tender joints Standard Deviation 5.48
Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-6.30 tender joints Standard Deviation 8.78	-9.00 tender joints Standard Deviation 8.94	-9.59 tender joints Standard Deviation 7.00	-9.88 tender joints Standard Deviation 7.50	-2.28 tender joints Standard Deviation 8.38
Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,26,23,24)	-9.42 tender joints Standard Deviation 8.90	-10.84 tender joints Standard Deviation 9.00	-12.88 tender joints Standard Deviation 10.77	-12.09 tender joints Standard Deviation 8.23	-4.04 tender joints Standard Deviation 7.17
Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-10.23 tender joints Standard Deviation 8.84	-9.96 tender joints Standard Deviation 10.79	-14.42 tender joints Standard Deviation 10.43	-12.71 tender joints Standard Deviation 8.01	-5.13 tender joints Standard Deviation 7.27

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Swollen Joint Count (SJC) Baseline (n=28,27,27,26,28)	13.18 swollen joints Standard Deviation 5.63	15.11 swollen joints Standard Deviation 7.92	15.59 swollen joints Standard Deviation 12.41	15.12 swollen joints Standard Deviation 9.96	13.82 swollen joints Standard Deviation 6.27
Swollen Joint Count (SJC) Week 1 (n=28,26,27,26,28)	10.07 swollen joints Standard Deviation 5.87	12.62 swollen joints Standard Deviation 9.21	12.70 swollen joints Standard Deviation 12.66	9.73 swollen joints Standard Deviation 10.98	13.18 swollen joints Standard Deviation 7.45
Swollen Joint Count (SJC) Week 2 (n=27,27,27,25,26)	8.26 swollen joints Standard Deviation 4.81	9.67 swollen joints Standard Deviation 6.23	9.41 swollen joints Standard Deviation 11.52	8.04 swollen joints Standard Deviation 11.36	12.04 swollen joints Standard Deviation 6.95
Swollen Joint Count (SJC) Week 4 (n=27,26,27,24,25)	7.85 swollen joints Standard Deviation 6.00	8.19 swollen joints Standard Deviation 6.50	7.41 swollen joints Standard Deviation 9.28	6.63 swollen joints Standard Deviation 7.83	11.80 swollen joints Standard Deviation 7.88
Swollen Joint Count (SJC) Week 8 (n=26,25,26,23,24)	5.92 swollen joints Standard Deviation 4.86	6.12 swollen joints Standard Deviation 5.40	4.62 swollen joints Standard Deviation 4.99	5.17 swollen joints Standard Deviation 6.31	11.08 swollen joints Standard Deviation 8.10
Swollen Joint Count (SJC) Week 12 (n=26,24,24,21,24)	5.19 swollen joints Standard Deviation 5.87	5.29 swollen joints Standard Deviation 5.43	3.83 swollen joints Standard Deviation 4.24	4.05 swollen joints Standard Deviation 5.98	11.13 swollen joints Standard Deviation 7.12

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-3.11 swollen joints Standard Deviation 5.26	-2.54 swollen joints Standard Deviation 6.11	-2.89 swollen joints Standard Deviation 2.81	-5.38 swollen joints Standard Deviation 5.08	-0.64 swollen joints Standard Deviation 3.71
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT Week 2 (n=27,27,27,25,26)	-4.74 swollen joints Standard Deviation 5.45	-5.44 swollen joints Standard Deviation 6.57	-6.19 swollen joints Standard Deviation 5.02	-6.84 swollen joints Standard Deviation 4.87	-1.69 swollen joints Standard Deviation 3.48
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-5.15 swollen joints Standard Deviation 7.25	-6.69 swollen joints Standard Deviation 7.07	-8.19 swollen joints Standard Deviation 5.94	-8.50 swollen joints Standard Deviation 5.16	-1.68 swollen joints Standard Deviation 4.59
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,26,23,24)	-6.92 swollen joints Standard Deviation 6.56	-8.96 swollen joints Standard Deviation 8.25	-11.35 swollen joints Standard Deviation 8.91	-10.09 swollen joints Standard Deviation 6.08	-2.08 swollen joints Standard Deviation 6.55
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-7.65 swollen joints Standard Deviation 7.53	-9.71 swollen joints Standard Deviation 8.16	-12.58 swollen joints Standard Deviation 10.06	-11.71 swollen joints Standard Deviation 6.68	-2.04 swollen joints Standard Deviation 5.77

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Patient Assessment of Arthritis Pain Baseline (n=28,26,27,26,28)	54.18 mm Standard Deviation 23.48	57.59 mm Standard Deviation 20.18	53.22 mm Standard Deviation 25.94	52.19 mm Standard Deviation 24.97	53.32 mm Standard Deviation 23.63
Patient Assessment of Arthritis Pain Week 1 (n=28,26,27,26,28)	45.36 mm Standard Deviation 20.32	43.50 mm Standard Deviation 20.69	40.19 mm Standard Deviation 24.03	37.08 mm Standard Deviation 23.38	49.36 mm Standard Deviation 24.42
Patient Assessment of Arthritis Pain Week 2 (n=27,27,27,25,26)	45.11 mm Standard Deviation 20.11	40.52 mm Standard Deviation 24.32	33.19 mm Standard Deviation 24.63	31.40 mm Standard Deviation 20.92	48.58 mm Standard Deviation 25.56
Patient Assessment of Arthritis Pain Week 4 (n=27,26,27,25,26)	42.44 mm Standard Deviation 20.98	34.88 mm Standard Deviation 22.45	25.19 mm Standard Deviation 20.67	30.46 mm Standard Deviation 23.60	49.72 mm Standard Deviation 24.46
Patient Assessment of Arthritis Pain Week 8 (n=26,25,27,23,24)	32.65 mm Standard Deviation 17.84	30.04 mm Standard Deviation 23.37	22.59 mm Standard Deviation 21.45	19.43 mm Standard Deviation 18.64	48.88 mm Standard Deviation 23.01
Patient Assessment of Arthritis Pain Week 12 (n=26,24,24,21,24)	32.19 mm Standard Deviation 17.69	27.17 mm Standard Deviation 21.40	17.58 mm Standard Deviation 17.27	16.90 mm Standard Deviation 20.29	44.96 mm Standard Deviation 25.41

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-8.82 mm Standard Deviation 18.21	-14.35 mm Standard Deviation 16.99	-13.04 mm Standard Deviation 18.78	-15.12 mm Standard Deviation 19.89	-3.96 mm Standard Deviation 14.90
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT Week 2 n=27,27,27,25,26)	-10.41 mm Standard Deviation 20.16	-17.07 mm Standard Deviation 25.47	-20.04 mm Standard Deviation 22.04	-22.44 mm Standard Deviation 27.77	-3.69 mm Standard Deviation 10.60
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-13.07 mm Standard Deviation 23.22	-23.35 mm Standard Deviation 22.89	-28.04 mm Standard Deviation 23.74	-24.29 mm Standard Deviation 26.28	-1.00 mm Standard Deviation 14.27
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,27,23,24)	-22.54 mm Standard Deviation 26.84	-28.92 mm Standard Deviation 23.46	-30.63 mm Standard Deviation 25.40	-34.26 mm Standard Deviation 26.19	-2.04 mm Standard Deviation 22.66
Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-23.00 mm Standard Deviation 25.13	-32.50 mm Standard Deviation 22.75	-31.38 mm Standard Deviation 22.67	-38.43 mm Standard Deviation 28.38	-5.96 mm Standard Deviation 22.61

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Patient Global Assessment (PtGA) of Arthritis Baseline (n=28,27,27,26,28)	58.00 mm Standard Deviation 18.27	60.26 mm Standard Deviation 21.79	58.67 mm Standard Deviation 23.63	52.04 mm Standard Deviation 26.27	53.50 mm Standard Deviation 24.04
Patient Global Assessment (PtGA) of Arthritis Week 1 (n=28,26,27,26,28)	45.89 mm Standard Deviation 21.08	44.27 mm Standard Deviation 19.25	42.56 mm Standard Deviation 24.48	34.73 mm Standard Deviation 21.41	46.54 mm Standard Deviation 23.49
Patient Global Assessment (PtGA) of Arthritis Week 2 (n=27,27,27,25,26)	46.07 mm Standard Deviation 22.39	42.63 mm Standard Deviation 23.82	33.78 mm Standard Deviation 25.04	30.44 mm Standard Deviation 20.57	48.42 mm Standard Deviation 25.65
Patient Global Assessment (PtGA) of Arthritis Week 4 (n=27,26,27,24,25)	44.59 mm Standard Deviation 22.89	34.23 mm Standard Deviation 21.81	28.93 mm Standard Deviation 21.61	30.04 mm Standard Deviation 22.62	49.16 mm Standard Deviation 25.09
Patient Global Assessment (PtGA) of Arthritis Week 8 (n=26,25,27,23,24)	35.12 mm Standard Deviation 17.80	30.68 mm Standard Deviation 24.36	21.81 mm Standard Deviation 22.22	20.39 mm Standard Deviation 20.85	49.17 mm Standard Deviation 22.00
Patient Global Assessment (PtGA) of Arthritis Week 12 (n=26,24,24,21,24)	31.42 mm Standard Deviation 17.08	24.21 mm Standard Deviation 19.82	17.13 mm Standard Deviation 16.00	16.48 mm Standard Deviation 18.62	43.75 mm Standard Deviation 24.60

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-12.11 mm Standard Deviation 17.07	-16.92 mm Standard Deviation 17.48	-16.11 mm Standard Deviation 20.72	-17.31 mm Standard Deviation 20.45	-6.96 mm Standard Deviation 15.78
Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT Week 2 (n=27,27,27,25,26)	-12.19 mm Standard Deviation 18.44	-17.63 mm Standard Deviation 25.30	-24.89 mm Standard Deviation 21.03	-23.40 mm Standard Deviation 28.28	-3.69 mm Standard Deviation 12.29
Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-13.67 mm Standard Deviation 20.21	-27.50 mm Standard Deviation 21.80	-29.74 mm Standard Deviation 21.90	-24.50 mm Standard Deviation 26.24	-1.40 mm Standard Deviation 14.92
Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,27,23,24)	-22.85 mm Standard Deviation 25.79	-32.04 mm Standard Deviation 22.17	-36.85 mm Standard Deviation 22.07	-33.09 mm Standard Deviation 27.70	-1.46 mm Standard Deviation 23.75
Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-26.54 mm Standard Deviation 24.18	-38.00 mm Standard Deviation 21.09	-37.46 mm Standard Deviation 19.91	-38.33 mm Standard Deviation 29.46	-6.88 mm Standard Deviation 21.45

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Physician Global Assessment (PGA) of Arthritis Baseline (n=28,27,27,26,28)	66.00 mm Standard Deviation 16.32	61.44 mm Standard Deviation 19.18	59.37 mm Standard Deviation 17.67	59.04 mm Standard Deviation 18.00	59.39 mm Standard Deviation 19.88
Physician Global Assessment (PGA) of Arthritis Week 1 (n=28,26,27,26,28)	49.96 mm Standard Deviation 17.44	47.96 mm Standard Deviation 19.95	45.26 mm Standard Deviation 21.43	36.12 mm Standard Deviation 19.45	50.64 mm Standard Deviation 22.39
Physician Global Assessment (PGA) of Arthritis Week 2 (n=27,27,27,25,26)	44.04 mm Standard Deviation 18.74	42.52 mm Standard Deviation 23.78	34.59 mm Standard Deviation 22.64	28.84 mm Standard Deviation 18.90	44.62 mm Standard Deviation 22.26
Physician Global Assessment (PGA) of Arthritis Week 4 (n=27,26,27,24,25)	41.30 mm Standard Deviation 20.94	33.04 mm Standard Deviation 18.66	24.67 mm Standard Deviation 17.67	23.92 mm Standard Deviation 16.60	47.96 mm Standard Deviation 23.20
Physician Global Assessment (PGA) of Arthritis Week 8 (n=26,25,26,23,24)	29.65 mm Standard Deviation 15.94	26.08 mm Standard Deviation 18.70	17.46 mm Standard Deviation 14.83	16.57 mm Standard Deviation 13.62	40.21 mm Standard Deviation 21.40
Physician Global Assessment (PGA) of Arthritis Week 12 (n=26,24,24,21,24)	26.31 mm Standard Deviation 20.39	23.38 mm Standard Deviation 17.00	13.71 mm Standard Deviation 10.58	14.86 mm Standard Deviation 12.28	40.92 mm Standard Deviation 21.69

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 = very good and 100 = very bad.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-16.04 mm Standard Deviation 15.29	-14.12 mm Standard Deviation 13.11	-14.11 mm Standard Deviation 12.67	-22.92 mm Standard Deviation 21.00	-8.75 mm Standard Deviation 15.39
Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT Week 2 (n=27,27,27,25,26)	-22.33 mm Standard Deviation 18.70	-18.93 mm Standard Deviation 18.12	-24.78 mm Standard Deviation 16.65	-30.16 mm Standard Deviation 20.74	-13.69 mm Standard Deviation 18.05
Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-25.07 mm Standard Deviation 25.23	-28.23 mm Standard Deviation 17.91	-34.70 mm Standard Deviation 18.49	-34.83 mm Standard Deviation 19.77	-9.36 mm Standard Deviation 20.67
Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,26,23,24)	-35.88 mm Standard Deviation 23.06	-35.72 mm Standard Deviation 15.68	-41.46 mm Standard Deviation 17.19	-42.17 mm Standard Deviation 19.26	-16.63 mm Standard Deviation 23.24
Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-39.23 mm Standard Deviation 27.72	-36.92 mm Standard Deviation 17.53	-44.71 mm Standard Deviation 15.94	-45.05 mm Standard Deviation 20.37	-15.92 mm Standard Deviation 24.95

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 2 (n=27,27,27,25,26)	1.04 units on a scale Standard Deviation 0.72	1.12 units on a scale Standard Deviation 0.66	0.88 units on a scale Standard Deviation 0.56	0.79 units on a scale Standard Deviation 0.50	1.18 units on a scale Standard Deviation 0.76
Health Assessment Questionnaire-Disability Index (HAQ-DI) Baseline (n=28,27,27,26,28)	1.14 units on a scale Standard Deviation 0.74	1.29 units on a scale Standard Deviation 0.64	1.17 units on a scale Standard Deviation 0.60	1.16 units on a scale Standard Deviation 0.58	1.25 units on a scale Standard Deviation 0.70
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 1 (n=28,26,27,26,28)	1.05 units on a scale Standard Deviation 0.75	1.23 units on a scale Standard Deviation 0.66	1.05 units on a scale Standard Deviation 0.54	0.85 units on a scale Standard Deviation 0.54	1.25 units on a scale Standard Deviation 0.74
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 4 (n=27,26,27,24,25)	0.94 units on a scale Standard Deviation 0.74	1.04 units on a scale Standard Deviation 0.75	0.79 units on a scale Standard Deviation 0.55	0.77 units on a scale Standard Deviation 0.58	1.07 units on a scale Standard Deviation 0.70
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 8 (n=26,25,27,23,24)	0.80 units on a scale Standard Deviation 0.69	0.96 units on a scale Standard Deviation 0.78	0.72 units on a scale Standard Deviation 0.54	0.64 units on a scale Standard Deviation 0.53	1.21 units on a scale Standard Deviation 0.80
Health Assessment Questionnaire-Disability Index (HAQ-DI) Week 12 (n=26,24,24,21,24)	0.78 units on a scale Standard Deviation 0.70	0.81 units on a scale Standard Deviation 0.73	0.56 units on a scale Standard Deviation 0.41	0.59 units on a scale Standard Deviation 0.54	1.13 units on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-0.08 units on a scale Standard Deviation 0.29	-0.11 units on a scale Standard Deviation 0.37	-0.12 units on a scale Standard Deviation 0.18	-0.31 units on a scale Standard Deviation 0.39	-0.00 units on a scale Standard Deviation 0.19
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT Week 2 (n=27,27,27,25,26)	-0.13 units on a scale Standard Deviation 0.35	-0.17 units on a scale Standard Deviation 0.39	-0.29 units on a scale Standard Deviation 0.32	-0.39 units on a scale Standard Deviation 0.38	-0.02 units on a scale Standard Deviation 0.26
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-0.22 units on a scale Standard Deviation 0.48	-0.25 units on a scale Standard Deviation 0.47	-0.38 units on a scale Standard Deviation 0.30	-0.43 units on a scale Standard Deviation 0.42	-0.10 units on a scale Standard Deviation 0.26
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,27,23,24)	-0.36 units on a scale Standard Deviation 0.58	-0.32 units on a scale Standard Deviation 0.49	-0.45 units on a scale Standard Deviation 0.31	-0.52 units on a scale Standard Deviation 0.44	0.03 units on a scale Standard Deviation 0.40
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-0.38 units on a scale Standard Deviation 0.55	-0.41 units on a scale Standard Deviation 0.46	-0.49 units on a scale Standard Deviation 0.35	-0.57 units on a scale Standard Deviation 0.46	-0.05 units on a scale Standard Deviation 0.43

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
C-Reactive Protein (CRP) Baseline (n=28,27,27,26,28)	26.71 mg/L Standard Deviation 31.02	27.63 mg/L Standard Deviation 26.00	16.59 mg/L Standard Deviation 16.15	20.03 mg/L Standard Deviation 21.22	22.25 mg/L Standard Deviation 25.05
C-Reactive Protein (CRP) Week 1 (n=28,26,27,26,28)	15.45 mg/L Standard Deviation 21.23	13.22 mg/L Standard Deviation 16.89	4.52 mg/L Standard Deviation 6.49	3.29 mg/L Standard Deviation 4.91	20.63 mg/L Standard Deviation 22.24
C-Reactive Protein (CRP) Week 2 (n=27,27,27,25,26)	15.79 mg/L Standard Deviation 20.73	10.34 mg/L Standard Deviation 14.03	3.16 mg/L Standard Deviation 5.37	2.15 mg/L Standard Deviation 3.43	18.12 mg/L Standard Deviation 21.97
C-Reactive Protein (CRP) Week 4 (n=27,26,27,24,25)	14.33 mg/L Standard Deviation 21.04	9.59 mg/L Standard Deviation 14.22	2.35 mg/L Standard Deviation 3.36	2.40 mg/L Standard Deviation 5.13	17.24 mg/L Standard Deviation 18.87
C-Reactive Protein (CRP) Week 8 (n=26,25,27,23,24)	13.82 mg/L Standard Deviation 22.16	4.19 mg/L Standard Deviation 5.31	4.18 mg/L Standard Deviation 12.36	10.72 mg/L Standard Deviation 23.02	15.29 mg/L Standard Deviation 16.50
C-Reactive Protein (CRP) Week 12 (n=26,24,24,21,24)	12.04 mg/L Standard Deviation 21.23	8.78 mg/L Standard Deviation 17.44	2.98 mg/L Standard Deviation 8.72	7.00 mg/L Standard Deviation 16.05	17.37 mg/L Standard Deviation 25.30

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT Week 1 (n=28,26,27,26,28)	-11.26 mg/L Standard Deviation 14.29	-15.37 mg/L Standard Deviation 20.41	-12.07 mg/L Standard Deviation 11.50	-16.75 mg/L Standard Deviation 19.28	-1.62 mg/L Standard Deviation 11.47
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT Week 2 (n=27,27,27,25,26)	-11.83 mg/L Standard Deviation 16.03	-17.29 mg/L Standard Deviation 20.63	-13.43 mg/L Standard Deviation 12.71	-18.54 mg/L Standard Deviation 21.03	-2.38 mg/L Standard Deviation 16.85
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT Week 4 (n=27,26,27,24,25)	-13.29 mg/L Standard Deviation 20.00	-18.35 mg/L Standard Deviation 22.09	-14.24 mg/L Standard Deviation 13.90	-17.31 mg/L Standard Deviation 21.16	-3.26 mg/L Standard Deviation 16.48
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT Week 8 (n=26,25,27,23,24)	-14.66 mg/L Standard Deviation 22.72	-22.90 mg/L Standard Deviation 24.20	-12.41 mg/L Standard Deviation 16.40	-9.19 mg/L Standard Deviation 23.29	-5.83 mg/L Standard Deviation 16.73
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT Week 12 (n=26,24,24,21,24)	-16.43 mg/L Standard Deviation 27.15	-17.89 mg/L Standard Deviation 28.20	-10.49 mg/L Standard Deviation 14.72	-14.10 mg/L Standard Deviation 22.34	-3.75 mg/L Standard Deviation 19.97

SECONDARY outcome

Timeframe: Week 1, 2, 4, 8, 12/EOT

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

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.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Numeric Index of American College of Rheumatology Response (ACR-n) Week 1	4.80 units on a scale Standard Deviation 32.73	6.06 units on a scale Standard Deviation 20.00	10.60 units on a scale Standard Deviation 19.13	10.73 units on a scale Standard Deviation 42.87	-11.08 units on a scale Standard Deviation 21.61
Numeric Index of American College of Rheumatology Response (ACR-n) Week 2	8.74 units on a scale Standard Deviation 28.66	17.43 units on a scale Standard Deviation 25.30	30.61 units on a scale Standard Deviation 26.21	25.15 units on a scale Standard Deviation 28.64	-8.84 units on a scale Standard Deviation 26.69
Numeric Index of American College of Rheumatology Response (ACR-n) Week 4	14.67 units on a scale Standard Deviation 38.45	23.83 units on a scale Standard Deviation 32.99	40.88 units on a scale Standard Deviation 26.07	37.08 units on a scale Standard Deviation 25.42	-23.54 units on a scale Standard Deviation 51.98
Numeric Index of American College of Rheumatology Response (ACR-n) Week 8	30.40 units on a scale Standard Deviation 33.10	31.64 units on a scale Standard Deviation 33.87	56.76 units on a scale Standard Deviation 24.53	45.62 units on a scale Standard Deviation 29.46	-18.74 units on a scale Standard Deviation 62.37
Numeric Index of American College of Rheumatology Response (ACR-n) Week 12	30.26 units on a scale Standard Deviation 35.83	34.64 units on a scale Standard Deviation 48.37	60.16 units on a scale Standard Deviation 24.26	52.08 units on a scale Standard Deviation 32.22	-11.19 units on a scale Standard Deviation 38.76

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: FAS included all randomized participants who received at least 1 dose of study medication. Missing values were imputed using LOCF method.

ACR-n = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of 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. The AUC for ACR-n is measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute AUC.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	1708.31 units on a scale*weeks Standard Deviation 2458.38	2096.79 units on a scale*weeks Standard Deviation 2355.96	3685.71 units on a scale*weeks Standard Deviation 1721.44	3124.40 units on a scale*weeks Standard Deviation 2011.19	-1346.24 units on a scale*weeks Standard Deviation 2995.11

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

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

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Baseline (n=28,27,27,26,28)	5.03 units on a scale Standard Deviation 0.68	5.13 units on a scale Standard Deviation 0.94	5.00 units on a scale Standard Deviation 0.96	4.94 units on a scale Standard Deviation 1.01	4.90 units on a scale Standard Deviation 0.87
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 1 (n=28,26,27,26,28)	4.30 units on a scale Standard Deviation 0.86	4.30 units on a scale Standard Deviation 1.10	4.09 units on a scale Standard Deviation 1.28	3.74 units on a scale Standard Deviation 0.93	4.61 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=27,27,27,25,26)	4.23 units on a scale Standard Deviation 0.95	3.95 units on a scale Standard Deviation 1.18	3.46 units on a scale Standard Deviation 1.25	3.25 units on a scale Standard Deviation 1.01	4.43 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 4 (n=27,26,27,24,25)	3.96 units on a scale Standard Deviation 1.13	3.63 units on a scale Standard Deviation 1.05	3.21 units on a scale Standard Deviation 1.27	2.80 units on a scale Standard Deviation 0.94	4.56 units on a scale Standard Deviation 1.15
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 8 (n=26,25,26,23,24)	3.43 units on a scale Standard Deviation 1.03	3.03 units on a scale Standard Deviation 1.10	2.77 units on a scale Standard Deviation 0.97	2.52 units on a scale Standard Deviation 0.96	4.31 units on a scale Standard Deviation 1.21
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Week 12 (n=26,24,24,21,24)	3.21 units on a scale Standard Deviation 1.05	3.14 units on a scale Standard Deviation 1.27	2.55 units on a scale Standard Deviation 0.90	2.14 units on a scale Standard Deviation 0.61	4.15 units on a scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12/EOT

DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 1 (n=28,26,27,26,28)	5.42 units on a scale Standard Deviation 0.98	5.33 units on a scale Standard Deviation 1.22	5.09 units on a scale Standard Deviation 1.34	4.88 units on a scale Standard Deviation 1.08	5.46 units on a scale Standard Deviation 1.11
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Baseline (n=28,27,27,26,28)	6.11 units on a scale Standard Deviation 0.79	6.06 units on a scale Standard Deviation 1.04	6.02 units on a scale Standard Deviation 1.03	5.86 units on a scale Standard Deviation 0.95	5.86 units on a scale Standard Deviation 0.96
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 2 (n=27,27,27,25,26)	5.29 units on a scale Standard Deviation 1.07	5.03 units on a scale Standard Deviation 1.36	4.48 units on a scale Standard Deviation 1.37	4.28 units on a scale Standard Deviation 1.04	5.34 units on a scale Standard Deviation 1.24
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 4 (n=27,26,27,24,25)	5.00 units on a scale Standard Deviation 1.04	4.54 units on a scale Standard Deviation 1.29	4.03 units on a scale Standard Deviation 1.43	3.72 units on a scale Standard Deviation 1.13	5.49 units on a scale Standard Deviation 1.29
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 8 (n=26,25,26,23,24)	4.37 units on a scale Standard Deviation 1.05	4.00 units on a scale Standard Deviation 1.34	3.49 units on a scale Standard Deviation 1.21	3.13 units on a scale Standard Deviation 1.12	5.22 units on a scale Standard Deviation 1.42
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Week 12 (n=26,24,24,21,24)	4.07 units on a scale Standard Deviation 0.99	3.90 units on a scale Standard Deviation 1.36	3.13 units on a scale Standard Deviation 0.99	2.83 units on a scale Standard Deviation 0.99	5.07 units on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: Baseline, Week 12/EOT

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
36-Item Short-Form Health Survey (SF-36) Baseline:Role-Emotional (n=28,27,27,26,28)	40.61 units on a scale Standard Deviation 13.00	41.05 units on a scale Standard Deviation 13.47	45.37 units on a scale Standard Deviation 10.33	45.11 units on a scale Standard Deviation 14.93	44.91 units on a scale Standard Deviation 13.13
36-Item Short-Form Health Survey (SF-36) Baseline:Mental Health (n=28,27,27,26,28)	43.07 units on a scale Standard Deviation 10.15	44.27 units on a scale Standard Deviation 9.12	43.65 units on a scale Standard Deviation 10.11	46.97 units on a scale Standard Deviation 10.98	45.08 units on a scale Standard Deviation 11.81
36-Item Short-Form Health Survey (SF-36) Baseline:Physical Component (n=28,27,27,26,28)	37.16 units on a scale Standard Deviation 7.71	37.54 units on a scale Standard Deviation 7.92	38.75 units on a scale Standard Deviation 8.59	40.39 units on a scale Standard Deviation 7.02	37.35 units on a scale Standard Deviation 8.56
36-Item Short-Form Health Survey (SF-36) Baseline:Mental Component (n=28,27,27,26,28)	46.06 units on a scale Standard Deviation 12.16	45.81 units on a scale Standard Deviation 11.86	47.38 units on a scale Standard Deviation 9.60	48.48 units on a scale Standard Deviation 11.72	48.36 units on a scale Standard Deviation 12.08
36-Item Short-Form Health Survey (SF-36) Week 12:Physical functioning (n=26,24,24,21,24)	42.71 units on a scale Standard Deviation 10.07	43.27 units on a scale Standard Deviation 9.69	46.42 units on a scale Standard Deviation 9.00	47.51 units on a scale Standard Deviation 9.86	40.72 units on a scale Standard Deviation 9.40
36-Item Short-Form Health Survey (SF-36) Week 12:Role Physical (n=26,24,24,21,24)	44.61 units on a scale Standard Deviation 10.39	46.96 units on a scale Standard Deviation 10.60	50.73 units on a scale Standard Deviation 7.19	50.32 units on a scale Standard Deviation 9.37	44.81 units on a scale Standard Deviation 10.21
36-Item Short-Form Health Survey (SF-36) Week 12:Bodily Pain (n=26,24,24,21,24)	42.81 units on a scale Standard Deviation 7.05	44.58 units on a scale Standard Deviation 8.93	48.70 units on a scale Standard Deviation 7.20	49.94 units on a scale Standard Deviation 8.45	39.77 units on a scale Standard Deviation 7.98
36-Item Short-Form Health Survey (SF-36) Week 12:General Health (n=26,24,24,21,24)	42.08 units on a scale Standard Deviation 7.07	43.14 units on a scale Standard Deviation 8.63	45.03 units on a scale Standard Deviation 7.76	45.19 units on a scale Standard Deviation 8.06	37.78 units on a scale Standard Deviation 8.03
36-Item Short-Form Health Survey (SF-36) Week 12:Vitality (n=26,24,24,21,24)	50.53 units on a scale Standard Deviation 10.27	49.88 units on a scale Standard Deviation 11.52	53.65 units on a scale Standard Deviation 11.24	52.24 units on a scale Standard Deviation 11.53	48.71 units on a scale Standard Deviation 11.20
36-Item Short-Form Health Survey (SF-36) Week 12:Social Functioning (n=26,24,24,21,24)	48.46 units on a scale Standard Deviation 10.37	46.62 units on a scale Standard Deviation 12.49	51.85 units on a scale Standard Deviation 7.36	52.43 units on a scale Standard Deviation 8.20	47.99 units on a scale Standard Deviation 12.12
36-Item Short-Form Health Survey (SF-36) Week 12:Role-Emotional (n=26,24,24,21,24)	47.51 units on a scale Standard Deviation 8.64	46.16 units on a scale Standard Deviation 12.08	47.78 units on a scale Standard Deviation 10.12	48.47 units on a scale Standard Deviation 9.83	44.70 units on a scale Standard Deviation 12.15
36-Item Short-Form Health Survey (SF-36) Week 12:Mental Health (n=26,24,24,21,24)	50.22 units on a scale Standard Deviation 7.96	47.90 units on a scale Standard Deviation 11.87	51.53 units on a scale Standard Deviation 7.33	49.07 units on a scale Standard Deviation 12.51	46.25 units on a scale Standard Deviation 13.81
36-Item Short-Form Health Survey (SF-36) Week 12:Physical Component (n=26,24,24,21,24)	41.21 units on a scale Standard Deviation 9.42	43.87 units on a scale Standard Deviation 7.75	47.27 units on a scale Standard Deviation 6.61	48.39 units on a scale Standard Deviation 7.18	39.77 units on a scale Standard Deviation 6.59
36-Item Short-Form Health Survey (SF-36) Week 12:Mental Component (n=26,24,24,21,24)	51.90 units on a scale Standard Deviation 8.68	48.93 units on a scale Standard Deviation 13.44	52.07 units on a scale Standard Deviation 8.99	50.68 units on a scale Standard Deviation 10.10	49.00 units on a scale Standard Deviation 13.09
36-Item Short-Form Health Survey (SF-36) Baseline:Physical functioning (n=28,27,27,26,28)	37.87 units on a scale Standard Deviation 9.10	37.94 units on a scale Standard Deviation 9.37	38.87 units on a scale Standard Deviation 10.41	40.93 units on a scale Standard Deviation 9.47	38.69 units on a scale Standard Deviation 9.80
36-Item Short-Form Health Survey (SF-36) Baseline:Role Physical (n=28,27,27,26,28)	39.27 units on a scale Standard Deviation 11.83	41.43 units on a scale Standard Deviation 13.22	44.25 units on a scale Standard Deviation 10.25	45.64 units on a scale Standard Deviation 13.33	42.77 units on a scale Standard Deviation 11.69
36-Item Short-Form Health Survey (SF-36) Baseline:Bodily Pain (n=28,27,27,26,28)	37.27 units on a scale Standard Deviation 7.89	36.89 units on a scale Standard Deviation 7.53	38.59 units on a scale Standard Deviation 8.44	40.58 units on a scale Standard Deviation 7.00	36.81 units on a scale Standard Deviation 9.61
36-Item Short-Form Health Survey (SF-36) Baseline:General Health (n=28,27,27,26,28)	37.54 units on a scale Standard Deviation 6.14	37.56 units on a scale Standard Deviation 7.53	37.57 units on a scale Standard Deviation 10.16	38.87 units on a scale Standard Deviation 8.25	37.42 units on a scale Standard Deviation 7.00
36-Item Short-Form Health Survey (SF-36) Baseline:Vitality (n=28,27,27,26,28)	45.07 units on a scale Standard Deviation 11.58	46.31 units on a scale Standard Deviation 10.49	46.19 units on a scale Standard Deviation 11.13	46.69 units on a scale Standard Deviation 9.86	46.96 units on a scale Standard Deviation 9.58
36-Item Short-Form Health Survey (SF-36) Baseline:Social Functioning (n=28,27,27,26,28)	46.72 units on a scale Standard Deviation 13.5	42.71 units on a scale Standard Deviation 13.21	45.54 units on a scale Standard Deviation 10.47	46.78 units on a scale Standard Deviation 11.82	45.16 units on a scale Standard Deviation 12.74

SECONDARY outcome

Timeframe: Baseline, Week 12/EOT

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, selfcare, 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score Baseline (n=28,27,27,26,28)	0.55 units on a scale Standard Deviation 0.26	0.45 units on a scale Standard Deviation 0.29	0.58 units on a scale Standard Deviation 0.24	0.55 units on a scale Standard Deviation 0.32	0.51 units on a scale Standard Deviation 0.33
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score Week 12 (n=26,24,24,21,24)	0.65 units on a scale Standard Deviation 0.23	0.70 units on a scale Standard Deviation 0.27	0.79 units on a scale Standard Deviation 0.13	0.78 units on a scale Standard Deviation 0.28	0.59 units on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: Baseline, Week 2, 12/EOT

Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales:sleep disturbance(SD),snoring(Sno),awakened short of breath(ASOB),sleep adequacy(Ade),somnolence(Som)(range:0-100);sleep quantity(Qua)(range:0-24),optimal(Opt) sleep(yes:1,no:0),9 item index measures of sleep disturbance provide composite scores:sleep problem summary(SPS),overall SP(OSP).Except Ade,Opt,Qua,higher scores=more impairment.Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range\*100);total score range:0-100;higher score=more intensity of attribute.

Outcome measures

Outcome measures
Measure	CP-690,550 1 mg n=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: SPS (n=28,27,27,26,28)	27.38 units on a scale Standard Deviation 11.42	27.41 units on a scale Standard Deviation 14.36	29.38 units on a scale Standard Deviation 17.54	30.51 units on a scale Standard Deviation 18.78	23.93 units on a scale Standard Deviation 12.57
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: OSP (n=28,27,27,26,28)	28.00 units on a scale Standard Deviation 10.53	27.55 units on a scale Standard Deviation 12.40	31.07 units on a scale Standard Deviation 17.38	31.28 units on a scale Standard Deviation 18.60	25.95 units on a scale Standard Deviation 12.89
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Ade (n=28,27,27,26,28)	52.86 units on a scale Standard Deviation 24.47	52.96 units on a scale Standard Deviation 24.93	49.63 units on a scale Standard Deviation 27.80	51.54 units on a scale Standard Deviation 26.64	58.57 units on a scale Standard Deviation 27.98
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: ASOB (n=28,27,27,26,28)	3.57 units on a scale Standard Deviation 9.51	4.44 units on a scale Standard Deviation 10.13	8.15 units on a scale Standard Deviation 22.37	10.00 units on a scale Standard Deviation 14.14	3.57 units on a scale Standard Deviation 7.80
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: SD (n=28,27,27,26,28)	24.06 units on a scale Standard Deviation 17.70	23.84 units on a scale Standard Deviation 21.10	25.28 units on a scale Standard Deviation 20.95	25.77 units on a scale Standard Deviation 21.45	21.43 units on a scale Standard Deviation 16.66
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Opt (n=28,27,27,26,28)	0.61 units on a scale Standard Deviation 0.50	0.30 units on a scale Standard Deviation 0.47	0.41 units on a scale Standard Deviation 0.50	0.42 units on a scale Standard Deviation 0.50	0.39 units on a scale Standard Deviation 0.50
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Qua (n=28,27,27,26,28)	6.61 units on a scale Standard Deviation 1.10	6.37 units on a scale Standard Deviation 1.45	6.30 units on a scale Standard Deviation 0.87	6.38 units on a scale Standard Deviation 1.27	6.43 units on a scale Standard Deviation 1.29
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Sno (n=28,27,27,26,28)	25.00 units on a scale Standard Deviation 27.01	32.59 units on a scale Standard Deviation 34.26	31.85 units on a scale Standard Deviation 31.99	23.08 units on a scale Standard Deviation 29.77	31.43 units on a scale Standard Deviation 29.53
Medical Outcome Study- Sleep Scale (MOS-SS) Baseline: Som (n=28,27,27,26,28)	29.05 units on a scale Standard Deviation 19.13	28.64 units on a scale Standard Deviation 17.81	34.57 units on a scale Standard Deviation 25.22	32.05 units on a scale Standard Deviation 22.86	31.90 units on a scale Standard Deviation 19.49
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: SPS (n=27,27,27,25,26)	27.04 units on a scale Standard Deviation 11.52	25.19 units on a scale Standard Deviation 12.55	22.10 units on a scale Standard Deviation 16.28	27.87 units on a scale Standard Deviation 19.41	26.67 units on a scale Standard Deviation 16.49
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: OSP (n=28,27,27,26,28)	27.61 units on a scale Standard Deviation 10.05	25.62 units on a scale Standard Deviation 12.35	22.78 units on a scale Standard Deviation 15.29	27.47 units on a scale Standard Deviation 18.67	27.74 units on a scale Standard Deviation 15.79
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Ade (n=28,27,27,26,28)	53.33 units on a scale Standard Deviation 23.86	54.81 units on a scale Standard Deviation 22.42	64.07 units on a scale Standard Deviation 27.49	51.20 units on a scale Standard Deviation 29.48	55.38 units on a scale Standard Deviation 25.33
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: ASOB (n=28,27,27,26,28)	5.93 units on a scale Standard Deviation 16.47	4.44 units on a scale Standard Deviation 8.47	8.15 units on a scale Standard Deviation 20.95	7.20 units on a scale Standard Deviation 12.75	4.62 units on a scale Standard Deviation 11.74
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: SD (n=28,27,27,26,28)	22.31 units on a scale Standard Deviation 14.11	19.68 units on a scale Standard Deviation 19.19	17.92 units on a scale Standard Deviation 14.88	21.40 units on a scale Standard Deviation 21.39	21.44 units on a scale Standard Deviation 18.22
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Opt (n=28,27,27,26,28)	0.63 units on a scale Standard Deviation 0.49	0.44 units on a scale Standard Deviation 0.51	0.56 units on a scale Standard Deviation 0.51	0.52 units on a scale Standard Deviation 0.51	0.38 units on a scale Standard Deviation 0.50
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Qua (n=28,27,27,26,28)	6.70 units on a scale Standard Deviation 0.82	6.52 units on a scale Standard Deviation 1.16	6.70 units on a scale Standard Deviation 1.14	6.84 units on a scale Standard Deviation 1.25	6.50 units on a scale Standard Deviation 1.24
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Sno (n=28,27,27,26,28)	25.19 units on a scale Standard Deviation 26.94	25.19 units on a scale Standard Deviation 22.60	23.70 units on a scale Standard Deviation 29.89	17.60 units on a scale Standard Deviation 24.71	30.00 units on a scale Standard Deviation 34.06
Medical Outcome Study- Sleep Scale (MOS-SS) Week 2: Som (n=28,27,27,26,28)	30.37 units on a scale Standard Deviation 18.05	29.14 units on a scale Standard Deviation 19.93	27.90 units on a scale Standard Deviation 23.46	26.13 units on a scale Standard Deviation 23.88	35.64 units on a scale Standard Deviation 20.65
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: SPS (n=26,24,24,21,24)	24.49 units on a scale Standard Deviation 10.83	24.17 units on a scale Standard Deviation 14.22	23.89 units on a scale Standard Deviation 11.78	25.56 units on a scale Standard Deviation 14.47	28.75 units on a scale Standard Deviation 14.24
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: OSP (n=26,24,24,21,24)	25.19 units on a scale Standard Deviation 10.33	24.19 units on a scale Standard Deviation 13.39	23.08 units on a scale Standard Deviation 10.74	24.52 units on a scale Standard Deviation 14.29	29.56 units on a scale Standard Deviation 13.10
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Ade (n=26,24,24,21,24)	60.00 units on a scale Standard Deviation 22.63	58.75 units on a scale Standard Deviation 26.75	51.67 units on a scale Standard Deviation 24.08	53.33 units on a scale Standard Deviation 23.94	54.17 units on a scale Standard Deviation 19.54
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: ASOB (n=26,24,24,21,24)	6.92 units on a scale Standard Deviation 13.79	9.17 units on a scale Standard Deviation 14.42	5.00 units on a scale Standard Deviation 10.63	3.81 units on a scale Standard Deviation 8.05	10.00 units on a scale Standard Deviation 20.43
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: SD (n=26,24,24,21,24)	20.34 units on a scale Standard Deviation 13.42	19.22 units on a scale Standard Deviation 18.43	14.43 units on a scale Standard Deviation 10.52	18.99 units on a scale Standard Deviation 19.05	21.09 units on a scale Standard Deviation 16.56
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Opt (n=26,24,24,21,24)	0.54 units on a scale Standard Deviation 0.51	0.38 units on a scale Standard Deviation 0.49	0.38 units on a scale Standard Deviation 0.49	0.48 units on a scale Standard Deviation 0.51	0.46 units on a scale Standard Deviation 0.51
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Qua (n=26,24,24,21,24)	6.35 units on a scale Standard Deviation 1.20	6.54 units on a scale Standard Deviation 1.28	6.38 units on a scale Standard Deviation 0.97	6.71 units on a scale Standard Deviation 1.38	6.54 units on a scale Standard Deviation 1.53
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Sno (n=26,24,24,21,24)	24.62 units on a scale Standard Deviation 22.13	21.67 units on a scale Standard Deviation 22.78	29.17 units on a scale Standard Deviation 32.83	13.33 units on a scale Standard Deviation 20.33	33.33 units on a scale Standard Deviation 31.02
Medical Outcome Study- Sleep Scale (MOS-SS) Week 12: Som (n=26,24,24,21,24)	30.26 units on a scale Standard Deviation 18.59	25.28 units on a scale Standard Deviation 20.99	25.28 units on a scale Standard Deviation 16.33	24.13 units on a scale Standard Deviation 23.24	40.28 units on a scale Standard Deviation 19.51

SECONDARY outcome

Timeframe: Baseline, Week 2, 12/EOT

FACIT-F 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=28 Participants CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 Participants CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 Participants CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 Participants CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 Participants Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline (n=28,27,27,26,28)	34.25 units on a scale Standard Deviation 10.45	33.37 units on a scale Standard Deviation 11.03	34.48 units on a scale Standard Deviation 9.99	36.85 units on a scale Standard Deviation 9.43	37.07 units on a scale Standard Deviation 9.87
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 2 (n=27,27,27,25,26)	36.78 units on a scale Standard Deviation 8.64	36.48 units on a scale Standard Deviation 9.72	39.30 units on a scale Standard Deviation 10.56	40.80 units on a scale Standard Deviation 6.87	37.38 units on a scale Standard Deviation 10.31
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Week 12 (n=26,24,24,21,24)	39.35 units on a scale Standard Deviation 7.47	37.96 units on a scale Standard Deviation 9.95	42.79 units on a scale Standard Deviation 8.47	40.76 units on a scale Standard Deviation 10.65	36.46 units on a scale Standard Deviation 9.93

Adverse Events

CP-690,550 1 mg

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

CP-690,550 3 mg

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

CP-690,550 5 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

CP-690,550 10 mg

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CP-690,550 1 mg n=28 participants at risk CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 participants at risk CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 participants at risk CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 participants at risk CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 participants at risk Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Cardiac disorders Cardiac failure	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Foot deformity	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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=28 participants at risk CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.	CP-690,550 3 mg n=27 participants at risk CP-690,550 3 mg tablet orally twice daily for 12 weeks.	CP-690,550 5 mg n=27 participants at risk CP-690,550 5 mg tablet orally twice daily for 12 weeks.	CP-690,550 10 mg n=26 participants at risk CP-690,550 10 mg tablet orally twice daily for 12 weeks.	Placebo n=28 participants at risk Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
Musculoskeletal and connective tissue disorders Monarthritis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Cataract	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Conjunctivitis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dry eye	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Eyelid pain	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Vision blurred	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 mucosal lesion	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Gastrooesophageal reflux disease	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haematochezia	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Paraesthesia oral	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Malaise	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Acute tonsillitis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dermatitis infected	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Enterocolitis viral	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Erysipelas	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.4% 2/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis viral	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Localised infection	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	10.7% 3/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 4/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 4/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Paronychia	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Peritonsillitis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Viral upper respiratory tract infection	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 candidiasis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Vulvovaginitis trichomonal	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Fall	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Foot fracture	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Thermal burn	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.4% 2/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	22.2% 6/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Apolipoprotein A-I increased	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.4% 2/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.8% 4/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 alkaline phosphatase increased	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 cholesterol increased	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 3/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatine phosphokinase MM increased	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Epstein-Barr virus test positive	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.4% 2/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Lymphocyte count decreased	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Lymphocyte percentage decreased	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Viral DNA test positive	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.4% 2/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Joint swelling	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 fatigue	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 tightness	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Synovial cyst	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Cervical myelopathy	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	7.1% 2/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.4% 2/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sciatica	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Calculus ureteric	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Cystitis-like symptom	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Enuresis	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Urinary incontinence	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Breast pain	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Dysmenorrhoea	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Pleural effusion	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Upper respiratory tract inflammation	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 contact	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 2/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Haemorrhage subcutaneous	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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 Purpura	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 2/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 1/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.7% 1/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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	7.1% 2/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/27 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.8% 1/26 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/28 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious 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